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OSILODROSTAT PHOSPHATE
CAS NO.: 1315449-72-9
Chemical Formula: C13H13FN3O4P
Molecular Weight: 325.2300
DMF&GMP status: Please contact us for more details.
Description:
Osilodrostat is an orally bioavailable inhibitor of both steroid 11beta-hydroxylase (cytochrome P450 (CYP) 11B1) and aldosterone synthase (CYP11B2; steroid 18-hydroxylase), with potential anti-adrenal activity and ability to treat Cushing disease (CD). Upon administration, osilodrostat binds to and inhibits the activity of CYP11B1, the enzyme that catalyzes the final step of cortisol synthesis from the precursor 11-deoxycortisol, and CYP11B2, the enzyme that catalyzes aldosterone synthesis from corticosterone and 11-deoxycorticosterone in the adrenal gland. The inhibition of CYP11B1 prevents the production of excess cortisol, thereby decreasing and normalizing the levels of cortisol. CD is most often caused by an adrenocorticotropic hormone (ACTH)-secreting pituitary tumor.

Osilodrostat is an inhibitor of 11β-hydroxylase (also referred to as CYP11B1), the enzyme that catalyzes the final step in the biosynthesis of endogenous cortisol. It is used to lower circulating cortisol levels in the treatment of Cushing's disease, a disorder in which cortisol levels are chronically and supraphysiologically elevated. Cushing's disease is often the result of ACTH hypersecretion secondary to a pituitary tumor, and surgical resection of the tumour is generally the treatment of choice. As an orally bioavailable drug therapy, osilodrostat provides a novel treatment option for patients in whom removal of the causative tumor is not an option or for whom previous pituitary surgery has not been curative. Osilodrostat is manufactured by Novartis under the brand name Isturisa. It has undergone phase II clinical trials for the treatment of solid tumours, hypertension, and heart failure, but development for these indications was discontinued by Novartis in January 2013. Osilodrostat was approved for use in the EU in January 2020 for the treatment of endogenous Cushing's syndrome (i.e. Cushing's disease), and was granted FDA approval and Orphan Drug designation in the US in March 2020 for the same indication.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
OSILODROSTAT PHOSPHATETABLET;ORALEQ 1MG BASEISTURISARECORDATI RARE DISEASES INC
OSILODROSTAT PHOSPHATETABLET;ORALEQ 5MG BASEISTURISARECORDATI RARE DISEASES INC
OSILODROSTAT PHOSPHATETABLET;ORALEQ 10MG BASEISTURISARECORDATI RARE DISEASES INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
831409703/27/2029DSDP
860986201/13/2031U-2770
883564608/23/2026DSDP
943475401/13/2031DS
1014368007/06/2035DP
1070969110/12/2035U-2770
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 03/06/2025
ODE-286 03/06/2027