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Drug ReportsTemsirolimus
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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3M
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YTD
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5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
immune system diseasesD007154
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
TORISELCV SciencesN-022088 RX2007-05-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
temsirolimusANDA2024-02-15
toriselNew Drug Application2025-03-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
renal cell carcinomaEFO_0000376D002292
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Temsirolimus, Torisel, Pf Prism Cv
87910972032-05-10U-1550, U-1551
80262762026-01-20DP
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EG: Mammalian target of rapamycin (mtor) kinase inhibitors
L01EG01: Temsirolimus
HCPCS
Code
Description
J9330
Injection, temsirolimus, 1 mg
Clinical
Clinical Trials
1764 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9221128
Kidney transplantationD016030111147
Non-hodgkin lymphomaD008228C85.91315
Mantle-cell lymphomaD020522C83.11124
Graft rejectionD006084112
InflammationD007249MP_000184511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8014518
Breast neoplasmsD001943EFO_0003869C50245
Head and neck neoplasmsD0062582113
RecurrenceD012008213
Multiple myelomaD009101C90.022
Colorectal neoplasmsD015179122
Squamous cell neoplasmsD018307212
Non-small-cell lung carcinomaD002289212
GlioblastomaD005909EFO_0000515112
Squamous cell carcinomaD002294111
Show 21 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Port-wine stainD019339Q82.522
Capillary hemangiomaD018324Q82.522
Triple negative breast neoplasmsD06472611
LeukemiaD007938C9511
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011
T-cell lymphoma peripheralD01641111
Lymphoid leukemiaD007945C9111
SarcomaD01250911
OsteosarcomaD01251611
Neoplasm metastasisD009362EFO_000970811
Show 9 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A11
Neuroendocrine tumorsD018358EFO_1001901D3A.811
Islet cell adenomaD007516EFO_0007331D13.711
Kidney diseasesD007674EFO_0003086N0811
ViremiaD014766B34.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTemsirolimus
INNtemsirolimus
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 classimmunosuppressives
Image (chem structure or protein)Loading
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-ID162635-04-3
RxCUI
ChEMBL IDCHEMBL1201182
ChEBI ID79699
PubChem CID6918289
DrugBankDB06287
UNII ID624KN6GM2T (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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,102 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,127 adverse events reported
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