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Drug ReportsEverolimus
Afinitor(everolimus)
Afinitor, Everolimus, Votubia, Zortress (everolimus) is a small molecule pharmaceutical. Everolimus was first approved as Afinitor on 2009-03-30. It has been approved in Europe to treat breast neoplasms, pancreatic neoplasms, renal cell carcinoma, and tuberous sclerosis. The pharmaceutical is active against serine/threonine-protein kinase mTOR.
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Novartis Pharmaceuticals
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
nervous system diseasesD009422
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
Trade Name
FDA
EMA
Afinitor, Afinitor disperz, Zortress (generic drugs available since 2018-04-12)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Everolimus
Tradename
Company
Number
Date
Products
ZORTRESSNovartisN-021560 RX2010-04-20
4 products, RLD
AFINITORNovartisN-022334 RX2009-03-30
4 products, RLD
AFINITOR DISPERZNovartisN-203985 RX2012-08-29
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
afinitorNew Drug Application2023-08-01
everolimusANDA2050-01-01
zortressNew Drug Application2023-09-14
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
EVEROLIMUS, AFINITOR DISPERZ, NOVARTIS PHARM
2025-04-10ODE-169
EVEROLIMUS, AFINITOR, NOVARTIS
2023-02-26ODE-108
Patent Expiration
Patent
Expires
Flag
FDA Information
Everolimus, Afinitor, Novartis
90062242028-07-01U-1681
84101312025-11-01U-1368
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
L01EG02: Everolimus
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA18: Everolimus
HCPCS
Code
Description
J7527
Everolimus, oral, 0.25 mg
Clinical
Clinical Trials
1142 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery diseaseD003324I25.1121853117191
Breast neoplasmsD001943EFO_0003869C50326314214112
Renal cell carcinomaD002292EFO_00003762538751278
NeoplasmsD009369C80472422977
Coronary diseaseD0033273102942
Kidney transplantationD01603051418239
Coronary stenosisD023921EFO_1000882492639
Neuroendocrine tumorsD018358EFO_1001901D3A.8121373638
Myocardial ischemiaD017202EFO_1001375I20-I25242430
Acute coronary syndromeD054058EFO_000567212391428
Show 49 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25912117
Non-small-cell lung carcinomaD00228914316
Head and neck neoplasmsD0062589914
Neuroendocrine carcinomaD01827821011
SarcomaD0125094710
Colorectal neoplasmsD0151795810
GliomaD005910EFO_00005205510
Hodgkin diseaseD006689C81769
LymphomaD008223C85.9659
GlioblastomaD005909EFO_0000515649
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Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318HP_00016261313
Heart diseasesD006331EFO_0003777I51.966
Arterial occlusive diseasesD001157EFO_000908555
Drug-eluting stentsD05485533
Optical coherence tomographyD04162333
ArteriosclerosisD001161EFO_0009086I7033
AngioplastyD01713022
Islets of langerhans transplantationD01638111
InfarctionD007238EFO_000946311
NecrosisD00933611
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEverolimus
INNeverolimus
Description
Everolimus is a macrocyclic lactone that is rapamycin in which the hydroxy group attached to the cyclohexyl moiety has been converted into the corresponding 2-hydroxyethyl ether. It is an immunosuppressant and antineoplastic agent. It has a role as an antineoplastic agent, an immunosuppressive agent, a mTOR inhibitor, an anticoronaviral agent and a geroprotector. It is a primary alcohol, a secondary alcohol, an ether, a cyclic ketone, a cyclic acetal and a macrolide lactam. It is functionally related to a member 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](OCCO)[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-ID159351-69-6
RxCUI
ChEMBL IDCHEMBL1908360
ChEBI ID68478
PubChem CID6442177
DrugBankDB01590
UNII ID9HW64Q8G6G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Afinitor Novartis
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Zortress Novartis
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 36,209 documents
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Safety
Black-box Warning
Black-box warning for: Everolimus, Zortress
Adverse Events
Top Adverse Reactions
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47,149 adverse events reported
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