Overview
A recombinant chimeric (murine/human) monoclonal antibody (IgG1k) that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor a-chain (IL-2R alpha, also known as CD25 antigen) on the surface of activated T-lymphocytes. It is a 144 kDa glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2R alpha.
Indication
For prophylactic treatment of kidney transplant rejection
Associated Conditions
- Rejection Acute Renal
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/28 | Phase 2 | Not yet recruiting | Anhui Provincial Hospital | ||
2024/04/18 | N/A | Recruiting | Mario Negri Institute for Pharmacological Research | ||
2023/10/17 | N/A | Completed | Gang Chen | ||
2023/10/04 | Phase 4 | Recruiting | The First Affiliated Hospital of Soochow University | ||
2022/05/23 | Phase 3 | Not yet recruiting | |||
2021/12/01 | Phase 1 | Active, not recruiting | City of Hope Medical Center | ||
2021/08/19 | Phase 2 | UNKNOWN | Fort Worth Clinical Sciences Working Group | ||
2021/05/04 | Phase 2 | Recruiting | City of Hope Medical Center | ||
2020/05/27 | Phase 4 | Recruiting | |||
2020/04/07 | Phase 2 | UNKNOWN | Beijing Tongren Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0393 | INTRAVENOUS | 10 mg in 2.5 mL | 12/5/2019 | |
| Novartis Pharmaceuticals Corporation | 0078-0331 | INTRAVENOUS | 20 mg in 5 mL | 12/5/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/9/1998 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SIMULECT FOR INJECTION 20 mg/vial | SIN10441P | INJECTION, POWDER, FOR SOLUTION | 20 mg/vial | 11/19/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Basiliximab for Injection | 国药准字SJ20171040 | 生物制品 | 注射剂 | 4/27/2022 |
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 |
|---|---|---|---|---|---|
| SIMULECT basiliximab (rmc) 20mg powder for injection vial and diluent ampoule | 66740 | Medicine | A | 2/18/1999 | |
| SIMULECT basiliximab (rmc) 20mg powder for injection vial | 440470 | Medicine | A | 10/22/2024 |
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