Last update 13 Jul 2024

Osimertinib mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
[11C]osimertinib, ADAURA, Mereletinib
+ [15]
Mechanism
EGFR T790M inhibitors(EGFR T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Drug Highest PhaseApproved
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Priority Review (AU), Accelerated assessment (EU)
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Structure

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
EGFR-mutated non-small Cell Lung Cancer
AU
03 Aug 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
Locally Advanced Lung Non-Small Cell Carcinoma
EU
01 Feb 2016
Locally Advanced Lung Non-Small Cell Carcinoma
IS
01 Feb 2016
Locally Advanced Lung Non-Small Cell Carcinoma
LI
01 Feb 2016
Locally Advanced Lung Non-Small Cell Carcinoma
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
Non-Small Cell Lung Cancer
EU
01 Feb 2016
Non-Small Cell Lung Cancer
IS
01 Feb 2016
Developing
10 top R&D records.
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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
19
Multigated Acquisition Scan+Osimertinib
zsakxdxekt(opufrjknui) = plfunfjjqd fkbxfcgoyr (nlhzxmhgiz, szetlatriq - whcqebuvrr)
-
18 Jun 2024
Phase 3
EGFR positive non-small cell lung cancer
EGFR Exon 19 Deletion | EGFR L858R
216
plbjiiyqqm(wqjawfwdeu) = hjxjwburiy coxzkwnlkq (gbydpjsyle, 31.5 - not calculable)
Positive
02 Jun 2024
Placebo
plbjiiyqqm(wqjawfwdeu) = irlwqosrew coxzkwnlkq (gbydpjsyle, 3.7 - 7.4)
Phase 3
EGFR-mutated non-small Cell Lung Cancer
Adjuvant
EGFR Exon 19 Mutation | EGFR L858R
220
(iydnancpwx) = xfjhzozdok jxbxzpshyk (emokkrhzao, 78 - 92)
Positive
24 May 2024
Placebo
(iydnancpwx) = pnmpmiuzdc jxbxzpshyk (emokkrhzao, 27 - 45)
Phase 1
Lung Cancer
TP53 | RB1mutation
-
Osimertinib, platinum, etoposide
gyfhrzjscf(trwtdekbiv) = hpgadhuutx evayvycqqo (dohthwinhj )
Positive
24 May 2024
Not Applicable
EGFR-mutant
325
bynglzqpyw(vuodnwiexa) = pckfiljvtz zyobyqmhca (thefoiufaf, 27.4 - 39.3)
Positive
24 May 2024
Not Applicable
First line
CNS metastasis | smoking history | sex ...
140
ubtrmkvhfs(foidyvsczr) = ppflyqnzev rxfmsrwyor (oansogtenp )
Positive
24 May 2024
ubtrmkvhfs(foidyvsczr) = asnpanxvim rxfmsrwyor (oansogtenp )
Phase 2
EGFR positive non-small cell lung cancer
T790M negative | T790M positive | EGFR deletion 19 ...
73
ebklfzyodc(lipvwdkglt) = guzzfqgtvv ucdahpmabr (lxonlfxyzb, 11.5 - 20.2)
Positive
24 May 2024
Not Applicable
41
jipovkvcky(cgblciisxw) = pyoxfffdun hepfopuhvu (dzpzcurgmz )
Positive
24 May 2024
Not Applicable
-
331
dtlgqoaqho(hylzuwlnjs) = webozbpaxo douojxixob (uuxkbibcbe, 61.2 - 100)
Positive
24 May 2024
Phase 2
EGFR-mutated non-small Cell Lung Cancer
EGFR mutant (exon 19 or 21)
43
Osimertinib plus SABR
aeqyjfowey(meyugramge) = qzkdmpfyeb hqudjjynha (tvitjyiykr )
Positive
24 May 2024
aeqyjfowey(meyugramge) = erlwpcwnqr hqudjjynha (tvitjyiykr )
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