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Pancrelipase Capsules
Pancrelipase Capsules is a Pancreatic enzyme replacement therapy Small molecule drug developed by Ohio State University. It is currently FDA-approved for Pancreatic exocrine insufficiency due to chronic pancreatitis, Pancreatic exocrine insufficiency due to cystic fibrosis, Pancreatic exocrine insufficiency due to pancreatic surgery or obstruction. Also known as: CREON.
Pancrelipase is a mixture of pancreatic enzymes (lipase, protease, and amylase) that replaces deficient endogenous pancreatic enzymes to restore normal digestion of fats, proteins, and carbohydrates.
Pancrelipase is a mixture of pancreatic enzymes (lipase, protease, and amylase) that replaces deficient endogenous pancreatic enzymes to restore normal digestion of fats, proteins, and carbohydrates. Used for Pancreatic exocrine insufficiency due to chronic pancreatitis, Pancreatic exocrine insufficiency due to cystic fibrosis, Pancreatic exocrine insufficiency due to pancreatic surgery or obstruction.
At a glance
| Generic name | Pancrelipase Capsules |
|---|---|
| Also known as | CREON |
| Sponsor | Ohio State University |
| Drug class | Pancreatic enzyme replacement therapy |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Pancrelipase contains lipase, protease, and amylase derived from porcine pancreatic tissue. These enzymes are essential for breaking down dietary macronutrients in the small intestine. In patients with pancreatic insufficiency, endogenous enzyme production is inadequate, leading to malabsorption; pancrelipase supplementation restores digestive capacity and nutrient absorption.
Approved indications
- Pancreatic exocrine insufficiency due to chronic pancreatitis
- Pancreatic exocrine insufficiency due to cystic fibrosis
- Pancreatic exocrine insufficiency due to pancreatic surgery or obstruction
Common side effects
- Abdominal pain
- Nausea
- Diarrhea
- Constipation
- Hyperuricemia
Key clinical trials
- 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)
- Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO) (NA)
- Endotherapy and/or Extracorporeal Shockwave Lithotripsy for Painless Chronic Pancreatitis (NA)
- Efficacy of PERT for PEI in Unresectable Pancreatic Cancer. (PHASE4)
- Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes (EARLY_PHASE1)
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:
- Pancrelipase Capsules CI brief — competitive landscape report
- Pancrelipase Capsules updates RSS · CI watch RSS
- Ohio State University portfolio CI
Frequently asked questions about Pancrelipase Capsules
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Related
- Drug class: All Pancreatic enzyme replacement therapy drugs
- Manufacturer: Ohio State University — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Pancreatic exocrine insufficiency due to chronic pancreatitis
- Indication: Drugs for Pancreatic exocrine insufficiency due to cystic fibrosis
- Indication: Drugs for Pancreatic exocrine insufficiency due to pancreatic surgery or obstruction
- Also known as: CREON
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing