ZENPEP (pancrelipase (amylase) · EURAND PHARMA LTD
ZENPEP is indicated for the treatment of exocrine pancreatic insufficiency in both adult and pediatric patients. This medication serves as a therapeutic replacement for digestive enzymes that are normally secreted by the pancreas. By providing these essential enzymes, the drug supports the digestive process in patients whose bodies cannot produce them in sufficient quantities.
How ZENPEP Works
ZENPEP contains a mixture of lipases, proteases, and amylases that mimic the physiological activity of natural pancreatic enzymes. These enzymes catalyze the hydrolysis of fats into fatty acids, proteins into peptides and amino acids, and starches into dextrins and short-chain sugars. This process occurs within the duodenum and proximal small intestine to facilitate the breakdown of nutrients for digestion.
Details
- Status
- Prescription
- First Approved
- 2009-08-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
Companies
ZENPEP Approval History
What ZENPEP Treats
1 indicationsZENPEP is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Exocrine Pancreatic Insufficiency
ZENPEP Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01159119 EUR-1066 | PR-012 | Ph 1 | terminated | A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain |
Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZENPEP FDA Label Details
Indications & Usage
FDA Label (PDF)ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ZENPEP ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.