Mirum Pharmaceuticals

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First potential therapy for primary sclerosing cholangitis clears Phase 2b

Sponsor of volixibat; targeting NDA filing in 2H 2026

For the roughly 30,000 Americans living with primary sclerosing cholangitis (PSC), the U.S. Food and Drug Administration has never approved a single drug. On May 4, 2026, Mirum Pharmaceuticals reported that its experimental pill volixibat hit the primary endpoint of its Phase 2b VISTAS trial, reducing the relentless itch far more than placebo.

Updated May 31