Prescription medicine
Mavorixafor Brand names: Xolremdi
Mavorixafor (Xolremdi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the mavorixafor FDA label on DailyMed (effective November 12, 2024, X4 Pharmaceuticals, Inc.); the NDA 218709 record on Drugs@FDA; every mavorixafor label on DailyMed.
Highlights of the record
FDA label of November 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXOLREMDI is indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lympocytes.
Forms and strengths
- 100 mg
Gelatin-coated capsule.
On the market
- Earliest approval on file
- April 26, 2024 Xolremdi, X4 Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 11, 2038 Xolremdi capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8 through July 30, 2026
What is mavorixafor used for?
From the label: indications and usageXOLREMDI is indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lympocytes. XOLREMDI is a CXC chemokine receptor 4 antagonist indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.
FDA pharmacologic class: CXC Chemokine Receptor 4 Antagonist.
Source: FDA drug label (XOLREMDI), NDA218709 (X4 Pharms), as published by X4 Pharmaceuticals, Inc., effective November 12, 2024 (SPL set 7f3a5ee3-ca73-4876-85a0-ed1e108a2237), via openFDA; the full label on DailyMed
Is there a generic for mavorixafor (Xolremdi)?
No generic mavorixafor is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Xolremdi capsules, the last expiring on December 11, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mavorixafor label say about other medicines?
The mavorixafor label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Measure serum digoxin concentrations before initiating concomitant use with XOLREMDI, and continue monitoring serum digoxin concentrations as recommended in the Prescribing Information for digoxin [see Clinical Pharmacology (12.3) ]. Mavorixafor is an inhibitor of P-gp. |
| Metformin | drug interactions | Monitor for glycemic control and adjust the dose of metformin as necessary. |
Source: FDA drug label (XOLREMDI), NDA218709 (X4 Pharms), as published by X4 Pharmaceuticals, Inc., effective November 12, 2024 (SPL set 7f3a5ee3-ca73-4876-85a0-ed1e108a2237), via openFDA; the full label on DailyMed
What do FAERS reports show for mavorixafor?
The FDA Adverse Event Reporting System holds 8 reports that list mavorixafor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Mavorixafor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other