Friday, July 10, 2026

Drug profile · INN

neratinib

neratinib (NERLYNX) is a receptor protein-tyrosine kinase erbb-2 inhibitor.

EMA: approved Antineoplastic and immunomodulating agents (L01) L01EH02
Patents linked 0
Pipeline programs 28
News articles 0
Drug details — neratinib
Class
Antineoplastic and immunomodulating agents (L01)
Route
Patents
0
Programs
28
Data quality
0.83

Quick answer

neratinib (NERLYNX) is a receptor protein-tyrosine kinase erbb-2 inhibitor.

Key facts

INN neratinib
Brand NERLYNX
Mechanism Receptor protein-tyrosine kinase erbB-2 inhibitor
Target Epidermal growth factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
ATC code L01EH02

Mechanism of action

Receptor protein-tyrosine kinase erbB-2 inhibitor

Primary target: Epidermal growth factor receptor

Approval history

Authority Status Date
EMA approved

Pipeline programs

  1. IMFINZI for Advanced Biliary Cancer (ABC) Phase 3 · Ningbo Cancer Hospital · Advanced Biliary Cancer (ABC)
  2. Trastuzumab and neratinib Phase 3 · Sun Yat-sen Memorial · Early-stage Breast Cancer
  3. neratinib Phase 3 · PUMA BIOTECHNOLOGY · HER2+ Metastatic Breast Cancer (MBC)
  4. NERATINIB Phase 2 · PUMA BIOTECHNOLOGY · Stage IV (Metastatic) Breast Cancer
  5. NERATINIB, Sindiar 2 mg cápsulas duras Phase 2 · Ningbo Cancer Hospital · HER2 positive (HER2+), Hormone Receptor positive (HR+) Early
  6. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Triple Negative Breast Cancer
  7. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Early-stage Breast Cancer
  8. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Breast Cancer

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is neratinib?

neratinib (NERLYNX) is a receptor protein-tyrosine kinase erbb-2 inhibitor.

What is the brand name for neratinib?

NERLYNX is a marketed brand name for neratinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.