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An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

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Trial Profile

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Status: Active, no longer recruiting
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
  • Acronyms CORT125134-452
  • 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 phase 2 study of endogenous hypercortisolism, and this trials data.
  • 16 Dec 2024 According to Corcept Therapeutics Incorporated media release,the company plans to submit new drug application (NDA) in December 2024.

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