DURECT is a clinical-stage biopharmaceutical company focused almost entirely on developing larsucosterol, an experimental IV-administered drug for alcohol-associated hepatitis (AH). AH is an acute, life-threatening liver disease with no FDA-approved treatments, causing over 160,000 U.S. hospitalizations per year and roughly 30% mortality within 90 days. Larsucosterol is a small molecule that works by inhibiting DNA methyltransferases — enzymes overexpressed in AH patients — to modulate gene expression related to inflammation, cell death, and liver regeneration. DURECT completed a Phase 2b trial (AHFIRM) in late 2023 across 307 patients; the primary endpoint missed statistical significance, but the U.S. subgroup showed 57–58% reductions in 90-day mortality. Based on these results and a Breakthrough Therapy Designation, the FDA agreed that a single successful Phase 3 trial would support an NDA filing. DURECT has designed a ~200-patient, U.S.-only Phase 3 trial using 90-day survival as the primary endpoint, estimated to cost roughly $20M in external trial costs. The core challenge is funding: DURECT had only $12M in cash at year-end 2024, sufficient only through Q3 2025. DURECT sold its ALZET lab research product line in late 2024 for $17.5M to repay debt and extend its runway, leaving the company debt-free but reliant on partnerships or capital markets financing to initiate the Phase 3. If approved, DURECT would target hospitals and hepatologists through a focused specialty sales force, or potentially license commercial rights to a larger partner.