Wednesday, July 8, 2026

Drug profile · INN

neratinib maleate

neratinib maleate (NERATINIB MALEATE) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with PUMA BIOTECHNOLOGY, INC.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 22
News articles 0
Drug details — neratinib maleate
US status
approved
Class
Route
ORAL
Patents
0
Programs
22
Data quality
0.89

Quick answer

neratinib maleate (NERATINIB MALEATE) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with PUMA BIOTECHNOLOGY, INC.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN neratinib maleate
Brand NERATINIB MALEATE
Mechanism Receptor protein-tyrosine kinase erbB-2 inhibitor
Target Epidermal growth factor receptor
Route ORAL
Formulation TABLET

Mechanism of action

Receptor protein-tyrosine kinase erbB-2 inhibitor

Primary target: Epidermal growth factor receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. neratinib Phase 3 · PUMA BIOTECHNOLOGY · HER2+ Metastatic Breast Cancer (MBC)
  2. NERATINIB Phase 2 · PUMA BIOTECHNOLOGY · Stage IV (Metastatic) Breast Cancer
  3. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Advanced Breast Cancer
  4. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Triple Negative Breast Cancer
  5. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Early-stage Breast Cancer
  6. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Anatomic Stage I Breast Cancer
  7. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Breast Cancer
  8. Neratinib Phase 2 · PUMA BIOTECHNOLOGY · Early Stage HER2+ Breast Cancer

Related & competitor drugs

  1. erlotinib hydrochloride Epidermal growth factor receptor erbB1 inhibitor
  2. lapatinib ditosylate Receptor protein-tyrosine kinase erbB-2 inhibitor
  3. mobocertinib Antineoplastic and immunomodulating agents (L01)
  4. mobocertinib succinate Epidermal growth factor receptor erbB1 inhibitor
  5. afatinib dimaleate Epidermal growth factor receptor erbB1 inhibitor
  6. amivantamab-vmjw Epidermal growth factor receptor erbB1 inhibitor

Frequently asked questions

What is neratinib maleate?

neratinib maleate (NERATINIB MALEATE) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with PUMA BIOTECHNOLOGY, INC.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for neratinib maleate?

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

What is the US approval status of neratinib maleate?

neratinib maleate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.