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AboutPricing
Drug ReportsOsimertinib
Tagrisso(osimertinib)
Tagrisso (osimertinib) is a small molecule pharmaceutical. Osimertinib was first approved as Tagrisso on 2015-11-13. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. It is known to target epidermal growth factor receptor.
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Events Timeline
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3M
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YTD
1Y
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5Y
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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
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Tagrisso
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Osimertinib mesylate
Tradename
Company
Number
Date
Products
TAGRISSOAstraZenecaN-208065 RX2015-11-13
2 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
OSIMERTINIB MESYLATE, TAGRISSO, ASTRAZENECA
2027-12-18ODE-337
2025-04-18ODE-176
2023-12-18I-853
Patent Expiration
Patent
Expires
Flag
FDA Information
Osimertinib Mesylate, Tagrisso, Astrazeneca
101830202035-01-02DPU-1777, U-2289, U-3016
89462352032-08-08DS, DPU-1777, U-2289, U-3016
97320582032-07-25DS, DPU-1777, U-2289, U-3016
115249512032-07-25DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EB: Epidermal growth factor receptor (egfr) tyrosine kinase inhibitors
— L01EB04: Osimertinib
HCPCS
No data
Clinical
Clinical Trials
281 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——588522338186
NeoplasmsD009369—C807821—14
Neoplasm metastasisD009362EFO_0009708——4—1—5
CarcinomaD002277—C80.02211—5
AdenocarcinomaD000230——22—1—4
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175HP_0100526C34.9017213—135
Small cell lung carcinomaD055752——412—17
Brain neoplasmsD001932EFO_0003833C71121—15
Progression-free survivalD000077982———11——1
Small cell carcinomaD018288————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Adenocarcinoma of lungD000077192——13———3
Bronchogenic carcinomaD002283——31———3
Bronchial neoplasmsD001984EFO_1000849—31———3
Colorectal neoplasmsD015179——11———2
Stomach neoplasmsD013274EFO_0003897C1612———2
Head and neck neoplasmsD006258——11———2
GliomaD005910EFO_0000520—11———2
Kidney neoplasmsD007680EFO_0003865C64—2———2
GlioblastomaD005909EFO_0000515—11———2
Respiratory tract diseasesD012140——21———2
Show 28 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
AstrocytomaD001254EFO_0000271—1————1
OligodendrogliomaD009837EFO_0000631—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Germ-line mutationD018095——————11
Erbb-1 genesD018773——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOsimertinib
INNosimertinib
Description
Osimertinib is a member of the class of aminopyrimidines that is 4-(1-methylindol-3-yl)pyrimidin-2-amine in which one of the amino hydrogens is replaced by a 2-methoxy-4-[2-(dimethylamino)ethyl](methyl)amino-5-acrylamidophenyl group. Used (as the mesylate salt) for treatment of EGFR T790M mutation positive non-small cell lung cancer. It has a role as an antineoplastic agent and an epidermal growth factor receptor antagonist. It is a member of indoles, an aminopyrimidine, a biaryl, a secondary amino compound, a tertiary amino compound, a monomethoxybenzene, a member of acrylamides, a substituted aniline and a secondary carboxamide. It is a conjugate base of an osimertinib(1+).
Classification
Small molecule
Drug classtyrosine kinase inhibitors: epidermal growth factor receptor (EGFR) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=CC(=O)Nc1cc(Nc2nccc(-c3cn(C)c4ccccc34)n2)c(OC)cc1N(C)CCN(C)C
Identifiers
PDB—
CAS-ID1421373-65-0
RxCUI—
ChEMBL IDCHEMBL3353410
ChEBI ID—
PubChem CID71496458
DrugBankDB09330
UNII ID3C06JJ0Z2O (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
1956
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Tagrisso – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,644 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,166 adverse events reported
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