Delving into the Latest Updates on Udenafil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Udenafil (USAN/INN), Udzire, Zydena

+ [7]

Target

PDE5A

Action

inhibitors

Mechanism

PDE5A inhibitors(Phosphodiesterase 5A inhibitors)

Therapeutic Areas

Urogenital DiseasesCardiovascular DiseasesCongenital Disorders+ [1]

Active Indication

Erectile DysfunctionUniventricular Heart

Inactive Indication

Alzheimer DiseaseChronic systolic heart failureCognitive Dysfunction+ [12]

Originator Organization

Dong-A Pharmaceutical Co., Ltd.

Active Organization

Dong-A Pharmaceutical Co., Ltd.

Dong-A ST Co., Ltd.

Mezzion Pharma Co., Ltd.

Inactive Organization

Dr. Falk Pharma GmbH

Meiji Seika Pharma Co., Ltd.

License Organization

Mezzion Pharma Co., Ltd.

Tabuk Pharmaceuticals Manufacturing Co.

Drug Highest PhaseApproved

First Approval Date

South Korea (29 Nov 2005),

Erectile Dysfunction

RegulationOrphan Drug (United States), Orphan Drug (European Union)

Login to view timeline

Structure/Sequence

Molecular FormulaC25H36N6O4S

InChIKeyIYFNEFQTYQPVOC-UHFFFAOYSA-N

CAS Registry268203-93-6

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 ; Rathod, Rahul H. ; Manlhiot, Cedric ; 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.

18

News (Medical) associated with Udenafil

14 May 2026

·www.prnewswire.com

Mezzion Secures Strategic Financing to Support Advancement of Global Phase 3 FUEL-2 Trial in Fontan Patients

Institutional financing supports continued execution of late-stage program evaluating JURVIGO® (udenafil) in patients living with Fontan circulation FORT LEE, N.J., May 14, 2026 /PRNewswire/ -- Mezzion Pharmaceuticals, Inc., a late-stage rare disease biopharmaceutical company focused on therapies for patients with single ventricle congenital heart disease and Fontan circulation, today announced the successful completion of strategic financing from institutional investors. The financing is expected to support continued advancement of Mezzion's ongoing global confirmatory Phase 3 FUEL-2 clinical trial evaluating udenafil in adolescents and young adults living with Fontan circulation, a serious and life-limiting form of congenital heart disease for which there are currently no approved therapies specifically indicated for Fontan patients. "This financing represents an important step in supporting the continued advancement of FUEL-2 and our commitment to the Fontan community," said Dr. Ridwan Shabsigh, President and COO of Mezzion Pharmaceuticals. "We remain focused on executing the study with the goal of potentially bringing the first approved therapy specifically indicated for individuals with Fontan physiology." The financing follows the continued enrollment momentum and operational progress in the global FUEL-2 program, which is being conducted across leading pediatric congenital heart centers internationally. "Despite a challenging biotech financing environment, we are grateful for the support and confidence of the institutional investors participating in this financing," said Dean Park, Chairman and CEO of Mezzion Pharmaceuticals. "We believe this support reflects the significant unmet medical need in patients with Fontan physiology and the potential for udenafil to meaningfully impact this underserved community." 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. Udenafil 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

Phase 3

07 May 2026

·www.prnewswire.com

Mezzion Reports Pre-IND FDA Feedback on the Development of Udenafil in ADPKD

SEOUL, South Korea, May 7, 2026 /PRNewswire/ -- Mezzion Pharma Co., Ltd. today announced written feedback from the U.S. Food and Drug Administration (FDA) following a pre-IND Type C Guidance meeting interaction for the development of udenafil in autosomal dominant polycystic kidney disease (ADPKD). Based on its review, the FDA indicated that Mezzion's nonclinical data package together with its prior clinical and safety experience with udenafil may provide a reasonable foundation to support development in clinical studies. To date, udenafil has been studied in multiple clinical programs in other therapeutic areas with multi-year exposure. Now, Mezzion plans to add to this dataset with the goal of advancing the program toward potential Phase 2 clinical and subsequent Phase 3 development in ADPKD. "We are encouraged by the FDA's feedback, which we feel supports our scientific rationale and stated development approach for udenafil in ADPKD," said Dean Park, Chairman and CEO of Mezzion. "We hope that our existing clinical dataset may enable a more efficient path into potential clinical studies." ADPKD is a serious, progressive genetic kidney disease with significant unmet medical need and limited treatment options. Mezzion believes udenafil's mechanism and prior clinical experience in other therapeutic areas may support evaluation as a potential investigational therapy in ADPKD. Mezzion views this pre-IND interaction as an additional step in advancing the potential development of udenafil for ADPKD and expanding potential treatment options for patients living with this progressive disease. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd., based in South 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 potential indications in Fontan physiology and autosomal dominant polycystic kidney disease (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

Phase 3

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

100 Deals associated with Udenafil

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D10027	Udenafil	G04BE11	DB06267

R&D Status

Approved

10 top approved records.

Login

to view more data

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

Developing

10 top R&D records.

Login

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.	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
Hypertension, Portal	Phase 3	Austria	Dr. Falk Pharma GmbH	04 Apr 2012
Chronic systolic heart failure	Phase 3	South Korea	Dong-A Pharmaceutical Co., Ltd.	01 Dec 2011

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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)	vgaybrefuq(jzuhjoddus) = mxvenpgohe zsogjvgvyy (rrpbkwckkn, 470.80) View more	-	09 Dec 2025
				Udenafil (In PHN-Udenafil-02 (FUEL) Received Placebo)	vgaybrefuq(jzuhjoddus) = cwualzllwn zsogjvgvyy (rrpbkwckkn, 444.26) View more
NCT03430583 (FALD, CTgov)	Phase 3	Univentricular Heart	88	Udenafil (Udenafil Continuation (U+))	xayqdnhcmu(aexabnclyw) = ofcmbnyabe globksusqa (cffskkyygf, 0.380) View more	-	18 Sep 2025
				Udenafil (Udenafil Naive (U-))	xayqdnhcmu(aexabnclyw) = zsesbcqdqg globksusqa (cffskkyygf, 0.450) View more
NCT02741115 (FUEL, CTgov)	Phase 3	Univentricular Heart	400	Placebo (Placebo)	xdrkmrjwdg(emhpyecnul) = afbatbruqf ttmlfwezce (fgpsyoygyj, 3.672) View more	-	21 May 2025
				Udenafil (Drug)	lkzsliibdq(gevtyrtdzv) = zeehruqznf omkwwnhcrf (kunpfuelxy, 0.112) View more
NCT01553721 (Pubmed \| Clin Ther)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50-mg	cwroagjmid(fjuxiroidt) = fvpmrlignj xrvaneocoy (rsgyjxkxfq )	Positive	01 Aug 2019
NCT01553721 (Pubmed \| Korean Circ J)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50 mg	ktdmuzhnge(qivnyzrnkw) = asbjayjegl lvzdyeijuz (rcnnbuilqv ) View more	-	01 Apr 2019
				Udenafil 100 mg	ktdmuzhnge(qivnyzrnkw) = bfmzgtussy lvzdyeijuz (rcnnbuilqv ) View more
KCT0001436 (Pubmed \| J Clin Pharmacol)	Phase 1	-	-	Udenafil (Healthy young men (21-27 years))	uiyuumzsvv(xnrxcltwjm) = ijmgljuvhn knkhvjpict (svfandfvpv ) View more	-	01 Nov 2016
				Udenafil (Healthy elderly men (65-78 years))	uiyuumzsvv(xnrxcltwjm) = rceyrlksdw knkhvjpict (svfandfvpv ) View more
NCT01280266 (EULAR2014)	Phase 2/3	Raynaud Disease	12	Udenafil 100 mg/day	zlfvrtlomm(btrvkwcxin) = sqmtgqyitk cndxbheiyi (irstsxyubt ) View more	-	11 Jun 2014
NCT01280266 (CTgov)	Phase 2/3	Raynaud Disease	29	Amlodipine (Amlodipine)	thsugukgxt(rcpbsbkwbi) = rxkfktdfso qvvdeuodnl (qexwtfbylb, 1.4) View more	-	11 Dec 2012
				Udenafil (Udenafil)	thsugukgxt(rcpbsbkwbi) = wlwaiftywi qvvdeuodnl (qexwtfbylb, 0.9) View more
NCT01364181 (Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Udenafil 50 mg	ghwjmousad(bjeeeevgic) = txiuwhcipj lqorgeosxr (ebdwyyzxzs ) View more	-	01 Aug 2012
NCT01037244 (CTgov)	Phase 3	Erectile Dysfunction	618	Udenafil (Udenafil 50 mg)	ptpsnneckr(utkylfjtvq) = cqfzawpdfo uhzhhyedyd (kderzmxtvw, qrkotvxssh - jntihpeqtj) View more	-	22 Dec 2011
				Udenafil (Udenafil 100 mg)	ptpsnneckr(utkylfjtvq) = przfmalonc uhzhhyedyd (kderzmxtvw, arqkynbnor - leonuzwncp) View more