Trials will evaluate udenafil for heart defects in adolescents
New studies led by researchers with the NHLBI-supported Pediatric Heart Network will assess the use of udenafil in adolescents with single-ventricle heart defects.
The clinical studies are part of an agreement between Mezzion Pharma and New England Research Institutes, Inc., according to a press release.
The studies, which will be funded by a grant from the NHLBI, will evaluate the improvement in certain acute and chronic symptoms in adolescents who had the Fontan procedure earlier in life. Phosphodiesterase type 5 (PDE5) inhibitors like udenafil have demonstrated utility in reducing pulmonary vascular resistance and improving ventricular performance in other types of patients, according to the release.
Mezzion Pharma announced plans to file an investigational new drug application (IND) with the FDA early this year, with the clinical trials beginning soon after.