At the European Society for Medical Oncology meeting in 2025, Corcept Pharmaceuticals disclosed late‑breaker results indicating that relacorilant produced a measurable benefit in patients with platinum‑resistant ovarian cancer who had previously been treated with PARP inhibitors. The announcement adds momentum to a drug program that is already navigating parallel regulatory pathways in the United States and the European Union.

Relacorilant is currently under review by the Food and Drug Administration and the European Commission for different indications. The FDA has set a Prescription Drug User Fee Act date of December 30, 2025 for relacorilant as a treatment for hypercortisolism and July 11, 2026 for the indication of platinum‑resistant ovarian cancer. Corcept has also submitted a Marketing Authorization Application to the European Commission seeking approval in the bloc, underscoring the company’s bid to secure approvals on both sides of the Atlantic.

Platinum‑resistant ovarian cancer, defined by disease progression within six months of platinum‑based chemotherapy, represents a major clinical challenge. Patients who have already been treated with PARP inhibitors—a class of targeted agents that became standard in maintenance therapy—have even fewer effective options. The ESMO late‑breaker designation signals that the data merit urgent attention from oncologists and regulators alike.

Details presented at the meeting focused on a patient cohort that had received one or two prior lines of therapy, including PARP inhibition. While the company did not release comprehensive survival or response figures in the initial synopsis, the reported benefit was sufficient to prompt discussions about the therapy’s potential role in this resistant setting. A separate, ongoing study enrolling patients who received one or two prior lines of therapy is expected to yield initial results in late 2026, which will provide more definitive evidence about efficacy and safety in a broader population.

The regulatory timeline frames how rapidly relacorilant could enter clinical practice if approved. The dual PDUFA dates indicate the FDA is conducting separate reviews for two distinct indications, with an earlier decision anticipated for hypercortisolism and a later one for ovarian cancer. An approved Marketing Authorization in Europe would similarly expand access, contingent on the regulator’s assessment of the benefit‑risk profile based on submitted data.

Experts caution that late‑breaking presentations, while important, require careful scrutiny of full data sets. Crucial questions remain about the magnitude and durability of benefit, side‑effect profiles, and how relacorilant would be integrated with existing standards such as chemotherapy, angiogenesis inhibitors, and further targeted agents. The forthcoming trial readouts and regulatory determinations will be pivotal in resolving those uncertainties.

For patients and clinicians confronting platinum‑resistant disease after PARP inhibitor therapy, relacorilant’s emerging data provide a cautiously optimistic prospect. If subsequent trials confirm the initial signals, relacorilant could fill a pressing unmet need in ovarian cancer care and influence regulatory and clinical decision‑making in the next two years.