BLAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
5/8 — Partial
Priority Review
CREON (pancrelipase) by AbbVie is lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas. First approved in 2009.
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CREON is an oral delayed-release capsule containing pancrelipase (a mixture of lipases, proteases, and amylases) approved by the FDA in 2009. It replaces missing pancreatic digestive enzymes in patients with pancreatic insufficiency, enabling the breakdown of fats, proteins, and starches in the small intestine. The drug works physiologically by mimicking the digestive enzyme secretion normally performed by a healthy pancreas.
$1.5BPart D
LOE ApproachingCREON commands significant Medicare volume ($1.5B annual Part D spend) with LOE approaching, signaling transition from growth to defense and potentially smaller field team investment.
Mechanism of Action
lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
Started Oct 2021
30 enrolled
Cystic FibrosisChronic Pancreatitis
Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Started Sep 2021
63 enrolled
Chronic Pancreatitis
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
Started Dec 2020
36 enrolled
Pancreatic Adenocarcinoma
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
Started May 2020
0Exocrine Pancreatic Insufficiency (EPI)
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Started Feb 2020
1 enrolled
Exocrine Pancreatic Insufficiency (EPI)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.