Gadofosveset Trisodium (DB06705): A Comprehensive Monograph on a First-in-Class Blood-Pool MRA Agent

Executive Summary

Gadofosveset trisodium is a gadolinium-based contrast agent (GBCA) developed as a specialized intravascular or "blood-pool" agent for magnetic resonance angiography (MRA).[1] Its key innovation was a unique pharmacological profile, characterized by reversible binding to serum albumin, which conferred a prolonged intravascular residence time. This property enabled high-resolution, steady-state imaging of the vascular system, representing a significant advantage over conventional extracellular GBCAs that rapidly extravasate into the interstitial space.[3] It was the first agent to be approved by the U.S. Food and Drug Administration (FDA) specifically for MRA, with proven efficacy in evaluating aortoiliac occlusive disease (AIOD) where it demonstrated superior diagnostic accuracy compared to unenhanced MRA.[3]

Despite its clinical efficacy, the agent's lifecycle was dominated by two critical safety issues. First, it was subject to the class-wide Black Box Warning for Nephrogenic Systemic Fibrosis (NSF), a rare but debilitating and potentially fatal condition occurring in patients with severe renal impairment. This risk was theoretically amplified for gadofosveset due to its significantly prolonged elimination half-life in this patient population.[7] Second, its use coincided with the emerging concern of long-term gadolinium deposition in the brain and other tissues, a phenomenon particularly associated with its structural class of linear GBCAs.[10]