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Neratinib · Nerlynx, HKI-272

Small molecule · Inhibitor of HER2 (ERBB2), EGFR and HER4 (ERBB4) · developed by Puma Biotech

Approved FDA, Jul 2017

PBYI Developer

4 Registered trials

What is Neratinib?

Neratinib is an oral irreversible kinase inhibitor that binds to HER2, EGFR, and HER4, reducing their autophosphorylation and downstream MAPK and AKT signaling.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Nerlynx, HKI-272
Drug type: Small molecule
Targets: HER2 (ERBB2), EGFR, HER4 (ERBB4)
Mechanism: Inhibitor of HER2 (ERBB2), EGFR and HER4 (ERBB4)
Pathways: MAPK/ERK, PI3K/Akt
Therapy area: Oncology
Developer: Puma Biotech (PBYI)
FDA status: Approved as Nerlynx (July 17, 2017), NDA208051 · FDA label

✅ FDA-approved uses

Extended adjuvant treatment of early-stage HER2-positive breast cancer
Advanced or metastatic HER2-positive breast cancer

From the indications section of the FDA label (version of Jul 2, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT01808573	Phase 3	HER2+ Metastatic Breast Cancer (MBC)	Completed	PBYI
NCT01494662	Phase 2	Breast Cancer	Completed	PBYI
NCT05274048	Phase 1	Gastric Cancer	Recruiting	PBYI
NCT04502602	Phase 1	Advanced Solid Tumor	Active not recruiting	PBYI

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Advanced Solid TumorGastric CancerGastrointestinal CancerHER2 Gene MutationOvarian CancerBreast CancerHER2+ Metastatic Breast Cancer (MBC)

Other drugs acting on ERBB2 / EGFR / ERBB4

Osimertinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved Actinium Ac 225 FPI-2068 Phase 1 ADCT-502 Phase 1 ALX2004 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 EGFR-TKI inhibitor based on investigator's choice Phase 3 ELVN-002 Phase 1

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the PBYI page.

Follow PBYI, the company behind Neratinib

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z