This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

Start Date30 Oct 2023

Sponsor / Collaborator

Mezzion Pharma Co., Ltd.

KCT0005833

/ CompletedPhase 4IIT

Effect of Udenafil Administration for Blood Flow Increase in the Prefrontal Cortex

Start Date01 Dec 2020

Sponsor / Collaborator-

NCT03430583

/ CompletedPhase 3

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

Start Date20 Feb 2018

Sponsor / Collaborator

Mezzion Pharma Co., Ltd.

[+1]

100 Clinical Results associated with Udenafil

100 Translational Medicine associated with Udenafil

100 Patents (Medical) associated with Udenafil

211

Literatures (Medical) associated with Udenafil

19 Aug 2025·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

Article

Author: Orr, William B. ; Goldberg, David J. ; Ploutz, Michelle ; Nowlen, Todd T. ; Frischhertz, Benjamin P. ; McCrindle, Brian W. ; DiMaria, Michael V. ; Lubert, Adam M. ; Cartoski, Mark J. ; Goldstein, Bryan H. ; McHugh, Kimberly E. ; Penny, Daniel J. ; Garg, Ruchira ; Zak, Victor ; Ginde, Salil ; Schumacher, Kurt R. ; Yauck, Jennifer S. ; Whitehill, Robert ; Mackie, Andrew S. ; Davis, Christopher K. ; Yetman, Anji T. ; Rathod, Rahul H. ; Wagner, Jonathan B. ; Kim, Gi Beom ; Payne, R. Mark ; Paridon, Stephen M. ; Pearson, Gail D. ; McBride, Michael G. ; Yeager, James ; Hill, Kevin D. ; Hu, Chenwei ; Detterich, Jon ; Richmond, Marc E. ; John, Anitha S. ; Files, Matthew

Background:

In the FUEL (Fontan Udenafil Exercise Longitudinal) trial, a positive treatment effect was identified for outcomes at the ventilatory anaerobic threshold but not for the primary outcome, oxygen consumption (V o2 ) at peak exercise. This disparate response may be explained by the physiologic challenge of improving peak V o2 in participants with near‐normal baseline exercise performance.

Methods:

Participants were divided into subgroups by baseline predicted peak V o2 (<80% versus ≥80%). Treatment effect was evaluated in those with a baseline peak V o2 <80% predicted and linear regression was performed to examine the interaction between subgroup and response to therapy for the primary and secondary outcomes.

Results:

Of the 379 participants with paired exercise data, 302 (80%) had a baseline peak V o2 <80% predicted. In this subgroup, the primary outcome of peak V o2 improved significantly after 6 months of udenafil treatment, when compared with placebo (0.23±4.17 mL/kg per min versus −0.90±3.74 mL/kg per min; P =0.021). Secondary outcome measures, including V o2 at ventilatory anaerobic threshold ( P =0.023), work at ventilatory anaerobic threshold ( P =0.032), and the myocardial performance index ( P =0.007) were all significantly improved as well. A significant interaction was found between exercise subgroups and response to udenafil for peak V o2 ( P =0.036) but not for other outcomes.

Conclusions:

In this post hoc subgroup analysis, after exclusion of patients with Fontan circulation with near‐normal baseline peak V o2 , a positive treatment effect of udenafil was identified for the primary outcome of peak V o2 . The interaction between baseline peak V o2 and treatment may have influenced the outcome of the FUEL trial.

Registration:

URL: https://clinicaltrials.gov ; Unique identifier: NCT0274115.

01 Apr 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Identification of Phosphodiesterase type 5 inhibitors (PDE5is) analogues using surface-enhanced Raman scattering and machine learning algorithm

Article

Author: Huang, Jiadong ; He, Hongyuan ; Li, Yujing ; Luan, Yujing

Phosphodiesterase type 5 inhibitors (PDE5is), primarily used for the treatment of erectile dysfunction, have been severely misused in recent years, posing a threat to public health and safety. This study developed a method that combines Surface-enhanced Raman spectroscopy (SERS) with machine learning algorithms to rapidly identify different PDE5is types. A total of 948 SERS spectra from 79 PDE5is were collected using gold nanoparticles (AuNPs) as the enhancement agent, and dimensionality reduction was performed through principal component analysis (PCA). Subsequently, six traditional machine learning models, partial least squares discriminant analysis (PLS-DA), orthogonal partial least squares discriminant analysis (OPLS-DA), support vector machines (SVM), k-nearest neighbors (KNN), random forest (RF), and multilayer perceptron (MLP) were applied for data classification and identification. Results showed that the MLP model achieved the highest classification accuracy of 99.65 %, with only 1.82 % of the samples misclassified from thiosildenafil to sildenafil analogues, significantly outperforming the other models. This method offers a rapid, cost-effective, and accurate alternative for the detection of PDE5is in health foods, with implications for improving regulatory oversight and public health safety.

01 Apr 2025·Journal of the American Heart Association

Methylated Arginine Metabolites as Biomarkers for Clinical Status and Response to Type 5 Phosphodiesterase Inhibition in Patients With Fontan Circulation

Article

Author: Hill, Kevin ; Fletcher, Scott ; Love Ko, Jong ; Cartoski, Mark ; Manlhiot, Cedric ; Rathod, Rahul H. ; Whitehill, Robert ; McCrindle, Brian W. ; Everett, Allen ; Khare, Pratik ; Detterich, Jon ; Garg, Ruchira ; Penny, Daniel J. ; Becker, Kristian ; Le, Anne ; Schumacher, Kurt ; Jacobsen, Roni ; Cedars, Ari ; Russell, Mark W. ; Wagner, Jonathan ; Kim, Gi Boem ; Sullivan, Rachel ; Atz, Andrew M. ; Goldberg, David ; Payne, R. Mark ; Kutty, Shelby ; Opotowsky, Alexander R. ; Nowlen, Todd ; Lewis, Matthew ; Zak, Victor ; Files, Matthew ; Ploutz, Michelle ; Chinni, Bhargava Kumar ; Wu, Fred ; Conway, Jennifer

Background:

There is significant interest in NO pathway modulators, specifically type 5 phosphodiesterase inhibitors (PDE5is), to treat patients with a Fontan circulation. Trials, however, have had mixed results. The relationship between the NO pathway and clinical status in patients with Fontan circulation is a significant knowledge gap.

Methods and Results:

We performed targeted metabolomic analysis using liquid chromatography coupled to mass spectrometry to quantify plasma NO pathway metabolite concentrations from 2 well‐characterized populations of patients with Fontan circulation: the Boston Adult Congenital Heart Disease Biobank and Fontan Udenafil Exercise Longitudinal studies. We investigated associations between NO metabolite concentrations and clinical outcomes, exercise capacity, and response to PDE5is. Increased plasma concentration of asymmetric dimethyl arginine (ADMA), an inhibitor of NO production, was associated with risk for hospitalization or death. Increased ADMA and symmetric dimethyl arginine (another inhibitor of NO production) concentrations were associated with decreased baseline exercise capacity among patients with Fontan circulation with <90% predicted peak oxygen uptake, and change in ADMA and symmetric dimethyl arginine concentrations were predictive of change in exercise capacity over time. Treatment with the PDE5i udenafil uncoupled this association. Finally, baseline ADMA and symmetric dimethyl arginine concentrations predicted response to PDE5is among patients with subnormal peak oxygen uptake.

Conclusions:

Plasma concentrations of metabolites that inhibit NO flux are associated with negative clinical outcomes and worse exercise capacity. Moreover, metabolite shifts over time associated with increased NO flux are associated with improved exercise capacity. In patients with a Fontan circulation, the NO pathway modulators ADMA and symmetric dimethyl arginine may be useful as biomarkers of clinical status and predictive of response to PDE5is.

News (Medical) associated with Udenafil

04 Feb 2026

·www.prnewswire.com

Mezzion Pharmaceuticals Applauds Give Kids a Chance Act Becoming Law

FORT LEE, N.J., Feb. 4, 2026 /PRNewswire/ -- Mezzion Pharmaceuticals today welcomed the Mikaela Naylon Give Kids a Chance Act becoming law following President Trump's signing of H.R. 7148, the Consolidated Appropriations Act, 2026. The legislation restores the Rare Pediatric Disease Priority Review Voucher (PRV) program and advances reforms designed to support pediatric drug development and accelerate patient access to life-saving therapies. "This signing reinforces a national commitment to children and families living with rare diseases," said Dean Park, Chairman and CEO of Mezzion Pharmaceuticals. "As Mezzion works to bring the first potential approved therapy for patients with Fontan physiology, policies like the Give Kids a Chance Act are critical to sustaining innovation and accelerating access for communities with no approved options." Single ventricle congenital heart disease was among the conditions represented in national efforts to restore the PRV program. During Congressional engagement, Mezzion served as an industry advocate while a patient representative highlighted the single ventricle community in legislative briefings and on a Congressional panel with the bill's author, bringing real-world patient impact directly into the policy discussion. As an active member of the Rare Disease Company Coalition (RDCC), Mezzion supported these efforts through the coalition's broader multi-year advocacy campaign. About Mezzion Pharmaceuticals Mezzion Pharmaceuticals, Inc., a U.S.-based subsidiary of Mezzion Pharma Co., Ltd. (KOSDAQ: 140410), is a late-stage biopharmaceutical company advancing therapies for rare and underserved diseases. Mezzion is developing JURVIGO® (udenafil) as a potential first-in-class therapy for patients with single ventricle congenital heart disease and Fontan physiology. JURVIGO is investigational and has not been approved by any regulatory authority. For more information, visit and . Trademarks JURVIGO® is a registered trademark of Mezzion Pharma Co., Ltd. Media Contacts: John Presser, EVP, CBO: [email protected] Mr. Sung-Il Noh, CFO: [email protected] SOURCE Mezzion Pharmaceuticals, Inc 21% more press release views with Request a Demo

Priority Review

20 Aug 2025

·www.prnewswire.com

XtalPi Signs MOU with Dong-A ST for Joint Research and Development of Immunology and Inflammation Therapies

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

12 Aug 2025

·www.prnewswire.com

Post-Hoc FUEL Trial Analysis Shows Udenafil Significantly Improves Exercise Capacity in Fontan Patients with Reduced Baseline Function

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

Phase 3Clinical ResultAHA

100 Deals associated with Udenafil

External Link

KEGG	Wiki	ATC	Drug Bank
D10027	Udenafil	G04BE11	DB06267

R&D Status

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10 top approved records.

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Indication	Country/Location	Organization	Date
Erectile Dysfunction	South Korea	Dong-A Pharmaceutical Co., Ltd.	29 Nov 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Univentricular Heart	Phase 3	United States	Mezzion Pharma Co., Ltd.	22 Jul 2016
Univentricular Heart	Phase 3	Canada	Mezzion Pharma Co., Ltd.	22 Jul 2016
Univentricular Heart	Phase 3	South Korea	Mezzion Pharma Co., Ltd.	22 Jul 2016
Pulmonary Arterial Hypertension	Phase 3	South Korea	Dong-A ST Co., Ltd.	01 Apr 2014
Alzheimer Disease	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Sep 2013
Heart failure with normal ejection fraction	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Oct 2012
Heart Failure, Diastolic	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Oct 2012
Idiopathic pulmonary arterial hypertension	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Sep 2012
Chronic systolic heart failure	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Dec 2011
Raynaud Disease	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Jan 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03013751 (FUELExten, CTgov)	Phase 3	Univentricular Heart	301	Udenafil (In PHN-Udenafil-02 (FUEL) Received Udenafil)	nwmvrhevco(nepseipcwz) = alpotjsfxk dohmtxekid (ameeprfnbb, 470.80) View more	-	09 Dec 2025
				Udenafil (In PHN-Udenafil-02 (FUEL) Received Placebo)	nwmvrhevco(nepseipcwz) = ytxxqhctwt dohmtxekid (ameeprfnbb, 444.26) View more
NCT03430583 (FALD, CTgov)	Phase 3	Univentricular Heart	88	Udenafil (Udenafil Continuation (U+))	hmtthesfrx(ltxunxksgc) = ydixhqnzsn qbnzyujbif (oputxbrscw, 0.380) View more	-	18 Sep 2025
				Udenafil (Udenafil Naive (U-))	hmtthesfrx(ltxunxksgc) = tanlrrcydt qbnzyujbif (oputxbrscw, 0.450) View more
NCT02741115 (FUEL, CTgov)	Phase 3	Univentricular Heart	400	Placebo (Placebo)	goojipwasg(tcbdoluumk) = eodiwzpdby ucosshwlia (mtqgzlcpnm, 3.672) View more	-	21 May 2025
				Udenafil (Drug)	nxkyjuwmjz(cedraytgnn) = gaihzcexgt gbxigfzgku (rolpninhzw, 0.112) View more
NCT01553721 (Pubmed \| Clin Ther)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50-mg	pjthdnktxi(xlorvzfjxf) = jmcsydgskq xukseodtbl (stvqdcyiaq )	Positive	01 Aug 2019
NCT01553721 (Pubmed \| Korean Circ J)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50 mg	kzkjbyjflr(vjquzlxrqc) = tgmibpxjka qgsgxicyuf (eeqjlgpmbj ) View more	-	01 Apr 2019
				Udenafil 100 mg	kzkjbyjflr(vjquzlxrqc) = womihasevc qgsgxicyuf (eeqjlgpmbj ) View more
KCT0001436 (Pubmed \| J Clin Pharmacol)	Phase 1	-	-	Udenafil (Healthy young men (21-27 years))	lpkpwbrexr(tiynigxhbz) = lipmahvtsk idmswihsra (lcbnepplwb ) View more	-	01 Nov 2016
				Udenafil (Healthy elderly men (65-78 years))	lpkpwbrexr(tiynigxhbz) = hzwzccxhwv idmswihsra (lcbnepplwb ) View more
NCT01280266 (EULAR2014)	Phase 2/3	Raynaud Disease	12	Udenafil 100 mg/day	uuukfpaxoz(nqartrapqz) = iyyjfkerwf uypelndnqj (sbvdznhgax ) View more	-	11 Jun 2014
NCT01280266 (CTgov)	Phase 2/3	Raynaud Disease	29	Amlodipine (Amlodipine)	qyfgaulbiz(ezspqtqazk) = cmvswbudsj pakpujqjht (eoxtghghar, 1.4) View more	-	11 Dec 2012
				Udenafil (Udenafil)	qyfgaulbiz(ezspqtqazk) = fmpbwomira pakpujqjht (eoxtghghar, 0.9) View more
NCT01364181 (Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Udenafil 50 mg	tcfwyptivo(ffacphowvc) = otyqczcaqd uhmsceqvgq (abkbmcpeks ) View more	-	01 Aug 2012
NCT01037244 (CTgov)	Phase 3	Erectile Dysfunction	618	Udenafil (Udenafil 50 mg)	cnnbrsifho(gexonivcej) = hkfaplwshw vzgmlnvplp (rhpgyiegvi, hxzsshuoka - rtoloejbto) View more	-	22 Dec 2011
				Udenafil (Udenafil 100 mg)	cnnbrsifho(gexonivcej) = dhqpzocdtj vzgmlnvplp (rhpgyiegvi, ixjgnokxpx - zggpgyfrjy) View more

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