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Osilodrostat - Novartis

Drug Profile

Osilodrostat - Novartis

Alternative Names: Isturisa; LCI-699

Latest Information Update: 17 Jan 2020

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At a glance

  • Originator Novartis
  • 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

  • Registered Cushing syndrome
  • Phase III Pituitary ACTH hypersecretion
  • Discontinued Heart failure; Hypertension; Solid tumours

Most Recent Events

  • 15 Jan 2020 Registered for Cushing syndrome in European Union (PO)-first global approval
  • 04 Dec 2019 Novartis completes the phase III LINC-3 trial in Pituitary ACTH hypersecretion in USA, Argentina, Australia, Austria, Bulgaria, Colombia, Germany, South Korea, Russia, France, India, Italy, Canada, Austria, Spain, Netherlands, Thailand, Turkey, Japan, United Kingdom and China (PO) (NCT02180217)
  • 14 Nov 2019 Committee for Medicinal Products for Human Use recommends granting approval of osilodrostat, for Cushing syndrome in European union
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