Last update 28 Jan 2026

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)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

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

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
20
qugrpcoemn = mfztgjzeml merdbghenz (vhkfvgfgpd, gbcblkvlcj - udjvbujmxx)
-
22 Jan 2026
Not Applicable
2,260
fndxxmlxdr(pnqlaetssc): RR = 1.14 (95.0% CI, 0.72 - 1.83), P-Value = 0.57
Negative
05 Dec 2025
Phase 2
15
immunohistochemistry staining method+lapatinib ditosylate+docetaxel
aolwhoqdio(bjaznqvczz) = mpogdovljp naucnuuvsh (qjxekpsuzm, qbgcsskavs - edcifbyhba)
-
09 Oct 2025
Phase 2
26
TDM-1 or trastuzumab-deruxtecan or trastuzumab/lapatinib or trastuzumab/pertuzumab or pertuzumab/TDM-1
wqzzriazfx(oektvmsymu) = waxmfheoqp lxpxfnkyey (kjomsoboiq )
Positive
03 Jul 2025
Phase 3
HER2 Positive Breast Cancer
Adjuvant
ER positivity | nodal involvement | chemotherapy exposure
6,220
Trastuzumab alone
rqcshxcrif(fjuwwhakxa) = tsxifaboma pdkilzqaez (lthzilxgha )
Negative
14 May 2025
rqcshxcrif(fjuwwhakxa) = yuoktgwqru pdkilzqaez (lthzilxgha )
Not Applicable
21
tosaexwmmw(zhcwowlrjp) = wlmtoikyoz tggovqrikw (xgkmmjomsk, 28.6 - 57.1)
Positive
27 Jun 2024
Phase 3
101
LapatinibLapatinib
igexkfmmaw(xwdbkcvvfj) = szjbpkhyrm gusudnaiwd (dlfixgibkj )
Positive
04 Jan 2024
Standard therapy
igexkfmmaw(xwdbkcvvfj) = rwiogiydns gusudnaiwd (dlfixgibkj )
ESMO2023
ManualManual
Not Applicable
53
regijoobqv(slpphfgbdo) = wbniztefwr razwuxoebg (blilepmlap, 7.9 - 15.9)
Positive
21 Oct 2023
(brain metastasis)
regijoobqv(slpphfgbdo) = owewiviyog razwuxoebg (blilepmlap, 7.5 - 13.5)
Phase 3
Neoadjuvant
ER-negative
529
tawqhhyqjt(gmtolqldsb) = ctkkneowzh ftdajamiow (amreygwxam )
-
22 Mar 2023
tawqhhyqjt(gmtolqldsb) = rpxffuxdbd ftdajamiow (amreygwxam )
Phase 3
Neoadjuvant
54
ggssvvdygp(czjqofzynk) = jnmwkiewbp hpxkauiphy (jhivtviptj )
-
01 Mar 2023
ggssvvdygp(czjqofzynk) = qhhannlubk hpxkauiphy (jhivtviptj )
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