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Larsucosterol

Phase 3

Hepatitis | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Aug 24, 2026

Target and mechanism

Molecular targetDNMTs
ModalitySmall molecule

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 Sites86

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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Competitive Landscape -Hepatitis B 30 trials (matched to "Hepatitis")

Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07428538lastUpdatePostDate: changed
LOWAug 24, 2026NCT07428538lastUpdatePostDate: changed
LOWJul 22, 2026NCT07428538lastUpdatePostDate: changed
LOWJul 22, 2026NCT07428538lastUpdatePostDate: 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.

What does Larsucosterol target?

Larsucosterol targets DNA methyltransferases (DNMTs), which are enzymes involved in epigenetic regulation. By modulating these enzymes, the drug aims to address the underlying mechanisms of alcohol-associated hepatitis.

Who is developing Larsucosterol?

Larsucosterol is being developed by Bausch Health Companies Inc., a company listed 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, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is Larsucosterol in?

Larsucosterol is being evaluated in a Phase 3 clinical trial with the identifier NCT07428538. This study is recruiting participants to assess the safety and efficacy of the drug in individuals with alcohol-associated hepatitis. The trial is randomized, double-blind, and placebo-controlled, with an estimated enrollment of 350 participants in the United States.