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Peptide

Motixafortide (Aphexda)

Motixafortide is a 14-amino acid cyclic peptide CXCR4 inhibitor for hematopoietic stem cell mobilization. FDA-approved September 2023 in combination with G-CSF for autologous transplant in multiple myeloma. First new stem cell mobilization agent in 15 years. GENESIS Phase 3 trial (n=122): 67.5% achieved collection goal of 6x10^6 CD34+ cells/kg in 2 apheresis sessions vs 9.5% placebo (P<0.0001). High-affinity (Ki 0.32 nM) with sustained mobilization effect (>48 hours).

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Best evidence
Grade A
Conditions studied
1
Outcomes
5
Graded outcomes
3110

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Multiple Myeloma

Multiple Myeloma: outcomes studied for Motixafortide (Aphexda)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Stem Cell Collection Target (Primary)

GENESIS Phase 3 (n=122): 67.5% motixafortide vs 9.5% placebo achieved >=6x10^6 CD34+ cells/kg in 2 apheresis sessions (P<0.0001). By local labs: 92.5% vs 21.4%. Led to FDA approval September 2023.

Improves (the measure goes up)Large effect11 studies

Studies that measured stem cell collection target (primary)

and 1 more in the citations list

CD34+ Cell Yield

GENESIS trial: Significantly higher total CD34+ cells mobilized vs placebo. More patients achieved target in first apheresis. Fewer total apheresis sessions required. First new mobilization agent in 15 years.

Improves (the measure goes up)Large effect11 studies

Studies that measured cd34+ cell yield

and 1 more in the citations list

Safety and Tolerability

GENESIS trial: Most common AEs (>20%) were injection site reactions, flushing, pruritus, back pain. Serious AEs in 5.4%. Manageable safety profile. No increased risks vs standard mobilization.

Improves (the measure goes up)Moderate effect5 studies

Studies that measured safety and tolerability

Allogeneic Donor Mobilization

Allogeneic donor study: 92% (22/24) achieved >=2.0x10^6 CD34+ cells/kg in 2 leukapheresis. 100% (11/11) at 1.25 mg/kg dose. Single injection regimen offers convenience vs repeated plerixafor dosing.

Improves (the measure goes up)Large effect11 studies

Studies that measured allogeneic donor mobilization

and 1 more in the citations list

General

General: outcomes studied for Motixafortide (Aphexda)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Anti-Cancer Activity

4 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Small effect5 studies

Studies that measured anti-cancer activity

Key findings

  • Stem Cell Collection Target (Primary)Multiple MyelomaImproves (the measure goes up)
  • CD34+ Cell YieldMultiple MyelomaImproves (the measure goes up)
  • Safety and TolerabilityMultiple MyelomaImproves (the measure goes up)

Studies cited

14 studies from PubMed

  1. Small molecule and peptide CXCR4 antagonists. A patent review from 2019 to 2024.Expert opinion on therapeutic patents, 2025 · PMID 39925185
  2. A comparative review of Aphexda and Mozobil for mobilization prior to stem cell collection.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2024 · PMID 38629183
  3. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trialNat Med, 2023 · PMID 37069359
  4. Innovations in hematopoietic stem-cell mobilization: a review of the novel CXCR4 inhibitor motixafortideTher Adv Hematol, 2023 · PMID 37250913
  5. Hematopoietic stem cell mobilization for allogeneic stem cell transplantation by motixafortide, a novel CXCR4 inhibitorBlood Adv, 2023 · PMID 37598900
  6. MSX-122: Is an effective small molecule CXCR4 antagonist in cancer therapy?International immunopharmacology, 2022 · PMID 35623288
  7. Hematopoietic stem cell mobilization: a concise reviewJ Cell Physiol, 2021 · PMID 32853612
  8. Biased action of the CXCR4-targeting drug plerixafor is essential for its superior hematopoietic stem cell mobilizationCommun Biol, 2021 · PMID 33958763
  9. At the Bedside: Profiling and treating patients with CXCR4-expressing cancers.Journal of leukocyte biology, 2021 · PMID 33089889
  10. Motixafortide and Pembrolizumab Combined to Nanoliposomal Irinotecan, Fluorouracil, and Folinic Acid in Metastatic Pancreatic Cancer: The COMBAT/KEYNOTE-202 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research, 2021 · PMID 34253578
  11. BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial.Nature medicine, 2020 · PMID 32451495
  12. BKT140 and BKT200 - Second-generation peptide CXCR4 antagonistsImmunol Lett, 2017 · PMID 28284983
  13. BL-8040, a CXCR4 antagonist: effects on progenitor cell release and on-going clinical trialsCurr Opin Hematol, 2015 · PMID 25531072
  14. Plerixafor, a CXCR4 antagonist for the mobilization of hematopoietic stem cellsExpert Opin Investig Drugs, 2009 · PMID 18847313