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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
Drugs Approved for Childhood Cancers
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Drug
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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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, Everolimus, Zortress
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
AFINITORNovartisN-022334 RX2009-03-30
4 products, RLD
ZORTRESSNovartisN-021560 RX2010-04-20
4 products, RLD
AFINITOR DISPERZNovartisN-203985 RX2012-08-29
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
afinitorNew Drug Application2024-07-22
everolimusANDA2050-01-01
torpenzANDA2024-07-31
zortressNew Drug Application2024-02-28
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
1157 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 diseaseD003324—I25.1122059133215
Breast neoplasmsD001943EFO_0003869C50367521316137
Myocardial ischemiaD017202EFO_1001375I20-I25—1102871110
NeoplasmsD009369—C8058375210103
CarcinomaD002277—C80.02764867102
Coronary diseaseD003327———19276198
Renal cell carcinomaD002292EFO_0000376—2850951496
Kidney transplantationD016030——391627558
Neuroendocrine tumorsD018358EFO_1001901D3A.8182473956
Coronary stenosisD023921EFO_1000882———4133148
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——19161—234
LymphomaD008223—C85.922191——34
Kidney neoplasmsD007680EFO_0003865C648191—330
Pancreatic neoplasmsD010190EFO_0003860C2510141—222
Prostatic neoplasmsD011471—C619111—220
Triple negative breast neoplasmsD064726——6123——20
GliomaD005910EFO_0000520—6101——16
Stomach neoplasmsD013274EFO_0003897C16793——16
B-cell lymphomaD016393——571——11
Carcinoid tumorD002276—D3A.00552——11
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95179——120
Non-small-cell lung carcinomaD002289——164———18
Neoplasm metastasisD009362EFO_0009708—810——117
Neuroendocrine carcinomaD018278——312——216
Head and neck neoplasmsD006258——119———16
Colorectal neoplasmsD015179——712——115
AdenocarcinomaD000230——811———14
SarcomaD012509——58——214
GlioblastomaD005909EFO_0000515—118———14
Lymphoid leukemiaD007945—C9194——111
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Merkel cell carcinomaD015266EFO_1001471C4A2————2
Medullary carcinomaD018276——2————2
Salivary gland neoplasmsD012468EFO_0003826D112————2
Nasopharyngeal carcinomaD000077274——2————2
Tongue neoplasmsD014062EFO_0003871C02.92————2
Laryngeal neoplasmsD007822EFO_0003817C322————2
Verrucous carcinomaD018289——2————2
Laryngeal diseasesD007818—J38.72————2
Uterine cervical neoplasmsD002583HP_0030159—2————2
Hematologic neoplasmsD019337——1————1
Show 33 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318HP_0001626—————1313
Arterial occlusive diseasesD001157EFO_0009085—————66
Drug-eluting stentsD054855——————33
Optical coherence tomographyD041623——————33
AngioplastyD017130——————22
HemorrhageD006470MP_0001914R58————22
Acute diseaseD000208——————11
Islets of langerhans transplantationD016381——————11
Mouth neoplasmsD009062EFO_0003868C06.9————11
NecrosisD009336——————11
Show 17 more
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
$
€
£
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Zortress – Novartis
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Afinitor – 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 38,186 documents
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Safety
Black-box Warning
Black-box warning for: Everolimus, Zortress
Adverse Events
Top Adverse Reactions
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53,125 adverse events reported
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