Shots:
The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism
While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional…
Shots:
Corcept has submitted NDA of relacorilant to the US FDA for the treatment of endogenous hypercortisolism (Cushing’s syndrome)
Submission was based on pivotal GRACE study, confirmatory P-III (GRADIENT) & long-term extension trials plus P-II hypercortisolism trial. Relacorilant showed improved symptoms without adrenal insufficiency, hypokalemia, QT prolongation, or progesterone receptor-related AEs (endometrial thickening or…

