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Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome

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Trial Profile

Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Relacorilant (Primary)
  • Indications Cushing syndrome
  • Focus Adverse reactions
  • Sponsors Corcept Therapeutics

    • Most Recent Events

    • 03 Mar 2025 According to a Corcept Therapeutics media release, U.S. Food and Drug Administration (FDA) filed its New Drug Application (NDA) submission for Relacorilant and FDA also assigns a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
    • 30 Dec 2024 According to a Corcept Therapeutics media release, the company has submitted a new drug application (NDA) to the U.S. FDA for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushings syndrome), based on GRACE, GRADIENT, a long-term extension study of endogenous hypercortisolism and this trials data.
    • 18 Apr 2019 According to a Corcept Therapeutics media release, the data will be presented at the 2019 American Association of Clinical Endocrinologists 28th Annual Congress

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