Peptide Graded

Motixafortide

Does Motixafortide work?

Yes, in a controlled trial of 122 patients.

AStrong human evidenceFDA approvedas of 2026-10-26

Approval rests on GENESIS, a randomized, double-blind, placebo-controlled phase 3 trial in 122 patients with multiple myeloma in which motixafortide plus filgrastim mobilized the target stem cell dose in far more patients than filgrastim alone. One trial of moderate size supports a narrow indication; the FDA accepted it because the endpoint is objective and the effect was large. Uses in sickle cell disease and solid tumors are in early trials only. 12

GENESIS randomized 122 patients with multiple myeloma who were preparing for autologous transplant. They got motixafortide or placebo, both with filgrastim. The main measure was collecting at least six million CD34-positive stem cells per kilogram in up to two apheresis sessions. In the motixafortide group, 92.5 percent met it. In the placebo group, 26.2 percent did. In a single session, 88.8 percent of the motixafortide group reached the target. On placebo, 9.5 percent did. After transplant, the new cells took hold quickly and lasted in both arms. 1

The trial also found that motixafortide pulled out more primitive stem cells. The authors suggested this may matter for graft quality over the long term. But clinical outcomes did not differ during the trial's follow-up. 1

Evidence checklist

  • Randomised controlled trial GENESIS, double-blind placebo-controlled
  • Human study over 100 people GENESIS, 122 patients
  • More than one research group One pivotal trial from the sponsor
  • Clinical outcomes, not surrogate markers Stem cell collection target reached
  • Human safety data beyond case reports Injection reactions, anaphylaxis documented

Read the full Motixafortide page

More on Motixafortide

Citations

  1. Crees 2023, Nature Medicine: Motixafortide and G-CSF for stem cell mobilization in multiple myeloma (GENESIS) doi.org
  2. FDA 2026: Aphexda (motixafortide) prescribing information accessdata.fda.gov

Reference information only, not medical advice. Drawn from the Motixafortide article, fact-checked against the cited sources. No dosing anywhere on this site.