Overview
Plerixafor is a small-molecule inhibitor of C-X-C chemokine receptor type 4 (CXCR4) that acts as a hematopoietic stem cell mobilizer. It is used to stimulate the release of stem cells from the bone marrow into the blood in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma to stimulate their immune system. These stem cells are then collected and used in autologous stem cell transplantation to replace blood-forming cells destroyed by chemotherapy. As an inhibitor of CXCR4, plerixafor blocks the binding of its ligand, stromal cell-derived factor-1-alpha (SDF-1α). Since CXCR4 and SDF-1α are involved in the trafficking and homing of CD34+ cells to the marrow compartment, blocking this interaction leads to an increase in CD34+ cell circulating levels. Compared to placebo with G-CSF, the plerixafor and G-CSF mobilization regimen has a higher probability of achieving the optimal CD34+ cell target for tandem transplantation in fewer apheresis procedures. Plerixafor has orphan drug status in the United States and European Union and was approved by the US Food and Drug Administration on December 15, 2008.
Background
Plerixafor is a small-molecule inhibitor of C-X-C chemokine receptor type 4 (CXCR4) that acts as a hematopoietic stem cell mobilizer. It is used to stimulate the release of stem cells from the bone marrow into the blood in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma to stimulate their immune system. These stem cells are then collected and used in autologous stem cell transplantation to replace blood-forming cells destroyed by chemotherapy. As an inhibitor of CXCR4, plerixafor blocks the binding of its ligand, stromal cell-derived factor-1-alpha (SDF-1α). Since CXCR4 and SDF-1α are involved in the trafficking and homing of CD34+ cells to the marrow compartment, blocking this interaction leads to an increase in CD34+ cell circulating levels. Compared to placebo with G-CSF, the plerixafor and G-CSF mobilization regimen has a higher probability of achieving the optimal CD34+ cell target for tandem transplantation in fewer apheresis procedures. Plerixafor has orphan drug status in the United States and European Union and was approved by the US Food and Drug Administration on December 15, 2008.
Indication
Plerixafor is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma or multiple myeloma.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/17 | Phase 1 | Recruiting | |||
2024/05/16 | Early Phase 1 | Recruiting | |||
2024/03/22 | Phase 1 | Suspended | |||
2024/01/17 | Phase 2 | Recruiting | |||
2023/12/06 | Phase 1 | Recruiting | |||
2023/11/21 | Phase 2 | Active, not recruiting | |||
2022/07/22 | Phase 1 | Recruiting | |||
2022/07/06 | Phase 2 | Terminated | Ensoma | ||
2022/06/09 | Phase 2 | Withdrawn | |||
2022/05/03 | Phase 1 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Teva Pharmaceuticals, Inc. | 0480-4320 | SUBCUTANEOUS | 24 mg in 1.2 mL | 1/1/2024 | |
Meitheal Pharmaceuticals Inc. | 71288-155 | SUBCUTANEOUS | 24 mg in 1.2 mL | 2/21/2023 | |
Zydus Pharmaceuticals USA Inc. | 70710-1208 | SUBCUTANEOUS | 24 mg in 1.2 mL | 10/3/2023 | |
sanofi-aventis U.S. LLC | 0024-5862 | SUBCUTANEOUS | 24 mg in 1.2 mL | 9/30/2023 | |
Dr. Reddy's Laboratories Inc | 43598-308 | SUBCUTANEOUS | 24 mg in 1.2 mL | 9/30/2023 | |
Zydus Lifesciences Limited | 70771-1776 | SUBCUTANEOUS | 24 mg in 1.2 mL | 7/28/2023 | |
Fresenius Kabi Usa, LLC | 65219-284 | SUBCUTANEOUS | 24 mg in 1.2 mL | 9/30/2023 | |
Eugia US LLC | 55150-356 | SUBCUTANEOUS | 24 mg in 1.2 mL | 8/2/2023 | |
Amneal Pharmaceuticals LLC | 70121-1694 | SUBCUTANEOUS | 24 mg in 1.2 mL | 12/26/2023 | |
Novadoz Pharmaceuticals LLC | 72205-249 | SUBCUTANEOUS | 24 mg in 1.2 mL | 5/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/16/2022 | ||
Authorised | 7/30/2009 | ||
Authorised | 7/30/2009 | ||
Authorised | 12/16/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Mozobil Solution for Injection 20mg/ml | SIN13894P | INJECTION, SOLUTION | 20mg/ml | 12/13/2010 | |
PLERISTEM SOLUTION FOR INJECTION 20MG/ML | SIN16879P | INJECTION, SOLUTION | 20mg/mL | 10/10/2023 | |
Plerixafor-AFT solution for injection 24 mg/1.2 mL | SIN17147P | INJECTION, SOLUTION | 24 mg/1.2 mL | 12/12/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Plerixafor Injection | 国药准字H20223333 | 化学药品 | 注射剂 | 5/25/2022 | |
Plerixafor Injection | 国药准字HJ20200037 | 化学药品 | 注射剂 | 5/16/2023 | |
Plerixafor Injection | 国药准字H20223309 | 化学药品 | 注射剂 | 5/10/2022 | |
Plerixafor Injection | 国药准字H20223433 | 化学药品 | 注射剂 | 6/28/2022 | |
Plerixafor Injection | 国药准字H20244973 | 化学药品 | 注射剂 | 9/26/2024 | |
Plerixafor Injection | 国药准字H20244761 | 化学药品 | 注射剂 | 8/27/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
MOZOBIL plerixafor 20 mg/mL solution for injection, type I clear glass vial | 158423 | Medicine | A | 5/31/2010 | |
PLERIXAFOR EPSL plerixafor 24 mg/ 1.2 mL solution for injection vial | 403667 | Medicine | A | 2/6/2024 | |
Plerixafor-AFT plerixafor 24 mg/1.2 mL solution for injection vial | 405030 | Medicine | A | 3/21/2024 | |
PLERIXAFOR ARX plerixafor 24 mg/1.2 mL solution for injection vial | 319845 | Medicine | A | 8/12/2020 | |
PLERIXAFOR EUGIA plerixafor 24 mg/ 1.2 mL solution for injection vial | 403666 | Medicine | A | 2/6/2024 | |
EUG-PLERIXAFOR plerixafor 24 mg/ 1.2 mL solution for injection vial | 403668 | Medicine | A | 2/6/2024 |