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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
Top 200 Pharmaceuticals by Retail Sales
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Commercial
Clinical
Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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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, Everolimus, Zortress (discontinued: Everolimus)
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 Application2026-06-01
everolimusANDA2050-01-01
torpenzANDA2026-06-10
yulithiraANDA2026-03-31
zortressNew Drug Application2026-09-16
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
1221 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—I25.1121959138219
Breast neoplasmsD001943EFO_0003869C50408023317147
Myocardial ischemiaD017202EFO_1001375I20-I25—1102667104
NeoplasmsD009369—C8058363310100
Renal cell carcinomaD002292EFO_0000376—29491051396
Coronary diseaseD003327———18245790
CarcinomaD002277—C80.0214645573
Kidney transplantationD016030——391627659
Neuroendocrine tumorsD018358EFO_1001901D3A.8192493957
Coronary stenosisD023921EFO_1000882———3143350
Show 83 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney neoplasmsD007680EFO_0003865C648192—331
RecurrenceD012008——18131—230
Triple negative breast neoplasmsD064726——8185——28
Prostatic neoplasmsD011471—C619111—220
Stomach neoplasmsD013274EFO_0003897C16792——15
Carcinoid tumorD002276—D3A.00552——11
B-cell lymphomaD016393——561——10
Peripheral arterial diseaseD058729EFO_0004265——31—710
LymphangioleiomyomatosisD018192—J84.81561—19
Large b-cell lymphoma diffuseD016403—C83.3551——9
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C251014——221
LeukemiaD007938—C95159——118
Non-small-cell lung carcinomaD002289——164———18
Colorectal neoplasmsD015179——813——116
Head and neck neoplasmsD006258——119———16
Neuroendocrine carcinomaD018278——212——215
GlioblastomaD005909EFO_0000515—118———14
SarcomaD012509——37——312
GliomaD005910EFO_0000520—67———12
Multiple myelomaD009101—C90.084———10
Show 152 more
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
Nasopharyngeal carcinomaD000077274——2————2
Laryngeal neoplasmsD007822EFO_0003817C322————2
Verrucous carcinomaD018289——2————2
Laryngeal diseasesD007818—J38.72————2
MedulloblastomaD008527——2————2
Uterine cervical neoplasmsD002583——2————2
Hematologic neoplasmsD019337——1————1
Myeloproliferative disordersD009196—D47.11————1
Show 37 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I98————1414
Arterial occlusive diseasesD001157EFO_0009085—————77
Drug-eluting stentsD054855——————33
Optical coherence tomographyD041623——————33
AngioplastyD017130——————22
Intermittent claudicationD007383EFO_0003876I73.9————22
HemorrhageD006470MP_0001914R58————22
Acute diseaseD000208——————11
Islets of langerhans transplantationD016381——————11
Patient acceptance of health careD010342——————11
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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
$
€
£
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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 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Everolimus, Zortress
Adverse Events
Top Adverse Reactions
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56,399 adverse events reported
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