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Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

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Trial Profile

Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Relacorilant (Primary)
  • Indications Cushing syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GRADIENT
  • 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, a phase 2 study of endogenous hypercortisolism, and this trials data.
  • 19 Nov 2024 Status changed from active, no longer recruiting to completed.

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