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PANCRELIPASE
Pancreatic enzyme products catalyze the breakdown of fats, proteins, and starches in the duodenum and proximal small intestine, mimicking natural pancreatic enzymes.
Pancrelipase is a marketed pancreatic enzyme product used to treat exocrine pancreatic insufficiency, currently holding a significant position in this therapeutic area. Its key strength lies in its mechanism, which effectively mimics natural pancreatic enzymes, facilitating the breakdown of fats, proteins, and starches. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic products.
At a glance
| Generic name | PANCRELIPASE |
|---|---|
| Modality | Enzyme |
| Phase | FDA-approved |
| First approval | 1996 |
Mechanism of action
Pancreatic enzyme products contain lipases, proteases, and amylases. These enzymes help break down fats into monoglycerides, glycerol, and free fatty acids; proteins into peptides and amino acids; and starches into dextrins and short chain sugars like maltose and maltriose. This process occurs in the duodenum and proximal small intestine, similar to the action of naturally secreted pancreatic enzymes.
Approved indications
- Exocrine Pancreatic Insufficiency
Common side effects
- vomiting
- dizziness
- cough
- vomiting
- irritability
- decreased appetite
- hyperglycemia
- hypoglycemia
- abdominal pain
- abnormal feces
- flatulence
- frequent bowel movements
Key clinical trials
- Phase 2 Study to Assess the Safety and Efficacy of ANG003 (PHASE2)
- Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) (PHASE1, PHASE2)
- Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency (PHASE2)
- Management of Steatorrhea in Children and Young Adults With Alagille Syndrome After Liver Transplantation (PHASE2)
- A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis (EARLY_PHASE1)
- Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency (PHASE4)
- Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis (NA)
- Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PANCRELIPASE CI brief — competitive landscape report
- PANCRELIPASE updates RSS · CI watch RSS