Drugs / Pancrelipase
Pancrelipase
also known as
Creon · pancreatin · SA001 · EUR-1008 · Zenpep · APT-1008 · Oryz-Aspergillus Enzyme and Pancreatin · PANCREASE MT · +6 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 49
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05303961 | Jun → Nov 2016 | — | Samjin Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02470286 | Jun → Sep 2015 | — | Samjin Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00676702 | Jul 2008 → Jan 2009 | chronic pancreatitis, exocrine pancreatic insufficiency, steatorrhea | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05642962 | Nov 2022 → Nov 2026 expected | pancreatic ductal adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02985801 | Dec 2016 → Apr 2019 | exocrine pancreatic insufficiency, malignant pancreatic neoplasm | Massimo Raimondo, M.D. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT07559175 | Oct 2026 → Jun 2027 expected | cystic fibrosis, exocrine pancreatic insufficiency | Aimmune Nestlé Health Science US R&D, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT04098237 | Dec 2020 → Jan 2024 overdue | pancreatic adenocarcinoma | Andrew Hendifar, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05269810 | May 2020 → Feb 2022 | Sjogren syndrome | Samjin Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03469258 | Apr 2018 → Oct 2019 | malignant pancreatic neoplasm | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03723798 | Nov 2017 → Oct 2018 | dry eye syndrome | Samjin Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03097029 | Mar 2017 → Feb 2019 | short bowel syndrome | Children's Hospital of Philadelphia | Completed | Missed primary |
| Phase 2 | NCT00217204 | Jul 2005 → Feb 2006 | cystic fibrosis, steatorrhea | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | Completed | No outcome recorded |
| Phase 316 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT03450772 | Aug 2017 → Apr 2022 | exocrine pancreatic insufficiency | Abbott | Unknown | No outcome recorded |
| Phase 3 | NCT02137382 | Jan → Aug 2014 | exocrine pancreatic insufficiency | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT01747330 | Jun → Dec 2012 | exocrine pancreatic insufficiency | Abbott Products | Completed | No outcome recorded |
| Phase 3 | NCT01641393 | Jun 2012 → Feb 2014 | exocrine pancreatic insufficiency | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT00623025 | Jan → Aug 2009 | steatorrhea | Abbott | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00662675 | Aug 2008 → Feb 2009 | cystic fibrosis, exocrine pancreatic insufficiency, malabsorption syndrome, steatorrhea | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00401076 | Jul 2008 → Sep 2010 | pancreas disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00705978 | Jun 2008 → May 2010 | exocrine pancreatic insufficiency | Abbott Products | Completed | No outcome recorded |
| Phase 3 | NCT00690820 | Jun → Dec 2008 | cystic fibrosis, exocrine pancreatic insufficiency | Solvay Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00788593 | Jan 2008 → Mar 2009 | chronic pancreatitis, exocrine pancreatic insufficiency | Forest Laboratories | Completed | Missed primary |
| Phase 3 | NCT00510484 | Nov 2007 → Mar 2008 | cystic fibrosis | Solvay Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00414908 | Oct 2007 → Aug 2008 | chronic pancreatitis, exocrine pancreatic insufficiency | Solvay Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00400842 | May 2007 → Aug 2009 | exocrine pancreatic insufficiency | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00981214 | May → Sep 2006 | cystic fibrosis, exocrine pancreatic insufficiency | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00297167 | May → Nov 2006 | cystic fibrosis, exocrine pancreatic insufficiency | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT00266721 | Jan → Oct 2000 | gas bloat syndrome | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 416 trials · 2 missed | ||||||
| Phase 4 | NCT07852988 | Aug 2026 → Dec 2027 expected | type 2 diabetes mellitus | Silesian Centre for Heart Diseases | Recruiting | No outcome recorded |
| Phase 4 | NCT06099119 | Feb 2024 → Jun 2027 expected | pancreas disorder | Hospital Clinico Universitario de Santiago | Recruiting | No outcome recorded |
| Phase 4 | NCT06477159 | Feb 2024 → Sep 2027 expected | exocrine pancreatic insufficiency | Ohio State University | Recruiting | No outcome recorded |
| Phase 4 | NCT05069597 | Oct 2021 → Jul 2023 | chronic pancreatitis, cystic fibrosis | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT04315311 | May 2020 → Sep 2021 | exocrine pancreatic insufficiency | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03859869 | Feb 2020 → Mar 2022 | exocrine pancreatic insufficiency | AbbVie | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03924947 | Oct 2019 → Jul 2022 | cystic fibrosis | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT02475369 | May 2015 → Jun 2019 | celiac disease | Beth Israel Deaconess Medical Center | Terminated | Missed primary |
| Phase 4 | NCT02127021 | Apr 2014 → Sep 2017 | pancreas disorder | Seoul National University Hospital | Completed | Missed primary |
| Phase 4 | NCT02009410 | Nov 2013 → Aug 2014 | exocrine pancreatic insufficiency | Abbott | Withdrawn | No outcome recorded |
| Phase 4 | NCT01131507 | Jul 2010 → Dec 2011 | cystic fibrosis, exocrine pancreatic insufficiency | Forest Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT01100606 | Jun → Dec 2010 | cystic fibrosis, exocrine pancreatic insufficiency | Forest Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT00744250 | Aug 2008 → May 2010 | chronic pancreatitis, cystic fibrosis, exocrine pancreatic insufficiency | Digestive Care, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00535756 | Apr 2008 → Jun 2011 | exocrine pancreatic insufficiency | Abbott Products | Completed | No outcome recorded |
| Phase 4 | NCT00957151 | Apr 2004 → Aug 2005 | chronic pancreatitis | Hospital Avicenne | Completed | No outcome recorded |
| Phase 4 | NCT00160186 | Dec 2003 → May 2006 | stomach disorder | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06826105 | Sep 2025 → Jan 2027 expected | nutritional deficiency disease | Philipp Schuetz | Recruiting | No outcome recorded |
| — | NCT05466838 | Jan 2023 → May 2024 overdue | exocrine pancreatic insufficiency | Sunnybrook Health Sciences Centre | Active not recruiting | No outcome recorded |
| — | NCT00663975 | Feb → Aug 2009 | cystic fibrosis, exocrine pancreatic insufficiency | Digestive Care, Inc. | Withdrawn | No outcome recorded |
| — | NCT01154608 | Apr 2005 → ? | pancreatitis | French National Research Institute for Agriculture, Food and Environment | Completed | No outcome recorded |
| — | NCT00006063 | Jul → Aug 1999 | cystic fibrosis | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Comparator or background therapy17 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 1 | NCT02733848 Comparator | Feb 2014 → Jan 2018 | hypoglycemia | East Carolina University | Terminated | No outcome recorded Stop: Business |
| 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 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 Stop: Business |
| Phase 3 | NCT00432861 Comparator | Jan → Sep 2007 | cystic fibrosis, exocrine pancreatic insufficiency | Digestive Care, Inc. | Completed | No outcome recorded |
| 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 |
| — | NCT07074379 Background | Jul 2025 → Dec 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 |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2024-06-03 | VIVUS LLC | Results Clinical Data Published at ASCO Support Potential to Stabilize Weight in Patients with Pancreatic Cancer vivus.com ↗
The data also suggest that PANCREAZE may reduce stool frequency and improve stool consistency. |
| 2020-02-05 | VIVUS LLC | Regulatory VIVUS Receives U.S. Food and Drug Administration Approval for Improved Formulation of PANCREAZE with a 36 Month Shelf Life vivus.com ↗
VIVUS, Inc. (Nasdaq: VVUS) (“VIVUS”), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for an improved formulation of PANCREAZE® (pancrelipase) Delayed Release Capsules that extends the shelf life to 36 months across all PANCREAZE dosages. |
| 2017-09-19 | Samjin Pharmaceutical Co., Ltd. | Regulatory 삼진제약(주), 경구용 안구건조증치료제 ‘SA-001' 임상 2상 승인 samjinpharm.co.kr ↗
삼진제약(주)(대표이사 이성우)은 18일 식품의약품안전처로부터 먹는 안구건조증 치료제로 개발 중인‘SA-001'의 임상2상 시험계획서를 승인받았다고 밝혔다. |
| 2015-04-21 | Samjin Pharmaceutical Co., Ltd. | Regulatory 삼진제약(주), 경구용 안구건조증치료제 'SA-001' 식약처 임상 승인 samjinpharm.co.kr ↗
삼진제약(주)(대표이사 이성우)은 최근 식품의약품안전처로부터 먹는 안구건조증 치료제로 개발 중인‘SA-001' 임상 승인을 받았다고 밝혔다. |
| 2011-04-22 | Eisai Inc. | Regulatory Abbott Japan and Eisai Receive Approval to Market the Pancreatic Digestive Enzyme Replacement Drug Lipacreon® (pancrelipase) in Japan eisai.com ↗
Lipacreon® is the first pancreatic digestive enzyme replacement drug to be approved in Japan for the treatment of PEI due to chronic pancreatitis, pancreatectomy, cystic fibrosis and other conditions. |
| 2009-12-24 | Eisai Inc. | Regulatory Submission of the New Drug Application for Pancreatic Enzyme Replacement Therapy Agent SA-001 in Japan eisai.com ↗
was submitted by Solvay Seiyaku on December 22, 2009 in Japan. |
All press releases naming this drug 14 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 68 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 | 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 | pancreatin | “Patients will use pancreatic enzymes (pancreatin enteric-coated capsules or oryz-aspergillus enzyme and pancreatin tablets) to control the symptoms of exocrine pancreatic insufficiency.” NCT07074379 ↗12“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 “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 | SA001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02470286 ↗ |
| 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 ↗ |