Exocrine Pancreatic Insufficiency
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CLINICAL_TRIALS trial_result · 2022-09-13Clinical Trial Update: OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis [Phase 2]
Phase 2 trial update for MS1819 in enteric capsules evaluating safety and efficacy in Exocrine Pancreatic Insufficiency and Cystic Fibrosis;…
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CLINICAL_TRIALS trial_result · 2022-06-13Clinical Trial Update: Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
A long-term safety/efficacy trial update for LipaCreon in patients with pancreatic exocrine insufficiency, completed with results posted in …
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CLINICAL_TRIALS trial_result · 2022-06-06Clinical Trial Update: OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis [Phase 2]
Phase 2 trial update for MS1819 in exocrine pancreatic insufficiency due to cystic fibrosis; trial completed with results posted in 2022.
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CLINICAL_TRIALS withdrawal · 2021-11-08Clinical Trial Update: 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 [Phase 4]
Phase 4 trial of oral CREON capsules in adults with Exocrine Pancreatic Insufficiency has been withdrawn.
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FDA approval · 2021-04-26FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
The FDA approved a supplemental application for Pancreaze (pancrelipase) from VIVUS LLC, updating its labeling and/or indications.
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EMA withdrawal · 2021-02-17EMA Withdrawn: Enzepi (pancreas powder) — Allergan Pharmaceuticals International Limited
The EMA has withdrawn Enzepi (pancreas powder) for exocrine pancreatic insufficiency.
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FDA approval · 2020-03-20FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA issued a supplemental approval for CREON (pancrelipase) from AbbVie, expanding its indication for exocrine pancreatic insufficiency.
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FDA approval · 2020-03-20FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, updating the labeling related to it…
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FDA approval · 2020-03-20FDA Approved: VIOKACE — Supplemental Application (Aimmune Therapeutics, Inc.)
FDA approved a supplemental application for Viokace (pancrelipase) by Aimmune Therapeutics, expanding its labeling for exocrine pancreatic i…
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FDA approval · 2020-03-20FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
The FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc., updating its labeling under the supplement…
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FDA approval · 2020-03-20FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for Pancreaze (pancrelipase) submitted by VIVUS LLC.
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CLINICAL_TRIALS trial_result · 2018-08-14Clinical Trial Update: SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis [Phase 3]
A Phase 3 trial update for SOLUTION study of an oral liprotamase unit-matched therapy in non-porcine origin for cystic fibrosis with exocrin…
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CLINICAL_TRIALS trial_result · 2018-05-17Clinical Trial Update: EASY: Extended Access to Sollpura Over Years [Phase 4]
Phase 4 extended-access study of Sollpura (pancrelipase) in Exocrine Pancreatic Insufficiency and Cystic Fibrosis completed with results pos…
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CLINICAL_TRIALS trial_result · 2018-05-11Clinical Trial Update: SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis [Phase 3]
Phase 3 trial SIMPLICITY evaluated liprotamase for malabsorption in cystic fibrosis-related exocrine pancreatic insufficiency; the study com…
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CLINICAL_TRIALS trial_result · 2018-03-08Clinical Trial Update: RESULT: Reliable, Emergent Solution Using Liprotamase Treatment [Phase 3]
Phase 3 trial update on Liprotamase for exocrine pancreatic insufficiency, including use in cystic fibrosis.
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FDA approval · 2017-07-12FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
The FDA approved a supplemental application for PERTZYE (pancrelipase) from Digestive Care, Inc.
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CLINICAL_TRIALS trial_result · 2017-01-20Clinical Trial Update: Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb) [NA]
This clinical trial update reports on the safety, tolerability, and fat absorption of Relizorb, an enteral feeding in-line enzyme cartridge,…
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CLINICAL_TRIALS trial_result · 2017-01-20Clinical Trial Update: A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI [Phase 2]
A completed Phase 2 trial investigating the prevalence of pancreatic exocrine insufficiency in Type 2 diabetes patients and how a single dos…
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FDA approval · 2016-12-19FDA Approved: ZENPEP — Supplemental Application (Aimmune Therapeutics, Inc.)
The FDA approved a supplemental application for ZENPEP (pancrelipase) submitted by Aimmune Therapeutics, Inc.
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FDA approval · 2016-10-06FDA Approved: PERTZYE — Supplemental Application (Digestive Care, Inc.)
FDA Supplemental Application for PERTZYE (pancrelipase) submitted by Digestive Care, Inc. under BLA022175. The submission pertains to a supp…
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FDA approval · 2016-06-16FDA Approved: CREON — Supplemental Application (AbbVie Inc.)
The FDA approved AbbVie's supplemental application for CREON (pancrelipase), updating its labeling to reflect expanded indications for exocr…
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CLINICAL_TRIALS trial_result · 2016-06-07Clinical Trial Update: Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis [Phase 1, Phase 2]
Phase 1/Phase 2 trial results evaluating the efficacy and tolerability of NM-BL in patients with exocrine pancreatic insufficiency due to cy…
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FDA approval · 2016-05-16FDA Approved: PANCREAZE — Supplemental Application (VIVUS LLC)
FDA approved a supplemental application for Pancreaze (pancrelipase) by VIVUS LLC, expanding labeling/indications related to exocrine pancre…
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CLINICAL_TRIALS trial_result · 2016-02-17Clinical Trial Update: Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis [Phase 2]
Phase 2 study evaluating the efficacy and safety of Creon IR in pancreatic exocrine insufficiency due to cystic fibrosis has completed, with…
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CLINICAL_TRIALS trial_result · 2015-09-28Clinical Trial Update: Baby Observational and Nutritional Study
The Baby Observational and Nutritional Study has completed, focusing on nutrition and growth in infants with cystic fibrosis and related pan…