Drug

Mavorixafor

Approved · EMA

Late-stage development

Also known as Xolremdi, 1,4-BUTANEDIAMINE, N-(1H-BENZIMIDAZOL-2-YLMETHYL)-N-((8S)-5,6,7,8-TETRAHYDRO-8-QUINOLINYL)-, 1,4-BUTANEDIAMINE, N1-(1H-BENZIMIDAZOL-2-YLMETHYL)-N1-((8S)-5,6,7,8-TETRAHYDRO-8-QUINOLINYL)-, N1-(1H-BENZIMIDAZOL-2-YLMETHYL)-N1-((S)-5,6,7,8-TETRAHYDROQUINOLIN-8-YL)-BUTANE-1,4-DIAMINE.

RxNorm2684021 ChEMBLCHEMBL518924UNII0G9LGB5O2W

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

Clinical trial2026-06-05Results expected Q3 2027 · ClinicalTrials.gov

Approval: Xolremdi (EMA)

Regulatory2026-04-27EMA

An Open-label, Non-randomized Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function

Clinical trial2026-03-01Primary completion · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Mavorixafor in Patients With WHIM Syndrome With Open-Label Extension

Clinical trial2025-12-23Completed · ClinicalTrials.gov

A Phase I, Randomized, Open-label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of a Moderate and a Strong CYP3A Inducer on the Pharmacokinetics and Safety of Mavorixafor in Healthy Male and Female Participants

Clinical trial2025-05-19Completed · ClinicalTrials.gov

A Phase 1b/2, Open-Label, Multicenter Study of Mavorixafor in Patients With Congenital Neutropenia and Chronic Neutropenia Disorders

Clinical trial2024-08-27Completed · ClinicalTrials.gov

A Phase 1b Trial of Mavorixafor, an Oral CXCR4 Antagonist, in Combination With Ibrutinib in Patients With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4

Clinical trial2022-10-31Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Mavorixafor

Aliases & brands

Xolremdi1,4-BUTANEDIAMINE, N-(1H-BENZIMIDAZOL-2-YLMETHYL)-N-((8S)-5,6,7,8-TETRAHYDRO-8-QUINOLINYL)-1,4-BUTANEDIAMINE, N1-(1H-BENZIMIDAZOL-2-YLMETHYL)-N1-((8S)-5,6,7,8-TETRAHYDRO-8-QUINOLINYL)-N1-(1H-BENZIMIDAZOL-2-YLMETHYL)-N1-((S)-5,6,7,8-TETRAHYDROQUINOLIN-8-YL)-BUTANE-1,4-DIAMINE

RxNorm CUI

2684021

ChEMBL ID

CHEMBL518924

UNII

0G9LGB5O2W

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2026-04-27

Latest approval

2026-04-27

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2026-04-27Approval

Approval: Xolremdi (EMA)

Indication: 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… Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.