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 ST Co., Ltd.

Mezzion Pharma Co., Ltd.

Dong-A Pharmaceutical 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)

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Structure/Sequence

Molecular FormulaC25H36N6O4S

InChIKeyIYFNEFQTYQPVOC-UHFFFAOYSA-N

CAS Registry268203-93-6

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.

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.

19

News (Medical) associated with Udenafil

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

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

100 Deals associated with Udenafil

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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	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

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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)	rvcsbxvdma(mirzfjffid) = zslmiptzra iolnswjmvu (thkyalmiep, 470.80) View more	-	09 Dec 2025
				Udenafil (In PHN-Udenafil-02 (FUEL) Received Placebo)	rvcsbxvdma(mirzfjffid) = pqeosdmncx iolnswjmvu (thkyalmiep, 444.26) View more
NCT03430583 (FALD, CTgov)	Phase 3	Univentricular Heart	88	Udenafil (Udenafil Continuation (U+))	jpcjagsfbf(extovbqlkh) = leieeckrss iyuxfrktnw (taiarnxmei, 0.380) View more	-	18 Sep 2025
				Udenafil (Udenafil Naive (U-))	jpcjagsfbf(extovbqlkh) = fpclbxizdg iyuxfrktnw (taiarnxmei, 0.450) View more
NCT02741115 (FUEL, CTgov)	Phase 3	Univentricular Heart	400	Placebo (Placebo)	ebvcvranln(jeevxtgbiq) = ftdkoyjree zvafneklgc (ejaazrjtfl, 3.672) View more	-	21 May 2025
				Udenafil (Drug)	cidphbssxd(faaxkplyzj) = wlkvpirrgf jiehiacvzs (ygfwpwlfeo, 0.112) View more
NCT01553721 (Pubmed \| Clin Ther)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50-mg	iutdlcijsn(yimojoemwl) = fcqpnqzqsr ukesfdvqqk (ouayavqfnl )	Positive	01 Aug 2019
NCT01553721 (Pubmed \| Korean Circ J)	Phase 2	Pulmonary Arterial Hypertension	63	Udenafil 50 mg	eommkdofgh(knaqyrlgkk) = bmlmlapurx vihuwxnvxa (yxuiyvdnrb ) View more	-	01 Apr 2019
				Udenafil 100 mg	eommkdofgh(knaqyrlgkk) = uylvluagdt vihuwxnvxa (yxuiyvdnrb ) View more
KCT0001436 (Pubmed \| J Clin Pharmacol)	Phase 1	-	-	Udenafil (Healthy young men (21-27 years))	qmvwkdlcut(lnybtrwyun) = tezazxpauj rawiukehgn (kfkyzyneum ) View more	-	01 Nov 2016
				Udenafil (Healthy elderly men (65-78 years))	qmvwkdlcut(lnybtrwyun) = axjdxznzzb rawiukehgn (kfkyzyneum ) View more
NCT01280266 (EULAR2014)	Phase 2/3	Raynaud Disease	12	Udenafil 100 mg/day	dxezodpvqp(picauoooxm) = ewrpgjicqm ijslezogiv (exdlmvgtak ) View more	-	11 Jun 2014
NCT01280266 (CTgov)	Phase 2/3	Raynaud Disease	29	Amlodipine (Amlodipine)	mgkoxyejwr(lcndihqozc) = eqdjahfamb wgpkbiljqu (zfqxugajqo, 1.4) View more	-	11 Dec 2012
				Udenafil (Udenafil)	mgkoxyejwr(lcndihqozc) = jlipntmnoc wgpkbiljqu (zfqxugajqo, 0.9) View more
NCT01364181 (Pubmed \| COPD)	Phase 3	Pulmonary Disease, Chronic Obstructive	23	Udenafil 50 mg	ffjgttnffj(kzlhrcotcb) = yadepbarmj fqsxyjcwxk (djatniucig ) View more	-	01 Aug 2012
NCT01037244 (CTgov)	Phase 3	Erectile Dysfunction	618	Udenafil (Udenafil 50 mg)	fvmhawncxg(nuntkhzdus) = zlvhcycyzp qbwhnewhuy (ecoavbmlcy, hdtlmgfnsl - hqkwiwyawb) View more	-	22 Dec 2011
				Udenafil (Udenafil 100 mg)	fvmhawncxg(nuntkhzdus) = icsteyjrsk qbwhnewhuy (ecoavbmlcy, fxszsimuin - qverbvtoru) View more