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

/ CompletedNot Applicable

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

297

Literatures (Medical) associated with Udenafil

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 Sep 2024·EXPERT OPINION ON INVESTIGATIONAL DRUGS

An overview of conventional and investigational phosphodiesterase 5 inhibitors for treating erectile dysfunction and other conditions

Review

Author: El-Sakka, Ahmed I. ; Ismail, Ezzat A.

INTRODUCTION:

There is a rising concern about developing innovative, efficacious PDE5I molecules that provide better safety, efficacy, and tolerability with less adverse effects. Innovative PDE5I with dual targets have also been defined in the literature. Additionally, some of PDE5I are able to selectively inhibit other enzymes such as histone deacetylase, acetylcholine esterase, and cyclooxygenase or act as nitric oxide donors. This review presents knowledge concerning the advanced trends and perspectives in using PDE5I in treatment of ED and other conditions.

AREAS COVERED:

Pre-clinical and early clinical trials that investigated the safety, efficacy, and tolerability of novel PDE5I such as Udenafil, Mirodenafil, Lodenafil, Youkenafil, Celecoxib, and TPN729 in treatment of ED and other conditions.

EXPERT OPINION:

Preclinical and limited early clinical studies of the new molecules of PDE5I have demonstrated encouraging results; however, safety, efficacy, and tolerability are still issues that necessitate further long-term multicenter clinical studies to ensure justification of their uses in treatment of ED and other conditions. Progress in molecular delivery techniques and tailored patient-specific management and additional therapeutic technology will dramatically improve care for ED and other conditions. The dream of ED and many other conditions becoming more effectively managed may be feasible in the near future.

01 Sep 2024·Neurourology and urodynamics

Postmicturition dribble in men with no previous urogenital surgery: Systematic review and meta‐analysis of treatment modalities

Review

Author: Mahdi, Mohammed ; Lock, Merilyn ; El Ansari, Walid ; Hothi, Hanaa Al ; Arafa, Mohamed ; Ghafouri, Ardalan ; Megahed, Heba ; Albakr, Ahmed

Abstract:

Introduction:

Postmicturition dribble (PMD) is common in males. Little is known about PMD etiology, but it is either secondary to urethral/prostatic surgery or primary (no previous surgery). Despite PMD's high prevalence, the effectiveness of its treatment modalities remains lacking.

Objective:

To undertake a systematic review of the available treatments for primary PMD in adult males and meta‐analysis of their effectiveness.

Materials and Methods:

We searched four electronic databases from inception to 2023 for original articles that evaluated PMD treatments in male adults without previous urethral/prostatic surgery (PROSPERO protocol CRD42023444591). Study quality and risk of bias were evaluated using established tools. We extracted a range of variables including treatment modality used and its effectiveness on PMD volume and patient complaint. Meta‐analysis was undertaken where feasible, and where this was not feasible, narrative synthesis was conducted.

Results:

Out of 335 studies, four were included (four clinical trials, n = 344 patients). Two trials used physical/behavioral therapy (pelvic floor muscle exercises [PFMEs], urethral milking); the other two employed phosphodiesterase (PDE5) inhibitors (tadalafil, Udenafil). All studies were of good quality, but physical/behavioral therapy studies had some risk of bias. As the two physical/behavioral therapy studies used heterogenous outcome measures, narrative synthesis showed PMD volume improvement with PFMEs more than with urethral milking, both modalities were more effective than counseling, and in one study, PFMEs were effective in reducing PMD self‐reported complaint than counseling. Meta‐analyses of the two PDE5 inhibitors studies showed a large effect size with high heterogeneity for decreased PMD volume favoring PDE5 inhibitors over placebo (g = −0.86, 95% confidence interval [CI] −1.75; 0.02, p = 0.05; I2 = 88%); and a significant improvement equivalent to −1.06 points on the Hallym PMD Questionnaire score with no discernable heterogeneity (95% CI −1.65; −0.47, p = 0.0004; I2 = 0%), favoring PDE5 inhibitors compared to controls.

Conclusions:

Physical/behavioral therapy and PDE5 inhibitors are effective primary PMD treatments. PMD management studies in males with no previous urethral/prostatic surgery are very scarce and lack the use of consistent/comparable outcome measures. Further studies addressing these deficiencies would benefit this very thin evidence base.

News (Medical) associated with Udenafil

11 Jun 2025

·www.prnewswire.com

Mezzion Secures $20 Million in Strategic Funding to Advance Global Phase 3 Clinical Development of Udenafil for Fontan Patients

SEOUL, South Korea, June 11, 2025 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion) announced a major milestone in their clinical development program, having secured approximately $20 million USD in strategic funding to support the ongoing global Phase 3 FUEL-2 trial of udenafil for patients with Fontan circulation. The financing was led by Midas-Meritz New Technology Finance Association and KDBC-Korea Investment & Securities New Technology Investment Association, representing a strong vote of confidence from top-tier institutional investors in Mezzion's late-stage pipeline and long-term growth strategy. "We are pleased to partner with Midas Private Equity (Midas PE) and KDBC as we enter a critical phase in the development of udenafil for the Fontan population, a community with significant unmet medical need," said Dean Park, Chairman and CEO of Mezzion. "This investment affirms the strength of our data, the quality of our science, and the potential impact of our work on patients worldwide." Midas PE, the lead investor, is a prominent private equity firm with over $230 million in assets under management. CEO Lim Chun-soo expressed strong confidence in Mezzion's direction: "After a detailed review of Mezzion's FUEL-1 results and the ongoing FUEL-2 protocol, we believe udenafil is well positioned for successful global Phase 3 completion and regulatory approval. We are proud to support Mezzion as it expands internationally and continues its leadership in rare disease innovation." This financing follows growing clinical and regulatory momentum for Mezzion. The introduction of dedicated ICD-10 codes for Fontan-associated conditions marks a major step forward in recognizing and addressing the needs of this long-overlooked population. It enhances care, improves coverage, and underscores Mezzion's leadership and long-term commitment to advancing treatment for rare congenital heart disease. Chairman Park added, "With accelerating enrollment and growing engagement across clinical sites, we believe time and data are now working in our favor. We have initially secured $20 million, and we will continue our efforts to receive valuable investments in the future." About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd., based in South Korea and listed on the KOSDAQ (140410), develops treatments for rare and underserved diseases. Its U.S. subsidiary, Mezzion Pharmaceuticals, Inc., headquartered in New Jersey, leads global clinical development and commercialization. The company is currently advancing udenafil, a first-in-class therapy for patients with Fontan physiology, a rare congenital heart condition, now in global phase 3 trials. For more information, visit and . Media Contacts: John Presser, CBO, [email protected] Mr. Sung-Il Noh, CFO, [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 3Phase 2

16 Apr 2025

·www.prnewswire.com

New ICD-10 Codes Recognize Fontan-Associated Conditions, Advancing Care and Coverage for Rare Congenital Heart Disease Community

SEOUL, South Korea, April 16, 2025 /PRNewswire/ -- Mezzion Pharmaceuticals, a global leader in the development of therapies for patients with single ventricle heart disease, announces a transformative milestone for the Fontan community: the introduction of new, dedicated ICD-10 diagnosis codes for Fontan-associated conditions in the U.S. Centers for Medicare & Medicaid Services (CMS) FY 2026 IPPS Proposed Rule. Listed under Table 6A of the proposed rule, the following new diagnostic codes represent the first-ever formal classification of complications specific to the Fontan circulation: I27.840 – Fontan-associated liver disease (FALD) I27.841 – Fontan-associated lymphatic dysfunction I27.848 – Other Fontan-associated condition I27.849 – Fontan-related circulation, unspecified These new codes will allow for improved clinical documentation, insurance reimbursement, and health system recognition of the unique and complex needs of patients living with Fontan physiology. "This is a monumental step forward for the Fontan community," said Dean Park, Chairman and CEO of Mezzion Pharmaceuticals. "The introduction of ICD-10 codes dedicated to Fontan-associated conditions represents long-overdue validation of the challenges faced by these patients and their families. We applaud the tireless efforts of our advocacy, clinical, and policy partners for making this achievement possible." The codes create a new branch within the ICD-10 classification system specific to Fontan physiology. This advancement will help clinicians better track and manage Fontan-related complications, fuel more accurate epidemiological research, and enable public and private payers to recognize Fontan patients as a distinct population with specific medical needs. For Mezzion, the new codes mark a significant regulatory and commercial milestone in the development of udenafil, a first-in-class therapy under investigation to improve exercise capacity in Fontan patients. Udenafil is currently being evaluated in FUEL-2, a Phase 3 confirmatory trial being conducted across the U.S., Europe, and APAC. "These codes bring clarity and structure to an area of medicine that has long lacked both. They strengthen the foundation for our continued development and future market access efforts," added Mr. Park. "As the only company solely focused on this patient population, Mezzion is proud to help lead the charge in advancing recognition, research, and treatment for those living with Fontan circulation." The proposed ICD-10 codes are open for public comment through June 10, 2025, with finalization expected by August 2025 and implementation anticipated by September 2025. About Mezzion Pharmaceuticals, Inc. Mezzion Pharmaceuticals is dedicated to improving outcomes for patients with rare congenital heart diseases. The company is advancing udenafil, a first-in-class therapy for individuals with Fontan physiology, currently in Phase 3 clinical trials. Learn more at and . Media Contacts: John Presser, EVP, CBO, [email protected] Mr. S.I. Noh, CFO, [email protected] SOURCE: CMS.gov 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 3

01 Mar 2024

·www.prnewswire.com

Mezzion Pharmaceuticals Announces Dr. Rahul Rathod of Boston Children's Hospital and Harvard Medical School as the Global Principal Investigator for the Confirmatory Pivotal Phase 3 Trial FUEL-2

FORT LEE, N.J., March 1, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr. Rahul Rathod, a pediatric cardiology specialist and leader with over 20 years of experience at Boston Children's Hospital, as the Global Principal Investigator of FUEL-2. Continue Reading FUEL-2 Dr. Rathod currently serves as the Associate Chair of Cardiology, Director of the Single Ventricle Program, and Director of the Fontan Clinic at Boston Children's Hospital as well as Associate Professor of Pediatrics at Harvard Medical School. He is an internationally recognized medical expert, researcher, and key opinion leader in the single ventricle heart disease space and Fontan circulation—with more than 80 peer-reviewed publications. Dr. Rathod is the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE). The FORCE Registry is a tech-enabled research platform dedicated to improving the quality and longevity of life for single ventricle patients by aggregating global Fontan data, advancing cardiac imaging through big data and analytics, and utilizing machine learning to improve workflows and patient outcomes. FORCE is the largest Fontan dataset in the world. As the Global Principal Investigator for FUEL-2, Dr. Rathod will lead the clinical trial, overseeing clinical protocol, conduct, and operations at all study sites. He will also lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA). "FUEL-2 represents a pivotal moment in Fontan research pioneering advancements for our patients. This landmark study delves into the potential of udenafil to empower individuals to reclaim vitality in their daily lives," said Dr. Rathod about the trial. "The Fontan population is one with significant medical complexities and unmet needs; this trial offers the promise of tangible solutions and a powerful tool that can redefine the treatment landscape for Fontan patients." "Dr. Rathod is a preeminent expert in Fontan physiology and the ideal clinical leader to serve as the Global Principal Investigator of FUEL-2. Mezzion is very proud and encouraged to have him as our partner as this pivotal clinical trial progresses," said Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion. Dr. Hariadi recently joined Mezzion from Johnson & Johnson, where he was senior director for global regulatory affairs. He previously served in several senior medical leadership roles at the FDA and the United States Department of Homeland Security. He will serve as Mezzion's primary liaison to the FUEL-2 clinical research organization, study sites, and investigators. FUEL-2 is a Mezzion Pharmaceuticals-sponsored clinical trial investigating the clinical efficacy and safety of udenafil in teenagers 12-18 years of age who have undergone the Fontan procedure. It is poised to be the world's largest Fontan clinical trial and is set to enroll 438 patients globally. Currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks. The latest site information for FUEL-2 can be found here. Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor and was previously studied in some adolescents with Fontan physiology. PDE5 inhibitors relax the blood vessels and may increase the blood flow to the lungs. This may mean higher blood oxygen levels; if so, individuals may be less tired when exercising or during everyday activities. For more information about the study, please visit FUEL2study.com. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., has an administrative office in Fort Lee, New Jersey. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media Contacts: PR Contact – Philicia Thompson, [email protected], 7047749643 Medical Contact – John Hariadi, [email protected], (443) 699-6746 Mezzion Pharma Co. Ltd. Contact – S.I. Noh, [email protected], +82 2 560 8000 SOURCE Mezzion Pharmaceuticals, Inc

Phase 3Executive Change

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.	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	United States	Dong-A ST Co., Ltd.	01 Apr 2014
Alzheimer Disease	Phase 3	United States	Dong-A Pharmaceutical Co., Ltd.	01 Sep 2013
Heart failure with normal ejection fraction	Phase 3	United States	Dong-A Pharmaceutical Co., Ltd.	01 Oct 2012
Heart Failure, Diastolic	Phase 3	United States	Dong-A Pharmaceutical Co., Ltd.	01 Oct 2012
Idiopathic pulmonary arterial hypertension	Phase 3	United States	Dong-A Pharmaceutical Co., Ltd.	01 Sep 2012
Chronic systolic heart failure	Phase 3	United States	Dong-A Pharmaceutical Co., Ltd.	01 Dec 2011
Raynaud Disease	Phase 3	United States	Dong-A Pharmaceutical Co., Ltd.	01 Jan 2011

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Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02741115 (FUEL, CTgov)	Phase 3	Univentricular Heart	400	Placebo (Placebo)	xszmlhygaw(ulzbkudvoj) = aevaogcqaq ghjcvkwsbm (vihelskgbs, 3.672) View more	-	21 May 2025
				Udenafil (Drug)	wirzyafrme(vwdjdsaslz) = fregsqejwj ohkldhnfvc (uyqbvdmesv, 0.112) View more
NCT01553721 (Pubmed \| Clin Ther)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50-mg	myjrhlkkri(abujttswhp) = qddymgmysf hljbvxsfks (lqfpbepldk )	Positive	01 Aug 2019
NCT01553721 (Pubmed \| Korean Circ J)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50 mg	jsgsuddbpr(yxhwzrulsu) = atntfzsdvx xtbomjbinv (koggjtffbj ) View more	-	01 Apr 2019
				Udenafil 100 mg	jsgsuddbpr(yxhwzrulsu) = cssqltyqfh xtbomjbinv (koggjtffbj ) View more
KCT0001436 (Pubmed \| J Clin Pharmacol)	Phase 1	-	-	Udenafil (Healthy young men (21-27 years))	uficxnglas(xietsnpigv) = pjujvebpds lsqpnyzgki (dogisuuxtv ) View more	-	01 Nov 2016
				Udenafil (Healthy elderly men (65-78 years))	uficxnglas(xietsnpigv) = pyfmipdqti lsqpnyzgki (dogisuuxtv ) View more
NCT01280266 (EULAR2014)	Phase 2/3	Raynaud Disease	12	Udenafil 100 mg/day	sypiiqnpds(yhnellqtdn) = byxoeecsvw ndqclzkahk (vecubrhewy ) View more	-	11 Jun 2014
NCT01364181 (Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Udenafil 50 mg	igihonqemw(gywunsnuef) = hoqtfxognv yjpdtodrgg (cxqpcfmqfo ) View more	-	01 Aug 2012
NCT01037244 (CTgov)	Phase 3	Erectile Dysfunction	618	Udenafil (Udenafil 50 mg)	kvhtdrkajg(ziopssqmgu) = gjwvjsrwgw zzmbstxnxe (hjxksqoiyg, oefetnebog - cdyrpvoztt) View more	-	22 Dec 2011
				Udenafil (Udenafil 100 mg)	kvhtdrkajg(ziopssqmgu) = hbibdujuhx zzmbstxnxe (hjxksqoiyg, wqcybrcoax - jebfjqgshg) View more
NCT01037218 (CTgov)	Phase 3	Erectile Dysfunction	601	Placebo+Udenafil (Udenafil 50 mg)	pzkggfwbag(ibpzseeoxf) = bcpiufeqfy vncpyrmrjb (kqgdivyaol, kfclkhnaoi - dsyyfmfaav) View more	-	22 Dec 2011
				Placebo+Udenafil (Udenafil 100 mg)	pzkggfwbag(ibpzseeoxf) = rdmxjvjppk vncpyrmrjb (kqgdivyaol, clfztubxfu - bhxmnonxpy) View more

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