Torisel(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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Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
neoplasms | D009369 |
urogenital diseases | D000091642 |
hemic and lymphatic diseases | D006425 |
immune system diseases | D007154 |
Trade Name
FDA
EMA
Torisel (generic drugs available since 2018-07-30)
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 |
---|---|---|
torisel | New Drug Application | 2019-12-05 |
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
367 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Kidney transplantation | D016030 | — | 2 | 2 | 6 | — | 10 | ||
Coronary disease | D003327 | — | — | — | 7 | 2 | 9 | ||
Non-hodgkin lymphoma | D008228 | C85.9 | 3 | 6 | — | 1 | — | 8 | |
Graft vs host disease | D006086 | D89.81 | 1 | 3 | 3 | 2 | — | 8 | |
Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | 2 | — | 3 |
Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | 1 | — | 2 |
Communicable diseases | D003141 | — | — | — | 1 | — | 1 | ||
Virus diseases | D014777 | B34 | — | — | — | 1 | — | 1 | |
Inflammation | D007249 | — | — | — | 1 | — | 1 | ||
Graft rejection | D006084 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Renal cell carcinoma | D002292 | 12 | 13 | 3 | — | 5 | 29 | ||
Prostatic neoplasms | D011471 | C61 | 10 | 10 | 1 | — | 1 | 16 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 8 | 7 | 2 | — | — | 15 |
Mantle-cell lymphoma | D020522 | C83.1 | 4 | 6 | 1 | — | 2 | 9 | |
Kidney neoplasms | D007680 | EFO_0003865 | C64 | 4 | 3 | 1 | — | 1 | 9 |
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 5 | 5 | 1 | — | — | 9 |
Tuberous sclerosis | D014402 | HP_0009720 | Q85.1 | 1 | 5 | 3 | — | — | 7 |
Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 4 | 1 | — | — | 6 |
Lymphoma | D008223 | C85.9 | 4 | — | 1 | — | — | 5 | |
Angiofibroma | D018322 | EFO_1001761 | 2 | 2 | 2 | — | — | 5 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 50 | 7 | — | — | 3 | 57 | |
Sarcoma | D012509 | 7 | 8 | — | — | — | 12 | ||
Melanoma | D008545 | 6 | 8 | — | — | — | 12 | ||
Endometrial neoplasms | D016889 | EFO_0004230 | 7 | 4 | — | — | — | 11 | |
Non-small-cell lung carcinoma | D002289 | 8 | 5 | — | — | — | 10 | ||
Glioblastoma | D005909 | EFO_0000515 | 7 | 7 | — | — | — | 9 | |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 4 | — | — | — | 8 |
Multiple myeloma | D009101 | C90.0 | 4 | 5 | — | — | — | 7 | |
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 4 | — | — | — | 7 |
Gliosarcoma | D018316 | 5 | 6 | — | — | — | 7 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lung neoplasms | D008175 | C34.90 | 2 | — | — | — | — | 2 | |
Immunosuppression therapy | D007165 | 1 | — | — | — | 1 | 2 | ||
Port-wine stain | D019339 | Q82.5 | 2 | — | — | — | — | 2 | |
Digestive system neoplasms | D004067 | 1 | — | — | — | — | 1 | ||
Respiratory tract neoplasms | D012142 | EFO_0003853 | D14 | 1 | — | — | — | — | 1 |
Castleman disease | D005871 | EFO_1001332 | D47.Z2 | 1 | — | — | — | — | 1 |
Soft tissue neoplasms | D012983 | 1 | — | — | — | — | 1 | ||
Neurofibromatosis 2 | D016518 | Q85.02 | 1 | — | — | — | — | 1 | |
Pharyngeal neoplasms | D010610 | C14.0 | 1 | — | — | — | — | 1 | |
Erdheim-chester disease | D031249 | 1 | — | — | — | — | 1 |
Show 36 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Coronary artery disease | D003324 | I25.1 | — | — | — | — | 3 | 3 | |
Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 2 | 2 | |
Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 1 | 1 |
Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 1 | 1 |
Coronary stenosis | D023921 | EFO_1000882 | — | — | — | — | 1 | 1 | |
Muscular atrophy | D009133 | HP_0003202 | — | — | — | — | 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 | 657797 |
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
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,365 adverse events reported
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