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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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Financial
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Events Timeline
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3M
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YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
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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
1219 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50133483760
NeoplasmsD009369—C80231413139
Kidney transplantationD016030——131420—38
Renal cell carcinomaD002292EFO_0000376—132013437
CarcinomaD002277—C80.092323235
Neuroendocrine tumorsD018358EFO_1001901D3A.8111133228
Liver transplantationD016031EFO_0010682——1112114
Neoplasm metastasisD009362EFO_0009708—6711—13
Tuberous sclerosisD014402—Q85.14742—13
Lung neoplasmsD008175—C34.9092—1—12
Show 35 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9551——10
AstrocytomaD001254EFO_0000271—251——7
Hepatocellular carcinomaD006528—C22.0341——6
Large b-cell lymphoma diffuseD016403—C83.3221——5
Carcinoid tumorD002276—D3A.00321——5
B-cell lymphomaD016393——121——4
Stomach neoplasmsD013274EFO_0003897C16121——4
LymphangioleiomyomatosisD018192—J84.81231——4
StomatitisD013280EFO_1001904K12.1—21——3
Organ transplantationD016377————1—12
Show 14 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney neoplasmsD007680EFO_0003865C6478———14
RecurrenceD012008——56———10
Non-small-cell lung carcinomaD002289——81———9
Colorectal neoplasmsD015179——67———9
Prostatic neoplasmsD011471—C6146———8
Head and neck neoplasmsD006258——55———8
Pancreatic neoplasmsD010190EFO_0003860C2537———8
SarcomaD012509——24———6
GlioblastomaD005909EFO_0000515—34———6
Neuroendocrine carcinomaD018278———6———6
Show 91 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Esophageal neoplasmsD004938—C152————2
Multiple myelomaD009101—C90.02————2
Uterine cervical neoplasmsD002583——2————2
Brain stem neoplasmsD020295EFO_1001767—1————1
Plasma cell neoplasmsD054219——1————1
Follicular lymphomaD008224—C821————1
Nasopharyngeal carcinomaD000077274——1————1
Adenoid cystic carcinomaD003528——1————1
Ureteral neoplasmsD014516EFO_0003844C661————1
Pelvic neoplasmsD010386——1————1
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vascular malformationsD054079——————11
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
$
€
£
₣
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 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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