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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 Application2023-04-28
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
1748 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—C80163678314235
CarcinomaD002277—C80.05210314613164
Breast neoplasmsD001943EFO_0003869C5052802339148
Coronary artery diseaseD003324—I25.133124572133
Renal cell carcinomaD002292EFO_0000376—436513516129
Kidney transplantationD016030——71725441299
LymphomaD008223—C85.9545251298
RecurrenceD012008——474921290
Myocardial ischemiaD017202EFO_1001375I20-I25——7274579
Coronary diseaseD003327————7314078
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C9540423—176
Prostatic neoplasmsD011471—C6124262—142
Myeloid leukemiaD007951—C9220222—241
Multiple myelomaD009101—C90.028211——41
Kidney neoplasmsD007680EFO_0003865C6412252—239
Myeloid leukemia acuteD015470—C92.016192—236
Precursor cell lymphoblastic leukemia-lymphomaD054198——17173—134
GlioblastomaD005909EFO_0000515—24231——34
Pancreatic neoplasmsD010190EFO_0003860C2517211——32
Lymphoid leukemiaD007945—C9117143—131
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——3816———42
SarcomaD012509——1925——138
Plasma cell neoplasmsD054219——2014———27
Colorectal neoplasmsD015179——1520———27
Endometrial neoplasmsD016889EFO_0004230—1117———27
MelanomaD008545——1117———24
Head and neck neoplasmsD006258——1613——123
AdenocarcinomaD000230——1317———22
PreleukemiaD011289——515———19
Central nervous system neoplasmsD016543——1611———19
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
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
Laryngeal neoplasmsD007822EFO_0003817C322————2
Laryngeal diseasesD007818—J38.72————2
PhenylketonuriasD010661—E70.02————2
Pancreatic ductal carcinomaD021441——2————2
GerminomaD018237——2————2
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318HP_0001626—————44
AngioplastyD017130——————22
Drug-eluting stentsD054855——————22
Arterial occlusive diseasesD001157EFO_0009085—————22
NecrosisD009336——————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Optical coherence tomographyD041623——————11
Lower urinary tract symptomsD059411EFO_0008008—————11
Balloon angioplastyD000800——————11
Bone diseasesD001847—M89.9————11
Show 65 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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,823 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,109 adverse events reported
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