Is Osilodrostat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Osilodrostat, including Isturisa (5 mg, Film-coated tablet, SAR 28499.35); Isturisa (1 mg, Film-coated tablet, SAR 7124.85); Isturisa (10 mg, Film-coated tablet, SAR 30307.15).

Is Osilodrostat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Osilodrostat, including ISTURISA (Prescription); ISTURISA (Discontinued).

Is Osilodrostat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Osilodrostat: Isturisa.

Are there safety signals or safety updates for Osilodrostat?

US FDA: 1 entry (latest 2025-07-03).

Active substance

Osilodrostat

SFDA 3
US FDA 2
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Isturisa	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 28499.35	NCE · Prescription	Recordati Rare Diseases	Valid
Isturisa	1 mg	Film-coated tablet · Oral use	60 Blister	SAR 7124.85	NCE · Prescription	Recordati Rare Diseases	Valid
Isturisa	10 mg	Film-coated tablet · Oral use	60 Blister	SAR 30307.15	NCE · Prescription	Recordati Rare Diseases	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ISTURISA	EQ 1MG BASE; EQ 5MG BASE	tablet · oral	RECORDATI RARE	Prescription	6 Mar 2020
ISTURISA	EQ 10MG BASE	tablet · oral	RECORDATI RARE	Discontinued	6 Mar 2020

EMA European Union — centrally authorised medicines

Isturisa Recordati Rare Diseases · Authorised · authorised 9 Jan 2020 · ATC H02CA02

Therapeutic indication (EMA)

Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ISTURISA	02558912	1 MG	TABLET · ORAL	RECORDATI RARE DISEASES CANADA INC
ISTURISA	02558920	5 MG	TABLET · ORAL	RECORDATI RARE DISEASES CANADA INC
ISTURISA	02558939	10 MG	TABLET · ORAL	RECORDATI RARE DISEASES CANADA INC

Safety signals and safety-related labeling changes

US FDA 3 Jul 2025 ISTURISA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for osilodrostat →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.