|
| Primary information |
|---|
| ID | 16073 |
| Therapeutic ID | Th1672 |
| Protein Name | Regdanvimab |
| Sequence | >Th1672_Regdanvimab
ELVLTQPPSVSAAPGQKVTISCSGSSSNIGNNYVSWYQQLPGTAPKLLIYDNNKRPSGIPDRFSGSKSGTSATLGITGLQTGDEADYYCGTWDSSLSAGVFGGGTELTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | The mean terminal half-life of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 17 days.[L39140] |
| Description | Regdanvimab (CT-P59) is a recombinant human IgG1 monoclonal antibody directed at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.[L39140] It blocks the interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) that allows for viral entry into the cell, thereby inhibiting the virus' ability to replicate. Trials investigating the use of regdanvimab as a therapeutic candidate for the treatment of COVID-19 began in mid-2020.[A235830,A241995] It received its first full approval in South Korea in September 2021,[A241995] followed by the EU in November 2021.[L39130] |
| Indication/Disease | Regdanvimab is indicated in the EU for the treatment of adult patients with COVID-19 who do not require supplemental oxygen and who are at risk of progressing to severe COVID-19.[L39140] |
| Pharmacodynamics | Regdanvimab exerts its antiviral activity by blocking the viral entry of SARS-CoV-2.[L39140] It should be given within seven days of the onset of COVID-19 symptoms, and is administered as a single intravenous infusion. Hypersensitivity reactions, including infusion-related reactions and anaphylaxis, have been reported during and after the intravenous administration of regdanvimab - patients should be observed during administration and for one hour after its completion to monitor for symptoms of infusion-related reactions such as fever, difficulty breathing, arrhythmia, and chills.[L39140] |
| Mechanism of Action | Regdanvimab is a recombinant human IgG1 monoclonal antibody that is targeted at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.[L39140,L39145] The interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) receptors facilitates viral entry into host cells - in blocking this interaction, regdanvimab neutralizes SARS-CoV-2 by preventing cellular entry and subsequent viral replication. The binding interaction between regdanvimab and the spike protein RBD is different as compared to most other neutralizing antibodies, as it appears regdanvimab binds to the RBD protein trimer exclusively in its "up" conformation and in an orientation distinct from most other ACE2-blocking antibodies.[A241990] |
| Toxicity | Single doses of up to 8000mg of ragdanvimab have been administered to patients in clinical trials without evidence of dose-limiting toxicities.[L39140] In the event of a suspected overdose, employ general supportive measures as clinically indicated. |
| Metabolism | As regdanvimab is a recombinant IgG1 antibody, it is likely to be degraded into smaller peptides and amino acids in the same way as endogenous IgG1.[L39140] |
| Absorption | The mean Cmax and AUC0-infof regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 were 1017 µg/mL and 182095 µg·h/ml, respectively.[L39140,L39155] |
| The steady-state apparent volume of distribution following intravenous administration of regdanvimab 40 mg/kg in patients with COVID-19 was 83 mL/kg.[L39140] |
| Clearance | The mean clearance of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 0.20 mL/hr/kg.[L39140] |
| Categories | Antibodies, Monoclonal |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Spike glycoprotein |
| Brand Name | NA |
| Company | NA |
| Brand Description | NA |
| Prescribed For | NA |
| Chemical Name | NA |
| Formulation | NA |
| Physical Appearance | NA |
| Route of Administration | NA |
| Recommended Dosage | NA |
| Contraindication | NA |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |