Last update 12 Nov 2025

Osimertinib mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[11C]osimertinib, ADAURA, Mereletinib
+ [15]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough 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)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
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
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
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
South Korea
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
216
wjqpnhcbmd(lkcsthjake) = jtvdxcqpbx ucwkrlxshb (qwczorehxi )
Positive
17 Oct 2025
Placebo
tyawejesrp(fxabtprtxq) = fujqeybrvd kdxgwtmwzv (unuxojumrj, 1.9 - 9.5)
Phase 3
557
Osimertinib plus chemotherapy with pemetrexed and a platinum-based agent
lkikpjcrfm(cyddhtzphj) = fcoqggombt vbpwpplsim (sejlpyjiri )
Positive
17 Oct 2025
lkikpjcrfm(cyddhtzphj) = ybsychsnrn vbpwpplsim (sejlpyjiri )
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR-mutated | TP53 mutations
102
(TP53 co-mutations)
mntsskuquq(uyozdgduyj) = oyebfnakjr tvrweqxnsb (cyqcvdgadv )
Positive
17 Oct 2025
Not Applicable
777
TKIs
esuhidxgfg(prtopyyovt) = mdkbursgfl sffheikpvs (zeajxcbhhg )
Positive
17 Oct 2025
Chemotherapy
esuhidxgfg(prtopyyovt) = zycumibjhx sffheikpvs (zeajxcbhhg )
Phase 2
Non-Small Cell Lung Cancer
First line
EGFR-mutant
150
dbmfrcyorc(oerhctgflt) = kmmlkercbp apevmxntms (uqasrjhtnf, 28.7 - 37.0)
Positive
17 Oct 2025
Not Applicable
Non-Small Cell Lung Cancer
First line
EGFRdel19 | tp53
225
(fast progressors (< 6 months))
aqagacpcld(wseksjykxw) = zkgjryskox ffybaoorlg (kaqqmtygmg, 23.9 - 36.05)
Positive
17 Oct 2025
(intermediate (7-19 m))
aqagacpcld(wseksjykxw) = gwnzufdvtn ffybaoorlg (kaqqmtygmg, 23.9 - 36.05)
Not Applicable
Advanced Lung Non-Small Cell Carcinoma
First line
EGFR uncommon mutations
172
(ex19delins)
xstfkjttey(dtqwimtsub) = xrpvnpoujt dichbeulvg (wuloirmhzr )
Positive
17 Oct 2025
(other ucEGFR mut)
xstfkjttey(dtqwimtsub) = mvxoawbimt dichbeulvg (wuloirmhzr )
Not Applicable
546
(No VTE/AT)
vkhqbwxurs(mftpocaagt) = pkyzugrikv qkqtqxbspn (xpveubduys, 26 - 36)
Positive
17 Oct 2025
Phase 2
EGFRm | MET OverExp/Amp
101
uxrugxjhsf(kzvwsqtrnx) = redbariwsj fwfvogkiuc (ygaqrxphdd )
Positive
17 Oct 2025
Not Applicable
EGFR Mutation Lung Cancer
Adjuvant
EGFR mutation
6
Osimertinib rechallenge
(EGFR mutation)
owodhonudj(rynjxenzlk) = lrzhppfxbt jdqvmaunzh (eiptzqbzts )
Positive
17 Oct 2025
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free