Overview
Rabbit anti-thymocyte globulin. Thymoglobulin is a polyclonal antibody that suppresses certain types of immune cells responsible for acute organ rejection in transplant patients. Thymoglobulin is a mixture of antibodies intended to bind to various cell surface antigens. The most common mode of action of Thymoglobulin is via selective depletion of T-cells.
Background
Rabbit anti-thymocyte globulin. Thymoglobulin is a polyclonal antibody that suppresses certain types of immune cells responsible for acute organ rejection in transplant patients. Thymoglobulin is a mixture of antibodies intended to bind to various cell surface antigens. The most common mode of action of Thymoglobulin is via selective depletion of T-cells.
Indication
For prevention of renal transplant rejection
Associated Conditions
- Rejection Acute Renal
Research Report
Antithymocyte Immunoglobulin (Rabbit) Report
Name: Antithymocyte immunoglobulin (rabbit) Name (English): Antithymocyte immunoglobulin (rabbit) DrugBank ID: DB00098 Type: Biotech CAS Number: 308067-60-9
Summary: Antithymocyte immunoglobulin (rabbit), also known as rabbit anti-thymocyte globulin (rATG) or Thymoglobulin, is a purified polyclonal antibody obtained from rabbits immunized with human thymocytes. It is an immunosuppressive medication used to prevent and treat acute rejection in kidney transplant patients. rATG works by depleting T-lymphocytes, which are key mediators of transplant rejection, through complement-mediated cytotoxicity and apoptosis.
Pharmacology:
- Mechanism of Action: rATG binds to various cell surface antigens on T-lymphocytes, leading to their depletion. This reduces the host immune response against the transplanted organ.
- Indication: Prophylaxis and treatment of acute rejection in kidney transplant recipients. Off-label uses include treatment of acute graft-versus-host disease (GVHD), severe aplastic anemia, and as part of conditioning regimens for stem cell transplantation.
- Pharmacokinetics: T-cell depletion is usually observed within one day of initiating therapy. The half-life is reported to be 2-3 days and may increase with multiple doses. rATG is likely removed by opsonization via the reticuloendothelial system or by the production of human anti-rabbit antibodies.
Adverse Reactions: Common adverse reactions include fever, chills, leukopenia, thrombocytopenia, infections (including urinary tract infections), hypertension, nausea, headache, and anxiety. Serious immune-mediated reactions such as anaphylaxis and cytokine release syndrome can occur.
Drug Interactions: rATG can increase the immunosuppressive effects and the risk of infection when used with other immunosuppressants like canakinumab and rilonacept.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/23 | Phase 1 | Not yet recruiting | |||
2025/03/12 | Phase 2 | Recruiting | |||
2024/05/14 | Phase 2 | Recruiting | |||
2024/04/18 | N/A | Recruiting | Mario Negri Institute for Pharmacological Research | ||
2024/04/15 | Phase 2 | Completed | |||
2024/03/18 | Phase 2 | Not yet recruiting | |||
2024/03/07 | Phase 1 | Recruiting | Instituto Nacional de Cancer, Brazil | ||
2024/02/28 | Phase 1 | Not yet recruiting | |||
2024/02/20 | Phase 2 | Recruiting | |||
2023/10/31 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genzyme Corporation | 58468-0080 | INTRAVENOUS | 5 mg in 1 mL | 3/31/2023 |
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 |
|---|---|---|---|---|---|
| Thymoglobuline 5mg/ml Powder for concentrate for solution for infusion | SIN03951P | INJECTION, POWDER, FOR SOLUTION | 25 mg/vial | 3/7/1990 | |
| GRAFALON 20 mg/ml | SIN05994P | INFUSION, SOLUTION CONCENTRATE | 20 mg/ml | 5/27/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rabbit Anti-human Thymocyte Immunoglobulin | 国药准字SJ20150035 | 生物制品 | 注射剂 | 10/8/2024 | |
| Rabbit Anti-human Thymocyte Immunoglobulin | 国药准字SJ20150036 | 生物制品 | 注射剂 | 10/8/2024 | |
| Rabbit Anti-human Thymocyte Immunoglobulin | S20150036 | 生物制品 | 注射剂 | 4/24/2020 | |
| Rabbit Anti-human Thymocyte Immunoglobulin | S20150035 | 生物制品 | 注射剂 | 4/24/2020 |
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. | |||||