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3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis

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Trial Profile

3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2026

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At a glance

  • Drugs Hydrocortisone (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CESSA
  • Sponsors Cristcot

Most Recent Events

  • 29 Apr 2026 According to a Cristcot media release, data from the trial will be presented at the 2026 Digestive Disease Week (DDW) Annual Meeting.
  • 21 Apr 2026 According to a Cristcot Media Release, the U.S. Food and Drug Administration (FDA) has accepted the Companys New Drug Application (NDA) for its next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository administered using Cristcots patented, FDA-approved Sephure suppository applicator. The FDA has set a PDUFA target date in October 2026.
  • 26 Oct 2025 Results presented in a Cristcot Media Release

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