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Drug

Lapatinib

Approved · EMA
Emerging researchLate-stage developmentSteady momentum

Also known as N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-4-quinazolinamine, Tykerb.

4
Research papers
4
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1 Study of Dabrafenib in Combination With Lapatinib in BRAF Mutant Thyroid Cancer

Clinical trial2026-04-29Primary completion · ClinicalTrials.gov

Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

Clinical trial2026-01-20Completed · ClinicalTrials.gov

Anti-HER2 Drugs for the Treatment of Advanced HER2 Positive Breast Cancer.

Research2023-10-25Current treatment options in oncology

Approval: Tyverb (EMA)

Regulatory2008-06-10EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lapatinib
Aliases & brands
N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-4-quinazolinamineTykerb
RxNorm CUI
480167
ChEMBL ID
CHEMBL554
ATC codes
L01EH01
UNII
0VUA21238F
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2008-06-10
Latest approval
2008-06-10
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2008-06-10Approval
Approval: Tyverb (EMA)
Indication: Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced orShow full indication

Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

155 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
155
registered trials across all phases
LATEST COMPLETION 2026
4
Active studies
1
Recruiting
29
Late-stage (III+)
101
Completed
50
Discontinued
PHASE DISTRIBUTIONn = 155
Early Phase 14Phase 131Phase 1 / 212Phase 279Phase 2 / 32Phase 324Phase 41Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092023
Major research themes2
Breast Neoplasms1Immunotherapy1
Journals, researchers & institutions
Top journals
  • British journal of cancer1
  • Current treatment options in oncology1
  • Journal of translational medicine1
  • The oncologist1
Leading researchers
  • Ashley S1
  • Bhatti R1
  • Blackwell K1
  • Broadwater G1
  • Camburn T1
  • Castro H1
  • Chan S1
  • Chen W1
Leading institutions
free-text, unnormalised
  • Department of Pathology and Laboratory Medicine1
  • Duke University Medical Center1
  • Medical University of Gdansk1
  • The Royal Marsden NHS Foundation Trust1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across the same disease area as Lapatinib in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Lapatinib in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Lapatinib in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Lapatinib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.