Overview
Equine anti-thymocyte globulin is composed of purified gamma globulin containing primarily IgG against human thymus lymphocytes. It is formed by inoculating a horse with an antigen (human thymoyctes) which then induces the horse immune system's B-lymphocytes to produce IgG immunoglobulins specific for that antigen. The result is polyclonal IgG that is then purified from the horse's serum to produce a usable drug product that can be used for immunosuppression. Although the exact mechanism of action is unknown, equine anti-thymocyte globulin targets a variety of immune system proteins including lymphocyte surface proteins, granulocytes, platelets, bone marrow cells, and other cell types. Equine ATG is currently indicated for the suppression of the immune system to prevent renal transplant rejection and in the treatment of aplastic anemia. Induction of T cell apoptosis and resulting T-cell lymphopenia found in vivo is credited for its therapeutic effect in these conditions. There are currently various ATG products available, which differ in the source of inoculated animal (rabbit, horse, or pig) and in the type of antigen product used to produce immunoglobulin (thymocytes, peripheral T cells, etc.).
Indication
For prevention of renal transplant rejection and for the treatment of aplastic anemia.
Associated Conditions
- Graft-versus-host Disease (GVHD)
- Heart Transplant Rejection
- Kidney Transplant Rejection
- Lung Transplant Rejection
- Moderate Aplastic Anemia
- Myelodysplastic Syndrome
- Severe Aplastic Anemia (SAA)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/09/20 | N/A | ENROLLING_BY_INVITATION | |||
2017/01/19 | Phase 2 | Completed | |||
2014/03/31 | Phase 3 | Completed | |||
2009/11/25 | Phase 2 | Completed |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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ATGAM equine antithymocyte immunoglobulin 250mg/5mL injection ampoule | 12282 | Medicine | A | 8/2/1991 |
Health Canada Drug Approvals
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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