PERTZYE (pancrelipase (amylase)
PERTZYE is indicated for the treatment of Exocrine Pancreatic Insufficiency.
How PERTZYE Works
The medication contains a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats, proteins, and starches in the duodenum and proximal small intestine. These enzymes break down fats into monoglycerides and fatty acids, proteins into peptides and amino acids, and starches into dextrins and short-chain sugars. By performing these catalytic actions, the drug mimics the physiological activity of endogenous pancreatic enzymes to aid digestion.
Details
- Status
- Prescription
- First Approved
- 2012-05-17
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
Companies
PERTZYE Approval History
What PERTZYE Treats
1 indicationsPERTZYE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Exocrine Pancreatic Insufficiency
PERTZYE 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 |
|---|---|---|---|---|
| NCT05642962 | 21-419 | Ph 1, Ph 2 | active not recruiting | Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) |
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.
PERTZYE FDA Label Details
Indications & Usage
FDA Label (PDF)PERTZYE 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.