Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant, its proprietary selective cortisol modulator, to treat patients with endogenous hypercortisolism (Cushing's syndrome). This submission marks a critical step towards potential market approval for the drug.
The NDA is supported by positive results from the pivotal GRACE trial, along with confirmatory evidence from the Phase 3 GRADIENT and long-term extension studies, and a Phase 2 study in hypercortisolism. These trials demonstrated that relacorilant improved a wide array of hypercortisolism's signs and symptoms.
Relacorilant's clinical data highlighted an acceptable safety profile, notably avoiding serious adverse events such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, which can occur with currently approved medications. The drug also showed no adverse events associated with progesterone receptor activity, such as endometrial thickening or vaginal bleeding.
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