TheraCLEC
TheraCLEC Uses, Dosage, Side Effects, Food Interaction and all others data.
TheraCLEC, 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. TheraCLEC has been granted orphan drug and fast-track designation as well as CMA Pilot 2 program status by the Food and Drug Administration (FDA).
| Trade Name | TheraCLEC |
| Generic | ALTU-135 |
| Type | |
| Groups | Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Investigated for use/treatment in cystic fibrosis and pancreatic disorders.
How TheraCLEC works
As TheraCLEC 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. TheraCLEC 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 TheraCLEC is expected to provide greater convenience for the patient and result in improved compliance and therefore effectiveness. TheraCLEC has been granted Orphan Drug designation in the United States and Europe. TheraCLEC 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.
Innovators Monograph
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