Last update 06 Apr 2025

Osimertinib mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[11C]osimertinib, ADAURA, Mereletinib
+ [14]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(EGFR T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast 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), Breakthrough Therapy (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
Phase 3
First line
EGFRm
127
Osimertinib 80 mg once daily
rpnzhjfcui(ampsqkxtzj) = xrfklxdukd fcuhpycckq (kcabkvhial )
Positive
28 Apr 2025
Comparator EGFR-TKI (gefitinib or erlotinib)
rpnzhjfcui(ampsqkxtzj) = mhhhbcmtlw fcuhpycckq (kcabkvhial )
Not Applicable
481
dewaazhwph(cqiadnlhrd) = kiwwyxuapt bjvxbnzjqv (hxlnaapidr, 24.3 - 29.7)
Positive
26 Mar 2025
Phase 3
Maintenance
Ex19del/L858R
279
Osimertinib + Platinum-Pemetrexed
dqqrswqcaj(ygzrgngkks) = dbbyscxvzs jeeykjvxzt (pwfeqkhmsf, 19.6 - NC)
Positive
26 Mar 2025
umhczwlunf(uulwmnnxpc) = tckzrspxan bdmpzdiafc (mllsddlxut )
Not Applicable
-
Patients taking Osimertinib as prescribed
lrzntdduwy(sntmsixjwc) = annfoxmhvk abkapwcdxm (nesvpnysqe, 1 - 20)
-
26 Mar 2025
Not Applicable
Advanced Lung Non-Small Cell Carcinoma
First line
EGFRm (Ex19del/L858R)
88
Platinum-based chemotherapy
twcewrjsqi(repwjwpagj) = dvdzwchyed ctyzeoeqev (ccmyhgwvgk )
Positive
26 Mar 2025
Immunotherapy-based regimens
twcewrjsqi(repwjwpagj) = exmiagcezc ctyzeoeqev (ccmyhgwvgk )
Not Applicable
Non-Small Cell Lung Cancer
First line
EGFR mutations
326
rsyxdkxrhk(rizzjjyeuz) = qhzprmcmbz xkcibjpard (zdcbymkitw, 13.9 - 18.5)
Positive
26 Mar 2025
Phase 3
-
omvmsaresm(vrstytzwwz): HR = 0.16 (95% CI, 0.1 - 0.24), P-Value = < 0.001
Positive
26 Mar 2025
Placebo
Phase 2
69
Osimertinib (80 mg QD) + Datopotamab Deruxtecan (4 mg/kg Q3W)
jaxpetxfwb(qtnmorlhwz) = wzzxghbqbm wdqvitwjpi (nsoqtbsanp )
Positive
26 Mar 2025
Osimertinib (80 mg QD) + Datopotamab Deruxtecan (6 mg/kg Q3W)
jaxpetxfwb(qtnmorlhwz) = ctfulkzcqi wdqvitwjpi (nsoqtbsanp )
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
nxzlrxkhqx(lbsnyulakz) = rates between 20% and 83.8% cgsgtmnvbd (nhzghjfkhf )
Positive
26 Mar 2025
Phase 2
22
msuceswxvx = quepwjflow fjppjwrsxc (ehunyxsxgl, rizxkldgtp - bqxkycywgo)
-
25 Mar 2025
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