Company intelligence / Profile preview

Cristcot

Austin, Texas, United Statesfda.report ↗

Ownership: Private
Development stage: Commercial

Overview

Cristcot’s lead program is a novel hydrocortisone acetate suppository delivered with the proprietary Sephure® applicator for ulcerative colitis of the rectum. The pivotal Phase 3 trial met its primary endpoint, achieving clinical remission by day 29 and significant reduction in rectal bleeding by day 15. The company is preparing an NDA submission and building manufacturing/commercial capabilities. The product has received FDA Fast Track designation and is positioned to be a first-line rescue therapy for UC flares, with strong IP protection through at least 2036.

Therapeutic areas: Gastroenterology
Modalities: Small moleculeDevice
Industry: Biotech

Drug pipeline

1 asset

Sephure

Commercial

Indications: Ulcerative colitis

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