eluxadoline

Trade name: viberzi

Small moleculeapprovedFast Track ^FDA

Approved

May 27, 2015

Eluxadoline, an orally active mixed μ opioid receptor (μOR) agonist δ opioid receptor (δOR) antagonist. Eluxadoline normalizes gastrointestinal (GI) transit and defecation under conditions of novel environment stress or post-inflammatory altered GI function. Allergan (previously Actavis) is developing eluxadoline for the treatment of diarrhoea-predominant irritable bowel syndrome. The agent was originated by Janssen Pharmaceutica. Eluxadoline has been launched in the US under trade name VIBERZI (eluxadoline) tablets, while is at the preregistration stage in the EU. — NCATS

Clinical trial activity

9 trials · 4 clinical orgs · 8 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started May 1, 2010 (NCT01130272)

Timeline

2000s

Nov 21, 2007
Johnson and Johnson — IND Organization
Nov 21, 2007
Johnson and Johnson — IND Organization

2010s

Jan 1, 2010
Furiex — Earliest Phase 2 Sponsor(trial)
Jan 1, 2012
Furiex — Earliest Phase 3 Sponsor(trial)
May 27, 2015
Furiex — Earliest FDA Approval
May 27, 2015
Allergan — NDA Secondary Org
May 27, 2015
Furiex — NDA Organization
May 27, 2015
AbbVie — Marketing Organization
May 27, 2015
AbbVie — NDA Secondary Org

2020s

Sep 23, 2021
MSN Laboratories — Marketing Organization
Dec 17, 2021
Ascend Laboratories Llc — Marketing Organization
Mar 14, 2025
Zydus Discovery DMCC — Marketing Organization
Jun 2, 2026
Aurobindo Pharma — Marketing Organization

Indications

Approved for

Irritable Bowel Syndrome

Studied for

Mechanism of action

Mu opioid receptorAGONIST
OPRM agonist
- Mu-type opioid receptor (OPRM) ↗

Approval history

approvedPriority reviewFast trackMay 27, 2015

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC=C(CN([C@@H](C)C2=NC(=CN2)C3=CC=CC=C3)C(=O)[C@@H](N)CC4=C(C)C=C(C=C4C)C(N)=O)C=C1C(O)=O

Mol. weight: 569.6508 g/mol
Lipinski Ro5: 1 violation(s)
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

5-({(4-carbamoyl-2,6-dimethyl-l-phenylalanyl)[(1s)-1-(4-phenyl-1h-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid
5-({(4-carbamoyl-2,6-dimethyl-l-phenylalanyl)[(1s)-1-(4-phenyl-1h-imidazol-2-yl)ethyl]amino}methyl)-2-methoxybenzoic acid
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
eluxadoline
jnj 27018966
jnj-27018966
jnj-27018966
jnj-27018966
jnj-27018966
mudelta
truberzi
truberzi
truberzi
truberzi
truberzi
viberzi
viberzi
viberzi
viberzi

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT04880876	Phase 3	Aug 13, 2021	Allergan
NCT04313088	Phase 2/Phase 3 (Phase 3)	Jun 30, 2020	Temple University
NCT03489265	Phase 2	Aug 30, 2018	Allergan, University of North Carolina at Chapel Hill
NCT03441581	Phase 4	Feb 23, 2018	Allergan
NCT03339128	Phase 2	Nov 10, 2017	Allergan
NCT02959983	Phase 4	Oct 25, 2016	Allergan
NCT01553747	Phase 3	May 1, 2012	Furiex
NCT01553591	Phase 3	May 1, 2012	Furiex
NCT01130272	Phase 2	May 1, 2010	Furiex

Showing 9 of 9 trials

Page 1 / 1

Organizations

Research & Development (4)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Allergan	For profit	5	4	3	2016
Furiex	For profit	3	3	2	2010
Temple University	Academic/Hospital	1	1	1	2020
University of North Carolina at Chapel Hill	Academic/Hospital	1	1	1	2018

4 organizations

Page 1 / 1

Marketing (9)

Organization	Org type	Relationship	Date
AbbVie	For profit	MKTG	May 27, 2015
AbbVie	For profit	NDA2	May 27, 2015
Allergan	For profit	NDA2	May 27, 2015
Ascend Laboratories Llc	For profit	MKTG	Dec 17, 2021
Aurobindo Pharma	For profit	MKTG	Jun 2, 2026
Furiex	For profit	NDA	May 27, 2015
Johnson and Johnson	For profit	IND	Nov 21, 2007
MSN Laboratories	For profit	MKTG	Sep 23, 2021
Zydus Discovery DMCC	For profit	MKTG	Mar 14, 2025