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Xolremdi (MAVORIXAFOR)
Xolremdi (generic name: MAVORIXAFOR) is a CXC Chemokine Receptor 4 Antagonist [EPC] Small molecule drug developed by X4 Pharms. It is currently FDA-approved (first approved 2024) for WHIM syndrome, warts, hypogammaglobulinemia.
Xolremdi blocks the CXC Chemokine Receptor 4 to treat WHIM syndrome.
At a glance
| Generic name | MAVORIXAFOR |
|---|---|
| Sponsor | X4 Pharms |
| Drug class | CXC Chemokine Receptor 4 Antagonist [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Mavorixafor is an orally bioavailable CXCR4 antagonist that blocks the binding of the CXCR4 ligand, stromal-derived factor-1α (SDF-1α)/CXC Chemokine Ligand 12 (CXCL12). SDF-1/CXCR4 plays a role in trafficking and homing of leukocytes to and from the bone marrow compartment. Gain of function mutations in the CXCR4 receptor gene that occur in patients with WHIM syndrome lead to increased responsiveness to CXCL12 and retention of leukocytes in the bone marrow. Mavorixafor inhibits the response to CXCL12 in both wild‑type and for mutated CXCR4 variants associated with WHIM syndrome. Treatment with mavorixafor results in increased mobilization of leukocytes and lymphocytes from the bone marrow into peripheral circulation.
Approved indications
- WHIM syndrome
- warts
- hypogammaglobulinemia
- infections
- myelokathexis
Common side effects
- Thrombocytopenia
- Pityriasis
- Rash
- Rhinitis
- Epistaxis
- Vomiting
- Dizziness
Drug interactions
- Strong CYP3A4 inhibitors
- Moderate CYP3A4 inhibitors
- Strong CYP3A4 inducers
- P-gp inhibitors
- CYP2D6 substrates
- CYP3A4 substrates
Key clinical trials
- 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 (PHASE3)
- A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders (PHASE1,PHASE2)
- Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome (PHASE3)
- Drug-Drug Interaction Potential of Mavorixafor (PHASE1)
- 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 (PHASE1)
- A Dose Determination and Safety Study of X4P-001 (Mavorixafor) in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome (PHASE2)
- Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma (PHASE1,PHASE2)
- A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4 (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xolremdi CI brief — competitive landscape report
- Xolremdi updates RSS · CI watch RSS
- X4 Pharms portfolio CI
Frequently asked questions about Xolremdi
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Related
- Drug class: All CXC Chemokine Receptor 4 Antagonist [EPC] drugs
- Manufacturer: X4 Pharms — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for WHIM syndrome
- Indication: Drugs for warts
- Indication: Drugs for hypogammaglobulinemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing