The role of gadopiclenol in the modern era of MRI

Gadopiclenol is the first high-relaxivity, low-dose, macrocyclic extracellular gadolinium-based contrast agent (HRLD-M-GBCA) available in Europe and the United States. It was approved by the U.S. Food and Drug Administration (FDA) in 2022 and by the European Medicines Agency (EMA) in 2023 for use in adults and pediatric patients aged 2 to 17 years. In January 2026, the indication was extended to include neonates and infants (0 to 1 years). The current Summary of Product Characteristics (February 2026) states: “Gadopiclenol is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax including breast, abdomen including liver and kidneys, pelvis including prostate, and musculo-skeletal system).” This novel agent is extracellular, non-specific, and does not exhibit albumin binding. The aim of this article is threefold. First, it reviews the evidence currently available regarding the diagnostic efficacy of gadopiclenol in patients undergoing contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions. Second, it explores the role of gadopiclenol in routine clinical practice. Finally, it discusses the potential environmental impact of anthropogenic gadolinium emissions.