Evaluation of Clearance Prediction Methods for Vepdegestrant (ARV-471) Using PBPK Modelling: Insights into PROTAC Clinical Pharmacokinetics

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September 11,2025

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Recently, vepdegestrant (ARV-471), an orally bioavailable Proteolysis-targeting chimaeras (PROTACs, proteolysis-targeting chimaeras) targeting the estrogen receptor (ER, estrogen receptor), was submitted as a New Drug Application (NDA, New Drug Application) to the U.S. Food and Drug Administration (FDA, Food and Drug Administration) for the treatment of ESR1-mutated (Estrogen Receptor 1-mutated), ER+ (Estrogen Receptor-positive), HER2- (Human Epidermal Growth Factor Receptor 2-negative) advanced or metastatic breast cancer. This submission represents a significant milestone, as ARV-471 may become the first FDA-approved PROTAC degrader, highlighting the growing clinical potential of PROTAC technology.

Evaluation of Clearance Prediction Methods for Vepdegestrant (ARV-471) Using PBPK Modelling: Insights into PROTAC Clinical Pharmacokinetics

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