Business
Mezzion Pharmaceuticals Reaches Key Enrollment Milestone in World's Largest Fontan Clinical Trial
Mezzion Pharmaceuticals, Inc. (Mezzion) announced that its confirmatory Phase 3 FUEL-2 study evaluating JURVIGO® (udenafil)1 in adolescents and young adults with Fontan circulation has surpassed a key enrollment milestone randomizing approximately 50% of the planned 400+ participants.
About this update from Mezzion Pharma Co., Ltd.
[{"type":"text","content":"SEOUL, South Korea, July 31, 2025 /PRNewswire/ -- Mezzion Pharmaceuticals, Inc. (Mezzion) announced that its confirmatory Phase 3 FUEL-2 study evaluating JURVIGO® (udenafil)1 in adolescents and young adults with Fontan circulation has surpassed a key enrollment milestone randomizing approximately 50% of the planned 400+ participants.","length":335,"tagName":"p"},{"type":"image","alt":"“FUEL-2 is aiming to bring hope to a resilient and underserved community.”","displaySize":"","headline":null,"caption":"“FUEL-2 is aiming to bring hope to a resilient and underserved community.”","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/3c52a8af21b52eeefcc40b3e8a7a5ef2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/4O7dWVOggZNIHQPxj7pmWQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/3c52a8af21b52eeefcc40b3e8a7a5ef2","width":400,"height":400}},"href":"https://mma.prnewswire.com/media/2741297/Mezzion_Pharmaceuticals_FUEL_2.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"FUEL-2 is the largest randomized clinical trial ever conducted for the Fontan population, a group of patients born with single ventricle congenital heart disease who require a series of surgeries culminating in the Fontan procedure. This population remains at high risk for heart failure, organ dysfunction, and early mortality, with no FDA-approved pharmacologic therapies available today.","length":390,"tagName":"p"},{"type":"text","content":""The Fontan journey is long, complex, and often isolating," said Dr. Rahul Rathod, Global Principal Investigator for FUEL-2 and Director of the Single Ventricle Program at Boston Children's Hospital. "With FUEL-2, we're doing more than just advancing a treatment – we're building hope, community, and scientific clarity around a disease that has gone too long without answers."","length":409,"tagName":"p","attribs":{}},{"type":"text","content":"Udenafil, a highly selective and long-acting PDE5 inhibitor, has demonstrated its clinical benefit in Fontan patients with reduced functional capacity (peak VO₂ < 80% of predicted). In the original FUEL trial, this subgroup experienced the most pronounced improvements, particularly in subm...