CREON (pancrelipase (amylase)
CREON is indicated for the treatment of Exocrine Pancreatic Insufficiency.
How CREON Works
This medication contains a mixture of lipases, proteases, and amylases that function in the duodenum and proximal small intestine. These enzymes catalyze the hydrolysis of fats into monoglycerides and fatty acids, proteins into peptides and amino acids, and starches into dextrins and sugars. By performing these chemical reactions, the drug acts as a substitute for the physiological digestive enzymes typically secreted by the pancreas.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-04-30
- Revenue
- $361M (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
CREON Approval History
What CREON Treats
1 indicationsCREON 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
CREON 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.
Drugs Similar to CREON
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07450547 | ANG003-25-201 2025-524569-25-00 | Ph 2 | recruiting | Phase 2 Study to Assess the Safety and Efficacy of ANG003 |
| NCT05069597 results posted | M21-432 | Ph 4 | completed | Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon |
| NCT02733848 | UMCIRB 11-001311 | Ph 1 | terminated | CREON for the Treatment of Post-RYGB Hypoglycemia |
| NCT04315311 | M16-112 | Ph 4 | withdrawn | Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer |
| NCT01865695 | STH16190 | Ph 4 | terminated | Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase |
| NCT02009410 | M13-954 2013-001347-31 | Ph 4 | withdrawn | A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2 |
| NCT00535756 | S245.4.008 2005-004854-29 | Ph 4 | completed | Creon After Pancreatic Surgery |
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.
CREON FDA Label Details
Indications & Usage
FDA Label (PDF)CREON is indicated for the treatment of Exocrine Pancreatic Insufficiency.
Pro Intelligence Preview
Deep insights for CREON
Revenue Insights
- • Q1-2026: $361M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 8 total trials
- • Stage: Mature
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment