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

196

Literatures (Medical) associated with Udenafil

22 Sep 2026·ONCOGENE

Transcription factor EN1 governs a lipogenic USP18-ACLY axis to drive bladder cancer malignancy

Article

Author: Yin, Zhuo ; Li, Xiangya ; Zhan, Ying ; Wen, Chuqi ; Guo, Xiaoyan ; Zhu, Chenxi ; Li, Yang ; Hu, Jia

Bladder cancer (BLCA) is a lethal malignancy with limited therapeutic options. The role of the transcription factor Engrailed-1 (EN1) in BLCA metabolic reprogramming was previously unknown. Our study demonstrates that EN1 is significantly overexpressed in BLCA, correlating with poor patient survival and driving tumor progression. Mechanistically, EN1 transcriptionally upregulates the deubiquitinase USP18. USP18, in turn, prevents the proteasomal degradation of ATP-citrate lyase (ACLY), thereby stabilizing this gatekeeping enzyme to enhance de novo lipogenesis. Crucially, we identified the FDA-approved drug Udenafil as a candidate EN1-targeting compound. Udenafil suppressed the USP18/ACLY axis and inhibited BLCA progression in preclinical models. This study defines the EN1-USP18-ACLY axis as a master regulator of lipogenesis and a promising therapeutic target in BLCA, supporting the repositioning of Udenafil as a potential treatment strategy.

01 Jul 2026·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

An integrative machine learning and structure-driven drug repositioning strategy for human IRAK4-targeted cancer therapy

Article

Author: Shen, Xiaolin ; Raza, Muhammad Ali ; Ahmad, Muneer ; Sun, Xinxiao ; Iqbal, Muhammad Waleed ; Lv, Jianlong

The upregulation of interleukin-1 receptor-associated kinase 4 (IRAK4) drives pro-tumorigenic signaling across various malignancies. Currently available IRAK4 inhibitors are all limited by suboptimal selectivity and off-target toxicity. To develop non-toxic and mechanistically focused IRAK4 inhibitors, an in silico machine learning (ML) pipeline combined with structure-driven drug repositioning was employed. An IRAK4-targeting dataset of bioactive compounds was systematically filtered and curated to train a random forest (RF) regression model. Comparative cross-validation against 41 independent ML frameworks demonstrated reasonable predictive accuracy, and the optimized model was deployed to screen a library of 1040 FDA-approved therapeutics. Orthogonal molecular docking supported the binding efficacy of RF-identified lead compounds, including udenafil, linagliptin, benflumetol, and nimodipine. Thermodynamic and conformational stability were validated using molecular dynamics (MD) simulations, yielding stable root mean square deviation (RMSD), radius of gyration (R_g), root mean square fluctuation (RMSF), principal component analysis (PCA), hydrogen bonding, and MMGBSA/MM-PBSA profiles. The efficacy of these candidates was further supported by their low toxicity profiles, via graph neural network (GNN)-based toxicity analysis. These findings establish a scalable computational strategy for identifying repurposable oncology therapeutics and propose udenafil, linagliptin, benflumetol, and nimodipine as mechanistically credible candidates for experimental validation.

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.

News (Medical) associated with Udenafil

02 Aug 2026

·www.prnewswire.com

Mezzion Reports Positive In Vivo Results for Udenafil in ADPKD

Seoul, Korea, Aug. 2, 2026 /PRNewswire/ -- Mezzion Pharma Co., Ltd. today announced positive results from a new in vivo study of udenafil, a novel phosphodiesterase type 5 (PDE5) inhibitor, in autosomal dominant polycystic kidney disease (ADPKD). In a preclinical ADPKD model, udenafil reduced kidney cyst burden and blood urea nitrogen (BUN), a blood marker linked to kidney function, compared with controls. Both findings were statistically significant and consistent across the treatment groups evaluated. The study also showed evidence of activity on udenafil's intended cyclic guanosine monophosphate (cGMP) signaling pathway in the kidney. In addition, udenafil produced a statistically significant reduction in a preclinical measure of cardiac hypertrophy, or heart enlargement. Because cardiovascular complications are an important part of ADPKD, this finding supports further study of udenafil's potential effects on cardiac remodeling. The study was conducted at Mayo Clinic in Florida, with Fouad T. Chebib, M.D., serving as principal investigator. The results build on two earlier preclinical studies in which udenafil inhibited cyst growth and reduced cyst burden. Across these complementary ADPKD models, udenafil has shown activity on its intended cGMP pathway, reduced measures of cystic disease, and improved a biochemical measure used in kidney assessment. Together, the data support clinical evaluation in people with ADPKD. "These findings strengthen the scientific rationale for advancing udenafil in ADPKD," said Dong Hyun Park, Chairman and CEO of Mezzion. "As previously announced, the U.S. Food and Drug Administration (FDA) indicated that Mezzion's nonclinical data package, together with its prior clinical and safety experience with udenafil, provides a reasonable foundation for clinical development. Udenafil has been studied in multiple clinical programs over approximately 20 years, including studies with multi-year exposure. This experience will help inform ADPKD study design and safety monitoring." "The consistency across multiple preclinical models is encouraging and supports evaluating udenafil in a well-designed Phase 2b study using established measures of ADPKD progression," said Ronald D. Perrone, M.D., of Tufts Medicine. "Patients with ADPKD need more treatment options for this serious, lifelong disease," said Ridwan Shabsigh, M.D., FACS, President and COO of Mezzion. "Advancing udenafil in ADPKD gives Mezzion a second rare-disease development program alongside our ongoing Phase 3 FUEL-2 study." "The preclinical data provide a compelling scientific rationale for clinical evaluation in ADPKD. Unlike vasopressin V2 receptor antagonists, udenafil is being investigated through modulation of the nitric oxide-cGMP pathway, providing a mechanistically distinct therapeutic approach. We look forward to participating in the study," said Professor Yong Chul Kim of Seoul National University Hospital. ADPKD is a progressive genetic kidney disease affecting approximately 1 in 400 to 1,000 people worldwide. As kidney cysts grow, kidney function can decline and ultimately lead to dialysis or kidney transplantation. ADPKD is also associated with cardiovascular and other complications. Mezzion plans to advance udenafil into a Phase 2b study in adults at risk of rapidly progressing ADPKD, subject to finalization of the protocol and receipt of regulatory and ethics approvals. The planned study is expected to evaluate kidney volume and function, disease-related biomarkers, pharmacokinetics, safety, and tolerability. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd., based in Korea and listed on the KOSDAQ (140410), is a clinical-stage biopharmaceutical company focused on developing therapies for rare and underserved diseases. The Company is developing udenafil across multiple potential indications, including Fontan circulation and ADPKD. Udenafil is an investigational product and has not been approved by any regulatory authority. Media Contacts: John Presser, EVP, CBO: [email protected] Mr. Sung-Il Noh, CFO: [email protected] SOURCE Mezzion Pharma Co., Ltd. 21% more press release views with Request a Demo

Clinical ResultPhase 2

16 Jul 2026

·www.prnewswire.com

FUEL FALD Study Published in Pediatric Cardiology

Peer-reviewed publication advances understanding of Fontan-associated liver disease (FALD) and adds to the growing body of evidence supporting udenafil in Fontan circulation FORT LEE, N.J., July 16, 2026 /PRNewswire/ -- Mezzion Pharmaceuticals today announced publication of "The FUEL FALD Study: Effects of Udenafil on Liver Stiffness and Fibrosis after Fontan" in the peer-reviewed journal Pediatric Cardiology. The publication reports findings from an exploratory substudy of the FUEL Open Label Extension (OLE) evaluating Fontan-associated liver disease (FALD) in adolescents and young adults who received 12 months of udenafil treatment. As survival following the Fontan procedure has improved, FALD has emerged as one of the most important long-term complications affecting patients living with Fontan circulation. Driven by the unique Fontan physiology, FALD is characterized by progressive liver injury and fibrosis and remains an area of significant unmet medical need, with no approved therapies specifically indicated for this condition. The publication highlights the substantial burden of liver disease in this population. At study entry, 95% of participants had elevated Enhanced Liver Fibrosis (ELF) scores, consistent with at least moderate fibrosis based on thresholds established in other liver diseases. Liver stiffness was also assessed using ultrasound shear wave elastography (SWE) and magnetic resonance elastography (MRE) . Following 12 months of udenafil treatment, investigators observed a significant decrease in the ELF score, a non-invasive biomarker associated with fibrotic remodeling, with 84% of participants demonstrating a reduction over the study period. Although liver stiffness measurements did not significantly change, the authors concluded that the findings suggest the possibility that udenafil may alter the overall Fontan fibrotic milieu and warrant further study. The publication adds to a growing body of peer-reviewed evidence from the FUEL clinical program examining udenafil across multiple dimensions of Fontan physiology, including exercise capacity, ventricular performance, cardiovascular safety, nitric oxide pathway biology, patient experience, and liver fibrosis biomarkers. "As patients with Fontan circulation continue to live longer, understanding and addressing the long-term complications of Fontan physiology has become increasingly important," said Kurt Schumacher, M.D., Chief of Pediatric Cardiology at University of Michigan Health C.S. Mott Children's Hospital and lead author of the publication. "These findings contribute to our growing understanding of Fontan-associated liver disease and reinforce the importance of continuing to investigate therapies that may address this serious long-term complication." "Fontan-associated liver disease is one of the most serious long-term complications of Fontan circulation, and patients and clinicians have very limited options to address it." said Ridwan Shabsigh, M.D., F.A.C.S, President and COO of Mezzion, "The FUEL FALD Study provides important new insight into the potential role of udenafil in the fibrotic process associated with Fontan physiology and supports continued investigation of this complex disease." "The breadth of research emerging from the FUEL program is providing increasingly comprehensive view of Fontan physiology and the potential role of udenafil," said Dean Park, Chairman and CEO of Mezzion. " As we advance through the final phase of enrollment in the confirmatory Phase 3 FUEL-2 trial, we remain focused on developing the first therapy specifically indicated for patients living with Fontan circulation." Mezzion gratefully acknowledges the patients and families who participated in the FUEL clinical program, the investigators and participating clinical sites, and the Pediatric Heart Network for their contributions to advancing research in Fontan circulation. About the FUEL-2 Trial FUEL-2 is Mezzion's global confirmatory Phase 3 trial evaluating udenafil in adolescents and young adults with Fontan circulation. The study is designed to evaluate exercise capacity and support potential regulatory approval of udenafil as the first therapy specifically developed for patients living with Fontan circulation. Learn more at . Publication The full publication is available in Pediatric Cardiology: About Mezzion Pharmaceuticals Mezzion Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapies for rare cardiovascular and renal diseases. Its lead investigational product, udenafil, is being evaluated in the global Phase 3 FUEL-2 trial for single ventricle congenital heart disease patients living with Fontan circulation. Mezzion Pharmaceuticals is the U.S. subsidiary of Mezzion Pharma Co., Ltd. (KOSDAQ: 140410). Learn more at . Forward-Looking Statements This press release contains forward-looking statements regarding the future development of Mezzion's investigational product candidates, including statements relating to the clinical development of udenafil, the FUEL-2 trial, regulatory interactions, potential regulatory approvals, future research, and anticipated clinical outcomes. These forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Mezzion undertakes no obligation to update any forward-looking statements except as required by applicable law. Media & Investor Contacts John Presser Executive Vice President & Chief Business Officer [email protected] Sung-Il Noh Chief Financial Officer [email protected] SOURCE Mezzion Pharmaceuticals, Inc 21% more press release views with Request a Demo

Phase 3Clinical Result

05 Jun 2026

·www.prnewswire.com

Mezzion Pharma Completes FUEL-2 Phase 3 Regulatory Milestone

After independent review, study continues as planned with enrollment on track for completion in 2026 SEOUL, South Korea and FORT LEE, N.J., June 5, 2026 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) today announced the results of a planned independent, blinded statistical review of its ongoing global confirmatory Phase 3 FUEL-2 study evaluating udenafil, its investigational therapy for single ventricle heart disease with Fontan circulation. After 50% of the planned study population completed the study's 26-week treatment period, an independent assessment was conducted to determine whether an increase in sample size would be required to maintain the study's planned statistical assumptions. The independent review determined that no increase in sample size was required and recommended that the study continue as planned with the enrollment of 436 patients. Moreover, no changes were recommended to the study design, primary endpoint, statistical analysis plan, or projected study timelines. "We believe the successful completion of this independent review marks an important milestone for the FUEL-2 program," said Dean Park, Chairman and CEO of Mezzion Pharma. "We remain focused on advancing udenafil toward becoming the first approved therapy specifically indicated for patients with single ventricle heart disease with Fontan circulation." Mezzion Pharma has now completed all major planned statistical review milestones prior to topline data. Single ventricle heart disease with Fontan circulation is a rare and serious form of congenital heart disease associated with significant long-term complications. Despite advances in surgical care, there are currently no approved therapies specifically indicated for this rare disease with unmet medical need. About Mezzion Pharma Mezzion Pharma Co., Ltd. (KOSDAQ: 140410) is a late-stage biopharmaceutical company focused on developing therapies for rare cardiovascular and renal diseases. Its lead program, udenafil, is being developed as a potential first therapy specifically indicated for patients with Fontan circulation. Udenafil is an investigational product and has not been approved by any regulatory authority. Mezzion conducts its U.S. operations through its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc. For more information, visit mezzion.com or FUEL2Study.com. Forward-Looking Statements This press release contains forward-looking statements regarding future events and the future performance of Mezzion Pharma, including statements regarding clinical development timelines, regulatory activities, potential approval of udenafil, and anticipated study outcomes. Actual results may differ materially from those expressed or implied by these forward-looking statements. Mezzion undertakes no obligation to update any forward-looking statements except as required by applicable law. Media Contacts: John Presser, EVP, CBO: [email protected] Mr. Sung-Il Noh, CFO: [email protected] SOURCE Mezzion Pharma Co., Ltd. 21% more press release views with Request a Demo

Phase 3

100 Deals associated with Udenafil

External Link

KEGG	Wiki	ATC	Drug Bank
D10027	Udenafil	G04BE11	DB06267

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

to view more data

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. (Old)	01 Sep 2013
Heart failure with normal ejection fraction	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd. (Old)	01 Oct 2012
Heart Failure, Diastolic	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd. (Old)	01 Oct 2012
Idiopathic pulmonary arterial hypertension	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd. (Old)	01 Sep 2012
Hypertension, Portal	Phase 3	Austria	Dr. Falk Pharma GmbH	04 Apr 2012
Liver Cirrhosis	Phase 3	Austria	Dr. Falk Pharma GmbH	04 Apr 2012

Clinical Result

Indication

Phase

Evaluation

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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)	gqnfxkwibr(xmjsbfxemm) = zeaqaqbjjd yvmrswekrm (gxdqoqejfa, 470.80) View more	-	09 Dec 2025
				Udenafil (In PHN-Udenafil-02 (FUEL) Received Placebo)	gqnfxkwibr(xmjsbfxemm) = fzcikwyvkw yvmrswekrm (gxdqoqejfa, 444.26) View more
NCT03430583 (FALD, CTgov)	Phase 3	Univentricular Heart	88	Udenafil (Udenafil Continuation (U+))	wuqyrlvuny(anvuisczhs) = giuztgmhvx dxixdxmrjh (vedywztegh, 0.380) View more	-	18 Sep 2025
				Udenafil (Udenafil Naive (U-))	wuqyrlvuny(anvuisczhs) = seitbbyjsu dxixdxmrjh (vedywztegh, 0.450) View more
NCT02741115 (FUEL, CTgov)	Phase 3	Univentricular Heart	400	Placebo (Placebo)	shrugmcfda(xxwwmlbniq) = oucbivlzkp ltbbhkhxzr (ejotavupmm, 3.672) View more	-	21 May 2025
				Udenafil (Drug)	vyuwbajrfj(adrwsenqgg) = skwhjqpwfs mueipbryam (apijjwmcyb, 0.112) View more
NCT01553721 (Pubmed \| Clin Ther)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50-mg	unkayuqmti(fxyyhqibxt) = ehlkluczrf nntftkwqcy (xxwdoaumqm )	Positive	01 Aug 2019
NCT01553721 (Pubmed \| Korean Circ J)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50 mg	utqoueouyy(ujwitikqkm) = skgkgdjcly fpifmjzefx (defqkqrbeh ) View more	-	01 Apr 2019
				Udenafil 100 mg	utqoueouyy(ujwitikqkm) = tytvbjgngn fpifmjzefx (defqkqrbeh ) View more
KCT0001436 (Pubmed \| J Clin Pharmacol)	Phase 1	-	-	Udenafil (Healthy young men (21-27 years))	bzwwmthqth(eqzmalrorb) = ojqfshzwzy gzgwjweidg (nbveuelucx ) View more	-	01 Nov 2016
				Udenafil (Healthy elderly men (65-78 years))	bzwwmthqth(eqzmalrorb) = zafojdaxut gzgwjweidg (nbveuelucx ) View more
NCT01280266 (EULAR2014)	Phase 2/3	Raynaud Disease	12	Udenafil 100 mg/day	hmlyvnhhjm(kbtiklehfh) = rqftduxhtl wlkxlrjime (bywfvchkbv ) View more	-	11 Jun 2014
NCT01280266 (CTgov)	Phase 2/3	Raynaud Disease	29	Amlodipine (Amlodipine)	yxtvefcwhf(wfrwumkgxi) = uruvkeikmx dobudrlpkg (ygxyasqyey, 1.4) View more	-	11 Dec 2012
				Udenafil (Udenafil)	yxtvefcwhf(wfrwumkgxi) = dgbnzsiklv dobudrlpkg (ygxyasqyey, 0.9) View more
NCT01364181 (Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Udenafil 50 mg	xyuqukdors(kopnqtxemp) = gtaeuzgzfe lhmywjcgcw (lazywcbhix ) View more	-	01 Aug 2012
NCT01037244 (CTgov)	Phase 3	Erectile Dysfunction	618	Udenafil (Udenafil 50 mg)	gmajuvvrfw(wfuuszeqil) = fgckbdpgmt jktwjqvdbe (jxaqllfmye, xqmfdotecr - kcxrhifihk) View more	-	22 Dec 2011
				Udenafil (Udenafil 100 mg)	gmajuvvrfw(wfuuszeqil) = mvgjsjiywa jktwjqvdbe (jxaqllfmye, vlsmstzdcg - ceysziegrc) View more

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