Cristcot’s NDA for Next-Generation Hydrocortisone Suppository Accepted by FDA
Wednesday, April 22, 2026
Cristcot, a clinical-stage pharmaceutical company focused on gastrointestinal diseases, has received acceptance from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for a next-generation hydrocortisone acetate (ngHCA) 90 mg suppository. The application has been submitted under the 505(b)(2) regulatory pathway. The FDA has set a target decision date for October 2026.
The investigational treatment is administered using Cristcot’s patented Sephure® suppository applicator. If approved, it would become the first FDA-approved hydrocortisone acetate suppository for this indication.
The NDA is supported by results from a Phase 3 trial, where the therapy met its primary endpoint. Patients achieved clinical remission based on a Modified Mayo Score of 0–2 at Day 29.
The therapy is designed to treat ulcerative colitis affecting the rectum, an area where there is currently a lack of approved suppository-based treatments. It aims to address limitations in existing therapies by providing targeted delivery directly to inflamed areas while reducing systemic exposure.
The formulation enables rapid and sustained drug release with improved bioavailability. The delivery system is also intended to improve patient adherence by addressing challenges associated with current treatment methods.
Ulcerative colitis is a chronic autoimmune condition that causes inflammation and ulcers in the large intestine, often beginning in the rectum. Common symptoms include rectal bleeding, diarrhoea, urgency, abdominal pain, and discomfort, which can significantly affect quality of life. The disease typically involves recurring flare-ups, and many patients require changes in treatment over time due to varying levels of disease activity.
Cristcot’s therapy aims to provide a more effective option for managing rectal symptoms and supporting continuity of care during treatment transitions.
Source: globenewswire.com
