Ozmosi | Lapatinib Drug Profile
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Lapatinib

Alternative Names: lapatinib, tykerb, gw572016, tyverb
Clinical Status: Inactive
Latest Update: 2026-02-27
Latest Update Note: Clinical Trial Update

Product Description

Lapatinib is a small molecule inhibitor of several tyrosine kinase receptors involved in tumor cell growth that is used in the therapy of advanced breast cancer and other solid tumors. Lapatinib therapy is associated with transient elevations in serum aminotransferase levels and rare instances of clinically apparent acute liver injury. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Lapatinib)

Mechanisms of Action: HER2 Inhibitor, EGFR Inhibitor, TK Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam

Approved Indications: None

Known Adverse Events: None

Company: GSK
Company Location: Europe
Company Founding Year: 2000
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Lapatinib

Countries in Clinic: China, United States

Active Clinical Trial Count: 6

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Adenocarcinoma|Breast Cancer|Esophageal Cancer|Gastrointestinal Cancer

Phase 2: Glioblastoma|Intestinal Cancer|Non-Small-Cell Lung Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2018-002190-21

ROME

P2

Completed

Breast Cancer|Non-Small-Cell Lung Cancer|Intestinal Cancer

2024-09-06

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT01591577

NCT01591577

P2

Completed

Glioblastoma

2024-05-07

30%

2024-05-17

Primary Endpoints

2007-005725-29

2007-005725-29

P3

Completed

Gastrointestinal Cancer|Adenocarcinoma|Esophageal Cancer

2024-10-03

39%

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

2013-005044-29

TYPHER (TYverb Plus HERceptin in metastatic breast cancer)

P2

Completed

Breast Cancer

2024-08-09

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

CTR20161036

CTR20161036

P2

Recruiting

Breast Cancer

None

2025-04-29

CTR20170095

CTR20170095

P3

Completed

Breast Cancer

2023-11-14

2025-04-29

Patient Enrollment|Primary Completion Date|Study Completion Date