Corcept Therapeutics (Nasdaq: CORT), based in Redwood City, California, plans to resubmit its New Drug Application to the US FDA for relacorilant as a treatment for patients with Cushing's syndrome. The move follows the receipt of a complete response letter from the FDA in December 2025. The company said it expects a Prescription Drug User Fee Act date six months after the date of resubmission.
The resubmission follows FDA-requested additional analyses of the existing NDA data. Corcept said the outcome of those analyses and the tenor of its discussions with the agency supported moving forward. No new clinical studies have been indicated as a requirement for the resubmission.
The original NDA for relacorilant in Cushing's syndrome was accepted by the FDA in March 2025, with a PDUFA target date of December 30, 2025. The agency issued a complete response letter on December 31, 2025, declining to approve the application in its then-current form and requesting further analytical work. Corcept said it plans to resubmit "in the coming weeks," which would place a potential FDA action date in late 2026 under the standard six-month review clock for resubmissions.
Relacorilant is an oral selective glucocorticoid receptor (GR) antagonist. It blocks cortisol from activating the GR at the tissue level, leaving circulating cortisol levels elevated while reducing downstream signaling. This peripheral receptor-level mechanism distinguishes it from steroidogenesis inhibitors, which reduce cortisol production at the adrenal gland.