Xolremdi

(Mavorixafor)

Phase 3Small molecule

XX4 Pharmaceuticals

Xolremdi is one of 31 small molecule programs targeting Neutropenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

NeutropeniaRecruiting

NeutropeniaPhase 3

Recruiting

Competition

Competitive Landscape

32 competitors in Neutropenia

#DrugCompanyPhaseTrials

Cipro

Bayer

Approved

4 2

Maxipime

Pfizer

Approved

2 3

Merrem

BB. Braun Medical Inc.

Approved

4 4

Levaquin

WWim Janssens

Approved

2 5

Amikin

IInsmed Incorporated

Approved

1 6

Mycamine

BBaxter Healthcare Corporation

Approved

1 7

Abelcet

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

1 8

Avycaz

PPhiladelphia Eye Associates

Approved

1 9

Lithobid

SSolvay Pharmaceuticals

Approved

—10

Noxafil

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

—

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Neutropenia

NCT06056297

Clinical

Trials by Indication[1]

Neutropenia2 trials

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

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

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

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

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 Insufficiency1 trial

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

Completed·XX4 Pharmaceuticals·Phase 1·NCT06858696·39 enrolled

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

Xolremdi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Neutropenia2 trials

Macroglobulinemia1 trial

Interaction1 trial

Hepatic Insufficiency1 trial

WHIM Syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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