hydrocortisone acetate suppository (ngHCA) / Cristcot - LARVOL DELTA

Cristcot Announces FDA Acceptance of NDA for Next-Generation Hydrocortisone Acetate (ngHCA) for Treatment of Ulcerative Colitis (UC) of the Rectum (GlobeNewswire) - "Fourth quarter 2026 commercial launch readiness planning underway...The FDA has set a PDUFA target date in October 2026. If approved, ngHCA would be the first and only FDA-approved hydrocortisone acetate (HCA) suppository...The NDA is supported by positive results from the Company’s Phase 3 pivotal trial, which achieved its primary endpoint of clinical remission based on the Modified Mayo Score of 0-2 at Day 29."

FDA approval • FDA filing • Launch US • Ulcerative Colitis