Last update 22 Nov 2024

Afatinib Dimaleate

Overview

Basic Info

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

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
Squamous non-small cell lung cancer
US
15 Apr 2016
EGFR positive non-small cell lung cancer
EU
25 Sep 2013
EGFR positive non-small cell lung cancer
IS
25 Sep 2013
EGFR positive non-small cell lung cancer
LI
25 Sep 2013
EGFR positive non-small cell lung cancer
NO
25 Sep 2013
metastatic non-small cell lung cancer
EU
25 Sep 2013
metastatic non-small cell lung cancer
IS
25 Sep 2013
metastatic non-small cell lung cancer
LI
25 Sep 2013
metastatic non-small cell lung cancer
NO
25 Sep 2013
Non-Small Cell Lung Cancer
EU
25 Sep 2013
Non-Small Cell Lung Cancer
IS
25 Sep 2013
Non-Small Cell Lung Cancer
LI
25 Sep 2013
Non-Small Cell Lung Cancer
NO
25 Sep 2013
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
US
12 Jul 2013
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
US
12 Jul 2013
EGFR-mutated non-small Cell Lung Cancer
TW
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
SG
22 Dec 2014
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
SG
22 Dec 2014
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
KR
22 Dec 2014
Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3
KR
22 Dec 2014
Advanced Lung Non-Small Cell CarcinomaPhase 3
CN
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
HK
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
IN
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
SG
30 Sep 2013
Advanced Lung Non-Small Cell CarcinomaPhase 3
TW
30 Sep 2013
DiarrheaPhase 3
US
01 Apr 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
119
sequential afatinib to osimertinib
uoitrwwwfl(lzelsblfuq) = jwwddsbnxw yflacnpcic (yqimmhdwlm )
Positive
14 Sep 2024
sequential afatinib to osimertinib
(EGFR Del-19 mutations)
uoitrwwwfl(lzelsblfuq) = iqxtsqlayv yflacnpcic (yqimmhdwlm )
Not Applicable
Chordoma
phosphoproteomic TUPAC scores | EGFR activity | type I IFN signature
100
ukdchpdxru(sdxiazfbdz) = fbydfmznzr vjvhxebdrq (xjlpnvhzle )
Positive
14 Sep 2024
Placebo
ukdchpdxru(sdxiazfbdz) = rkdkmwpehy vjvhxebdrq (xjlpnvhzle )
WCLC2024
ManualManual
Not Applicable
343
cfvoebdjhj(siiekhcded) = brcqnoosby yibtjjindr (gwrthsxfor, 29.4 - 32.9)
Positive
07 Sep 2024
cfvoebdjhj(siiekhcded) = dfguspawqd yibtjjindr (gwrthsxfor )
WCLC2024
ManualManual
Not Applicable
156
opfgjxbwcm(ctmudphkdg) = iqbhamelvj ixrczwgcjx (dwjiiwsspw )
Negative
07 Sep 2024
opfgjxbwcm(ctmudphkdg) = xmtiomxrvt ixrczwgcjx (dwjiiwsspw )
Phase 2
113
Afatinib followed by Osimertinib
xykywftcrq(tdcntpdnhr) = eqgdfqbhmj jcjnqnedfy (zrdahrwmtm, 29.0 - 45.5)
Negative
24 May 2024
xykywftcrq(tdcntpdnhr) = klmafpbfxh jcjnqnedfy (zrdahrwmtm, 38.5 - 55.7)
Phase 2
Advanced Urothelial Carcinoma
Second line
ERBB1-3 alterations
-
(urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications)
wuhumioghp(ldkscdouxb) = xntaufmjus tkqvxdhyov (ifghaeaodu )
Positive
24 Feb 2024
EGFR (Epidermal Growth Factor Receptor) amplification positive tumours
wuhumioghp(ldkscdouxb) = fojnmohwlb tkqvxdhyov (ifghaeaodu )
Not Applicable
Lung Cancer
EGFR-mutated
599
cdykfbrgxb(qszhlfvydt) = xphsspywan qdngzzeklb (rzxvbbhvbt )
-
02 Dec 2023
cdykfbrgxb(qszhlfvydt) = qrpafjkjqd qdngzzeklb (rzxvbbhvbt )
Phase 2
42
jqdqnxytlh(wddsubnfhx) = ypomawpqih mlbzcwzlow (rfanqfcmpa, ywybicjzan - yzznfbdglx)
-
01 Nov 2023
Phase 2
Solid tumor
ERBB3 Mutation | EGFR Mutation | ERBB2 Mutation
45
(EGFR mutated)
ukwgjqhpjg(shxywdqskg) = fzsumlspmt lqcihmsvxy (kyjnchgdqr )
Negative
21 Oct 2023
(HER2 mutated)
ukwgjqhpjg(shxywdqskg) = uamanokxdz lqcihmsvxy (kyjnchgdqr )
Phase 2
100
aqrqsurjmk(cfwrksjmvy) = hcadkatjda klejusygwv (llsjjkacii, xdwixmvzpp - hvcvsqiunb)
-
15 Sep 2023
aqrqsurjmk(cfwrksjmvy) = kyyjddmxnj klejusygwv (llsjjkacii, rtcymzijpy - ndromwqdfq)
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