Corcept Therapeutics (CORT) said late Monday it filed a new drug application to the US Food and Drug Administration for relacorilant to treat patients with endogenous hypercortisolism.
The application is based on positive results from the Grace trial and confirmatory evidence from the Phase 3 Gradient and long-term extension studies and a phase 2 study in hypercortisolism, the company said.
Hypercortisolism, or Cushing's syndrome, is caused by excessive activity of the hormone cortisol.