FDA Issues Complete Response Letter for Corcept's Relacorilant in Hypercortisolism
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.
The U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism, Corcept Therapeutics Incorporated announced on December 31, 2025. While the FDA acknowledged that Corcept's pivotal GRACE trial met its primary endpoint and that data from the company's GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.
The company's Chief Executive Officer stated that Corcept was surprised and disappointed by this outcome and that the company's commitment to patients suffering from the effects of hypercortisolism is unwavering. The CEO stated the company is confident it will find a way to get relacorilant to the patients it could help and that Corcept will meet with the FDA as soon as possible to discuss the best path forward.
As a result of this news, on December 31, 2025, the price of Corcept stock declined from a closing price on December 30, 2025 of $70.20 per share to close at $34.80 per share, a decline of $35.40 per share, or over 50%.
On January 30, 2026, a corrected version of the CRL dated January 28, 2026 was widely disseminated and it states that during the pre-submission meetings, the FDA informed Corcept on several occasions of its concerns about the adequacy of the clinical development program to assess the effect of relacorilant on hypertension in the intended population including the design of CORT 125134-455, and to expect significant review issues if Corcept were to submit its application. Following this news, the price of Corcept stock declined more than $5.60 per share, over 12%, during intraday trading on January 30, 2026.
Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is developing relacorilant in endogenous hypercortisolism and a variety of other serious disorders, including ovarian cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism and by the European Commission for the treatment of ovarian cancer.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA accepted Corcept's New Drug Application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer on September 10, 2025. Corcept's NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.
Corcept also recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California.