Viberzi

(Eluxadoline)

ApprovedSmall molecule

AbbVie

Viberzi is one of 35 small molecule programs targeting Irritable Bowel Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Irritable Bowel SyndromeCompleted

Irritable Bowel SyndromeApproved

Completed

Competition

Competitive Landscape

43 competitors in Irritable Bowel Syndrome

#DrugCompanyPhaseTrials

Linzess

AbbVie

Approved

12 2

Resotran

Takeda

Approved

2 3

Cymbalta

Jazz Pharmaceuticals

Approved

2 4

Lexapro

AbbVie

Approved

1 5

Nurtec

Pfizer

Approved

1 6

Golytely

Azulfidine

Alinia

RRomark Laboratories L.C.

Approved

2 9

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 10

Trental

VValidus Pharmaceuticals

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Irritable Bowel Syndrome6 trials

Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

Completed·FFuriex Pharmaceuticals, Inc·Phase 3·NCT01553591·1,282 enrolled

Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

Completed·FFuriex Pharmaceuticals, Inc·Phase 3·NCT01553747·1,146 enrolled

Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

Completed· AbbVie logo

AbbVie·Phase 4·NCT02959983·346 enrolled

Show 3 more trials

A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Enrolling by invitation· AbbVie logo

AbbVie·Phase 3·NCT04880876·124 enrolled

Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

Completed·FFuriex Pharmaceuticals, Inc·Phase 2·NCT01130272·807 enrolled

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Completed· AbbVie logo

AbbVie·Phase 2·NCT03339128·272 enrolled

Bile Acid Malabsorption1 trial

Eluxadoline Bile Acid Malabsorption (BAM) Study

Completed· AbbVie logo

AbbVie·Phase 4·NCT03441581·24 enrolled

Diarrhea1 trial

Investigation of Eluxadoline for Diabetic Diarrhea

Withdrawn·TTemple University·Phase 2/3·NCT04313088

Fecal Incontinence1 trial

Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT03489265

Regulatory

FDA Approval Timeline[4]

May 27, 2015

VIBERZI

NDA NDA206940

Feb 2, 2017

VIBERZI

NDA NDA206940

Apr 20, 2017

VIBERZI

NDA NDA206940

Nov 8, 2017

VIBERZI

NDA NDA206940

Apr 13, 2018

VIBERZI

NDA NDA206940

Jun 26, 2018

VIBERZI

NDA NDA206940

Jun 17, 2020

VIBERZI

NDA NDA206940

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Eluxadoline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Eluxadoline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Eluxadoline. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA206940). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Viberzi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Jul 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8691860Jul 7, 2028

9364489Jul 7, 2028

9789125Jul 7, 2028

9115091Jul 7, 2028

7741356May 27, 2029

9 more patents

11090291Mar 14, 2033

11311516Mar 14, 2033

11229627Mar 14, 2033

10188632Mar 14, 2033

11160792Mar 14, 2033

11484527Mar 14, 2033

12097187Mar 14, 2033

9675587Mar 14, 2033

11007179Mar 14, 2033

Viberzi

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Irritable Bowel Syndrome6 trials

Bile Acid Malabsorption1 trial

Diarrhea1 trial

Fecal Incontinence1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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