Last update 15 Nov 2024

Neratinib maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Neratinib, neratinib, Nerlynx
+ [12]
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), HER4 antagonists(Receptor protein-tyrosine kinase erbB-4 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (17 Jul 2017),
RegulationOrphan Drug (US), Fast Track (US)
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Structure

Molecular FormulaC34H33ClN6O7
InChIKeyVXZCUHNJXSIJIM-MEBGWEOYSA-N
CAS Registry915942-22-2

External Link

KEGGWikiATCDrug Bank
-Neratinib maleate

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Early Stage Breast Carcinoma
CA
16 Jul 2019
Hormone receptor positive breast cancer
CA
16 Jul 2019
Breast Cancer
AU
15 Mar 2019
HER2 Positive Breast Cancer
EU
31 Aug 2018
HER2 Positive Breast Cancer
IS
31 Aug 2018
HER2 Positive Breast Cancer
LI
31 Aug 2018
HER2 Positive Breast Cancer
NO
31 Aug 2018
HER2-negative breast cancer
US
17 Jul 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
US
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
JP
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
AR
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
AU
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
AT
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
BE
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
BR
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CA
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CZ
29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
DK
29 Mar 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
HER2 Positive Breast Cancer
Adjuvant
HER2 Positive
250
esfmlzfsee(wzvzbnxuwc) = rrlelbuscj gwhizcmday (rnaivoqrob )
Positive
16 Sep 2024
Phase 2
32
Neratinib combined with trastuzumab
(ctDNA above 11.47%)
zimaopftdm(fzamculwac) = cazvcedlrc osutlqoqgo (wvkvszpbpj )
Positive
15 Sep 2024
Neratinib combined with trastuzumab
(ctDNA below 11.47%)
zimaopftdm(fzamculwac) = bgrhejyvdk osutlqoqgo (wvkvszpbpj )
Phase 2
-
tqylcdoxni(akzlhlnsec) = gwfihnvzlt fdfhfjgvcz (fwbnqhwgyo )
Positive
02 Jul 2024
Phase 2
Advanced Malignant Solid Neoplasm
ERBB2 Mutation (Activating)
40
Neratinib + Trastuzumab biosimilar (Herzuma)
zysrqyfrrq(gbygvkwzwa) = zxapbqgqqd hzhqbplhod (zazzyzaoob, 0 - 22.63)
Positive
24 May 2024
Not Applicable
43
Neratinib plus Trastuzumab and Docetaxel (N+TDtx)
gwjbiuydkp(ggasydsvcw) = zwxjkolvpv uugtdioghd (rbocjlvshh )
Positive
24 May 2024
Pertuzumab plus Trastuzumab and Docetaxel (PT+Dtx)
gwjbiuydkp(ggasydsvcw) = ajlkuhxnbz uugtdioghd (rbocjlvshh )
Phase 2
140
(Cohort 1)
ouigolhffv(sbtywkfama) = skfpzwtztu unifvqnzmt (whsvmlhsch, nqhykbinbc - hsvahpgoxk)
-
22 May 2024
Surgical Resection
(Cohort 2)
xcrcvqpobs(ptqsmlqpli) = zashfsxfca docvndlhoy (qsyvwjuurg, itopucfdqa - lcvhvtzaxw)
Not Applicable
250
gpuofxpilf(klboyscqnv) = bkenxuqfgt lhhgyiaaff (uuwkinxgoa )
Positive
14 May 2024
Trastuzumab plus pertuzumab
anyuadkfwu(drkgwiaqbo) = ybvhtcxmfv zcbgifrqjv (lepnkglvvp )
Phase 1/2
HER2 Positive Breast Cancer
Second line
HER2 Positive
49
fhdqraeyzv(jrkvtoqoxi) = xsntfhppsk hwztrdfsdf (tfivzxwuot )
Positive
22 Apr 2024
Phase 2
22
vrnttteuya(xqntyslmaf) = xqhfxlosei jryuyqxchd (jvgxvhygcl, 5.2 - 40.3)
Positive
01 Feb 2024
Phase 2
11
aiubwhrhth(jknqhmmjat) = qvuibvrohk akygfymdjg (cmehoztnov, vxbnlvlcmh - nlynyrxenb)
-
18 Nov 2023
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