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Updated: Jul 10, 2025

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Motixafortide: First Approval.

Sheridan M Hoy¹

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

|November 23, 2023

Summary

This summary is machine-generated.

Motixafortide is a novel CXCR4 inhibitor approved for mobilizing hematopoietic stem cells (HSCs) in multiple myeloma patients. This milestone marks a significant advancement in stem cell transplantation and cancer therapy.

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Area of Science:

Oncology
Hematology
Pharmacology

Background:

Motixafortide is a selective CXCR4 inhibitor.
It is developed for hematopoietic stem cell (HSC) mobilization and cancer treatment.

Purpose of the Study:

To summarize the development milestones of motixafortide.
To highlight its recent FDA approval for HSC mobilization in multiple myeloma.

Main Methods:

Review of clinical development data for motixafortide.
Analysis of regulatory submissions and approvals.

Main Results:

Motixafortide approved in the USA on September 11, 2023, with filgrastim for HSC mobilization in multiple myeloma.
Orphan Drug Designation granted for pancreatic cancer and acute myeloid leukemia.

Conclusions:

Motixafortide's approval represents a significant advancement in stem cell mobilization.
Ongoing trials target gene therapy for sickle cell disease, expanding its therapeutic potential.