Drug Profile

Neratinib - Puma Biotechnology

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

Latest Information Update: 06 Aug 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 ERBB 2 receptor antagonists; ERBB 4 receptor antagonists; ErbB 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
Preclinical Marginal zone B-cell lymphoma

02 Jul 2026 M.D. Anderson Cancer Center, Pfizer and Puma Biotechnology terminates a phase I trial in Solid tumours (Combination therapy, Second-line therapy or greater, Late-stage disease) in USA (PO), due to <75% participation (NCT03065387)
22 Apr 2026 Preclinical trials in Marginal zone B-cell lymphoma in USA (unspecified route)
22 Apr 2026 Pharmacodynamics data from a preclinical trial in Marginal zone lymphoma presented at the 117th Annual Meeting of the American Association for Cancer Research (AACR-2026)

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