Is Treosulfan approved by the US FDA?

Drugs@FDA lists 1 application product line for Treosulfan, including GRAFAPEX (Prescription).

Is Treosulfan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Treosulfan: Trecondi.

Active substance

Treosulfan

US FDA 1
EMA 1
Health Canada 2

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

Product	Strength	Form · route	Applicant	Status	First approved
GRAFAPEX	1GM/VIAL; 5GM/VIAL	powder · intravenous	MEDEXUS	Prescription	21 Jan 2025

EMA European Union — centrally authorised medicines

Trecondi medac Gesellschaft für klinische Spezialpräparate mbH · Authorised · authorised 20 Jun 2019 · ATC L01AB02

Therapeutic indication (EMA)

Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRECONDYV	02517388	5 G / VIAL	POWDER · INTRAVENOUS	MEDEXUS PHARMACEUTICALS INC.
TREOSULFAN FOR INJECTION	02560585	5 G / VIAL	POWDER · INTRAVENOUS	MARCAN PHARMACEUTICALS INC

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.