Overview
Temsirolimus is a derivative of sirolimus used in the treatment of renal cell carcinoma (RCC). It was developed by Wyeth Pharmaceuticals under the trade name Torisel. Temsirolimus was approved by the FDA in late May 2007 as well as the European Medicines Agency (EMEA) on November 2007.
Indication
For the treatment of renal cell carcinoma (RCC). Also investigated for use/treatment in breast cancer, lymphoma (unspecified), rheumatoid arthritis, and multiple myeloma.
Associated Conditions
- Advanced Renal Cell Carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/17 | Early Phase 1 | Recruiting | Nader Sanai | ||
2020/06/16 | Phase 3 | Not yet recruiting | |||
2019/12/13 | Not Applicable | Recruiting | |||
2019/05/08 | Phase 2 | Terminated | |||
2018/06/27 | Not Applicable | Recruiting | University Hospital, Grenoble | ||
2017/09/29 | Phase 2 | Recruiting | |||
2017/06/29 | Phase 1 | Recruiting | |||
2017/05/18 | Phase 1 | Completed | |||
2016/09/20 | Phase 2 | UNKNOWN | |||
2016/02/26 | Phase 2 | Recruiting |
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 |
|---|---|---|---|
Authorised | 11/19/2007 |
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TORISEL | 02304104 | Solution - Intravenous | 25 MG / ML | 1/11/2008 | |
| GD-TEMSIROLIMUS | genmed a division of pfizer canada ulc | 02441810 | Solution - Intravenous | 25 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TEMSIROLIMUS ACCORD 30 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION EFG | 86058 | CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| TORISEL 30 MG CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | 07424001 | CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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