{"id":"pancrecarb-pancrelipase","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Hyperuricemia"}]},"_chembl":{"chemblId":"CHEMBL2108074","moleculeType":"Enzyme"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pancrelipase contains a mixture of pancreatic enzymes (lipase, protease, and amylase) derived from porcine pancreatic tissue. In patients with exocrine pancreatic insufficiency, the pancreas cannot produce sufficient enzymes to properly digest food, leading to malabsorption. Pancrelipase supplements these missing enzymes to restore normal digestive function and nutrient absorption.","oneSentence":"Pancrelipase is a pancreatic enzyme replacement therapy that supplies lipase, protease, and amylase to aid digestion of fats, proteins, and carbohydrates in patients with pancreatic insufficiency.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:25:31.906Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Exocrine pancreatic insufficiency due to chronic pancreatitis"},{"name":"Exocrine pancreatic insufficiency due to cystic fibrosis"},{"name":"Exocrine pancreatic insufficiency due to pancreatic surgery or obstruction"}]},"trialDetails":[{"nctId":"NCT06149546","phase":"NA","title":"Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)","status":"RECRUITING","sponsor":"Cancer Trials Ireland","startDate":"2024-05-01","conditions":"Pancreatic Cancer","enrollment":70},{"nctId":"NCT06320379","phase":"NA","title":"Zypan Functional Dyspepsia","status":"RECRUITING","sponsor":"National University of Natural Medicine","startDate":"2023-03-15","conditions":"Dyspepsia","enrollment":64},{"nctId":"NCT05069597","phase":"PHASE4","title":"Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon","status":"COMPLETED","sponsor":"AbbVie","startDate":"2021-10-14","conditions":"Cystic Fibrosis, Chronic Pancreatitis","enrollment":30},{"nctId":"NCT01228643","phase":"PHASE3","title":"Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs","status":"WITHDRAWN","sponsor":"Azidus Brasil","startDate":"2007-06","conditions":"Chronic Renal Failure","enrollment":""},{"nctId":"NCT03450772","phase":"PHASE3","title":"Equivalence Study to Compare Two Strengths of Creon in China","status":"UNKNOWN","sponsor":"Abbott","startDate":"2017-08-31","conditions":"Pancreatic Insufficiency","enrollment":60},{"nctId":"NCT01131507","phase":"PHASE4","title":"PR-018: An Open-Label, Safety Extension of Study PR-011","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2010-07","conditions":"Cystic Fibrosis, Exocrine Pancreatic Insufficiency","enrollment":15},{"nctId":"NCT00981214","phase":"PHASE3","title":"Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2006-05","conditions":"Cystic Fibrosis, Exocrine Pancreatic Insufficiency","enrollment":19},{"nctId":"NCT00880100","phase":"PHASE3","title":"Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2009-04","conditions":"Cystic Fibrosis, Pancreatic Insufficiency","enrollment":49},{"nctId":"NCT00513682","phase":"PHASE3","title":"Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2007-07","conditions":"Cystic Fibrosis, Pancreatic Insufficiency","enrollment":9},{"nctId":"NCT00408317","phase":"PHASE3","title":"Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2006-11","conditions":"Cystic Fibrosis, Exocrine Pancreatic Insufficiency","enrollment":36},{"nctId":"NCT00559364","phase":"PHASE3","title":"Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2007-11","conditions":"Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy","enrollment":50},{"nctId":"NCT01771146","phase":"NA","title":"Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer","status":"UNKNOWN","sponsor":"Baylor Research Institute","startDate":"2012-10","conditions":"Pancreas Cancer, Localized Pancreas Cancer, Non-metastatic Pancreas Cancer","enrollment":30},{"nctId":"NCT02415959","phase":"PHASE2","title":"Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis","status":"COMPLETED","sponsor":"Abbott","startDate":"2015-03","conditions":"Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis","enrollment":70},{"nctId":"NCT02137382","phase":"PHASE3","title":"A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis","status":"COMPLETED","sponsor":"Abbott","startDate":"2014-01","conditions":"Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis","enrollment":41},{"nctId":"NCT02009410","phase":"PHASE4","title":"A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2","status":"WITHDRAWN","sponsor":"Abbott","startDate":"2013-11","conditions":"Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2","enrollment":""},{"nctId":"NCT01327703","phase":"PHASE4","title":"Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2011-04","conditions":"Exocrine Pancreatic Insufficiency, Cystic Fibrosis","enrollment":87},{"nctId":"NCT01100606","phase":"PHASE4","title":"A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2010-06","conditions":"Cystic Fibrosis, Exocrine Pancreatic Insufficiency","enrollment":15},{"nctId":"NCT00744250","phase":"PHASE4","title":"Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control","status":"TERMINATED","sponsor":"Digestive Care, Inc.","startDate":"2008-08","conditions":"Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic Fibrosis","enrollment":3},{"nctId":"NCT00749099","phase":"NA","title":"Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)","status":"TERMINATED","sponsor":"Digestive Care, Inc.","startDate":"2007-04","conditions":"Exocrine Pancreatic Insufficiency","enrollment":11},{"nctId":"NCT00432861","phase":"PHASE3","title":"Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis","status":"COMPLETED","sponsor":"Digestive Care, Inc.","startDate":"2007-01","conditions":"Cystic Fibrosis, Pancreatic Insufficiency","enrollment":29},{"nctId":"NCT00535756","phase":"PHASE4","title":"Creon After Pancreatic Surgery","status":"COMPLETED","sponsor":"Abbott Products","startDate":"2008-04","conditions":"Pancreatic Insufficiency","enrollment":58},{"nctId":"NCT00623025","phase":"PHASE3","title":"Creon in HIV Patients With Steatorrhea","status":"TERMINATED","sponsor":"Abbott","startDate":"2009-01","conditions":"Steatorrhea","enrollment":34},{"nctId":"NCT01012908","phase":"PHASE2, PHASE3","title":"Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency","status":"UNKNOWN","sponsor":"Azidus Brasil","startDate":"2010-03","conditions":"Pancreatic Insufficiency","enrollment":25}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":135,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["MS-16"],"phase":"phase_3","status":"active","brandName":"PANCRECARB® (pancrelipase)","genericName":"PANCRECARB® (pancrelipase)","companyName":"Digestive Care, Inc.","companyId":"digestive-care-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pancrelipase is a pancreatic enzyme replacement therapy that supplies lipase, protease, and amylase to aid digestion of fats, proteins, and carbohydrates in patients with pancreatic insufficiency. Used for Exocrine pancreatic insufficiency due to chronic pancreatitis, Exocrine pancreatic insufficiency due to cystic fibrosis, Exocrine pancreatic insufficiency due to pancreatic surgery or obstruction.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}