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. |