FORT LEE, N.J., Jan. 6, 2026 /PRNewswire/ -- Mezzion Pharmaceuticals, Inc. (Mezzion), a late-stage rare disease biopharmaceutical company developing the first potential treatment for people born with single ventricle congenital heart disease (SV-CHD) living with Fontan circulation, today announced the appointment of Ridwan Shabsigh, MD, FACS to the newly created role of President and Chief Operating Officer.
Dr. Shabsigh's appointment comes at a pivotal stage for Mezzion as the company advances JURVIGO® (udenafil) through its global confirmatory Phase 3 FUEL-2 trial and prepares for potential regulatory submission and commercialization.
Dr. Shabsigh brings more than 35 years of experience in leadership and advisory roles in clinical research, drug development and commercialization. He has provided consulting services across the life sciences ecosystem, guiding clinical development programs in the pharmaceutical and medical device industries. He is widely recognized as a global key opinion leader in the PDE5 inhibitor class and has played a central role in the development and commercialization of multiple leading therapies in this category.
Dr. Shabsigh most recently served as Chair of the Department of Surgery at SBH Health System in New York City and is a Full Professor of Clinical Urology at Weill-Cornell Medical School as well as an Affiliate Professor of Medicine at the CUNY School of Medicine. He received his medical degree from Damascus University and completed his urology residency and fellowship at Baylor College of Medicine. He is a Diplomate of the American Board of Urology and Editor-in-Chief of the Journal of Men's Health.
"Ridwan brings a rare combination of physician leadership, late-stage drug development experience and operational execution," said Dean Park, Chairman and Chief Executive Officer of Mezzion. "As we advance the FUEL-2 program and prepare for the next phase of Mezzion's growth, his leadership will be instrumental in strengthening execution and building a scalable organization positioned to deliver long-term value for patients, partners and shareholders."
"Our mission is clear, to successfully complete the FUEL-2 clinical trial and, if approved, make JURVIGO® available to children and adults living with Fontan circulation who face a profound unmet medical need." said Dr. Shabsigh. "I am honored to join Mezzion and look forward to working alongside patients, families, clinicians and investigators to help deliver a first-in-class therapy and to build Mezzion into a trusted long-term partner to the Fontan community."
Mezzion is developing JURVIGO®, a highly selective oral PDE5 inhibitor, as a potential first-in-class pharmacotherapy for approximately 70,000 individuals worldwide living with Fontan physiology. There are currently no FDA-approved treatments for this population, which faces substantial long-term morbidity and mortality. Recent health-economic analyses estimate that complex congenital heart disease imposes an annual economic burden of approximately $74 billion in the U.S. The global FUEL-2 trial is actively enrolling patients in the U.S. and Asia, with European sites in start-up.
About Mezzion Pharmaceuticals
Mezzion Pharmaceuticals, Inc., a U.S.-based subsidiary of Mezzion Pharma Co., Ltd. (KOSDAQ: 140410), is a late-stage biopharmaceutical company focused on developing therapies for rare and underserved diseases. Mezzion is advancing JURVIGO® (udenafil) through a global Phase 3 clinical program as a potential first-in-class therapy for patients with single ventricle congenital heart disease and Fontan physiology.
JURVIGO® is an investigational drug and has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Its safety and efficacy have not been established. For more information, visit www.mezzion.com and www.FUEL2Study.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the advancement of Mezzion's clinical program, the progress and timing of the FUEL-2 trial, potential regulatory submissions and future business plans. Actual results may differ materially due to risks and uncertainties, including clinical trial outcomes, regulatory review timelines and other factors. Mezzion undertakes no obligation to update forward-looking statements except as required by law.
Trademarks
JURVIGO® is a registered trademark of Mezzion Pharma Co., Ltd.
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SOURCE Mezzion Pharmaceuticals, Inc
