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Xolremdi

(Mavorixafor)

Phase 3Small molecule

XX4 Pharmaceuticals

Xolremdi is one of 87 small molecule programs targeting Neutropenia. It is currently in Phase 3.

3

Indications

6

Total Trials

2

Active Trials

86

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

6

Patents

Pipeline

Status by Indication[3][1]

Indication

NeutropeniaActive, not recruiting

MacroglobulinemiaActive, not recruiting

WHIM SyndromeCompleted

NeutropeniaPhase 1/Phase 2

Active, not recruiting

MacroglobulinemiaPhase 1

Active, not recruiting

WHIM SyndromePhase 3

Completed

Competition

Competitive Landscape

124 competitors in Neutropenia

#DrugCompanyPhaseTrials

Cubicin

BBaxter Healthcare Corporation

Mycostatin

GGood Molecules, LLC

Caspofungin Acetate

Amphotericin B Deoxycholate

Liposomal Lurtotecan

Alcohol

Medrol

Cytosar

Ellence

G-CSF

AArog Pharmaceuticals, Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Infections

NCT06056297

Clinical

Trials by Indication[1]

Macroglobulinemia1 trial

A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4

Completed·XX4 Pharmaceuticals·Phase 1·NCT04274738·16 enrolled

Interaction1 trial

Drug-Drug Interaction Potential of Mavorixafor

Completed·XX4 Pharmaceuticals·Phase 1·NCT06914869·38 enrolled

Hepatic Impairment (HI)1 trial

A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function

Recruiting·XX4 Pharmaceuticals·Phase 1·NCT06858696·48 enrolled

Infections1 trial

A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

Recruiting·XX4 Pharmaceuticals·Phase 3·NCT06056297·176 enrolled

Neutropenia1 trial

A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders

Completed·XX4 Pharmaceuticals·Phase 1/2·NCT04154488·32 enrolled

1 more indication

WHIM Syndrome1 trial

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

Completed·XX4 Pharmaceuticals·Phase 3·NCT03995108·31 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 26, 2024

XOLREMDI

NDA NDA218709

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Mavorixafor. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mavorixafor compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mavorixafor. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218709). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xolremdi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — X4 Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: XX4 Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Dec 14, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10953003Dec 14, 2036

11219621Dec 22, 2036

10610527Dec 22, 2036

11045461Dec 11, 2038

12115156Dec 11, 2038

1 more patents

10548889Dec 11, 2038

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