Is Vorasidenib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Vorasidenib, including Voranigo (10 mg, Film-coated tablet, SAR 57172.50); Voranigo (40 mg, Film-coated tablet, SAR 114345.00).

Is Vorasidenib approved by the US FDA?

Drugs@FDA lists 1 application product line for Vorasidenib, including VORANIGO (Prescription).

Is Vorasidenib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vorasidenib: Voranigo.

Are there safety signals or safety updates for Vorasidenib?

US FDA: 1 entry (latest 2026-06-10).

Active substance

Vorasidenib

SFDA 2
US FDA 1
EMA 1
Health Canada 2
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
Voranigo	10 mg	Film-coated tablet · Oral use	30 Bottle	SAR 57172.50	NCE · Prescription	LES LABORATOIRES SERVIER	Valid
Voranigo	40 mg	Film-coated tablet · Oral use	30 Bottle	SAR 114345.00	NCE · Prescription	LES LABORATOIRES SERVIER	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
VORANIGO	10MG; 40MG	tablet · oral	SERVIER	Prescription	6 Aug 2024

EMA European Union — centrally authorised medicines

Voranigo Les Laboratoires Servier · Authorised · authorised 17 Sep 2025 · ATC L01XM04

Therapeutic indication (EMA)

Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VORANIGO	02551225	10 MG	TABLET · ORAL	SERVIER CANADA INC
VORANIGO	02551233	40 MG	TABLET · ORAL	SERVIER CANADA INC

Safety signals and safety-related labeling changes

US FDA 10 Jun 2026 VORANIGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for vorasidenib →

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.