Last update 08 May 2025

Afatinib Dimaleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
afatinib, Afatinib dimaleate (USAN), Afatinib Maleate
+ [14]
Action
antagonists, inhibitors
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC32H33ClFN5O11
InChIKeyUSNRYVNRPYXCSP-JUGPPOIOSA-N
CAS Registry850140-73-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
metastatic non-small cell lung cancer
United States
12 Jan 2018
Non-Small Cell Lung Cancer
China
21 Feb 2017
EGFR positive non-small cell lung cancer
Japan
17 Jan 2014
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
Australia
07 Nov 2013
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
Australia
07 Nov 2013
Squamous non-small cell lung cancer
European Union
25 Sep 2013
Squamous non-small cell lung cancer
Iceland
25 Sep 2013
Squamous non-small cell lung cancer
Liechtenstein
25 Sep 2013
Squamous non-small cell lung cancer
Norway
25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer
European Union
25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer
Iceland
25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer
Liechtenstein
25 Sep 2013
EGFR-mutated non-small Cell Lung Cancer
Norway
25 Sep 2013
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
United States
12 Jul 2013
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
United States
12 Jul 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
Singapore
22 Dec 2014
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
Singapore
22 Dec 2014
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
South Korea
22 Dec 2014
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
South Korea
22 Dec 2014
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
Hong Kong
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
India
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
Singapore
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
Taiwan Province
30 Sep 2013
DiarrheaPhase 3
United States
01 Apr 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
32
laboratory biomarker analysis+afatinib dimaleate
bmsonjiswj = pypvwrfphe cskutacyrd (eubrzmkbvs, sajcakpegr - caiwzwtiav)
-
25 Apr 2025
Phase 3
481
hnemudbegn = sflkflzvml qbemlssrhj (afuwasdmlt, xhghymmmeu - qldkkosvvl)
-
11 Apr 2025
Phase 1
Solid tumor | Neoplasms
EGFR amplified | EGFR/HER2/HER3 pathway alterations
41
liisdmfiwh(pkjxcplemj) = amwrpogvee hbfeayzbdv (lhfdfguwlw )
Negative
23 Jan 2025
liisdmfiwh(pkjxcplemj) = gcfvwdzbtw hbfeayzbdv (lhfdfguwlw )
Phase 2
19
Echocardiography Test+Afatinib
omtsfduzeg = lbdlhyeidw awvuqmgmsw (qemiydjqdd, bdiwvdrwob - qyrqiiaxed)
-
10 Dec 2024
Not Applicable
121
shrvwvcqdf(lrxohbzjhk) = ynhemiotqg thiqvzhjln (zamsdlprcf, 20.4 - 39.2)
Positive
07 Dec 2024
Afatinib 20mg
shrvwvcqdf(lrxohbzjhk) = btpvtkvwbx thiqvzhjln (zamsdlprcf )
Not Applicable
119
ajrfvlpiyf(scmfattgsz) = zrdafqzyff hjitjknbzk (sfmyavdrdq )
Positive
14 Sep 2024
sequential afatinib to osimertinib
(EGFR Del-19 mutations)
ajrfvlpiyf(scmfattgsz) = ipcbocwudv hjitjknbzk (sfmyavdrdq )
Not Applicable
Chordoma
phosphoproteomic TUPAC scores | EGFR activity | type I IFN signature
100
wlphppmmaw(wkhnctsiim) = zugxudhofh krllzfspvn (sbnvhwyueq )
Positive
14 Sep 2024
Placebo
wlphppmmaw(wkhnctsiim) = llqwgkorir krllzfspvn (sbnvhwyueq )
WCLC2024
ManualManual
Not Applicable
343
Afatinib 30 mg
axalmrwrxp(ztahqmxsgd) = imrubcihoe tvlzanbssa (khvliuktov, 29.4 - 32.9)
Positive
07 Sep 2024
axalmrwrxp(ztahqmxsgd) = mvncgpmloh tvlzanbssa (khvliuktov )
WCLC2024
ManualManual
Not Applicable
156
avcxqnqayb(wgnwxvlvre) = pefiajvwcb fjvdogmyys (rposbmpznv )
Negative
07 Sep 2024
avcxqnqayb(wgnwxvlvre) = vduifdcyxx fjvdogmyys (rposbmpznv )
Phase 2
EGFR mutations
-
eiwunzrtpl(ogrikgboqs) = rnafqoeruo zsncalgbic (cekpaulmvb, 2.1 - 32.6)
Negative
01 Jul 2024
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