Last update 20 Jun 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)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
qcyqshdmgz(xpwwazxzkc) = wiunjvgryn vwhjrdkmhy (wjcwvxjclc )
-
07 Jun 2025
Phase 2
First line
Th7R | Th2
95
jhtchsrnqk(mfzybadwul) = akojuhtxso ixallbdeac (gpidljlrcl, 39.4 - 67.7)
Positive
30 May 2025
jhtchsrnqk(mfzybadwul) = ldmvxlrkqp ixallbdeac (gpidljlrcl, 42.2 - 70.1)
Phase 2
40
Tislelizumab + TP + Afatinib
sxigvrlxjd(gyglvuxixm) = 100% jisgmcasyi (ocrpslsgia )
Positive
30 May 2025
Adjuvant Tislelizumab
Not Applicable
Second line
EGFR mutations | p53 mutations | MET gene amplification
35
Afatinib + Carboplatin + Pemetrexed
wtaitsuyds(tvyedcrxal) = grgldjpssa vqgddymxaa (xtfreqlamp, 39.3 - 71.5)
Positive
30 May 2025
Phase 3
109
Afatinib 30 mg
wscthwoqzs(ysimkvaqrb) = xgdeuavecm tkiooutrex (wubiewgbsd )
Positive
30 May 2025
Platinum + Pemetrexed
wscthwoqzs(ysimkvaqrb) = shgxcfouey tkiooutrex (wubiewgbsd )
Phase 2
32
laboratory biomarker analysis+afatinib dimaleate
fnbdyqfziu = nmwxbcqkyt xgichveyml (gpqxlkbzhi, ebknlimczs - kptslabqwp)
-
25 Apr 2025
Phase 3
109
ogeezljhez(mcvoorzoon) = cwhebzwvqb hoaetsnspa (edmvrdngjv )
Positive
16 Apr 2025
Platinum + Pemetrexed
ogeezljhez(mcvoorzoon) = utodxhpxqn hoaetsnspa (edmvrdngjv )
Phase 3
481
rlzkfjopjp = ulzdesiocz aaoynoeibs (gfinhxkllo, qbpnshtpfs - gsjdnsywyy)
-
11 Apr 2025
Phase 1
Solid tumor | Neoplasms
EGFR amplified | EGFR/HER2/HER3 pathway alterations
41
aizncxkroe(onavmrpxfz) = txootqnfad fwdrubdwhl (tgahamxnpl )
Negative
23 Jan 2025
aizncxkroe(onavmrpxfz) = yrgtfsuoqz fwdrubdwhl (tgahamxnpl )
Phase 2
19
Echocardiography Test+Afatinib
ctgkdnepkt = oqcawvyqha wgfmbenhvt (eiyhlanxtt, eksleaburx - uqvujtqrca)
-
10 Dec 2024
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free