Corcept asks FDA to OK relacorilant for Cushing’s syndrome
Therapy designed to block specific receptors, inhibiting cortisol activity
Corcept Therapeutics has asked the U.S. Food and Drug Administration (FDA) to approve relacorilant for people with endogenous Cushing’s syndrome.
“Relacorilant’s combination of efficacy and safety give it the potential to become the standard of care for the medical treatment of patients with hypercortisolism,” Joseph Belanoff, MD, CEO of Corcept, said in a company press release. “Our commitment to the health of patients with hypercortisolism is unwavering. We are optimistic that relacorilant will be of great benefit to them.”
Cushing’s syndrome is a broad term encompassing health conditions driven by excessive levels of the hormone cortisol, called hypercortisolism. It’s considered to be endogenous when the underlying cause of hypercortisolism is a problem within the body itself, most often a tumor. Cushing’s disease is a specific form of endogenous Cushing’s caused by a tumor in the pituitary gland.
Cortisol normally exerts its effects by binding to specific cellular receptors. Relacorilant is an oral medication that’s designed to selectively block these receptors, thereby inhibiting the activity of cortisol and easing the cortisol-driven symptoms that characterize Cushing’s.
Results of studies of relacorilant
Corcept’s application is based on data from several clinical trials that tested the medication in people with Cushing’s syndrome. These include a Phase 2 study (NCT02804750), two Phase 3 trials, GRACE (NCT03697109) and GRADIENT (NCT04308590), and an extension study (NCT03604198). Data from the studies indicate relacorilant is able to ease Cushing’s symptoms as designed.
Results from GRACE, which enrolled Cushing’s patients who had cooccurring diabetes or high blood pressure, which are common complications of hypercortisolism, showed the experimental therapy was able to reduce blood pressure. Long-term data from the extension study showed relacorilant was able to help keep blood pressure under control, reduce blood sugar levels, and promote weight loss.
Relacorilant has been generally well tolerated. Corcept pointed out that the therapy didn’t cause adrenal insufficiency, which is reduced activity of the adrenal glands that normally produce cortisol, low potassium levels, called hypokalemia, or a type of heart rhythm abnormality called QT prolongation. All these conditions are potentially serious side effects that have been associated with other Cushing’s treatments. The therapy also hasn’t been associated with side effects related to the activity of the progesterone receptor, such as vaginal bleeding or thickening of the lining of the uterus.
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