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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
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 |
|---|---|---|---|---|
| TAGRISSO | AstraZeneca | N-208065 RX | 2015-11-13 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tagrisso | New Drug Application | 2024-09-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OSIMERTINIB MESYLATE, TAGRISSO, ASTRAZENECA | |||
| 2027-12-18 | ODE-337 | ||
| 2025-04-18 | ODE-176 | ||
| 2023-12-18 | I-853 | ||
HCPCS
No data
Clinical
Clinical Trials
320 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 carcinoma | D002289 | — | — | 73 | 118 | 36 | 7 | 58 | 265 |
| Lung neoplasms | D008175 | — | C34.90 | 51 | 85 | 23 | 3 | 33 | 176 |
| Carcinoma | D002277 | — | C80.0 | 14 | 14 | 2 | 1 | 3 | 28 |
| Neoplasms | D009369 | — | C80 | 14 | 12 | 2 | 2 | 1 | 27 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 10 | 1 | 1 | 2 | 14 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | — | 6 | — | 1 | 1 | 8 |
| Adenocarcinoma | D000230 | — | — | 2 | 3 | — | 1 | — | 6 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 4 | 8 | 3 | — | 2 | 17 |
| Small cell lung carcinoma | D055752 | — | — | 4 | 1 | 2 | — | 1 | 7 |
| Disease progression | D018450 | — | — | 1 | 3 | 1 | — | 1 | 5 |
| Residual neoplasm | D018365 | — | — | — | — | 1 | — | 1 | 2 |
| Progression-free survival | D000077982 | — | — | — | 1 | 1 | — | — | 1 |
| Small cell carcinoma | D018288 | — | — | — | — | 1 | — | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma of lung | D000077192 | — | — | 1 | 5 | — | — | — | 5 |
| Colorectal neoplasms | D015179 | — | — | 3 | 2 | — | — | — | 4 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 3 | — | — | — | 3 |
| Recurrence | D012008 | — | — | — | 3 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 2 | — | — | — | 3 |
| Squamous cell neoplasms | D018307 | — | — | — | 2 | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | — | 2 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | — | — | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Bronchogenic carcinoma | D002283 | — | — | 3 | — | — | — | 1 | 4 |
| Bronchial neoplasms | D001984 | EFO_1000849 | — | 3 | — | — | — | 1 | 4 |
| Respiratory tract diseases | D012140 | — | — | 2 | — | — | — | 1 | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 2 | — | — | — | 1 | 3 |
| Respiratory tract neoplasms | D012142 | EFO_0003853 | D14 | 2 | — | — | — | 1 | 3 |
| Thoracic neoplasms | D013899 | — | — | 2 | — | — | — | 1 | 3 |
| Neoplasms by site | D009371 | — | — | 2 | — | — | — | 1 | 3 |
| Neoplasms by histologic type | D009370 | — | — | 2 | — | — | — | — | 2 |
| Nerve tissue neoplasms | D009380 | — | — | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Germ-line mutation | D018095 | — | — | — | — | — | — | 1 | 1 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | — | — | — | 1 | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | — | — | — | — | 1 | 1 |
| Hypogonadism | D007006 | — | E23.0 | — | — | — | — | 1 | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Osimertinib |
| INN | osimertinib |
| 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 class | tyrosine kinase inhibitors: epidermal growth factor receptor (EGFR) inhibitors |
| Image (chem structure or protein) |  |
| 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-ID | 1421373-65-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3353410 |
| ChEBI ID | — |
| PubChem CID | 71496458 |
| DrugBank | DB09330 |
| UNII ID | 3C06JJ0Z2O (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
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
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Variants
No data
Financial
Revenue by drug
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£
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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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,547 adverse events reported
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