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Isturisa FDA Approval History

Last updated by Judith Stewart, BPharm on April 22, 2025.

FDA Approved: Yes (First approved March 6, 2020)
Brand name: Isturisa
Generic name: osilodrostat
Dosage form: Tablets
Company: Recordati
Treatment for: Cushing's Syndrome

Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Development timeline for Isturisa

DateArticle
Apr 16, 2025Approval FDA Grants Isturisa (osilodrostat) Expanded Indication for the Treatment of Endogenous Hypercortisolemia in Patients with Cushing’s Syndrome
Mar  8, 2020Approval FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease

Further information

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