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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: 05 Mar 2026

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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

  • 17 Feb 2026 According to Recordati media release, Isturisa was granted regulatory approval in both Canada and Russia, in Q2 2025.
  • 13 Jan 2026 According to Recordati media release, the company announced the Canadian product availability of ISTURISA (osilodrostat) for the treatment of adult patients with Cushing's disease who have persistent or recurrent hypercortisolism following pituitary surgery and/or irradiation, or for whom surgery is not an option.
  • 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.

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