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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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EMA approval date
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Study first post 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
989 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8011635219150
LymphomaD008223—C85.9373221264
RecurrenceD012008——3331—1159
Kidney transplantationD016030——6101022952
Graft vs host diseaseD006086—D89.811025103—42
Non-hodgkin lymphomaD008228—C85.9172321—36
Coronary artery diseaseD003324—I25.1——171826
Mantle-cell lymphomaD020522—C83.191631225
SyndromeD013577——71722123
Coronary diseaseD003327————191323
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.032436—1179
Renal cell carcinomaD002292EFO_0000376—21255—1156
Breast neoplasmsD001943EFO_0003869C5023257—352
LeukemiaD007938—C9523292—150
Multiple myelomaD009101—C90.025191——36
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.015183—133
Myeloid leukemia acuteD015470—C92.012202—132
Myelodysplastic syndromesD009190—D468202——28
Prostatic neoplasmsD011471—C6116151—126
Neoplasm metastasisD009362EFO_0009708—17101——25
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——1520——230
Non-small-cell lung carcinomaD002289——2412———26
Lung neoplasmsD008175—C34.90159———21
Pancreatic neoplasmsD010190EFO_0003860C251211———20
Neuroendocrine tumorsD018358EFO_1001901D3A.8513——218
Endometrial neoplasmsD016889EFO_0004230—910———18
Plasma cell neoplasmsD054219——1310———17
MelanomaD008545——1110———17
GliomaD005910EFO_0000520—137———17
Ovarian neoplasmsD010051EFO_0003893C5689———16
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Germ cell and embryonal neoplasmsD009373——4————4
Healthy volunteers/patients———4————4
Medullary carcinomaD018276——3————3
Port-wine stainD019339—Q82.52———13
Capillary hemangiomaD018324—Q82.52———13
Female genital neoplasmsD005833——2————2
PheochromocytomaD010673——2————2
Adenoid cystic carcinomaD003528——2————2
Laryngeal neoplasmsD007822EFO_0003817C322————2
Laryngeal diseasesD007818—J38.72————2
Show 62 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Herpesviridae infectionsD006566EFO_0007309B00.4————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Islets of langerhans transplantationD016381——————11
HemoglobinopathiesD006453—D58.2————11
ViremiaD014766—B34.9————11
CystsD003560——————11
Dietary proteinsD004044——————11
Crohn diseaseD003424EFO_0000384K50————11
Vertebrobasilar insufficiencyD014715EFO_1001449G45.0————11
Post-traumatic stress disordersD013313EFO_0001358F43.1————11
Show 59 more
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
2475
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
Q9Y4I3
Mouse ortholog
Mtor (56717)
serine/threonine-protein kinase mTOR (Q9JLN9)
Alternate
No data
Variants
No data
Financial
No data
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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