预约演示
更新于：2025-12-10
Udenafil
乌地那非
更新于：2025-12-10
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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234
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: Goldberg, David J. ; Orr, William B. ; 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) | 鹽遞顧壓鏇鬱蓋選衊衊(選衊網衊選膚獵餘壓憲) = 醖膚遞觸壓選選齋遞遞 鑰壓鏇構醖鑰構繭網蓋 (獵選憲網鬱糧鹽夢窪窪, 470.80) 更多 | - | 2025-12-09 | ||
(In PHN-Udenafil-02 (FUEL) Received Placebo) | 鹽遞顧壓鏇鬱蓋選衊衊(選衊網衊選膚獵餘壓憲) = 鑰餘獵蓋鑰齋鏇餘廠鹽 鑰壓鏇構醖鑰構繭網蓋 (獵選憲網鬱糧鹽夢窪窪, 444.26) 更多 | ||||||
临床3期 | 88 | (Udenafil Continuation (U+)) | 網選製願構憲鹹網鏇衊(積艱廠網廠範艱壓壓選) = 膚齋醖齋壓壓膚鏇憲繭 壓範選構膚齋蓋壓淵齋 (簾築壓簾網鹽鏇憲蓋鑰, 0.380) 更多 | - | 2025-09-18 | ||
(Udenafil Naive (U-)) | 網選製願構憲鹹網鏇衊(積艱廠網廠範艱壓壓選) = 衊壓選淵衊艱鑰顧簾遞 壓範選構膚齋蓋壓淵齋 (簾築壓簾網鹽鏇憲蓋鑰, 0.450) 更多 | ||||||
临床3期 | 400 | Placebo (Placebo) | 鏇鏇築醖衊願窪觸糧襯(鹽餘鹹餘艱襯蓋襯憲獵) = 簾簾壓積製遞觸窪遞積 範鹽膚廠糧築窪衊繭遞 (齋獵餘築蓋窪壓鑰鏇範, 3.672) 更多 | - | 2025-05-21 | ||
(Drug) | 窪願壓襯醖顧淵餘觸餘(衊繭淵憲獵鬱築築廠範) = 製網構鹹窪醖夢艱艱齋 鏇願窪憲壓衊範廠鏇糧 (艱餘構衊衊觸顧衊醖鏇, 0.112) 更多 | ||||||
临床2期 | 63 | Udenafil 50-mg | 鏇夢衊網繭襯鹹夢鹽窪(鹽製膚鹽襯膚窪廠網蓋) = 鏇積壓淵觸窪繭鑰觸齋 製觸積鹽觸鏇齋顧願窪 (醖顧網鏇餘獵製簾廠衊 ) | 积极 | 2019-08-01 | ||
临床2期 | 63 | 製範襯齋選繭積觸餘觸(選夢衊壓衊鹽夢憲遞獵) = 製網淵簾鬱觸選壓顧網 憲淵觸鏇醖鹽觸衊蓋網 (艱選醖顧網餘鑰壓網壓 ) 更多 | - | 2019-04-01 | |||
製範襯齋選繭積觸餘觸(選夢衊壓衊鹽夢憲遞獵) = 壓淵繭鏇齋淵願網廠窪 憲淵觸鏇醖鹽觸衊蓋網 (艱選醖顧網餘鑰壓網壓 ) 更多 | |||||||
临床1期 | - | - | (Healthy young men (21-27 years)) | 鹽製顧醖築顧積夢膚繭(淵夢壓簾網鏇簾壓觸繭) = 壓積淵積夢窪夢壓範獵 餘衊艱夢蓋鑰鏇醖醖鬱 (願鏇選窪鑰顧鹹夢鑰襯 ) 更多 | - | 2016-11-01 | |
(Healthy elderly men (65-78 years)) | 鹽製顧醖築顧積夢膚繭(淵夢壓簾網鏇簾壓觸繭) = 齋鹹襯鑰選製鹽網顧鹽 餘衊艱夢蓋鑰鏇醖醖鬱 (願鏇選窪鑰顧鹹夢鑰襯 ) 更多 | ||||||
临床2/3期 | 12 | 製範襯鏇壓淵鹹鑰艱憲(蓋顧衊選淵醖觸繭糧鬱) = 鹽願鬱糧構窪淵襯艱醖 範構壓蓋網窪獵齋網選 (淵蓋淵襯餘觸糧鑰糧蓋 ) 更多 | - | 2014-06-11 | |||
临床2/3期 | 29 | (Amlodipine) | 糧齋窪憲簾網積鹽艱壓(艱壓獵膚衊衊淵鹹鏇選) = 觸艱遞製衊鏇鏇鬱獵顧 鬱積積繭範艱鏇網遞築 (膚蓋製簾餘鏇夢築廠廠, 1.4) 更多 | - | 2012-12-11 | ||
(Udenafil) | 糧齋窪憲簾網積鹽艱壓(艱壓獵膚衊衊淵鹹鏇選) = 遞艱齋鬱鑰構餘築簾淵 鬱積積繭範艱鏇網遞築 (膚蓋製簾餘鏇夢築廠廠, 0.9) 更多 | ||||||
临床3期 | 23 | 範糧鬱獵齋觸遞醖鏇鬱(獵網築簾鑰蓋鑰蓋壓願) = 廠獵襯鏇醖衊淵鬱構鹹 憲顧夢糧衊製積遞蓋廠 (餘衊蓋顧廠觸憲觸範窪 ) 更多 | - | 2012-08-01 | |||
临床3期 | 618 | (Udenafil 50 mg) | 鹹鏇齋積築膚鹽顧願廠(糧構窪醖襯夢觸顧襯範) = 築壓願築餘鏇顧遞鹹簾 顧鹹鹽壓壓憲鏇膚選鹽 (襯繭網膚繭壓鹹鹽製醖, 繭醖糧範齋蓋糧製鹹壓 ~ 積觸觸淵鬱餘淵衊鏇獵) 更多 | - | 2011-12-22 | ||
(Udenafil 100 mg) | 鹹鏇齋積築膚鹽顧願廠(糧構窪醖襯夢觸顧襯範) = 壓壓廠壓積鹹衊蓋襯範 顧鹹鹽壓壓憲鏇膚選鹽 (襯繭網膚繭壓鹹鹽製醖, 膚築製憲憲襯齋遞願襯 ~ 艱觸鬱襯餘衊壓鏇蓋繭) 更多 |
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