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Drug

Neratinib

Approved · EMA
ClassReceptor protein-tyrosine kinase erbB-2 inhibitorEmerging researchLate-stage development

Also known as Nerlynx, 奈拉替尼.

RxNorm1940643ChEMBLCHEMBL180022ATCL01EH02UNIIJJH94R3PWB
1
Research papers
17
Active clinical trials
3
Protein targets
1
Regulatory events
Latest activity
beta

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

Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination With Everolimus, Palbociclib, or Trametinib in Advanced Cancer Subjects With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

Clinical trial2026-07-22Status changed to Terminated · ClinicalTrials.gov

Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

Clinical trial2026-06-23Results expected Q1 2028 · ClinicalTrials.gov

An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Cancers Hoosier Cancer Research Network BRE17-141

Clinical trial2026-06-22Primary completion · ClinicalTrials.gov

A Phase II Study Of Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Overexpressing Gastroesophageal Cancers

Clinical trial2026-06-12Results expected Q1 2028 · ClinicalTrials.gov

Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

Clinical trial2026-05-19Results expected Q2 2027 · ClinicalTrials.gov

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

Clinical trial2026-05-06Results expected Q4 2030 · ClinicalTrials.gov

Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)

Clinical trial2026-05-06Results expected Q4 2029 · ClinicalTrials.gov

Phase Ib/II Study of Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

Clinical trial2026-04-16Results expected Q4 2026 · ClinicalTrials.gov

Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial.

Research2020-09-10The Lancet. Oncology

Approval: Nerlynx (EMA)

Regulatory2018-08-31EMA

Profile

Identifiers & mechanism

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

Canonical name
Neratinib
Aliases & brands
Nerlynx奈拉替尼
RxNorm CUI
1940643
ChEMBL ID
CHEMBL180022
ATC codes
L01EH02
UNII
JJH94R3PWB
Primary mechanism
Receptor protein-tyrosine kinase erbB-2 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Receptor tyrosine-protein kinase erbB-2
ERBB2 · P04626
INHIBITORReceptor protein-tyrosine kinase erbB-2 inhibitor
Epidermal growth factor receptor
EGFR · P00533
INHIBITOREpidermal growth factor receptor erbB1 inhibitor
Receptor tyrosine-protein kinase erbB-4
ERBB4 · Q15303
INHIBITORReceptor protein-tyrosine kinase erbB-4 inhibitor

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
2018-08-31
Latest approval
2018-08-31
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-08-31Approval
Approval: Nerlynx (EMA)
Indication: Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less… Show full indication

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

Evidence ↗

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

Clinical trials

69 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
69
registered trials across all phases
LATEST COMPLETION 2022
17
Active studies
12
Recruiting
3
Late-stage (III+)
34
Completed
18
Discontinued
PHASE DISTRIBUTIONn = 69
Early Phase 11Phase 123Phase 1 / 210Phase 232Phase 33

Late-stage studies

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

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

RecruitingPH IIIUNICANCERn=8002028

A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)

CompletedPH IIIPuma Biotechnology, Inc.n=6212019

A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

CompletedPH IIIKey trialPuma Biotechnology, Inc.n=2,8402019

Recent completions

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

An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With HER2+ Breast Cancer Treated With Neratinib With or Without Trastuzumab

CompletedPH IIUniversity of California, San Franciscon=112022

Phase II Study of Neratinib in Patients 60 and Older With HER2 Positive Metastatic Breast Cancer

CompletedPH IICity of Hope Medical Centern=252022

An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

CompletedPH IIPuma Biotechnology, Inc.n=62021

A Phase Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer

CompletedPH I/IINSABP Foundation Incn=492021

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

CompletedPH IIPuma Biotechnology, Inc.n=5632021

A Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

CompletedPH IIWashington University School of Medicinen=562021

Research activity

1 papers

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

Major research themes1
Molecular Targeted Therapy1
Journals, researchers & institutions
Top journals
  • The Lancet. Oncology1
Leading researchers
  • Abraham J1
  • Baird RD1
  • Bliss JM1
  • Braybrooke JP1
  • Bye H1
  • Cameron D1
  • Cutts R1
  • Gevensleben H1
Leading institutions
free-text, unnormalised
  • Breast Cancer Now Toby Robins Research Centre1
  • Cancer Research UK Cambridge Centre1
  • Cancer Research UK Edinburgh Centre1
  • Clinical Trials and Statistics Unit1
  • Institute of Cancer Sciences1
  • Institute of Pathology1

Related drugs

2 matches

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

Capivasertib

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

1 shared disease1 shared paper
Fulvestrant

Studied across the same disease area as Neratinib 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.