Corcept seeks European approval of relacorilant for ovarian cancer
Similar application is under review in US, with decision due in July 2026
Corcept Therapeutics has submitted an application to the European Medicines Agency seeking approval of relacorilant for the treatment of platinum-resistant ovarian cancer.
A similar application is under review in the U.S., with a decision due in July 2026.
“Our … submission brings us a step closer to our goal of delivering relacorilant to patients with platinum-resistant ovarian cancer,” Joseph Belanoff, MD, Corcept’s CEO, said in a company press release.
While awaiting these regulatory decisions, Corcept is also running an open-label Phase 2 trial called BELLA (NCT06906341) that’s testing relacorilant in combination with the standard chemotherapy agent nab-paclitaxel and the antibody-based therapy bevacizumab (sold as Avastin, among others) in adults with platinum-resistant ovarian cancer.
BELLA is recruiting around 90 participants at sites in the U.S., Europe, and South Korea.
“Better treatment options are urgently needed,” Belanoff said. “Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.”
Relacorilant works to make cancer cells more vulnerable to chemotherapy
Surgery combined with platinum-based chemotherapy is a standard first-line treatment approach for ovarian cancer, a form of gynecological cancer characterized by uncontrolled cell growth around the ovaries and fallopian tubes.
However, the cancer can sometimes become resistant to platinum-based medications. For such patients, treatment options are very limited.
Cortisol, the body’s main stress hormone, is thought to help cancer cells resist chemotherapy when it binds to certain receptors on the cells’ surface. It helps cancer cells survive and grow, while also suppressing immune responses that the body needs to kill tumor cells.
Relacorilant works to make cancer cells more vulnerable to chemotherapy by blocking cortisol’s effects at these receptors.
The European Commission has granted the therapy orphan drug status for the treatment of ovarian cancer. This designation offers incentives to expedite relacorilant’s clinical development.
Studies show relacorilant and chemotherapy delay disease progression
The regulatory applications for relacorilant’s approval are supported by data from the pivotal Phase 3 ROSELLA clinical trial (NCT05257408) and earlier Phase 2 studies, which collectively demonstrated that relacorilant, on top of standard chemotherapy, delays disease progression and prolongs survival in adults with platinum-resistant ovarian cancer relative to chemotherapy alone.
ROSELLA enrolled 381 patients who had received one to three prior lines of treatment. All received nab-paclitaxel, with or without relacorilant added on.
The results showed that relacorilant with nab-paclitaxel significantly prolonged the time spent alive without cancer growth — a measure known as progression-free survival — relative to nab-paclitaxel alone.
Overall, people who received relacorilant were at about a 30% lower risk of disease progression than those who did not.
The combination was also associated with prolonged overall survival. After a year, 60% of people given relacorilant were still alive, compared with 49% of the chemotherapy-only group.
Notably, relacorilant was effective regardless of age, previous therapies, and other prognostic markers. Corcept believes that means it can be broadly used in people with platinum-resistant ovarian cancer without the need for a biomarker-based patient selection process.
Relacorilant was also well tolerated, with similar safety findings between the two treatment groups.
In BELLA, participants will all receive a combination of relacorilant, nab-paclitaxel, and bevacizumab, an antibody that works to block the formation of new blood vessels that tumors need to grow and survive.
The main goal is to evaluate progression-free survival, with treatment response rates, overall survival, and safety being secondary outcome measures.
Beyond ovarian cancer, Corcept is testing relacorilant as a possible treatment for prostate cancer. The therapy is also under regulatory review in the U.S. for the treatment of endogenous Cushing’s syndrome, which is marked by excessively high levels of cortisol in the body. That decision is due in December.
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