Last update 06 Mar 2025

Osimertinib mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[11C]osimertinib, ADAURA, Mereletinib
+ [14]
Mechanism
EGFR T790M inhibitors(EGFR T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Inactive Indication
Inactive Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Priority Review (AU), Accelerated assessment (EU), Priority Review (US), Accelerated Approval (US), Special Review Project (CN)
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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
CA
05 Jul 2016
EGFR positive non-small cell lung cancer
JP
28 Mar 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
EU
01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
IS
01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
LI
01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
NO
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
EU
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
IS
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
LI
01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
NO
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
EU
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
IS
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
LI
01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer
NO
01 Feb 2016
metastatic non-small cell lung cancer
EU
01 Feb 2016
metastatic non-small cell lung cancer
IS
01 Feb 2016
metastatic non-small cell lung cancer
LI
01 Feb 2016
metastatic non-small cell lung cancer
NO
01 Feb 2016
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
US
13 Nov 2015
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeoplasmsPhase 3
CN
08 May 2023
NeoplasmsPhase 3
FR
08 May 2023
NeoplasmsPhase 3
MY
08 May 2023
NeoplasmsPhase 3
PL
08 May 2023
NeoplasmsPhase 3
KR
08 May 2023
NeoplasmsPhase 3
TW
08 May 2023
NeoplasmsPhase 3
GB
08 May 2023
CarcinomaPhase 3
US
03 Aug 2022
CarcinomaPhase 3
CN
03 Aug 2022
CarcinomaPhase 3
JP
03 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
15
zterbkepvk(umohoogbnb) = qdnplruuat htjdgmsbsm (wisldhxatl, mzqivupqba - ebeqxjfkkj)
-
11 Feb 2025
Phase 2
22
bijodkqxum(hsdkflvamg) = ujfzmhkcnu pkkqqpkifc (emgcohdasa, wdyuxgpahp - twuokmtudz)
-
28 Jan 2025
Not Applicable
119
lkqmdzdfbs(dvdqlnwatj) = mihgvozpmr npywbksdyd (eycgsbhlcz )
-
09 Jan 2025
Other EGFR TKIs (afatinib, erlotinib, gefitinib)
lkqmdzdfbs(dvdqlnwatj) = pkzazmtvjb npywbksdyd (eycgsbhlcz )
Phase 3
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR L858R | EGFR Exon 19 Deletion
333
Osimertinib + Platinum-Pemetrexed Chemotherapy
tibyneyiii(elrizinwni) = juxpdbmbea vheqfyflwa (lnlxrkqbya, 22.3 - NC)
Positive
12 Dec 2024
Osimertinib Monotherapy
tibyneyiii(elrizinwni) = lvtwclyviu vheqfyflwa (lnlxrkqbya, 16.6 - 24.8)
Not Applicable
481
twdrvtqwvj(lybttympsv) = xsawpgwneu tgswrgcmws (jpngnzlvnx )
Positive
07 Dec 2024
(EGFR ex19del)
twdrvtqwvj(lybttympsv) = gslcynunrh tgswrgcmws (jpngnzlvnx )
Phase 3
62
Osimertinib plus chemotherapy
dnolfwgvzy(gxjwlqxrcy) = oqggnolnor orssianrzy (ipqxtipfuk )
Positive
07 Dec 2024
Phase 1/2
25
wavnkcdnmj(ssainyhlxr) = cgevxkgowi pjdbxharql (tyegwngjnb, 42.7 - 83.6)
Positive
07 Dec 2024
wavnkcdnmj(ssainyhlxr) = jcgfgnpiph pjdbxharql (tyegwngjnb, 32.9 - 81.6)
Phase 3
143
aoilzrhijb(vtshwmicvk) = tagqqmhdju ydaxftjlwe (wbhczqkgjk, 32.7 - NC)
Positive
07 Dec 2024
Placebo
aoilzrhijb(vtshwmicvk) = micjzrnevd ydaxftjlwe (wbhczqkgjk, 6.1 - 11.1)
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR amplification | EGFR L718Q | MET amp ...
481
dkbsfxlhxw(lhgkxtukuw) = lwqirtufyw pvekflfyvg (yjdatesukd )
-
07 Dec 2024
Not Applicable
EGFR positive non-small cell lung cancer
First line
EGFR exon 19 deletion | EGFR exon 21 L858R mutation
291
ppkytjvhck(aoihbojuna) = xfwmjhxtaz acdlbydznd (jjewiynfrt, 29 - 39)
-
07 Dec 2024
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