Drugs / Eluxadoline
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Truberzi | — | 2020-12-18 | europa.eu ↗ |
| Approved | EU (EMA) | Truberzi | — | 2016-09-19 | europa.eu ↗ |
| Approved | US (FDA) | VIBERZI | — | 2015-05-27 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT03489265 | Apr → Sep 2019 | anus disorder, diarrheal disease, overactive bladder | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03339128 | Nov 2017 → Aug 2026 | irritable bowel syndrome | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01130272 | Apr 2010 → Jul 2011 | irritable bowel syndrome | Furiex Pharmaceuticals, Inc | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04313088 | Jul 2022 → Dec 2023 | diabetes mellitus, diarrheal disease | Temple University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT04880876 | Aug 2021 → Dec 2032 expected | irritable bowel syndrome | AbbVie | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT01553591 | May 2012 → Jul 2014 | irritable bowel syndrome | Furiex Pharmaceuticals, Inc | Completed | Met primary |
| Phase 3 | NCT01553747 | May 2012 → Jan 2014 | irritable bowel syndrome | Furiex Pharmaceuticals, Inc | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03441581 | Feb 2018 → Apr 2020 | irritable bowel syndrome | Allergan | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT02959983 Comparator | Oct 2016 → Jan 2018 | irritable bowel syndrome | Allergan | Completed | No outcome recorded |
| — | NCT07635394 Background | Apr 2026 overdue | irritable bowel syndrome | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-03-16 | Zydus Lifesciences Limited | Eluxadoline Tablets receiving USFDA’s final approval zyduslife.com ↗ |
| 2015-08-05 | Ironwood Pharmaceuticals, Inc. | Ironwood and Allergan Enter Agreement to Co-Promote VIBERZI for Irritable Bowel Syndrome with Diarrhea (IBS-D) in the U.S. ironwoodpharma.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eluxadoline | “Eluxadoline 100 mg BID (75 mg BID in post-cholecystectomy patients)” NCT07635394 ↗ |
| Known as | Eluxadolina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2159122 ↗ |
| Known as | JNJ-27018966 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2159122 ↗ |
| Known as | Truberzi | ChEMBL registry synonym — accepted as the source's own label CHEMBL2159122 ↗ |
| Known as | Viberzi | ChEMBL registry synonym — accepted as the source's own label CHEMBL2159122 ↗ |
| Action | Activate | “Mu opioid receptor agonist” CHEMBL2159122 ↗ |
| Modality | Small molecule | — CHEMBL2159122 ↗ |
| Route | Oral | “5, 25, 100, or 200 mg oral eluxadoline” PMID 23583433 ↗ Apr 2013 |
| Target | OPRM1 | “Mu opioid receptor agonist” CHEMBL2159122 ↗ |