ISTURISA osilodrostat

Drug Class

Cortisol synthesis inhibitor

Mechanism

Osilodrostat is an inhibitor of 11-beta-hydroxylase, the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland.

Approved Indication

Treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative; and endogenous hypercortisolemia in adults with Cushing's syndrome.

What This Means For Patients

ISTURISA is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2020) — Sources
• EMA — Approved (2020) — Sources

Pivotal Clinical Evidence

• LINC-3 — Biller et al., Lancet Diabetes Endocrinol 2020 (NCT02180217) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212801s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/isturisa
• https://doi.org/10.1016/S2213-8587(20)30240-0