Relacorilant Advances in Platinum-Resistant Ovarian Cancer: Corcept's NDA Submission Marks New Hope for 20,000 Annual Patients

Clinical Breakthrough in Treatment-Resistant Ovarian Cancer

Corcept Therapeutics has officially submitted a New Drug Application (NDA) to the FDA for relacorilant, a selective cortisol modulator, targeting platinum-resistant ovarian cancer. The submission is grounded in compelling clinical evidence from pivotal Phase 3 ROSELLA and Phase 2 trials, where the combination of relacorilant with nab-paclitaxel demonstrated meaningful improvements in both progression-free survival and overall survival compared to nab-paclitaxel alone. Notably, these benefits were achieved without requiring patient biomarker selection, potentially broadening accessibility for eligible populations.

Safety Profile and Tolerability

One of relacorilant’s key advantages lies in its favorable safety profile. The clinical trials revealed that relacorilant did not increase the adverse event burden for patients. The type, frequency, and severity of side effects observed in combination therapy arms remained comparable to those seen with single-agent nab-paclitaxel treatment. This consistency in safety outcomes is particularly significant for oncology patients already managing treatment-related toxicities, making relacorilant a well-tolerated addition to existing chemotherapy regimens.

Understanding Cortisol’s Role in Cancer Resistance

The biological rationale supporting relacorilant’s development centers on cortisol’s multifaceted role in tumor biology. Cortisol impairs the effectiveness of chemotherapy by suppressing apoptosis — the programmed cell death mechanism that chemotherapy aims to trigger. Additionally, in certain malignancies, elevated cortisol can stimulate oncogenes, accelerating tumor progression. Beyond direct tumor effects, cortisol dampens immune function, reducing the body’s natural capacity to combat malignant disease. By modulating cortisol activity through glucocorticoid receptor antagonism, relacorilant addresses these mechanisms simultaneously.

Market Opportunity and Patient Population

Platinum-resistant ovarian cancer represents a significant clinical challenge. Ovarian cancer ranks as the fifth leading cause of cancer mortality among women, and patients whose disease progresses within six months of platinum-based chemotherapy face limited therapeutic options. Current standard single-agent chemotherapy yields a median overall survival of approximately 12 months following recurrence. Annually in the United States alone, roughly 20,000 women with platinum-resistant disease require new therapeutic approaches, with comparable numbers in Europe, underscoring the substantial unmet medical need.

Broader Development Pipeline

Beyond ovarian cancer, Corcept is simultaneously advancing relacorilant through clinical development in endogenous hypercortisolism and prostate cancer. The FDA has designated a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 for relacorilant’s hypercortisolism indication. Additionally, the compound carries orphan drug designation from both the FDA and European Commission for hypercortisolism treatment, with EC orphan status also granted for ovarian cancer applications.

About Corcept’s Research Foundation

Corcept Therapeutics has dedicated over 25 years to cortisol modulation research, resulting in the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. The company achieved a landmark milestone in February 2012 with FDA approval of Korlym®, becoming the first medication authorized for treating endogenous hypercortisolism. Currently, Corcept maintains advanced clinical trials in hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS), and liver disease. The organization is headquartered in Redwood City, California, and continues expanding its clinical development programs.

“This submission represents a significant milestone for Corcept as we now have two NDAs under FDA review — relacorilant for platinum-resistant ovarian cancer combined with nab-paclitaxel and relacorilant for hypercortisolism treatment,” stated Joseph K. Belanoff, M.D., Chief Executive Officer of Corcept Therapeutics. “Enhanced therapeutic options are urgently needed for patients battling these conditions. Our oncology and endocrinology divisions are actively preparing for relacorilant’s potential availability immediately following regulatory authorization.”