Drugs / Pancrelipase
Pancrelipase
also known as
Creon · pancreatin · SA-001 · EUR-1008 · Zenpep · APT-1008 · Creon36 · Oryz-Aspergillus Enzyme and Pancreatin · +9 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CREON | — | 2009-04-30 | fda.gov ↗ |
Trials 50 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 18 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07314489 Comparator | Apr 2025 → Dec 2026 expected | chronic pancreatitis | Shanghai Changzheng Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT05266963 Comparator | Sep 2022 → Mar 2024 | type 1 diabetes mellitus | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT02733848 Comparator | Feb 2014 → Jan 2018 | hypoglycemia | East Carolina University | Terminated | No outcome recorded |
| Phase 1 | NCT01159119 Comparator | Aug 2010 → Jul 2011 | chronic pancreatitis | Forest Laboratories | Terminated | No outcome recorded |
| Phase 1 | NCT01142128 Comparator | Feb 2009 → Dec 2011 | chronic pancreatitis | University of Florida | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07450547 Comparator | Apr 2026 → Jul 2027 expected | cystic fibrosis, exocrine pancreatic insufficiency | Anagram Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT02706236 Comparator | Apr 2016 → Dec 2018 | pancreatitis | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04542473 Comparator | Jul 2021 → Oct 2023 | infectious disease with sepsis, protein-energy malnutrition | University of Oxford | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00432861 Comparator | Jan → Sep 2007 | cystic fibrosis, exocrine pancreatic insufficiency | Digestive Care, Inc. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07557394 Background | May 2026 → Nov 2027 expected | malignant pancreatic neoplasm | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04786795 Comparator | Mar 2021 → Feb 2022 | postcholecystectomy syndrome | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01865695 Comparator | May 2013 → Aug 2014 | celiac disease, exocrine pancreatic insufficiency | Sheffield Teaching Hospitals NHS Foundation Trust | Terminated | No outcome recorded |
| Phase 4 | NCT01641341 Comparator | Nov 2010 → Mar 2012 | irritable bowel syndrome | American Academy of Family Physicians | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07074379 Background | Jul 2025 → Aug 2027 expected | chronic pancreatitis | Changhai Hospital | Recruiting | No outcome recorded |
| — | NCT05261997 Background | Mar 2022 → Nov 2023 | chronic pancreatitis, exocrine pancreatic insufficiency | Changhai Hospital | Unknown | No outcome recorded |
| — | NCT04057326 Comparator | Aug 2019 → Dec 2020 | cirrhosis of liver | Shenzhen Kangzhe Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| — | NCT02372383 Background | Oct 2014 → Jun 2016 | cystic fibrosis | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00749099 Comparator | Apr 2007 → Sep 2010 | exocrine pancreatic insufficiency | Digestive Care, Inc. | Terminated | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-01-27 | AbbVie | AbbVie and Allergan Announce Agreements to Divest Brazikumab and Zenpep abbvie.com ↗ |
| 2013-05-30 | AbbVie | AbbVie Announces Market Availability of New CREON® (pancrelipase) 36,000 Lipase-unit Capsules for Patients with Exocrine Pancreatic Insufficiency abbvie.com ↗ |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pancrelipase | “EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe...” NCT01100606 ↗26“A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an...” NCT05069597 ↗ “BACKGROUND: EUR-1008 (Zenpep [pancrelipase]) is a new, enteric-coated, porcine-derived pancreatic enzyme product (PEP)” PMID 19683970 ↗ Aug 2009 “oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients” NCT00662675 ↗ “PANCRECARB® (pancrelipase) Capsules is available in patients above age 2.” NCT00663975 ↗ “Zenpep® (pancrelipase) 3,000 lipase units delayed release capsules” NCT01131507 ↗ |
| Known as | APT-1008 | “EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe...” NCT01100606 ↗3“EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule” NCT00297167 ↗ “EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units will be given” NCT00788593 ↗ “Participants will receive EUR-1008 (APT-1008) Microtabs formulation.” NCT00981214 ↗ |
| Known as | Creon | “The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy” NCT00160186 ↗15“PEI can be treated with oral pancreatic enzyme replacement therapy (PERT), for example CREON.” NCT05466838 ↗ “enteral absorption in each subject before and after pancreatic enzyme medication (Creon).” PMID 35622082 ↗ May 2022 “Pancrelipase (Creon) 2 tablets with each meal” NCT00266721 ↗ “Creon（Pancreatin Enteric-coated Capsules）” NCT07314489 ↗ |
| Known as | Creon36 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02849704 ↗ |
| Known as | EUR-1008 | “EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe...” NCT01100606 ↗ |
| Known as | Oryz-Aspergillus Enzyme and Pancreatin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04057326 ↗ |
| Known as | PANCREASE MT | “The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces)...” NCT00217204 ↗ |
| Known as | Pancreatic Enzyme | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04542473 ↗ |
| Known as | pancreatic enzyme supplement | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00510744 ↗ |
| Known as | pancreatin | “a single capsule of 40,000 IU pancreatin, Norzyme (40,000 IU, Pankreatan; Nordmark Arzneimittel GmbH & Co, Uetersen, Germany), 3 times each day during meals for 3 months” PMID 31520730 ↗ Sep 201911“pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules” PMID 20171415 ↗ Jan 2010 “capsules containing pancreatin 35,000 Ph.U.” NCT06099119 ↗ “Pancreatin Enteric-Coated Capsules 25000” NCT03450772 ↗ |
| Known as | Pancreaze | “Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency” NCT04098237 ↗ |
| Known as | PANCRECARB | “PANCRECARB® (pancrelipase)” NCT00432861 ↗ |
| Known as | Pankreatan | “a single capsule of 40,000 IU pancreatin, Norzyme (40,000 IU, Pankreatan; Nordmark Arzneimittel GmbH & Co, Uetersen, Germany), 3 times each day during meals for 3 months” PMID 31520730 ↗ Sep 2019 |
| Known as | Pertzye | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05642962 ↗ |
| Known as | SA-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00400842 ↗ |
| Known as | Viokase 16 | “Viokase 16 (pancrelipase) + Nexium” NCT01142128 ↗ |
| Known as | Zenpep | “BACKGROUND: EUR-1008 (Zenpep [pancrelipase]) is a new, enteric-coated, porcine-derived pancreatic enzyme product (PEP)” PMID 19683970 ↗ Aug 20094“Zenpep® (pancrelipase) 3,000 lipase units delayed release capsules” NCT01131507 ↗ |
| Known as | Zenpep (pancrelipase) delayed release capsules | “Zenpep® (pancrelipase) delayed release capsules” NCT01100606 ↗ |
| Action | Restore | “pancreatic enzyme replacement (CREON)” NCT05266963 ↗ |
| Modality | Protein / enzyme biologic | “EUR-1008 (Zenpep [pancrelipase]) is a new, enteric-coated, porcine-derived pancreatic enzyme product (PEP)” PMID 19683970 ↗ Aug 2009 |
| Route | Oral | “enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules before meals and snacks” NCT00006063 ↗ |