Eluxadoline

Treats irritable bowel syndrome with diarrhea (IBS-D). Sold as Viberzi. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 14, 2026, FDA lists 5 applications for Eluxadoline (sold as Viberzi), first approved May 27, 2015, with 0 new uses approved and 0 published complete response letters.

First approved: May 27, 2015
Applications: 5
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $59.9M
First approved in the EU: Sep 19, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Viberzi	Part D	$59.9M	+1%	6,480

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

VIBERZI 100 MG TABLET: $28.09 per unitBrand · +5% in a year
VIBERZI 75 MG TABLET: $28.11 per unitBrand · +5% in a year

Approvals in the EU (EMA)

First approved in the EU 16 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Truberzi, new substanceAllergan Pharmaceuticals International Limited · Sep 19, 2016 · withdrawn

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy of Pregabalin for Patients With Irritable Bowel SyndromeIrritable Bowel Syndrome (IBS) · Beijing Tiantan Hospital	Not applicable	Recruiting	Jun 9, 2026
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)Irritable Bowel Syndrome · AbbVie	Phase 3	Enrolling by invitation	May 11, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 27, 2015	ViberziNDA 206940 · New molecular entity	Abbvie	6	Marketed
Mar 14, 2025	EluxadolineANDA 213522	Zydus Pharms	0	Discontinued
Jun 2, 2026	EluxadolineANDA 213511	Aurobindo Pharma	0	Discontinued
—	EluxadolineANDA 213576	Msn Pharmaceuticals Inc	0	Discontinued
—	EluxadolineANDA 213613	Ascend Laboratories, Ltd	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA