MedPath

Oprelvekin

Generic Name
Oprelvekin
Drug Type
Biotech
CAS Number
145941-26-0
Unique Ingredient Identifier
HM5641GA6F

Overview

Oprelvekin, the active ingredient in Neumega®, is recombinant Interleukin-11 (IL-11), which is produced in Escherichia coli (E. coli) by recombinant DNA technology. With a molecular mass of approximately 19,000 daltons, the non-glycosylated protein is 177 amino acids in length in comparison to the natural IL-11, which is 178 amino acid long. However, it displays comparable biological activity compared to the natural IL-11 in vitro and in vivo. Oprelvekin works by stimulating megakaryocytopoiesis and thrombopoiesis. In mice and nonhuman primate studies of animals with moderate and severe myelosuppression, in addition to compromised hematopoiesis, oprelvekin was shown to potently induce thrombopoiesis and improve platelet nadirs and accelerated platelet recoveries compared to controls. In animal studies, oprelvekin was also shown to regulate intestinal epithelium growth by enhancing healing of gastrointestinal lesions, inhibit adiopegenesis and macrophageal released pro-inflammatory cytokines, and induce acute phase protein synthesis.

Background

Oprelvekin, the active ingredient in Neumega®, is recombinant Interleukin-11 (IL-11), which is produced in Escherichia coli (E. coli) by recombinant DNA technology. With a molecular mass of approximately 19,000 daltons, the non-glycosylated protein is 177 amino acids in length in comparison to the natural IL-11, which is 178 amino acid long. However, it displays comparable biological activity compared to the natural IL-11 in vitro and in vivo. Oprelvekin works by stimulating megakaryocytopoiesis and thrombopoiesis. In mice and nonhuman primate studies of animals with moderate and severe myelosuppression, in addition to compromised hematopoiesis, oprelvekin was shown to potently induce thrombopoiesis and improve platelet nadirs and accelerated platelet recoveries compared to controls. In animal studies, oprelvekin was also shown to regulate intestinal epithelium growth by enhancing healing of gastrointestinal lesions, inhibit adiopegenesis and macrophageal released pro-inflammatory cytokines, and induce acute phase protein synthesis.

Indication

Indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.[Label]

Associated Conditions

  • Severe Thrombocytopenia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/06
Phase 3
Not yet recruiting
2023/01/18
N/A
Completed
Liaoning Tumor Hospital & Institute
2019/01/30
Phase 2
UNKNOWN
2018/10/25
Phase 3
UNKNOWN
2014/12/11
Phase 4
Completed
Shanghai Children's Medical Center
2012/08/13
Phase 3
Completed
2011/03/18
N/A
Withdrawn
Ming Hou
2009/04/23
Phase 2
Terminated
2007/06/28
Phase 2
Completed
2005/09/08
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Recombinant Human Interleukin-2 for Injection
国药准字S10970055
生物制品
注射剂
7/23/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10970084
生物制品
冻干粉针剂
7/13/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10970054
生物制品
注射剂
7/23/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10970086
生物制品
冻干粉针剂
7/13/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10970083
生物制品
冻干粉针剂
7/13/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10970057
生物制品
注射剂
7/23/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10980049
生物制品
注射剂
2/9/2021
Recombinant Human Interleukin-2 for Injection
国药准字S10970018
生物制品
注射剂
8/13/2020
Recombinant Human Interleukin-2 for Injection
国药准字S10980048
生物制品
注射剂
2/9/2021
Recombinant Human Interleukin-2 for Injection
国药准字S10980069
生物制品
注射剂(冻干)
7/15/2020

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
No TGA approvals found for this drug.
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