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12176 details
Primary information
ID12176
Therapeutic IDTh1295
Protein NameALTU-135
SequenceNA
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeNA
DescriptionALTU-135, the Company's orally administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 has been granted orphan drug and fast-track designation as well as CMA Pilot 2 program status by the Food and Drug Administration (FDA).
Indication/DiseaseInvestigated for use/treatment in cystic fibrosis and pancreatic disorders.
PharmacodynamicsNA
Mechanism of ActionAs ALTU-135 consists of three enzymes, lipase, protease and amylase that are delivered in a consistent ratio and is designed to improve fat, protein, and carbohydrate absorption in pancreatic insufficient individuals. ALTU-135 is designed to be highly concentrated, stable and pure and to allow patients to take a single capsule per meal or snack, whereas current products are derived from pig pancreases and require a significantly higher pill burden. This reduced pill burden for ALTU-135 is expected to provide greater convenience for the patient and result in improved compliance and therefore effectiveness. ALTU-135 has been granted Orphan Drug designation in the United States and Europe. ALTU-135 was also granted fast track designation by the U.S. Food and Drug Administration (FDA) in November 2003, and was accepted into the FDA’s Continuous Marketing Application Pilot 2 Program in February 2004.
ToxicityNA
MetabolismNA
AbsorptionNA
NA
ClearanceNA
CategoriesEnzymes
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetNA
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