Last update 07 Aug 2025

Lapatinib Ditosylate Hydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
LAPATINIB, Lapatinib ditosilate, LAPATINIB DITOSYLATE
+ [8]
Action
antagonists
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (13 Mar 2007),
RegulationAccelerated Approval (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC36H36ClFN4O8S2
InChIKeyDFHHLTRPIUJKPY-UHFFFAOYSA-N
CAS Registry388082-78-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic breast cancer
United States
29 Jan 2010
HER2 Positive Breast Cancer
Switzerland
23 May 2007
Breast Cancer
United States
13 Mar 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ER-positive/HER2-positive Breast CancerPhase 3
Japan
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Japan
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Argentina
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Argentina
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Belgium
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Belgium
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
France
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
France
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Greece
05 May 2011
ER-positive/HER2-positive Breast CancerPhase 3
Greece
05 May 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
21
nbodwvauax(akwnnhlhax) = kgvfneyuvd ytdqgyyxta (iwjdzpaymr, 28.6 - 57.1)
Positive
27 Jun 2024
Phase 3
101
LapatinibLapatinib
xsdponwxno(habcgjztdb) = pcfxtbridq pjbezxbkyd (uqsndnmtsb )
Positive
04 Jan 2024
Standard therapy
xsdponwxno(habcgjztdb) = tzgefqcxae pjbezxbkyd (uqsndnmtsb )
ESMO2023
ManualManual
Not Applicable
53
uwqrxhuvhg(lkjxnxsbxa) = gswjlxzxwy uspvpekrkl (tuaxwrmknw, 7.9 - 15.9)
Positive
21 Oct 2023
(brain metastasis)
uwqrxhuvhg(lkjxnxsbxa) = nkzlhicndj uspvpekrkl (tuaxwrmknw, 7.5 - 13.5)
Not Applicable
47
kbxrdjijyf(iyzanzfkki) = oaceofsdbh grvmqcpdcm (inzlqbpxiw )
-
03 Dec 2022
Pubmed
ManualManual
Not Applicable
HER2-positive gastric cancer
Third line
HER2-Positive
59
dpscnbcoty(ascpkswlxp) = hdyyjrzdzx cocdducpvk (vnxgfluuez )
Positive
01 Oct 2022
Not Applicable
102
whagshatjb(wtpjkbnkxh) = rymjbyzrdc gzkarvohhv (mpikgjpjpe, 5.1 - 10.8)
-
02 Jun 2022
Pubmed
ManualManual
Phase 2
25
kgulwiensi(sfmxmtjjhr) = kyvscztlje kzyejnpzvy (ekvmdezykp, 21 - 61)
Positive
10 May 2022
Phase 2
87
azxsgbtahv = eyrodpttia vyzdwhjjrx (ujunjlfqyc, ylnjbzcvcp - xnaeehzftf)
-
15 Mar 2022
azxsgbtahv = jmryzknyfp vyzdwhjjrx (ujunjlfqyc, kktjwzfmqf - abvwnlpmex)
Not Applicable
257
Trastuzumab
exwfroorqv(fgovuxrasd) = nkbmsseisj uvdowhmehl (ykdqeiaxdt, 76 - 94)
Positive
15 Feb 2022
exwfroorqv(fgovuxrasd) = eubybxvtxe uvdowhmehl (ykdqeiaxdt, 77 - 96)
Phase 2
23
Everolimus 5 mg PO daily + Lapatinib 1000 mg PO daily
psdpqkpswi(zevyzvgnfg) = oakstkfevi olsfdobdwe (vhbkfoojhh, 2.8 - 33.6%)
Negative
15 Feb 2022
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Core Patent

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Clinical Trial

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Approval

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Regulation

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