Corcept gives FDA new relacorilant data in resubmitted application

Corcept Therapeutics has resubmitted its application to the U.S. Food and Drug Administration (FDA) seeking approval of relacorilant to treat endogenous Cushing’s syndrome, with new analyses as requested by the agency.

The company submitted its initial new drug application in late 2024. It was rejected by the FDA, which asked for additional evidence demonstrating that the therapy’s benefits outweigh its risks.

The resubmitted application includes new analyses of results from the Phase 3 GRACE (NCT03697109) and GRADIENT (NCT04308590) trials showing relacorilant provides sustained reductions in high blood pressure (hypertension) and high blood sugar (hyperglycemia), two clinical manifestations driven by excessive cortisol production in Cushing’s syndrome.

The company expects the resubmission to be reviewed within six months.

“We are pleased to return relacorilant’s NDA to the review process and look forward to working with the Agency to advance relacorilant toward approval as a treatment for patients with Cushing’s syndrome,” Joseph K. Belanoff, MD, Corcept’s CEO, said in a company press release. “Relacorilant has the potential to benefit many patients and it’s important we make it available as quickly as possible. We appreciate the FDA’s ongoing engagement with our application.”

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Cushing’s syndrome is a group of disorders caused by excess cortisol (hypercortisolism). Endogenous Cushing’s syndrome results from problems within the body, most commonly Cushing’s disease, which is caused by pituitary tumors.

Relacorilant selectively blocks glucocorticoid receptors to which cortisol binds to produce its effects. This is expected to prevent Cushing’s symptoms, including hypertension and hyperglycemia.

The GRACE study enrolled people with Cushing’s who had diabetes or high blood pressure and were treated with the medication for about five months. Results showed that patients experienced fast and sustained reductions in blood pressure and clinically meaningful reductions in blood sugar.

The GRADIENT trial enrolled adults whose Cushing’s was caused by a tumor on the adrenal glands, and who were randomly assigned to receive relacolirant or a placebo for about five months. Results showed that patients treated with relacorilant experienced clinically significant reductions in blood pressure, blood sugar, and body weight.

Relacorilant was also well tolerated, and most side effects were mild to moderate.

Data from an open-label extension study (NCT03604198) involving patients who completed previous studies supported the treatment’s long-term safety and efficacy.

Relacorilant has been granted orphan drug status in the U.S. and Europe for endogenous Cushing’s. The designation aims to incentivize the development of treatments for rare conditions.