ZENPEP (pancrelipase (amylase)
ZENPEP is indicated for the treatment of Exocrine Pancreatic Insufficiency.
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
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.