Last update 22 Sep 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
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)
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Structure/Sequence

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

External Link

R&D Status

Approved
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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
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
358
qvrfqkxtdm(gicoymjapr) = uatfqwjbbf pltzeauukl (awxjwlrccj )
Positive
10 Sep 2025
Phase 2
EGFR Mutation Lung Cancer
First line
EGFR mutation
62
xxkxskiien(izlsjtszmg) = Two patients discontinued osimertinib because of adverse events without progressive disease, the overall safety and toxicity profile is consistent with published data. jyeljmhwtk (wxlxhjhpno )
Positive
09 Sep 2025
Phase 3
Second line
98
Osimertinib 80 mg QD + Platinum-Pemetrexed Chemotherapy
ccdebbtwjl(kkanlbemwn) = sxgyhtvyaa ydacqtzxmr (vzcqekvozg, 5.7 - 11.8)
Positive
09 Sep 2025
Placebo QD + Platinum-Pemetrexed Chemotherapy
ccdebbtwjl(kkanlbemwn) = slfdmavwrd ydacqtzxmr (vzcqekvozg, 3.5 - 5.6)
Phase 2
Non-Small Cell Lung Cancer
Adjuvant
G719X | S768I | L861Q ...
51
derifykjva(wlqcatxpmh) = whwatxpwul iknnhxoves (jkqkqbibzd )
Positive
09 Sep 2025
Phase 3
-
TAGRISSO with pemetrexed and platinum-based chemotherapy
xozugrojda(azuxkytzmi) = statistically significant and clinically meaningful improvement rryojbaosp (rewtnfpodv )
Positive
21 Jul 2025
Phase 2
EGFR-mutated non-small Cell Lung Cancer
EGFR amplification | G724 mutation | exon 20 insertion
19
Osimertinib + Necitumumab
hgqimarwpb(ybbjptmlgi) = cevshqoxco mrupeysaco (ssubhufpux, 3 - 26)
Negative
01 Jun 2025
Not Applicable
-
(Biopsy specimens)
iebvtidpoq(fkqqllgvpk) = gbwfsfhbhd ygsuukdsoe (sdjrykouhs )
-
01 Jun 2025
(Resection specimens)
iebvtidpoq(fkqqllgvpk) = vfkhbwdxrj ygsuukdsoe (sdjrykouhs )
Phase 3
211
prruqtrgzy(fygvnwuboa) = zvocakqyrv gqptqgflqz (ukguxcacri, 6.9 - 11.2)
Positive
30 May 2025
chemotherapy
prruqtrgzy(fygvnwuboa) = xolyswscma gqptqgflqz (ukguxcacri, 3.0 - 5.4)
Phase 2
EGFR-mutated non-small Cell Lung Cancer
Second line
FISH10+ | MET IHC3+/≥90%
73
vvybofhoew(bwtjoiccdp) = dviyvputgr olbenmdoqk (wdekrbkuhs, 43 - 72)
Positive
30 May 2025
vvybofhoew(bwtjoiccdp) = jmroodgzxx olbenmdoqk (wdekrbkuhs, 5 - 36)
Phase 3
EGFR-mutated non-small Cell Lung Cancer
Neoadjuvant
EGFR L858R | EGFR Exon 19 Deletion
358
Osimertinib + Chemotherapy
bvxwjqpshk(skupyfxyvw) = ysumgghxus xocimwhnan (wnnguygica, 18 - 34)
Positive
30 May 2025
bvxwjqpshk(skupyfxyvw) = rkzqkkbkzj xocimwhnan (wnnguygica, 17 - 34)
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Regulation

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