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Osilodrostat - Recordati

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Drug Profile

Osilodrostat - Recordati

Alternative Names: Isturisa; LCI-699

Latest Information Update: 24 Apr 2025

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At a glance

  • Originator Novartis
  • Developer Novartis; Recordati
  • Class Antihypertensives; Antineoplastics; Antisecretories; Corticosteroids; Fluorobenzenes; Heart failure therapies; Imidazoles; Nitriles; Pyridines; Pyrrolidines; Small molecules
  • Mechanism of Action Aldosterone synthase inhibitors; Steroid 11-beta-hydroxylase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pituitary ACTH hypersecretion; Cushing syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cushing syndrome; Pituitary ACTH hypersecretion
  • Discontinued Heart failure; Hypertension; Solid tumours

Most Recent Events

  • 16 Apr 2025 US FDA approves sNDA for Osilodrostat for Cushing syndrome in USA
  • 30 Sep 2024 Preregistration for Cushing syndrome in China (PO), prior to September 2024
  • 30 Sep 2024 Registered for Cushing syndrome in China (PO)

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