Corcept Will Seek FDA Approval of Relacorilant in 2023
Corcept Therapeutics is on track to ask the U.S. Food and Drug Administration (FDA) to approve the investigational therapy relacorilant to treat Cushing’s syndrome by the middle of next year, the company announced.
Cushing’s syndrome is characterized by excessive levels of the stress hormone cortisol, which causes a range of effects by binding to cells’ protein receptors, ultimately causing symptoms such as weight gain. Cushing’s disease is a particular form of the syndrome that is caused by a tumor in the brain’s pituitary gland.
Relacorilant is an experimental oral medication designed to block one of cortisol’s receptors, called the glucocorticoid receptor, thereby decreasing the effects of the hormone’s excess levels.
Corcept is conducting two Phase 3 clinical trials to test the safety and effectiveness of relacorilant in people with Cushing’s syndrome.
One trial, GRADIENT (NCT04308590), seeks to enroll about 130 people with Cushing’s syndrome that’s caused by a tumor in the adrenal glands, which sit atop the kidneys and are responsible for cortisol production. The other, called GRACE (NCT03697109), wants to enroll about 130 people with Cushing’s of any underlying cause who have type 2 diabetes, impaired glucose tolerance, and/or high blood pressure.
Both GRADIENT and GRACE are enrolling participants at study sites across North America, Europe, and Israel.
“Our Phase 3 GRACE and GRADIENT trials continue to accrue patients and generate data,” Bill Guyer, Corcept’s chief development officer, said in a press release.
“We expect GRACE to serve as the basis for relacorilant’s new drug application in Cushing’s syndrome, and we are on track to make this submission [to the FDA] in the second quarter of 2023,” Guyer said. “GRADIENT is on track to produce valuable data about an etiology of Cushing’s syndrome that affects many patients, but has not been subject to rigorous, controlled study.”
Corcept markets a therapy called Korlym (mifepristone) that is approved to manage hyperglycemia, or high blood sugar, in adults with Cushing’s syndrome who have type 2 diabetes or glucose intolerance, and for whom surgery was not an option or ineffective.
Corcept reported $366 million in revenue last year, and expects its revenue this year to surpass $400 million.
“Korlym is an excellent treatment for Cushing’s syndrome and there are many eligible patients who have yet to receive it,” said Joseph K. Belanoff, MD, Corcept’s CEO. “As pandemic restrictions and fears recede, as they already have in certain locations, we expect our growth to continue.”