Insights Into Vepdegestrant (ARV‐471): The First‐in‐Class Estrogen Receptor Proteolysis‐Targeting Chimera Approaching Food and Drug Administration Approval for Breast Cancer
Vepdegestrant (ARV-471) is an orally bioavailable, proteolysis-targeting chimera (PROTAC)-based estrogen receptor (ER) degrader and is among the most clinically advanced ER-targeting PROTAC degraders, identified through a rational medicinal chemistry optimization campaign. It is being developed as an oral small-molecule endocrine therapy for advanced or metastatic ER-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, with particular relevance for tumors harboring ESR1 mutations. On June 6, 2025, Arvinas and Pfizer submitted a New Drug Application (NDA) for vepdegestrant to the U.S. Food and Drug Administration (FDA), representing an important step in the clinical translation of PROTAC technology. This review summarizes the design, synthesis, degradation mechanism, preclinical pharmacology, and clinical development of vepdegestrant and discusses the broader implications and future prospects of oral PROTAC-based ER degraders in breast cancer therapy.
Authors
- Wen Wang (ORCID: https://orcid.org/0000-0002-3709-021X)
- Meiyan Wei (ORCID: https://orcid.org/0000-0001-6280-6665)
- Qiang Zhang (ORCID: https://orcid.org/0000-0001-6662-1668)
- Lei Tian (ORCID: https://orcid.org/0000-0002-4225-0038)
- Chao Tang (ORCID: https://orcid.org/0000-0002-5072-5849)
- Yang Zhang (ORCID: https://orcid.org/0000-0002-0883-8233)
- Mengdi Wang (ORCID: https://orcid.org/0000-0002-2101-9507)
- Bin Tian (ORCID: https://orcid.org/0000-0002-4202-8090)
- Changhua Ke
- Bingxing Zhang
- Xintao Deng
- Mengxin Chen
- Chengyuan Liang
- Meiling He
- Juan Xia
Institutions
- Central People's Hospital of Zhanjiang (CN)
- Buchang Pharma (China) (CN)
- People's Government of Shaanxi Province (CN)
- Sarepta Therapeutics (United States) (US)
- Shaanxi University of Science and Technology (CN)
Publication Details
- Journal
- ChemMedChem
- Published
- 2026-03-22
- DOI
- https://doi.org/10.1002/cmdc.202501111
- Primary Topic
- Protein Degradation and Inhibitors
- Type
- article
- Field-Weighted Citation Impact
- 0.00