🇪🇺 Osilodrostat (Isturisa) in European Union

EMA authorised Osilodrostat (Isturisa) on 9 January 2020

Marketing authorisation

EMA — authorised 9 January 2020

  • Application: EMEA/H/C/004821
  • Marketing authorisation holder: Recordati Rare Diseases
  • Local brand name: Isturisa
  • Indication: Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.
  • Pathway: orphan
  • Status: approved

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Osilodrostat (Isturisa) in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Endocrinology approved in European Union

Frequently asked questions

Is Osilodrostat (Isturisa) approved in European Union?

Yes. EMA authorised it on 9 January 2020.

Who is the marketing authorisation holder for Osilodrostat (Isturisa) in European Union?

Recordati Rare Diseases holds the EU marketing authorisation.