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Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

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Trial Profile

Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs Osilodrostat (Primary)
  • Indications Pituitary ACTH hypersecretion
  • Focus Registrational; Therapeutic Use
  • Acronyms LINC-3
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 16 Apr 2025 According to Recordati media release, USFDA has approved the supplemental new drug application (sNDA) for ISTURISA (osilodrostat) granting it the expanded indication for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative. This indication expansion was supported by the ISTURISA extensive clinical development program which includes over 350 patients.
  • 13 Feb 2025 According to Recordati media release, the company announced that it has submitted the supplemental New Drug Application (sNDA) for the label extension of osilodrostat (Isturisa) for Cushing syndrome in the U.S. in June 2024, with a regulatory decision expected in mid-2025.
  • 08 Nov 2024 According to Recordati media release, Isturisa new drug application (NDA) was approved by the China National Medical Products Administration (NMPA) in September for the treatment of adult patients with Cushing syndrome.

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