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Th1596 details
Primary information
ID15428
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesAmino Acids, Peptides, and Proteins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameVyepti
CompanyLundbeck Pharmaceuticals Llc
Brand DescriptionLundbeck Pharmaceuticals Llc
Prescribed ForIntravenous
Chemical Name100 mg/1mL
FormulationVYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included angioedema [see WARNINGS AND PRECAUTIONS].
Physical Appearance runny or stuffy nose and hypersensitivity reactions (itching, flushing)
Route of AdministrationVyepti is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if this medicine is safe and effective in children.
Recommended DosageVYEPTI is indicated for the preventive treatment of migraine in adults.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID15429
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesAntibodies
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameVyepti
CompanyLundbeck Inc.
Brand DescriptionLundbeck Inc.
Prescribed ForIntravenous
Chemical Name100 mg / mL
FormulationVYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included angioedema [see WARNINGS AND PRECAUTIONS].
Physical Appearance runny or stuffy nose and hypersensitivity reactions (itching, flushing)
Route of AdministrationVyepti is a prescription medicine used for the preventive treatment of migraine in adults. It is not known if this medicine is safe and effective in children.
Recommended DosageVYEPTI is indicated for the preventive treatment of migraine in adults.
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2Link
RemarksNA


Primary information
ID15430
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesAntibodies, Monoclonal
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15431
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesAntibodies, Monoclonal, Humanized
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15432
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesAntimigraine Preparations
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15433
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesBlood Proteins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15434
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesCalcitonin Gene-Related Peptide (CGRP) Antagonists
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15435
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesCalcitonin Gene-related Peptide Antagonist
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15436
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesGlobulins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15437
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesImmunoglobulins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15438
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesImmunoproteins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15439
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesProteins
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
Brand NameNA
CompanyNA
Brand DescriptionNA
Prescribed ForNA
Chemical NameNA
FormulationNA
Physical Appearance NA
Route of AdministrationNA
Recommended DosageNA
ContraindicationNA
Side EffectsNA
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID15440
Therapeutic IDTh1596
Protein NameEptinezumab
Sequence>Th1596_Eptinezumab EVQLVESGGGLVQPGGSLRLSCAVSGIDLSGYYMNWVRQAPGKGLEWVGVIGINGATYYASWAKGRFTISRDNSKTTVYLQMNSLRAEDTAVYFCARGDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDARVEPKSCDKTHTCPPCPAPELLGGPSVTLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight143000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeThe plasma half-life after an intravenous infusion is approximately 27 days.[L12318]
DescriptionEptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (_Pichia pastoris_) and developed by Lundbeck Seattle Biopharmaceuticals.[L12318] Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]
Indication/DiseaseEptinezumab is indicated for the preventive treatment of migraine in adults.[L12318]
PharmacodynamicsEptinezumab is experimentally administered as an intravenous infusion and/or subcutaneous injection [A33105, A33108]. During Phase 3 clinical trials, it was noted that patients with episodic migraine who on average had 8.6 days of migraine per month demonstrated significant reductions in migraine frequency over weeks 1-12, associated with the 300mg dose arm.[L2825] Additionally, 29.7% of patients achieved a 75% or greater reduction in migraine days from baseline, compared to 16.2% for placebo (p<0.0007).[L2825] Moreover, a post hoc analysis revealed that those patients achieving a 75% or greater response rate had over an eight-fold increase in days between migraines.[L2825]
Mechanism of ActionEptinezumab is a fully-humanized IgG1 antibody manufactured and designed specifically to bind both alpha and beta forms of the human calcitonin gene-related peptide (CGRP).[F94,A33105,A33106,A33108,A33114] Studies since 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after efficacious sumatriptan therapy.[A33090] Moreover, research has also shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For all these reasons, the binding of CGRP to interfere with its activity was specifically designed to be the form and mechanism of action for eptinezumab. The binding of eptinezumab to natural endogenous CGRP subsequently interferes with its activities, such as its binding to CGRP receptors, for example.
ToxicityThe most frequent adverse events associated with eptinezumab use include upper respiratory tract infection, urinary tract infection, fatigue, back pain, arthralgia, and nausea and vomiting [A33108]. No data regarding overdosage has been reported yet.
MetabolismMonoclonal antibody agents like eptinezumab are not expected to generate toxic metabolites as they generally undergo proteolysis to their constituent amino acids.[F94]
AbsorptionEptinezumab is the only potent and selective and anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered by quarterly infusion for migraine prevention delivering 100% bioavailability by way of the intravenous route of administration to immediately inhibit CGRP .[L2825] With an intravenous dose of eptinezumab 1000 mg, the mean maximum concentration of 336.4 ug/mL (SD 79.9) occurred after 4.8 hours after the start of the 1 hour infusion [A33108]. The mean exposure to free eptinezumab, as characterized by area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and from time zero to infinity were 8245 days per ug per mL (SD 2619) and 8722 days per ug per mL (SD 2522), respectively [A33108].
The central volume of distribution for eptinezumab is approximately 3.7 L.[L12318]
ClearanceThe apparent clearance of eptinezumab is 0.006 L/h.[L12318]
CategoriesSerum Globulins
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TargetCalcitonin gene-related peptide 1,Calcitonin gene-related peptide 2
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