FDA Accepts New Drug Application for Relacorilant in Ovarian Cancer

The FDA has accepted a new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.

The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.

The development was announced in a news release issued by Corcept Therapeutics, the commercial-stage company behind relacorilant. According to the news release, the FDA has assigned a prescription drug user fee act of July 11, 2026, meaning the agency must respond to the application by then.

“The FDA's acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease,” said Dr. Joseph Belanoff, Corcept’s Chief Executive Officer, in a statement included in the news release. “Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.”

Relacorilant, as explained by the National Cancer Institute on its website, binds to and blocks glucocorticoid receptor proteins, decreasing the negative effects resulting from excess levels of endogenous glucocorticoids such as those seen when tumors overproduce glucocorticoids. Additionally, inhibition with the drug is intended to inhibit the proliferation of glucocorticoid receptor-overexpressing cancer cells.

The NDA from Corcept is supported by positive data from the phase 3 ROSELLA and phase 2 clinical trials where patients who were treated with relacorilant plus nab-paclitaxel chemotherapy saw improvements in progression-free survival and overall survival versus patients who received chemotherapy monotherapy, according to the news release.

The company stated that the drug was well-tolerated consistent with its known safety profile.

More Relacorilant Clinical Trial Results from ROSELLA

Relacorilant, as previously reported by CURE, in the ROSELLA clinical trial was associated with a 30% lower risk of disease progression for patients treated with relacorilant and nab-paclitaxel versus those who received nab-paclitaxel alone, with median progression-free survival times of 6.5 months versus 5.5 months. Additionally, an interim overall survival analysis showed a significant improvement with relacorilant, with a median of 16 months compared with 11.5 months for patients who received nab-paclitaxel alone.

The research continues. BELLA, a phase 2 clinical trial evaluating the efficacy and safety of the regimen relacorilant plus nab-paclitaxel and Avastin (bevacizumab) among patients with advanced, epithelial ovarian, primary peritoneal or fallopian-tube cancer, has been launched and is currently recruiting patients, according to its listing on clinicaltrials.gov.

BELLA is a phase 2, single-arm, open-label study to evaluate the effectiveness and safety of intermittent dosing of relacorilant in combination with nab-paclitaxel and Avastin among patients with ovarian cancer, according to the listing. With a planned eventual enrollment of approximately 90 patients, the trial has an estimated primary completion date of August 2026, followed by a study completion date of December 2026, according to the listing.

Platinum-resistant cancer, as explained by the National Cancer Institute on its website, is cancer that responds at first to drugs that contain platinum, such as the chemotherapies cisplatin and carboplatin, but then comes back within a certain window of time — in the case of ovarian cancer, if the disease comes back within six months after treatment, it is considered to be platinum resistant.

Platinum-resistant ovarian cancer, according to data presented in the Asian Pacific Journal of Cancer Prevention, is experienced by approximately 20% to 30% of patients, with a median overall survival of approximately 12 to 18 months.

It is estimated that in the United States in 2025, approximately 20,890 women will receive a new diagnosis of ovarian cancer and about 12,730 women will die from the disease, according to statistics presented by the American Cancer Society.

References

1. “FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer,” news release, Sept. 10, 2025; https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0
2. “Relacorilant,” National Cancer Institute; https://www.cancer.gov/publications/dictionaries/cancer-drug/def/relacorilant
3. “Relacorilant Plus Chemo Meets Primary Goal in Ovarian Cancer Trial,” CURE, March 31, 2025; https://www.curetoday.com/view/relacorilant-plus-chemo-meets-primary-goal-in-ovarian-cancer-trial
4. “BELLA Clinical Trial Initiated in Platinum-Resistant Ovarian Cancer,” CURE, April 7, 2025; https://www.curetoday.com/view/bella-clinical-trial-initiated-in-platinum-resistant-ovarian-cancer
5. “Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer;” https://clinicaltrials.gov/study/NCT06906341?cond=%22Peritoneal%20Neoplasms%22&aggFilters=status:not%20rec&rank=1#study-overview
6. “Platinum resistant cancer,” National Cancer Institute; https://www.cancer.gov/publications/dictionaries/cancer-terms/def/platinum-resistant-cancer
7. “Outcomes and Prognostic Factors of Patients with Platinum- Resistant or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer and Peritoneal Cancer,” Asian Pacific Journal of Cancer Prevention; https://journal.waocp.org/article_90588.html
8. “Key Statistics for Ovarian Cancer,” American Cancer Society; https://www.cancer.org/cancer/types/ovarian-cancer/key-statistics.html

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