Also known as: Aphexda · BL-8040 · BKT140 · 4F-benzoyl-TN14003
Motixafortide (Aphexda) is a 14-residue cyclic peptide that blocks the CXCR4 receptor, releasing blood stem cells from the bone marrow into the bloodstream so they can be collected for transplant. FDA-approved in September 2023, given with filgrastim, to mobilize stem cells for autologous transplantation in multiple myeloma.
Before an autologous stem cell transplant, patients with multiple myeloma need enough of their own blood-forming (CD34+) stem cells collected by apheresis. Filgrastim (G-CSF) alone often falls short. Motixafortide is added as a single injection after four days of filgrastim to push more stem cells out of the marrow.
In the Phase 3 GENESIS trial (Crees et al., Nature Medicine, 2023), 67.5% of patients on motixafortide plus filgrastim collected at least 6 × 10⁶ CD34+ cells/kg within two apheresis sessions, versus 9.5% on placebo plus filgrastim (central-lab assessment; 92.5% vs 21.4% by local-lab assessment). Most patients reached the target in a single apheresis. The FDA approved it on that basis in September 2023.
BioLineRx developed the drug. Since November 2024 Ayrmid (Gamida Cell's parent) holds commercial rights outside Asia, and Gloria Biosciences in Asia. BioLineRx kept rights in solid tumors and is studying it in pancreatic cancer.
Stem cells are held in the bone marrow by the chemokine CXCL12 (SDF-1) binding to the CXCR4 receptor on their surface. Motixafortide binds CXCR4 with high affinity and slow dissociation, breaking that tether so stem cells move into the circulating blood.
Filgrastim expands and loosens the stem cell pool over several days. Motixafortide then delivers a fast, large release within hours, which is why it is dosed 10–14 hours before apheresis.
Despite a plasma half-life of about 2 hours, its slow off-rate at CXCR4 keeps mobilization going long enough to support collection over consecutive days.
Motixafortide is a prescription drug used in transplant centres, not a self-administered peptide. The label warns of anaphylactic-type and injection-site reactions (hence the mandatory premedication), and says it may mobilize leukemic cells, so it should not be used in leukemia. Doses above are from the FDA label for stem cell collection in multiple myeloma only.
Motixafortide is used once per stem cell collection, alongside filgrastim, ahead of an autologous transplant. There is no repeat-dosing or cycling protocol.
Hospital use only. Requires premedication and monitoring for hypersensitivity reactions.
FDA-approved prescription drug, given in hospital or clinic by subcutaneous injection, only with filgrastim, for stem cell collection in multiple myeloma. The label requires premedication (H1 antihistamine, H2 blocker and leukotriene inhibitor) 30–60 minutes before each dose because of injection-site and hypersensitivity reactions. It may mobilize leukemic cells and should not be used in leukemia. It is not a wellness or self-administered peptide.
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