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Pancreatic enzyme capsules
Pancreatic enzyme capsules replace deficient pancreatic enzymes (amylase, lipase, protease) to restore normal digestion in patients with pancreatic insufficiency.
Pancreatic enzyme capsules replace deficient pancreatic enzymes (amylase, lipase, protease) to restore normal digestion in patients with pancreatic insufficiency. Used for Pancreatic exocrine insufficiency, Chronic pancreatitis, Cystic fibrosis-related pancreatic insufficiency.
At a glance
| Generic name | Pancreatic enzyme capsules |
|---|---|
| Sponsor | Asian Institute of Gastroenterology, India |
| Drug class | Pancreatic enzyme replacement therapy |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
The capsules contain a mixture of pancreatic enzymes that break down carbohydrates, fats, and proteins in the small intestine. In pancreatic insufficiency, the pancreas fails to produce adequate enzymes, leading to malabsorption; supplementation restores digestive capacity and nutrient absorption.
Approved indications
- Pancreatic exocrine insufficiency
- Chronic pancreatitis
- Cystic fibrosis-related pancreatic insufficiency
- Post-pancreatectomy malabsorption
Common side effects
- Abdominal pain or cramping
- Diarrhea
- Nausea
- Constipation
- Hyperuricemia (with high-dose use)
Key clinical trials
- Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis (PHASE3)
- Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency (PHASE2)
- The Pancreatic Enzymes After Gastrectomy Trial (PHASE3)
- 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)
- Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma (PHASE2)
- Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer (PHASE3)
- Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency (PHASE4)
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 |
|---|---|
| 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:
- Pancreatic enzyme capsules CI brief — competitive landscape report
- Pancreatic enzyme capsules updates RSS · CI watch RSS
- Asian Institute of Gastroenterology, India portfolio CI