CREON

LOE Approaching

pancrelipase

BLAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16

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…

Clinical Trials (5)

NCT05069597Phase 4Completed

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
NCT04949828N/ACompleted

Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Started Sep 2021
63 enrolled
Chronic Pancreatitis
NCT04315311Phase 4Withdrawn

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
0
Exocrine Pancreatic Insufficiency (EPI)
NCT03859869Phase 4Terminated

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)
NCT03924947Phase 4Completed

A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Started Oct 2019
36 enrolled
Cystic Fibrosis
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.