Udenafil

CAMBRIDGE, Mass., Aug. 19, 2025 /PRNewswire/ -- XtalPi announced on the 20th that it signed a Memorandum of Understanding (MOU) with Korea's leading pharmaceutical company Dong-A ST, to jointly develop therapeutics for immunological and inflammatory diseases. This collaboration will be based on XtalPi's intelligent and automated drug discovery platform, which integrates artificial intelligence (AI), quantum physics, and large-scale automated robotic experiments. The two companies plan to co-identify targets and discover first-in-class or best-in-class drug candidates using XtalPi's proprietary AI-driven drug discovery platform. The XtalPi platform combines the speed and generative power of AI with the accuracy of its robotic lab-in-the-loop to accelerate drug discovery and vastly expand the explorable chemical space. This integrated workflow spans deep-learning-based molecule design, quantum physics and molecular dynamics simulations for predicting drug-target interactions, automated chemical synthesis, and experimental validation of candidate compounds' key pharmaceutical properties. Leveraging its expertise in immunology and inflammation as well as its experience in small molecule drug development, Dong-A ST will actively participate throughout the entire R&D process—including candidate validation, efficacy and safety testing, and the formulation of preclinical and clinical development strategies. The company also plans to explore strategies for pipeline expansion and assess commercialization potential. Through this partnership, Dong-A ST aims to strengthen its pipeline in the immunology and inflammation space and expand its R&D scope beyond small molecule therapeutics into areas such as targeted protein degradation (TPD), biologics, antibody-drug conjugates (ADC), and gene therapies. John Wang, Senior Vice President of Drug Discovery at XtalPi, stated: "The combination of Dong-A ST's extensive expertise and XtalPi's proven AI-robotics platform is well-positioned to translate scientific innovation into competitive precision medicines. Together, we aim to rapidly discover and rigorously validate novel drug candidates across multiple modalities to unlock unique market opportunities, and deliver transformative therapies for global patients." Jae-Hong Park, Head of R&D at Dong-A ST, remarked, "This collaboration marks a pivotal step in expanding Dong-A ST's R&D capabilities," adding, "By leveraging synergies with XtalPi's AI platform, we expect to accelerate the development of next-generation treatments for immune and inflammatory diseases." Meanwhile, both Dong-A ST and XtalPi operate open innovation offices in Boston, USA. This geographic proximity will facilitate closer and more efficient collaboration throughout the drug discovery process. About Dong-A ST Dong-A ST Co., Ltd. (170900.KO) was established in 1932 and is a leading Korean pharmaceutical company engaged in the development, manufacturing, and commercialization of ethical drugs, biosimilars, medical devices, and diagnostics. Its key products include Stillen (gastritis), Zydena (erectile dysfunction), Motilitone (functional dyspepsia), and Imuldosa (ustekinuma biosimilar). Leveraging strong R&D capabilities and a history of innovation, Dong-A ST is expanding its pipeline in immunology, inflammation, neurological disease, metabolic diseases, and oncology, while advancing into new modalities such as biologics, ADCs, TPD, and gene therapies. About XtalPi XtalPi Holdings Limited (XtalPi, 2228.HK) was founded in 2015 by three physicists from the Massachusetts Institute of Technology (MIT). It is an innovative R&D platform powered by quantum physics, artificial intelligence, and robotics. By integrating first-principles calculations, AI algorithms, high-performance cloud computing, and standardized automation systems, XtalPi provides digital and intelligent R&D solutions for companies in the pharmaceutical, materials science, agricultural technology, energy, new chemicals, and cosmetics industries. SOURCE XtalPi Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SEOUL, South Korea, Aug. 12, 2025 /PRNewswire/ -- A newly published post-hoc analysis of the landmark FUEL (Fontan Udenafil Exercise Longitudinal) Trial demonstrates that udenafil, a PDE5 inhibitor, significantly improves peak oxygen consumption (peak VO₂) in adolescents with single ventricle congenital heart disease (SV-CHD) who have undergone the Fontan procedure and have reduced exercise capacity. Published in the Journal of the American Heart Association: "Revisiting the Effect of Udenafil on Exercise Performance in Patients With Fontan Circulation: Results of a Post Hoc Analysis of the FUEL Trial" The original multinational, randomized, placebo-controlled Phase 3 FUEL trial demonstrated statistically significant improvements in key secondary endpoints – such as VO₂ at ventilatory anaerobic threshold (VAT) and myocardial performance index (MPI) – but narrowly missed statistical significance for the primary endpoint of peak VO₂ in the overall population. Recognition of a high performing "Super Fontan" subgroup prompted further analysis stratifying participants by baseline peak VO₂ (<80% vs. ≥80% of predicted) to assess whether initial exercise capacity influenced treatment response. Key findings from the post-hoc analysis: In the 302 patients with baseline peak VO₂ <80% predicted (80% of the evaluable cohort), udenafil significantly improved peak VO₂ compared to placebo (p=0.021). Significant improvements were also observed in VO₂ at VAT (p=0.023), work at VAT (p=0.032), and MPI (p=0.007). A significant interaction between baseline exercise capacity and treatment effect for peak VO₂ (p=0.036) suggests that including high-functioning patients, whose physiologic ceiling may limit measurable gains, could have masked the full treatment effect in the original trial. "These results provide a possible physiologic explanation for the outcomes of the FUEL trial and support further investigation of udenafil in Fontan patients with reduced exercise capacity," said Dr. David Goldberg, lead author and pediatric cardiologist at Children's Hospital of Philadelphia. "This analysis highlights the need for a confirmatory clinical trial targeted to the large majority of Fontan patients who are most likely to demonstrate benefit using peak VO2 as the primary endpoint." "Importantly, the absence of a detectable change in peak VO₂ among higher-functioning Fontan patients may reflect– what may be termed a 'ceiling effect' – rather than a lack of therapeutic response," added Dr. Bryan H. Goldstein, senior author and Director of the Cardiac Catheterization Laboratory at UPMC Children's Hospital of Pittsburgh. "These patients still achieve meaningful improvements in submaximal exercise measures such as VO₂ at VAT and MPI. Moreover, as these younger, high-performing individuals age and are further exposed to ongoing Fontan circulatory stresses, their exercise capacity with decline and therefore, the need for targeted pharmacotherapy will likely increase." The findings highlight the importance of selecting appropriate endpoints and stratifying populations in rare disease trials. Informed by FUEL, the ongoing confirmatory phase 3 FUEL-2 trial focuses on Fontan patients with reduced baseline exercise capacity – those in whom changes in peak VO₂ are most reliably measurable. "This focused design increases the likelihood of demonstrating efficacy on the primary endpoint, while still capturing udenafil's broader therapeutic potential," said Dr. Rahul Rathod, Global Principal Investigator for FUEL-2 and Director of the Single Ventricle Program at Boston Children's Hospital. "Given the strong link between peak VO₂ and long-term outcomes in Fontan patients, a +1.13 mL/kg/min improvement over six months is clinically meaningful and may influence disease progression." The FUEL trial was supported by the National Heart, Lung, and Blood Institute (NHLBI) and Mezzion Pharma Co., Ltd., the regulatory sponsor of udenafil development for Fontan patients. About Mezzion Mezzion Pharma Co., Ltd. is a biopharmaceutical company developing therapies for rare and orphan diseases. Udenafil is currently being evaluated in the Phase 3 FUEL-2 trial for improving exercise performance in adolescents and young adults with Fontan circulation. For more information, please visit and . Media Contacts: John Presser, Chief Business Officer – [email protected] Sung-Il Noh, Chief Financial Officer – [email protected] SOURCE Mezzion Pharmaceuticals, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED