Overview
Motixafortide is a cyclic peptide hematopoietic stem cell mobilizer used to improve stem cell collection prior to autologous transplantation. Hematopoietic stem cell transplantation (HSCT) is commonly employed in the context of hematologic cancers - high-dose chemotherapy regimens destroy cancerous blood cells, which are then replaced via infusion of the patient's own stem cells (i.e. an autologous transplant). Similar in mechanism to the previously approved plerixafor, motixafortide is an inhibitor of C-X-C Motif Chemokine Receptor 4 (CXCR4), a protein that helps to anchor stem cells to bone marrow matrix. When administered alongside filgrastim, another agent used to aid in stem cell collection, motixafortide enabled the collection of an adequate number of stem cells in ~92% of patients within two apheresis procedures, compared to ~26% of patients receiving only filgrastim. Motixafortide was approved by the FDA in September 2023, in combination with filgrastim, for use in stem cell mobilization prior to autologous stem cell transplant in patients with multiple myeloma. It has also been investigated alongside pembrolizumab for the treatment of pancreatic cancer.
Indication
Motixafortide is indicated for use in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/08/09 | Phase 1 | Recruiting | |||
2024/06/04 | Phase 1 | Recruiting | |||
2022/11/16 | Phase 1 | Completed | |||
2020/09/09 | Phase 2 | Recruiting | Gulam Manji | ||
2017/09/13 | Phase 1 | Active, not recruiting | |||
2017/06/20 | Phase 1 | Completed | |||
2017/05/16 | Phase 1 | Terminated | |||
2016/07/11 | Phase 2 | Completed | |||
2016/05/05 | Phase 2 | Terminated | |||
2015/12/24 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
BioLineRx USA Inc | 82737-073 | SUBCUTANEOUS | 62 mg in 1.7 mL | 9/4/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
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