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Larsucosterol

Phase 3

Hepatitis | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Jul 22, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment350

FDA Designations

No designations recorded

Clinical trial landscape

Larsucosterol · 1 trial · 1 indication

Phase 3 1
NCT07428538Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)Hepatitis
RECRUITING350 Analytics
PHASE3RECRUITING
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
HepatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Transplant Free Survival up to Day 90
Up to Day 90

Secondary Endpoints

Overall Survival at Day 90
Day 90
Time to Death up to Day 90
Up to Day 90
Number of Participants with Days Alive and Out of Hospital up to Day 90
Up to Day 90
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Larsucosterol 30 mgEXPERIMENTALParticipants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
PlaceboPLACEBO_COMPARATORParticipants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.

Interventions

NameTypeDescription
LarsucosterolDRUGLarsucosterol intravenous infusion.
PlaceboDRUGMatching-placebo (sterile water for injection) intravenous infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites84

Inclusion Criteria- A participant will be eligible for inclusion in this study if he/she meets all the following criteria: 1. Able to provide written informed consent (either from participant or participant's legally acceptable representative). 2. Onset of jaundice within 8 weeks before hospital a...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJul 22, 2026NCT07428538lastUpdatePostDate: changed
LOWJul 22, 2026NCT07428538lastUpdatePostDate: changed
LOWMay 26, 2026NCT07428538primaryCompletionDate: changed
LOWMay 24, 2026NCT07428538studyFirstPostDate: changed

Frequently asked questions about Larsucosterol

What is Larsucosterol used for?

Larsucosterol is an investigational small molecule being developed for the treatment of hepatitis, specifically alcohol-associated hepatitis. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes Larsucosterol?

Larsucosterol is being developed by Bausch Health Companies Inc., a company traded on the stock exchange under the ticker symbol BHC.

What phase is Larsucosterol in?

Larsucosterol is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved for any use.

What clinical trials is Larsucosterol in?

Larsucosterol is being studied in a Phase 3 clinical trial with the identifier NCT07428538. This randomized, double-blind, placebo-controlled trial is evaluating the safety and efficacy of Larsucosterol in participants with alcohol-associated hepatitis and is currently recruiting participants in the United States.

How does Larsucosterol work?

The specific molecular target of Larsucosterol has not been disclosed in available information, so its mechanism of action is not described here.