Motixafortide
Also known as: Aphexda, BL-8040, BSN324, POL6326
Summary
Motixafortide (BL-8040) is a synthetic cyclic peptide CXCR4 antagonist approved in the United States (2023) in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. It demonstrates potent, long-acting CXCR4 blockade enabling robust stem cell mobilization with fewer apheresis sessions compared to G-CSF alone.
Mechanism of Action
Selectively and reversibly blocks the CXCR4 chemokine receptor, inhibiting the CXCL12/SDF-1 signaling axis, thereby mobilizing hematopoietic stem cells (HSCs) from the bone marrow into the peripheral blood for collection via apheresis.
Routes of Administration
Goals & Uses
- Hematopoietic stem cell mobilizationHematologyHigh
- Pancreatic cancer treatmentOncologyLow
- Reduction of apheresis sessionsProcedural EfficiencyHigh
- Acute Myeloid Leukemia (AML) TreatmentHematology/OncologyLow
Contraindications
- Active systemic infectionInfectiousModerate
- Hypersensitivity to motixafortide or any excipientAllergyHigh
Adverse Effects
- Injection site reactionsLocalCommon
- Hypersensitivity/anaphylaxisImmunologicalUncommon
- Nausea/vomitingGastrointestinalCommon
- FlushingVascularCommonWarmth and redness of the skin
- Orthostatic hypotensionCardiovascularUncommon
- DizzinessNeurologicCommonFeeling faint, lightheaded, or unsteady
Drug Interactions
- Filgrastim (G-CSF)Low
- PlerixaforModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- LactationReproductiveRelative
Regulatory Status
- European UnionInvestigationalNot approved as of 2024; regulatory submissions under evaluation.
- United StatesApprovedApproved: Mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma, in combination with filgrastimFDA approved August 2023; Orphan Drug Designation. Brand name: Aphexda (BioLineRx / Motus Therapeutics).
- United KingdomUnknownNo MHRA approval confirmed as of 2024.
FDA approved August 2023 under the brand name Aphexda in combination with filgrastim for HSC mobilization in multiple myeloma patients. Orphan Drug Designation granted. Not yet approved in EU or UK as of 2024.
Evidence & Sources
No sources recorded yet.