Drugs / Kreon
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01641393 | Jun 2012 → Feb 2014 | exocrine pancreatic insufficiency | Forest Laboratories | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT01327703 Comparator | Apr 2011 → May 2012 | cystic fibrosis, exocrine pancreatic insufficiency | Forest Laboratories | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 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 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-12-24 | Eisai Inc. | Submission of the New Drug Application for Pancreatic Enzyme Replacement Therapy Agent SA-001 in Japan eisai.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Kreon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01641393 ↗ |
| Modality | Protein / enzyme biologic | “Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18” NCT01641393 ↗ |
| Route | Oral | “Kreon® 25,000 capsule will be given orally daily” NCT01327703 ↗ |