GTX-104

GTX-104 is a novel, clinical-stage, injectable intravenous (IV) formulation of nimodipine developed for the treatment of aneurysmal subarachnoid hemorrhage (aSAH), a rare and life-threatening type of stroke. Unlike traditional oral nimodipine, which can be problematic in critically ill patients due to swallowing difficulties and variable absorption, GTX-104 is designed for IV infusion to ensure consistent drug delivery. The formulation uses dispersed micelles of polysorbate 80 containing nimodipine in an aqueous solution with alcohol as an excipient. Clinical studies have shown that GTX-104 achieves similar pharmacokinetic profiles to oral nimodipine but with less variability and fewer episodes of clinically significant hypotension—a key side effect limiting oral use. In the pivotal Phase 3 STRIVE-ON trial, GTX-104 demonstrated improved dose compliance, better functional recovery at 90 days, reduced ICU readmissions and ventilator days compared to oral nimodipine. The drug is being advanced by Grace Therapeutics (formerly Acasti Pharma), with a New Drug Application submission anticipated in 2025[1][2][4][5][6][7].

Brand names

GTX-104GTX104GTX 104

Other names

GTx-104GTx104GTx 104