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Plerixafor

Generic Name
Plerixafor
Brand Names
Mozobil, Plerixafor Accord
Drug Type
Small Molecule
Chemical Formula
C28H54N8
CAS Number
110078-46-1
Unique Ingredient Identifier
S915P5499N

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

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.
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