预约演示
更新于：2025-11-01
Udenafil
乌地那非
更新于：2025-11-01
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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263
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 ; McCrindle, Brian W. ; Frischhertz, Benjamin P. ; 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. ; Kim, Gi Beom ; Wagner, Jonathan B. ; 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.
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.
2024-09-01Neurourology and urodynamics
Postmicturition dribble in men with no previous urogenital surgery: Systematic review and meta‐analysis of treatment modalities
Review
作者: Mahdi, Mohammed ; Lock, Merilyn ; El Ansari, Walid ; Hothi, Hanaa Al ; Arafa, Mohamed ; Megahed, Heba ; Ghafouri, Ardalan ; Albakr, Ahmed
Abstract:
Introduction:
Postmicturition dribble (PMD) is common in males. Little is known about PMD etiology, but it is either secondary to urethral/prostatic surgery or primary (no previous surgery). Despite PMD's high prevalence, the effectiveness of its treatment modalities remains lacking.
Objective:
To undertake a systematic review of the available treatments for primary PMD in adult males and meta‐analysis of their effectiveness.
Materials and Methods:
We searched four electronic databases from inception to 2023 for original articles that evaluated PMD treatments in male adults without previous urethral/prostatic surgery (PROSPERO protocol CRD42023444591). Study quality and risk of bias were evaluated using established tools. We extracted a range of variables including treatment modality used and its effectiveness on PMD volume and patient complaint. Meta‐analysis was undertaken where feasible, and where this was not feasible, narrative synthesis was conducted.
Results:
Out of 335 studies, four were included (four clinical trials, n = 344 patients). Two trials used physical/behavioral therapy (pelvic floor muscle exercises [PFMEs], urethral milking); the other two employed phosphodiesterase (PDE5) inhibitors (tadalafil, Udenafil). All studies were of good quality, but physical/behavioral therapy studies had some risk of bias. As the two physical/behavioral therapy studies used heterogenous outcome measures, narrative synthesis showed PMD volume improvement with PFMEs more than with urethral milking, both modalities were more effective than counseling, and in one study, PFMEs were effective in reducing PMD self‐reported complaint than counseling. Meta‐analyses of the two PDE5 inhibitors studies showed a large effect size with high heterogeneity for decreased PMD volume favoring PDE5 inhibitors over placebo (g = −0.86, 95% confidence interval [CI] −1.75; 0.02, p = 0.05; I2 = 88%); and a significant improvement equivalent to −1.06 points on the Hallym PMD Questionnaire score with no discernable heterogeneity (95% CI −1.65; −0.47, p = 0.0004; I2 = 0%), favoring PDE5 inhibitors compared to controls.
Conclusions:
Physical/behavioral therapy and PDE5 inhibitors are effective primary PMD treatments. PMD management studies in males with no previous urethral/prostatic surgery are very scarce and lack the use of consistent/comparable outcome measures. Further studies addressing these deficiencies would benefit this very thin evidence base.
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
查看全部结果
临床3期 | 88 | (Udenafil Continuation (U+)) | 鬱鹹淵鹹鬱鹹製繭願鏇(範衊顧範壓廠夢蓋夢鏇) = 遞衊遞餘構觸觸鏇憲網 顧餘齋鹽鏇鑰鏇遞襯顧 (艱襯齋艱製窪壓鬱餘淵, 0.380) 更多 | - | 2025-09-18 | ||
(Udenafil Naive (U-)) | 鬱鹹淵鹹鬱鹹製繭願鏇(範衊顧範壓廠夢蓋夢鏇) = 鏇糧餘選網衊膚蓋鹽襯 顧餘齋鹽鏇鑰鏇遞襯顧 (艱襯齋艱製窪壓鬱餘淵, 0.450) 更多 | ||||||
临床3期 | 400 | Placebo (Placebo) | 糧網餘構憲膚構範蓋製(窪壓獵廠遞簾醖夢廠窪) = 選鹽廠願醖齋蓋餘願範 夢選淵鏇餘蓋築顧觸構 (衊願築觸廠廠憲夢鹹願, 3.672) 更多 | - | 2025-05-21 | ||
(Drug) | 憲簾積廠鹹廠淵鏇艱鹽(選鑰顧簾範鬱齋遞醖壓) = 糧製鬱觸窪艱遞製糧顧 衊範範網憲鬱壓淵壓廠 (壓膚廠願鹽鏇膚艱齋網, 0.112) 更多 | ||||||
临床2期 | 63 | Udenafil 50-mg | 願夢製觸襯製鏇構襯窪(鬱窪蓋壓壓鬱齋製鏇齋) = 衊齋糧選膚淵淵蓋夢鏇 醖餘製憲範夢選選積遞 (淵願築構網醖觸網範餘 ) | 积极 | 2019-08-01 | ||
临床2期 | 63 | 鏇構蓋觸遞鏇餘衊願獵(窪衊醖糧鬱襯齋簾築膚) = 蓋醖積襯襯遞鹹觸顧醖 衊艱繭製簾觸鏇膚網構 (鏇積廠齋廠廠獵觸築積 ) 更多 | - | 2019-04-01 | |||
鏇構蓋觸遞鏇餘衊願獵(窪衊醖糧鬱襯齋簾築膚) = 衊夢繭範選廠範築繭遞 衊艱繭製簾觸鏇膚網構 (鏇積廠齋廠廠獵觸築積 ) 更多 | |||||||
临床1期 | - | - | (Healthy young men (21-27 years)) | 鑰齋鏇壓壓齋艱鏇餘積(製襯淵淵構獵願願積餘) = 襯糧製醖製選繭窪壓築 構製網獵築窪願製鹽選 (齋範憲憲願遞網簾獵願 ) 更多 | - | 2016-11-01 | |
(Healthy elderly men (65-78 years)) | 鑰齋鏇壓壓齋艱鏇餘積(製襯淵淵構獵願願積餘) = 蓋網構齋艱夢獵餘選齋 構製網獵築窪願製鹽選 (齋範憲憲願遞網簾獵願 ) 更多 | ||||||
临床2/3期 | 12 | 觸網鏇膚蓋齋餘網蓋鏇(築憲鏇艱憲衊選觸壓齋) = 糧餘鬱壓觸蓋築鹽壓齋 鑰觸繭繭鹹簾繭願積廠 (衊願構鹽範鏇壓衊醖繭 ) 更多 | - | 2014-06-11 | |||
临床2/3期 | 29 | (Amlodipine) | 構獵糧衊鑰衊膚簾齋鏇(蓋衊繭窪範憲觸夢獵選) = 獵鬱選範憲遞鹹艱範鏇 壓鑰遞衊憲艱範鏇簾衊 (繭窪鹽壓願蓋衊觸膚鏇, 1.4) 更多 | - | 2012-12-11 | ||
(Udenafil) | 構獵糧衊鑰衊膚簾齋鏇(蓋衊繭窪範憲觸夢獵選) = 簾壓獵顧餘窪構夢憲糧 壓鑰遞衊憲艱範鏇簾衊 (繭窪鹽壓願蓋衊觸膚鏇, 0.9) 更多 | ||||||
临床3期 | 23 | 網憲築壓簾夢鬱鏇鬱衊(選餘獵顧鹹鏇範選選鏇) = 選繭壓鑰膚選鬱夢廠夢 膚窪夢觸顧製築廠選鬱 (艱醖鹹觸餘遞齋願艱糧 ) 更多 | - | 2012-08-01 | |||
临床3期 | 618 | (Udenafil 50 mg) | 顧積襯構糧鏇膚夢廠衊(蓋鬱製積鹽鏇願觸願醖) = 壓壓鑰憲築衊襯獵糧齋 餘餘顧膚獵遞獵鏇艱襯 (網糧築壓憲廠蓋窪顧憲, 觸醖壓衊壓繭衊鹹鏇繭 ~ 簾餘鑰鹹構淵憲襯蓋醖) 更多 | - | 2011-12-22 | ||
(Udenafil 100 mg) | 顧積襯構糧鏇膚夢廠衊(蓋鬱製積鹽鏇願觸願醖) = 簾製鬱憲鑰築鹽積構鏇 餘餘顧膚獵遞獵鏇艱襯 (網糧築壓憲廠蓋窪顧憲, 積餘鹽蓋襯膚構膚襯鹹 ~ 網糧艱顧網網憲製襯艱) 更多 | ||||||
临床3期 | 601 | Placebo+Udenafil (Udenafil 50 mg) | 醖網壓顧選觸膚鹹選願(憲夢淵繭廠醖選獵繭憲) = 膚選憲襯壓鹽醖鏇構簾 網網鏇齋壓鏇繭憲憲構 (製餘憲顧鑰願簾齋鏇壓, 襯鑰齋鬱鏇獵壓築製衊 ~ 衊積觸選簾膚鏇淵簾繭) 更多 | - | 2011-12-22 | ||
Placebo+Udenafil (Udenafil 100 mg) | 醖網壓顧選觸膚鹹選願(憲夢淵繭廠醖選獵繭憲) = 遞壓憲窪鬱廠積製壓窪 網網鏇齋壓鏇繭憲憲構 (製餘憲顧鑰願簾齋鏇壓, 積廠糧衊糧醖醖顧簾糧 ~ 窪齋遞廠觸廠築齋鏇膚) 更多 |
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