Clinical Trial ResultsA subset analysis revealed that among patients who were enrolled in the U.S., mortality reductions at 90 days were 57% in the 30 mg arm and 58% in the 90 mg arm compared to standard-of-care (SoC).
Regulatory ApprovalThe FDA has granted the Breakthrough Therapy designation (BTD) to larsucosterol for the treatment of severe alcohol-associated hepatitis (AH).
Regulatory FeedbackDURECT announced that in a Type C meeting with the FDA, it has received feedback from the agency indicating that a single pivotal Phase 3 trial would sufficiently support larsucosterol's U.S. approval for alcohol-associated hepatitis (AH).