FDA Accepts NDA For Next-Generation Hydrocortisone Acetate in Ulcerative Colitis of the Rectum

Published on: April 21, 2026

If approved, the novel corticosteroid therapy would be the first and only FDA-approved hydrocortisone acetate suppository.

The US Food and Drug Administration has accepted Cristcot’s New Drug Application (NDA) under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository administered using the Company’s patented, FDA-approved Sephure® suppository applicator for the treatment of patients with ulcerative colitis (UC) of the rectum.

As described in an April 21, 2026, press release, 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. With the acceptance, 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 FDA’s acceptance of our NDA brings us one step closer to addressing the significant treatment gap for the roughly 1.3 million ulcerative colitis patients in the U.S.,” Jennifer Davagian, Cristcot Founder and Chief Executive Officer, said in a statement. “While the clinical use of HCA in treating UC is well characterized, there is significant unmet need with no FDA approved rectal suppository for the most stubborn symptoms associated with rectal disease involvement. ngHCA is designed to address the limitations of currently available UC therapies and the gap in treating rectal disease.”

ngHCA, Cristcot’s investigational hydrocortisone acetate (HCA) 90 mg suppository formulation, is a novel corticosteroid therapy delivering a small volume suppository administered using the Sephure® suppository applicator. Unlike other corticosteroid treatments, the advanced HCA formulation allows for rapid, sustained release with optimal bioavailability, and very limited systemic exposure. The innovative delivery system is designed to overcome the treatment barriers associated with currently available therapies and enhance patient compliance.

CESSA trial results were presented at the American College of Gastroenterology 2025 Annual Scientific Meeting and showed the trial achieved its primary endpoint of clinical remission at day 29 and secondary endpoint of clinical response at day 15, both using modified Mayo Score criteria, demonstrating statistically significant improvements for patients treated with the ngHCA 90 mg suppository compared to those who received placebo.

Clinical and endoscopic remission was achieved by 21.2% (P = .0005) of study participants in the ngHCA QD (once-daily) arm versus 1.5% of patients in the placebo arm. Additional secondary efficacy analyses showed treatment with ngHCA QD resulted in greater improvement in rectal bleeding and stool frequency scores at day 15 and day 29 versus placebo.

Safety results showed ngHCA was well tolerated with no treatment-related serious adverse events (SAEs). Treatment-related adverse events (TEAEs) were reported by 4.5% of patients in the QD treatment group and 7.6% in the placebo group, with the majority being mild and moderate in severity. Of note, compliance was very high, with 100% of subjects in the ngHCA QD group having > 90% adherence with the required dosing.

References

Cristcot. Cristcot Announces FDA Acceptance of NDA for Next-Generation Hydrocortisone Acetate (ngHCA) for Treatment of Ulcerative Colitis (UC) of the Rectum. April 21, 2026. Accessed April 21, 2026. https://cristcot.com/news/cristcot-announces-fda-acceptance-of-nda-for-next-generation-hydrocortisone-acetate-nghca-for-treatment-of-ulcerative-colitis-uc-of-the-rectum
Cristcot. Cristcot to Present Data on Novel Ulcerative Colitis Treatment at the American College of Gastroenterology 2025 Annual Meeting. October 26, 2025. Accessed April 21, 2026. https://cristcot.com/news/26-october-2025

FDA Accepts NDA For Next-Generation Hydrocortisone Acetate in Ulcerative Colitis of the Rectum

Next-Generation Hydrocortisone Acetate Fast Facts

References

Cristcot. Cristcot to Present Data on Novel Ulcerative Colitis Treatment at the American College of Gastroenterology 2025 Annual Meeting. October 26, 2025. Accessed April 21, 2026. https://cristcot.com/news/26-october-2025