Drug Profile

Neratinib - Puma Biotechnology

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

Latest Information Update: 10 Jun 2025

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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

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)
30 Apr 2025 Neratinib licensed to ErKIM for commercialisation in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan
11 Feb 2025 Registered for Breast cancer (Adjuvant therapy, Early-stage disease) in Thailand (PO)

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