Torisel(temsirolimus)
Temsirolimus, Torisel (temsirolimus) is a small molecule pharmaceutical. Temsirolimus was first approved as Torisel on 2007-05-30. It is used to treat renal cell carcinoma in the USA. It has been approved in Europe to treat mantle-cell lymphoma and renal cell carcinoma. The pharmaceutical is active against serine/threonine-protein kinase mTOR.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Temsirolimus, Torisel
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Temsirolimus
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TORISEL | CV Sciences | N-022088 RX | 2007-05-30 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| temsirolimus | ANDA | 2024-02-15 |
| torisel | New Drug Application | 2025-03-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| renal cell carcinoma | EFO_0000376 | D002292 | — |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J9330 | Injection, temsirolimus, 1 mg |
Clinical
Clinical Trials
993 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | 1 | 1 | 2 | 8 |
| Kidney transplantation | D016030 | — | — | 1 | 1 | 1 | 1 | 4 | 7 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 3 | — | 1 | — | 5 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | — | — | 1 | 1 | 2 | 4 |
| Graft rejection | D006084 | — | — | 1 | — | — | 1 | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 2 | 3 | — | 7 | 13 |
| Carcinoma | D002277 | — | C80.0 | 1 | 4 | 1 | — | 7 | 12 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | 1 | — | — | 4 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | 2 | — | — | 3 |
| Syndrome | D013577 | — | — | — | 2 | 1 | — | — | 2 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | — | — | 1 | — | — | 1 |
| Brain stem infarctions | D020526 | EFO_1000847 | G46.3 | — | 1 | 1 | — | — | 1 |
| Sturge-weber syndrome | D013341 | Orphanet_3205 | Q85.89 | — | 1 | 1 | — | — | 1 |
| Klippel-trenaunay-weber syndrome | D007715 | EFO_0007334 | Q87.2 | — | 1 | 1 | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 13 | 5 | — | — | — | 17 |
| Head and neck neoplasms | D006258 | — | — | 2 | 1 | — | — | 1 | 3 |
| Recurrence | D012008 | — | — | 2 | 1 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | — | 2 |
| Squamous cell neoplasms | D018307 | — | — | 2 | 1 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 1 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 2 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 2 | — | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | — | — | — | — | 2 |
| Port-wine stain | D019339 | — | Q82.5 | 2 | — | — | — | — | 2 |
| Capillary hemangioma | D018324 | — | Q82.5 | 2 | — | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | — | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | — | — | — | 1 | 1 |
| Viremia | D014766 | — | B34.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Temsirolimus |
| INN | temsirolimus |
| Description | Temsirolimus, sold under the brand name Torisel, is an intravenous drug for the treatment of renal cell carcinoma (RCC), developed by Wyeth Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in May 2007, and was also approved by the European Medicines Agency (EMA) in November 2007. It is a derivative and prodrug of sirolimus.
|
| Classification | Small molecule |
| Drug class | immunosuppressives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CO[C@H]1C[C@@H]2CC[C@@H](C)[C@@](O)(O2)C(=O)C(=O)N2CCCC[C@H]2C(=O)O[C@H]([C@H](C)C[C@@H]2CC[C@@H](OC(=O)C(C)(CO)CO)[C@H](OC)C2)CC(=O)[C@H](C)/C=C(\C)[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)/C=C/C=C/C=C/1C |
Identifiers
| PDB | — |
| CAS-ID | 162635-04-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201182 |
| ChEBI ID | 79699 |
| PubChem CID | 6918289 |
| DrugBank | DB06287 |
| UNII ID | 624KN6GM2T (ChemIDplus, GSRS) |
Target
Agency Approved
MTOR
MTOR
Organism
Homo sapiens
Gene name
MTOR
Gene synonyms
FRAP, FRAP1, FRAP2, RAFT1, RAPT1
NCBI Gene ID
Protein name
serine/threonine-protein kinase mTOR
Protein synonyms
FK506 binding protein 12-rapamycin associated protein 2, FK506-binding protein 12-rapamycin complex-associated protein 1, FKBP-rapamycin associated protein, FKBP12-rapamycin complex-associated protein, FKBP12-rapamycin complex-associated protein 1, Mammalian target of rapamycin, Mechanistic target of rapamycin, mechanistic target of rapamycin (serine/threonine kinase), mTOR, Rapamycin and FKBP12 target 1, rapamycin associated protein FRAP2, Rapamycin target protein 1
Uniprot ID
Mouse ortholog
Mtor (56717)
serine/threonine-protein kinase mTOR (Q9JLN9)
Alternate
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,147 adverse events reported
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