Drug Profile

Neratinib - Puma Biotechnology

Alternative Names: CAN 030; HKI-272; HLX-901; NERLYNX; Nerlynx; NERLYNX SKU; Ouyoubi; PB-272

Latest Information Update: 30 Jan 2026

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At a glance

Originator Wyeth
Developer CANbridge Pharmaceuticals; City of Hope National Medical Center; Fox Chase Cancer Center; M. D. Anderson Cancer Center; Memorial Sloan-Kettering Cancer Center; National Comprehensive Cancer Network; Novartis Oncology; NSABP Foundation; Pfizer; Pierre Fabre; Pint Pharma; Puma Biotechnology; Specialised Therapeutics Asia; University of California at San Francisco
Class Amides; Aniline compounds; Antineoplastics; Carboxylic acids; Chlorobenzenes; Dimethylamines; Ethers; Nitriles; Pyridines; Quinolines; Small molecules
Mechanism of Action Epidermal growth factor receptor antagonists; ERBB 2 receptor antagonists; ERBB 4 receptor antagonists; Protein tyrosine kinase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Breast cancer
New Molecular Entity Yes

Marketed Breast cancer; HER2 positive breast cancer
Phase II Colorectal cancer; Glioblastoma; Non-small cell lung cancer; Prostate cancer; Solid tumours
Phase I/II Haematological malignancies
Phase I Gastric cancer

23 Jan 2026 Launched for Breast cancer (Early-stage disease, Adjuvant therapy) in Thailand (PO)
23 Jan 2026 Launched for Breast cancer (Second-line therapy or greater, Combination therapy, Metastatic disease) in Thailand (PO)
13 May 2025 M.D. Anderson Cancer Center terminates a phase I/II trial in Breast cancer (Neoadjuvant therapy, Metastatic disease, Late-stage disease, Combination therapy) in USA (PO) due to less than 75% accrued (NCT03101748)

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