Overview
Regramostim (GM-CSF) is a differentially glycosylated factor produced mainly by activated T cells and macrophages. Endothelial cells and fibroblasts can also produce GM-CSF after exposure to TNF-α, IL-1, IL-2 and IFN-γ. GM-CSF is found associated with extracellular matrix and in membrane-bound formats too. GM-CSF stimulates proliferation, activation and differentiation of macrophages and granulocytes and their progenitors.
Background
Regramostim (GM-CSF) is a differentially glycosylated factor produced mainly by activated T cells and macrophages. Endothelial cells and fibroblasts can also produce GM-CSF after exposure to TNF-α, IL-1, IL-2 and IFN-γ. GM-CSF is found associated with extracellular matrix and in membrane-bound formats too. GM-CSF stimulates proliferation, activation and differentiation of macrophages and granulocytes and their progenitors.
Indication
Investigated for use/treatment in adverse effects (chemotherapy) and bone marrow transplant.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/04/01 | Phase 2 | Active, not recruiting | |||
2019/08/28 | Phase 1 | UNKNOWN | Xiangya Hospital of Central South University | ||
2017/04/14 | Phase 2 | Completed | Peking University Cancer Hospital & Institute | ||
2015/12/07 | Phase 2 | Withdrawn | Wuhan University | ||
2015/06/09 | Phase 2 | UNKNOWN | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences | ||
2013/11/14 | Phase 2 | UNKNOWN | Shanghai Pulmonary Hospital, Shanghai, China | ||
2013/03/07 | Phase 2 | UNKNOWN | Wei LUO | ||
2013/02/07 | Phase 4 | Completed | |||
2010/11/02 | Phase 4 | 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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||