REDWOOD CITY, Calif., June 17, 2026
Corcept Therapeutics Incorporated announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of relacorilant as a treatment for patients with Cushing’s syndrome, also known as hypercortisolism. The resubmission follows the FDA’s request for additional analyses of previously submitted clinical data rather than new clinical studies. According to the company, the updated application includes expanded analyses from the original submission, and Corcept expects the FDA to conduct a six-month review. The NDA is supported by data from the pivotal GRACE study, the Phase 3 GRADIENT trial, long-term extension studies, and earlier clinical development programs. If approved, relacorilant could provide a new treatment option for patients living with a serious endocrine disorder caused by excessive cortisol activity, addressing significant unmet medical needs while expanding Corcept’s cortisol modulation portfolio.
Phase 3 Clinical Data Demonstrate Durable Benefits
The NDA resubmission is built upon a comprehensive clinical development program that evaluated relacorilant across multiple studies. Corcept reported that data from the Phase 3 GRADIENT trial, a randomized, double-blind, placebo-controlled study, together with findings from the pivotal GRACE trial and long-term follow-up analyses, demonstrated meaningful and durable improvements in the signs and symptoms of Cushing’s syndrome. The company also highlighted an important potential safety advantage, stating that relacorilant did not demonstrate several serious adverse events commonly associated with currently approved therapies, including adrenal insufficiency, hypokalemia, QT prolongation, pregnancy termination, endometrial hypertrophy, and vaginal bleeding. As a selective glucocorticoid receptor antagonist, relacorilant is designed to modulate cortisol activity without interacting with other hormone receptors, offering a targeted therapeutic approach that may improve long-term disease management while minimizing off-target hormonal effects.
Addressing a Serious Endocrine Disorder with High Unmet Need
Cushing’s syndrome is a rare but potentially life-threatening disorder caused by prolonged exposure to excessive levels of the hormone cortisol. Patients commonly experience hypertension, central obesity, uncontrolled diabetes, muscle weakness, severe fatigue, anxiety, depression, and cognitive impairment, while untreated disease significantly increases the risk of cardiovascular complications, the leading cause of mortality in affected patients. Recent research suggests the condition may be more common than previously recognized, increasing the importance of expanding available treatment options. Relacorilant has already received Orphan Drug Designation from both the FDA and the European Commission for the treatment of hypercortisolism, recognizing its potential to address a rare disease with limited therapeutic alternatives. The investigational therapy is also protected by multiple patents covering composition, methods of use, and related intellectual property.
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Corcept Expands Cortisol-Modulating Therapeutic Portfolio
The NDA resubmission represents another milestone in Corcept Therapeutics’ long-standing strategy of developing medicines that selectively modulate the effects of cortisol across endocrine, oncology, metabolic, neurological, and inflammatory diseases. The company previously introduced Korlym®, the first FDA-approved treatment for endogenous Cushing’s syndrome, and in 2026 received FDA approval for Lifyorli™ (relacorilant) in combination with nab-paclitaxel for platinum-resistant ovarian cancer. Corcept has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant in ovarian cancer while continuing advanced clinical research across additional disease areas, including amyotrophic lateral sclerosis (ALS) and liver disease. With the FDA review process now restarted, Corcept aims to bring relacorilant to patients with Cushing’s syndrome, potentially providing a differentiated treatment option that combines clinical efficacy, durable symptom control, and an improved safety profile.
Source: Corcept Therapeutics press release
