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. MedsAcross supplies Osilodrostat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ISTURISA is 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. ISTURISA 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
Source: US FDA prescribing information
Osilodrostat is a cortisol synthesis inhibitor. It inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. In a Chinese hamster lung cell line V79-4 that overexpresses human CYP11B1, adrenodoxin and adrenodoxin reductase, osilodrostat inhibited the activity of human CYP11B1 dose-dependently with IC50 values of 2.5 ± 0.1 nM (n = 4).
Source: US FDA prescribing information
Correct hypokalemia and hypomagnesemia, and obtain baseline electrocardiogram prior to starting ISTURISA. Initiate dosage at 2 mg orally twice daily, with or without food. Titrate dosage by 1 mg to 2 mg twice daily, no more frequently than every 2 weeks based on rate of cortisol changes, individual tolerability and improvement in signs and symptoms. Maximum recommended dosage is 30 mg twice daily. See Full Prescribing Information for complete titration, laboratory, and dosage modification recommendations. Patients with Hepatic Impairment: Child-Pugh B: Recommended starting dose is 1 mg twice daily. Child-Pugh C: Recommended starting dose is 1 mg once daily in the evening
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Hypocortisolism: Monitor patients closely for hypocortisolism and potentially life-threatening adrenal insufficiency. Dosage reduction or interruption may be necessary. After interruption or discontinuation of ISTURISA, cortisol suppression may persist and patients should be regularly monitored. QTc Prolongation: Perform electrocardiogram in all patients Use with caution in patients with risk factors for QTc prolongation. Elevations in Adrenal Hormone Precursors and Androgens: Monitor for hypokalemia, worsening of hypertension, edema, and hirsutism
Source: US FDA prescribing information
Clinically significant adverse reactions that appear in other sections of the labeling include: Hypocortisolism QT Prolongation Elevations in Adrenal Hormone Precursors and Androgens Most common adverse reactions (incidence > 20%) are adrenal insufficiency, fatigue, nausea, headache, edema, decreased appetite, arthralgia, myalgia, and diarrhea
Source: US FDA prescribing information
CYP3A4 Inhibitor: Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor. CYP3A4 and CYP2B6 Inducers: An increase of ISTURISA dosage may be needed if ISTURISA is used concomitantly with strong CYP3A4 and CYP2B6 inducers. A reduction in ISTURISA dosage may be needed if strong CYP3A4 and CYP2B6 inducers are discontinued while using ISTURISA
Source: US FDA prescribing information
Store at room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F), protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Osilodrostat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Isturisa 1 mg tabletOral | Recordati Rare Diseases | US FDA | Available on request |
| Isturisa 5 mg tabletOral | Recordati Rare Diseases | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Osilodrostat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Osilodrostat, including Isturisa.
Yes. The US FDA first approved Osilodrostat on 6 March 2020, according to Drugs@FDA.
Yes. Osilodrostat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Osilodrostat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Osilodrostat is classified under ATC code H02CA02 (Osilodrostat).
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