Is Mavorixafor approved by the US FDA?

Drugs@FDA lists 1 application product line for Mavorixafor, including XOLREMDI (Prescription).

Is Mavorixafor authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mavorixafor: Xolremdi.

Active substance

Mavorixafor

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
XOLREMDI	100MG	capsule · oral	X4 PHARMS	Prescription	26 Apr 2024

EMA European Union — centrally authorised medicines

Xolremdi Norgine B.V. · Authorised · authorised 27 Apr 2026 · ATC L03AX24

Therapeutic indication (EMA)

Xolremdi is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.

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.