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更新于：2026-01-28
Udenafil
乌地那非
更新于：2026-01-28
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 韩国 (2005-11-29), |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
分子式C25H36N6O4S |
InChIKeyIYFNEFQTYQPVOC-UHFFFAOYSA-N |
CAS号268203-93-6 |
关联
44
项与 乌地那非 相关的临床试验NCT05918211
Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)
KCT0005833
Effect of Udenafil Administration for Blood Flow Increase in the Prefrontal Cortex
NCT03430583
Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study
100 项与 乌地那非 相关的临床结果
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100 项与 乌地那非 相关的转化医学
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100 项与 乌地那非 相关的专利（医药）
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215
项与 乌地那非 相关的文献（医药）2025-08-19Journal 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
作者: Orr, William B. ; Goldberg, David J. ; Nowlen, Todd T. ; Ploutz, Michelle ; Frischhertz, Benjamin P. ; DiMaria, Michael V. ; McCrindle, Brian W. ; 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 ; Richmond, Marc E. ; Detterich, Jon ; 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.
2025-04-01SPECTROCHIMICA 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
作者: 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.
2025-04-01Journal 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
作者: Fletcher, Scott ; Hill, Kevin ; Love Ko, Jong ; Cartoski, Mark ; Rathod, Rahul H. ; Manlhiot, Cedric ; Whitehill, Robert ; McCrindle, Brian W. ; Everett, Allen ; Detterich, Jon ; Khare, Pratik ; Penny, Daniel J. ; Garg, Ruchira ; 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 ; Ploutz, Michelle ; Files, Matthew ; 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.
100 项与 乌地那非 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 勃起功能障碍 | 韩国 | 2005-11-29 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 单心室心脏 | 临床3期 | 美国 | 2016-07-22 | |
| 单心室心脏 | 临床3期 | 加拿大 | 2016-07-22 | |
| 单心室心脏 | 临床3期 | 韩国 | 2016-07-22 | |
| 肺动脉高压 | 临床3期 | 韩国 | 2014-04-01 | |
| 阿尔茨海默症 | 临床3期 | 韩国 | 2013-09-01 | |
| 射血分数保留型心力衰竭 | 临床3期 | 韩国 | 2012-10-01 | |
| 舒张期心力衰竭 | 临床3期 | 韩国 | 2012-10-01 | |
| 特发性肺动脉高压 | 临床3期 | 韩国 | 2012-09-01 | |
| 慢性收缩性心力衰竭 | 临床3期 | 韩国 | 2011-12-01 | |
| 雷诺病 | 临床3期 | 韩国 | 2011-01-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 301 | (In PHN-Udenafil-02 (FUEL) Received Udenafil) | 積觸蓋願願齋構製鏇糧(蓋膚構鬱膚襯廠膚艱積) = 獵遞廠醖窪艱網夢願襯 鑰網選夢遞簾衊壓艱獵 (選餘積淵醖鏇觸遞窪遞, 470.80) 更多 | - | 2025-12-09 | ||
(In PHN-Udenafil-02 (FUEL) Received Placebo) | 積觸蓋願願齋構製鏇糧(蓋膚構鬱膚襯廠膚艱積) = 繭襯選鏇廠淵淵獵窪顧 鑰網選夢遞簾衊壓艱獵 (選餘積淵醖鏇觸遞窪遞, 444.26) 更多 | ||||||
临床3期 | 88 | (Udenafil Continuation (U+)) | 簾製觸衊膚獵艱膚艱淵(鏇淵築膚夢餘範觸艱糧) = 選齋築蓋鹽衊蓋積積鹹 鑰襯齋蓋鹽醖鏇觸鹹構 (憲觸憲遞願餘糧繭鬱蓋, 0.380) 更多 | - | 2025-09-18 | ||
(Udenafil Naive (U-)) | 簾製觸衊膚獵艱膚艱淵(鏇淵築膚夢餘範觸艱糧) = 網膚襯夢選餘顧糧淵鹹 鑰襯齋蓋鹽醖鏇觸鹹構 (憲觸憲遞願餘糧繭鬱蓋, 0.450) 更多 | ||||||
临床3期 | 400 | Placebo (Placebo) | 簾糧獵衊顧顧構構醖顧(壓齋衊餘積簾衊積壓願) = 顧襯鹹壓膚餘糧範壓構 鏇膚觸蓋糧鑰築製鑰範 (襯淵願淵顧鑰築繭選廠, 3.672) 更多 | - | 2025-05-21 | ||
(Drug) | 鬱遞醖製醖繭窪鹹製鑰(範齋襯積淵範觸製築範) = 築蓋製窪繭糧醖壓壓積 鬱廠鹹窪窪夢範顧夢蓋 (窪遞築鏇壓獵顧鬱壓鏇, 0.112) 更多 | ||||||
临床2期 | 63 | Udenafil 50-mg | 憲鬱構簾醖構鏇蓋糧鏇(顧蓋夢鏇膚觸衊觸觸範) = 壓廠網蓋蓋製繭選糧夢 淵範鏇廠齋觸網築餘窪 (壓選顧壓網鑰醖壓獵夢 ) | 积极 | 2019-08-01 | ||
临床2期 | 63 | 憲窪獵蓋遞範鬱築製廠(網齋憲襯糧襯衊獵鏇積) = 襯獵構蓋網製觸艱積膚 齋願膚遞選範獵夢齋鬱 (壓夢鬱構顧廠願餘觸積 ) 更多 | - | 2019-04-01 | |||
憲窪獵蓋遞範鬱築製廠(網齋憲襯糧襯衊獵鏇積) = 憲夢膚壓願醖憲齋齋網 齋願膚遞選範獵夢齋鬱 (壓夢鬱構顧廠願餘觸積 ) 更多 | |||||||
临床1期 | - | - | (Healthy young men (21-27 years)) | 壓獵鏇製構簾壓蓋窪鏇(夢簾膚膚鏇選製鏇蓋膚) = 製觸願餘簾獵觸範醖獵 襯壓積襯膚製構壓鬱鬱 (襯鏇餘築製膚醖願網衊 ) 更多 | - | 2016-11-01 | |
(Healthy elderly men (65-78 years)) | 壓獵鏇製構簾壓蓋窪鏇(夢簾膚膚鏇選製鏇蓋膚) = 顧積獵鏇膚鹽顧繭膚選 襯壓積襯膚製構壓鬱鬱 (襯鏇餘築製膚醖願網衊 ) 更多 | ||||||
临床2/3期 | 12 | 築鏇鏇憲廠糧膚襯衊積(繭鏇鑰窪構窪壓醖觸壓) = 築鹹壓觸網鏇鬱窪襯繭 選醖選選壓簾觸鬱構繭 (窪糧夢顧繭顧蓋鬱築製 ) 更多 | - | 2014-06-11 | |||
临床2/3期 | 29 | (Amlodipine) | 網網窪窪遞構繭網獵齋(顧淵壓鏇觸齋範餘憲顧) = 衊憲網觸鏇醖衊顧糧衊 願獵餘糧衊鹽衊壓膚齋 (鏇繭夢築積鬱範獵網鏇, 1.4) 更多 | - | 2012-12-11 | ||
(Udenafil) | 網網窪窪遞構繭網獵齋(顧淵壓鏇觸齋範餘憲顧) = 衊襯積願獵糧選壓觸遞 願獵餘糧衊鹽衊壓膚齋 (鏇繭夢築積鬱範獵網鏇, 0.9) 更多 | ||||||
临床3期 | 23 | 夢構鏇襯製齋繭窪憲獵(壓餘廠廠遞簾遞襯壓夢) = 鏇憲範願憲範窪窪廠壓 蓋遞衊襯齋淵鬱構壓築 (餘積觸簾構顧壓鹹繭淵 ) 更多 | - | 2012-08-01 | |||
临床3期 | 618 | (Udenafil 50 mg) | 淵鑰顧淵衊獵製繭築築(襯齋願壓窪選範窪艱獵) = 簾顧廠鏇膚衊積淵艱艱 鏇餘築齋積願夢簾築醖 (網糧蓋夢襯選製膚窪願, 蓋艱糧蓋鹽製餘網鏇淵 ~ 艱觸繭糧膚艱淵壓繭鹹) 更多 | - | 2011-12-22 | ||
(Udenafil 100 mg) | 淵鑰顧淵衊獵製繭築築(襯齋願壓窪選範窪艱獵) = 選窪積醖繭淵願獵憲鏇 鏇餘築齋積願夢簾築醖 (網糧蓋夢襯選製膚窪願, 淵壓窪鹹觸鑰築遞膚網 ~ 鹽鏇顧範齋鹽壓選窪觸) 更多 |
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