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Eluxadoline

Generic Name
Eluxadoline
Brand Names
Viberzi
Drug Type
Small Molecule
Chemical Formula
C32H35N5O5
CAS Number
864821-90-9
Unique Ingredient Identifier
45TPJ4MBQ1

Overview

Eluxadoline is a mixed mu-opioid receptor agonist, kappa-opioid receptor agonist, and a-delta opioid receptor antagonist indicated for use in diarrhea-predominant irritable bowel syndrome (IBS-D). The mu-, kappa-, and delta-opioid receptors mediate endogenous and exogenous opioid response in the central nervous system and peripherally in the gastrointestinal system. Agonism of peripheral mu-opioid receptors results in reduced colonic motility, while antagonism of central delta-opioid receptors results in improved analgesia, making eluxadoline usable for the symptoms of both pain and diarrhea characteristic of IBS-D. Marketed under the tradename Viberzi (FDA), eluxadoline is an antimotility agent that decreases bowel contractions, inhibits colonic transit, and reduces fluid/ion secretion resulting in improved symptoms of abdominal pain and reductions in the Bristol Stool Scale.

Indication

For the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Associated Conditions

  • Diarrhoea Predominant Irritable Bowel Syndrome

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2021/05/11
Phase 3
ENROLLING_BY_INVITATION
2020/03/18
Phase 2
Withdrawn
2018/04/05
Phase 2
Withdrawn
2018/02/22
Phase 4
Completed
2017/11/13
Phase 2
Recruiting
2016/11/09
Phase 4
Completed
2012/03/14
Phase 3
Completed
2012/03/14
Phase 3
Completed
2010/05/25
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Allergan, Inc.
61874-100
ORAL
100 mg in 1 1
11/13/2023
Allergan, Inc.
61874-075
ORAL
75 mg in 1 1
11/13/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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