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Larsucosterol

Phase 3

Hepatitis | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: May 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07428538Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)PHASE3 RECRUITING 350Jan 29, 2026Feb 1, 2028May 7, 202648 United States
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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 — N/A
SexALL
Healthy VolunteersNo
Study Sites48

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)
LOWMay 26, 2026NCT07428538primaryCompletionDate: changed
LOWMay 24, 2026NCT07428538studyFirstPostDate: changed