FDA Accepts Relacorilant NDA for Platinum-Resistant Ovarian Cancer

The acceptance of the NDA is based on results from the phase 3 ROSELLA trial and supplemented by other phase 2 trials.

The FDA has accepted a new drug application (NDA) for relacorilant (CORT125134) as a treatment for patients with platinum-resistant ovarian cancer, according to a news release from the drug’s developer, Corcept Therapeutics Incorporated.1

The acceptance of the NDA is based on results from the phase 3 ROSELLA trial (NCT05257408) and supplemented by other phase 2 trials. According to the release, patients received relacorilant in combination with nab-paclitaxel and experienced advantageous progression-free survival (PFS) and overall survival (OS) outcomes compared with those who received nab-paclitaxel monotherapy. Additionally, the experimental agent was well-tolerated, consistent with its known safety profile, and conferred benefit without increasing the safety burden to patients. Adverse effect (AE) type, frequency, and severity was similar between both arms.

Data from the phase 3 ROSELLA trial revealed that the relacorilant combination exhibited a median PFS of 6.54 months (95% CI, 5.55-7.43) vs 5.52 months (95% CI 3.94-5.88) with nab-paclitaxel monotherapy (HR, 0.70; 95% CI, 0.54-0.91; P = .0076).2 The median OS was 15.97 months (95% CI, 13.47- not reached [NR]) with relacorilant vs 11.50 months (95% CI, 10.02-13.57) with control therapy. Additionally, the objective response rate (ORR) was 36.9% vs 30.1% in each respective arm (P = .17), with a 24-week clinical benefit rate (CBR) of 51.1% vs 38.9% (P = .016).

Additionally, the federal agency has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026, for relacorilant as a treatment for platinum-resistant ovarian cancer.

“The FDA's acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease,” Joseph Belanoff, MD, chief executive officer of Corcept Therapeutics, said in the news release.1 “Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.”

Investigators in the open-label phase 3 trial enrolled women 18 years and older with a confirmed diagnosis of platinum-resistant epithelial, ovarian, primary peritoneal, or fallopian tube cancer previously treated with 1 to 3 prior lines of systemic anticancer therapy. Those enrolled were randomly assigned 1:1 to receive nab-paclitaxel with relacorilant or nab-paclitaxel alone.

Relacorilant was administered at a dose of 150 mg orally the day before, of, and following nab-paclitaxel treatment. In the combination group, nab-paclitaxel was given at 80 mg/m2 intravenously vs 100 mg/m2 intravenously in the control group, both at a schedule of days 1, 8, and 15 of each 28-day cycle.

In the investigational and control arms, the median age was 61.0 years (range, 26-85) vs 62.0 years (range, 33-86), with 38% vs 41% being 65 years and older. Most patients were White (72% vs 70%), non-Hispanic (77% vs 76%), and based in Europe (57% vs 56%). Patients mostly had an ECOG performance score of 0 (72% vs 66%), stage I to III cancer at diagnosis (59% vs 59%), BRCA1 and BRCA2 wild-type disease (71% vs 66%), and no prior lines in the platinum-resistant setting (64% vs 58%).

The coprimary end points of the study were PFS per RECIST v1.1 criteria by blinded independent review and OS. Secondary end points included investigator-assessed PFS, ORR, CBR, duration of response, and safety.

Investigators engineered relacorilant as an oral, selective glucocorticoid receptor (GR) antagonist to modulate cortisol activity through binding to the GR but not the body’s other hormone receptors. The developers are assessing the drug in ovarian cancer as well as other disorders including endogenous hypercortisolism and prostate cancer, the former of which has a PDUFA date set for December 30, 2025.

Developers previously submitted a supplemental NDA to the FDA in July 2025 for relacorilant as a treatment for adult patients with platinum-resistant ovarian cancer.3

References

1. FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Incorporated. September 10, 2025. Accessed September 10, 2025. https://tinyurl.com/5yx7cbsp
2. Olawaiye AB, Gladieff L, O'Malley DM, et al. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025;405(10496):2205-2216. doi:10.1016/S0140-6736(25)01040-2
3. Corcept submits new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. News release. Corcept Therapeutics Incorporated. July 14, 2025. Accessed September 10, 2025. https://tinyurl.com/re6betf5