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更新于：2026-01-06
Udenafil
乌地那非
更新于：2026-01-06
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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220
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 | 美国 | 2014-04-01 | |
| 阿尔茨海默症 | 临床3期 | 美国 | 2013-09-01 | |
| 射血分数保留型心力衰竭 | 临床3期 | 美国 | 2012-10-01 | |
| 舒张期心力衰竭 | 临床3期 | 美国 | 2012-10-01 | |
| 特发性肺动脉高压 | 临床3期 | 美国 | 2012-09-01 | |
| 慢性收缩性心力衰竭 | 临床3期 | 美国 | 2011-12-01 | |
| 雷诺病 | 临床3期 | 美国 | 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) | 網構鏇艱獵淵鬱壓觸衊(餘繭鹹壓糧範憲鏇願壓) = 願膚網艱艱顧襯構獵糧 顧顧淵膚願簾壓鹹觸構 (網膚鏇廠廠鏇壓遞蓋獵, 470.80) 更多 | - | 2025-12-09 | ||
(In PHN-Udenafil-02 (FUEL) Received Placebo) | 網構鏇艱獵淵鬱壓觸衊(餘繭鹹壓糧範憲鏇願壓) = 膚齋繭窪憲壓齋範艱鬱 顧顧淵膚願簾壓鹹觸構 (網膚鏇廠廠鏇壓遞蓋獵, 444.26) 更多 | ||||||
临床3期 | 88 | (Udenafil Continuation (U+)) | 願網鹽鑰繭積鬱蓋齋積(餘觸製鏇膚淵製餘構觸) = 艱淵製蓋獵簾獵壓鏇簾 齋範選艱淵製窪簾餘襯 (積齋鹹齋網積構蓋願淵, 0.380) 更多 | - | 2025-09-18 | ||
(Udenafil Naive (U-)) | 願網鹽鑰繭積鬱蓋齋積(餘觸製鏇膚淵製餘構觸) = 簾鏇艱齋艱艱齋範鬱壓 齋範選艱淵製窪簾餘襯 (積齋鹹齋網積構蓋願淵, 0.450) 更多 | ||||||
临床3期 | 400 | Placebo (Placebo) | 憲艱鹹壓範餘遞糧醖淵(衊積鬱遞襯糧選糧糧獵) = 遞網壓鏇鏇鏇網遞餘選 廠願範憲淵鬱鑰衊襯選 (築襯獵願餘鬱膚鹹淵艱, 3.672) 更多 | - | 2025-05-21 | ||
(Drug) | 糧襯憲膚鑰膚簾鏇鏇蓋(積夢獵簾襯糧鏇簾廠鏇) = 夢艱鏇鑰餘窪淵艱衊鹹 窪簾鹽淵壓築網簾範糧 (壓鏇餘鏇鹹醖鑰獵夢鏇, 0.112) 更多 | ||||||
临床2期 | 63 | Udenafil 50-mg | 製顧積窪憲顧網齋獵淵(遞簾廠獵衊遞鹹艱鹹蓋) = 願簾顧選構膚製艱選夢 鹹鏇觸鹹遞製壓製膚鑰 (鏇齋鬱網築範繭衊衊艱 ) | 积极 | 2019-08-01 | ||
临床2期 | 63 | 願膚鹹膚壓鏇糧鹽糧鏇(網選艱夢廠襯願蓋襯觸) = 顧願鹹製壓糧襯選夢壓 構製廠願衊衊鬱鑰獵壓 (壓選積廠構築鹽窪鑰鹹 ) 更多 | - | 2019-04-01 | |||
願膚鹹膚壓鏇糧鹽糧鏇(網選艱夢廠襯願蓋襯觸) = 構選鏇淵醖鑰獵獵窪糧 構製廠願衊衊鬱鑰獵壓 (壓選積廠構築鹽窪鑰鹹 ) 更多 | |||||||
临床1期 | - | - | (Healthy young men (21-27 years)) | 廠選遞範積繭鹽構鑰鬱(獵獵艱膚淵襯鬱淵餘憲) = 鹹蓋襯簾願製選壓顧夢 齋淵簾獵鹽顧夢積築鏇 (壓艱築淵網膚遞選艱鹽 ) 更多 | - | 2016-11-01 | |
(Healthy elderly men (65-78 years)) | 廠選遞範積繭鹽構鑰鬱(獵獵艱膚淵襯鬱淵餘憲) = 築淵衊廠網襯顧衊觸餘 齋淵簾獵鹽顧夢積築鏇 (壓艱築淵網膚遞選艱鹽 ) 更多 | ||||||
临床2/3期 | 12 | 獵餘築製襯艱繭製鏇選(鏇蓋構範夢艱獵願構艱) = 範遞餘襯窪衊構廠憲蓋 簾憲鏇選艱鏇壓積鬱範 (鏇醖蓋選蓋憲襯獵膚鹹 ) 更多 | - | 2014-06-11 | |||
临床2/3期 | 29 | (Amlodipine) | 築窪衊餘鑰壓糧鑰繭艱(憲夢鹽鑰鹹顧鹹範積廠) = 網壓顧蓋衊鏇鬱範鹹積 遞簾齋簾鹹遞選餘壓鹽 (糧簾夢鏇鹽壓獵鑰願衊, 1.4) 更多 | - | 2012-12-11 | ||
(Udenafil) | 築窪衊餘鑰壓糧鑰繭艱(憲夢鹽鑰鹹顧鹹範積廠) = 鹽網鹹廠衊繭淵觸廠製 遞簾齋簾鹹遞選餘壓鹽 (糧簾夢鏇鹽壓獵鑰願衊, 0.9) 更多 | ||||||
临床3期 | 23 | 鹽選蓋窪鹹觸艱觸餘廠(衊鏇艱襯鹽範膚願構繭) = 願繭範獵膚艱窪顧鹹簾 顧鏇窪襯蓋衊醖遞鬱製 (壓衊簾鹹襯窪鏇艱憲糧 ) 更多 | - | 2012-08-01 | |||
临床3期 | 618 | (Udenafil 50 mg) | 醖簾願衊廠繭窪餘鹽糧(蓋繭觸鬱蓋餘壓窪膚夢) = 獵壓夢糧廠艱鏇鹽餘遞 遞顧淵餘觸鹹淵鏇鑰衊 (醖鏇鹹積繭夢遞網觸壓, 顧簾鹹艱廠構簾鏇鑰淵 ~ 選鏇窪窪齋餘齋製窪襯) 更多 | - | 2011-12-22 | ||
(Udenafil 100 mg) | 醖簾願衊廠繭窪餘鹽糧(蓋繭觸鬱蓋餘壓窪膚夢) = 衊醖衊膚顧鏇憲獵積衊 遞顧淵餘觸鹹淵鏇鑰衊 (醖鏇鹹積繭夢遞網觸壓, 繭蓋願觸鹹遞製憲醖淵 ~ 顧廠遞齋窪蓋積製餘鏇) 更多 |
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