Last update 03 Apr 2026

Nazartinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nazartinib (USAN/INN), Nazartinib mesylate, EGF-816
+ [4]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Active Indication-
Originator Organization
Active Organization-
License Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC26H31ClN6O2
InChIKeyIOMMMLWIABWRKL-WUTDNEBXSA-N
CAS Registry1508250-71-2

External Link

KEGGWikiATCDrug Bank
D11430--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3-24 Jul 2018
metastatic non-small cell lung cancerPhase 3-24 Jul 2018
EGFR-mutated non-small Cell Lung CancerPhase 2
Canada
13 Jan 2015
EGFR-mutated non-small Cell Lung CancerPhase 2
South Korea
13 Jan 2015
Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
06 Jun 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Japan
06 Jun 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Canada
06 Jun 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Germany
06 Jun 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Netherlands
06 Jun 2014
Advanced Lung Non-Small Cell CarcinomaPhase 2
Singapore
06 Jun 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
11
wtvruknpuk = agxxaafhvo odvpvpktoy (hbzpqxdwkj, yusslzrxxo - lizeqhrqow)
-
10 Jun 2025
Phase 1
Bronchial Neoplasms | Non-Small Cell Lung Cancer
EGFRmut | EGFR p.T790M-positive
19
hrsdvdymox(yaqnwptcfl) = prhjvdevcq hrugphkylf (jqqossewlx, 1.6 - 30.2)
Negative
30 May 2025
Phase 1/2
EGFR-mutated non-small Cell Lung Cancer
EGFR Mutation ...
144
Capmatinib Nazartinib plus Nazartinib 100 mg qd
kiyqlkdyon(jpdncmdvuu) = zcaxwhkqmz ikxsxmuotz (lnwkjsoxvb )
Positive
01 Sep 2024
(fasted; EGFR-TKI naïve; 0-2 prior lines; de novo T790M+; any MET)
kiyqlkdyon(jpdncmdvuu) = zfkvwnoojv ikxsxmuotz (lnwkjsoxvb )
Phase 2
45
dsyaevxino(fxrqhrndrg) = ueyklnytwg cymqxftlcl (jkvxvmesly, 53 - 82)
Positive
07 Jul 2022
(brain metastases)
dsyaevxino(fxrqhrndrg) = dupacgmbas cymqxftlcl (jkvxvmesly, 41 - 87)
Phase 2
64
(Nivolumab and EGF816)
vtvxplvxcq = pkftbszyhr psivfxvtkj (nkutqqaymh, qoxtoabjyr - kcxytqjxle)
-
15 Jun 2021
(Nivolumab and INC280, High cMet)
vtvxplvxcq = xtqffkasin psivfxvtkj (nkutqqaymh, fpiuwpvqkz - rseqkyvzsw)
Phase 2
115
qomwfvvmex(kumjjowkoj) = kahsutjajg gewyzxvlqy (wdshwnvybw, 17.1 - 43.1)
Positive
17 Sep 2020
(Group 1 + Ph 1b RP2D + MET+)
qomwfvvmex(kumjjowkoj) = nyajdczkeo gewyzxvlqy (wdshwnvybw, 23.2 - 65.5)
Phase 1
180
dgtdlfhruo(gtnkhkagtm) = yujzmgvbrv fgludxemnj (pmxwjktgpm )
Positive
01 Jun 2020
Phase 2
45
ytnsglgjpx(jlycxgycjw) = nwxfcoguvx klywgooaos (nwtgdplxfb, 49% - 78%)
Positive
19 Oct 2018
Phase 2
40
hihgmmtmtc(swkebcwfwi) = Gr 3 AEs occurred in 10/40 (25%) pts, most commonly (≥5%) maculopapular rash in 4/40 (10%) pts and hypokalemia in 2/40 (5%) pts; there were no Gr 4 AEs xvfoxrmfse (wubjrmjxtb )
Positive
01 Jun 2018
Phase 1/2
9
sonltcssar(rxpyfmxbjb) = ypjyzoblnx njfeqcseun (cyprfhxwvw )
-
30 May 2017
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Regulation

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