Our History
Since our founding in South Korea in 2002, Mezzion, Co., Ltd has remained steadfast in our efforts as a rare disease company to develop new treatments for people with single ventricle heart disease and Fontan circulation. Right now, we are focused on bringing forward JURVIGO® (udenafil), which would be a first-to-market treatment option to improve the physiology and exercise capacity of Fontan patients 12 years and older. If successfully brought to market, udenafil would be a major innovation with the potential to impact 70,000+ Fontan patients around the world.
In 2016, we were proud to solidify our presence and commitment to the U.S. market by establishing ourselves as Mezzion Pharmaceuticals, Inc. Since then, we’ve made significant regulatory progress on the road to the approval of udenafil including a pivotal Phase 3 clinical study in the Fontan population that was recognized by the American Heart Association as the biggest advancement in congenital heart disease in 2019. We are confident about what the future holds for our clinical program and patient access to new and needed medicine.
Highlights from our Recent Timeline
2023
Mezzion submitted protocol and selected contract research organization for the confirmatory phase 3 clinical trial, FUEL-2.
Mezzion secured $40 million dollar investment to fund the FUEL-2 clinical trial.
2022
Mezzion received a clear path forward for approval of udenafil, with direction to complete one additional clinical trial.
2021
Mezzion re-submitted a new drug application (NDA) including a request for Priority Review for udenafil to the U.S. Food and Drug Administration (FDA).
2020
Mezzion submitted a new drug application (NDA) for udenafil to the U.S. FDA.
FUEL study recognized by the American Heart Association as the biggest advancement in congenital heart disease in 2019.
2019
Topline data from FUEL study presented at American Heart Association Scientific Sessions.
2018
First patient enrolled in Fontan Associated Liver Disease (FALD) Study.
US. Corporation became Mezzion Pharmaceuticals, Inc.
2017
First patient enrolled in FUEL Open Label Extension (OLE) Study to test the long-term safety of udenafil after administration.
2016
Establishment of the U.S. corporation Mezzion International, LLC.
Initiation of the phase 3 clinical trial, Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL.)