Last update 17 May 2025

Osimertinib mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[11C]osimertinib, ADAURA, Mereletinib
+ [14]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China), Priority Review (Australia), Accelerated assessment (European Union), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC29H37N7O5S
InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N
CAS Registry1421373-66-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-Small Cell Lung Cancer
Canada
05 Jul 2016
EGFR positive non-small cell lung cancer
Japan
28 Mar 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
European Union
01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
Iceland
01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
Liechtenstein
01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
Norway
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
European Union
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
Iceland
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
Liechtenstein
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
Norway
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
European Union
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
Iceland
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
Liechtenstein
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
Norway
01 Feb 2016
metastatic non-small cell lung cancer
European Union
01 Feb 2016
metastatic non-small cell lung cancer
Iceland
01 Feb 2016
metastatic non-small cell lung cancer
Liechtenstein
01 Feb 2016
metastatic non-small cell lung cancer
Norway
01 Feb 2016
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
United States
13 Nov 2015
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsPhase 3
United States
08 May 2023
NeoplasmsPhase 3
China
08 May 2023
NeoplasmsPhase 3
France
08 May 2023
NeoplasmsPhase 3
Malaysia
08 May 2023
NeoplasmsPhase 3
Poland
08 May 2023
NeoplasmsPhase 3
Taiwan Province
08 May 2023
NeoplasmsPhase 3
United Kingdom
08 May 2023
CarcinomaPhase 3
United States
03 Aug 2022
CarcinomaPhase 3
China
03 Aug 2022
CarcinomaPhase 3
Japan
03 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(Biopsy specimens)
svotssmxpc(lugkqdusqk) = otgfiliuhh nxdemjbcpn (arzrhqchvl )
-
01 Jun 2025
(Resection specimens)
svotssmxpc(lugkqdusqk) = ddhnrpuxdd nxdemjbcpn (arzrhqchvl )
Phase 2
344
Savolitinib 300 mg QD + Osimertinib 80 mg QD
pkhhciuqdy(wwlpaohowf) = ztyhwqjeil dhttpmwlxq (psguulwejl )
Positive
30 Apr 2025
Phase 2
Non-small cell lung cancer stage I
Adjuvant
EGFR-sensitive mutation | TP53 | EGFR-other mutations ...
70
Osimertinib 80mg qd
sdqefejdkt(ethkmlnbcl) = rfwvagtpym ykjqnumjdk (dllqpjacgi )
Positive
29 Apr 2025
Phase 3
First line
EGFRm
127
Osimertinib 80 mg once daily
ityzhxvibd(kftyshtxfo) = qcykkldhwo rvwjawsdbh (hckurfywrw )
Positive
28 Apr 2025
Comparator EGFR-TKI (gefitinib or erlotinib)
ityzhxvibd(kftyshtxfo) = nfvtftvwso rvwjawsdbh (hckurfywrw )
Phase 2
31
Osimertinib + Anlotinib
afoeuihcnh(gkmonudctq) = no grade 4 or higher adverse events observed jxtkibxbes (rcrvhcywqp )
Positive
15 Apr 2025
Phase 2
EGFR positive non-small cell lung cancer
Second line
MET Overexpression | MET Amplification | EGFR Mutation
101
Savolitinib 300 mg BID + Osimertinib 80 mg QD
nwtblricie(zapgqfhxuy) = nqjxsdwikv facovsgiws (uylreridfo, 45 - 67)
Positive
26 Mar 2025
Not Applicable
Advanced Lung Non-Small Cell Carcinoma
First line
EGFRm (Ex19del/L858R)
88
Platinum-based chemotherapy
eenlxxextc(lzudyxvjna) = yqmyfqsbih efhvjvfmem (ldxgdjyewh )
Positive
26 Mar 2025
Immunotherapy-based regimens
eenlxxextc(lzudyxvjna) = fcqwjpnmpb efhvjvfmem (ldxgdjyewh )
Not Applicable
Non-Small Cell Lung Cancer
First line
EGFR mutations
326
egyyvhtdjm(wtduagcfyz) = lhyymqgsnl afqwzctfhy (crlmknxvtc, 13.9 - 18.5)
Positive
26 Mar 2025
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
EGFR-TKI-sensitizing mutations | EGFR-T790M resistance mutation | exon 19 deletions ...
1,838
Osimertinib plus Chemotherapy
nplwfoajwz(zlwziwfosi) = rates between 20% and 83.8% myxjnrywin (zgsatlaurt )
Positive
26 Mar 2025
Phase 3
-
apsgdiirsi(btesmvodvo): HR = 0.16 (95% CI, 0.1 - 0.24), P-Value = < 0.001
Positive
26 Mar 2025
Placebo
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