Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study - PubMed

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Relacorilant is a selective glucocorticoid receptor modulator designed to treat Cushing's syndrome by reducing excess cortisol activity.
The GRACE study was a phase 3, double-blind, placebo-controlled, randomized-withdrawal trial conducted across 77 centers in 11 countries.
Patients with endogenous hypercortisolism and hypertension or hyperglycemia were enrolled, receiving relacorilant (100-400 mg daily) in an open-label phase followed by a randomized withdrawal phase.
The primary outcome was the proportion of patients losing hypertension control during the withdrawal phase, with relacorilant showing significantly better maintenance of control compared to placebo.
Common adverse events included back pain, acne, arthralgia, bursitis, headache, and insomnia, with no cases of severe glucocorticoid receptor antagonism or adrenal insufficiency.
The study supports relacorilant as a therapeutic option for managing the harmful effects of endogenous hypercortisolism.
Funding and conflicts of interest: The study was funded by Corcept Therapeutics, with several authors reporting ties to pharmaceutical companies including Corcept, Recordati, and others.

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