This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

开始日期2023-10-30

申办/合作机构

Mezzion Pharma Co., Ltd.

KCT0005833

/ Completed临床4期IIT

Effect of Udenafil Administration for Blood Flow Increase in the Prefrontal Cortex

开始日期2020-12-01

申办/合作机构-

NCT03430583

/ Unknown statusN/A

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

开始日期2018-02-20

申办/合作机构

Mezzion Pharma Co., Ltd.

[+1]

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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296

项与乌地那非相关的文献（医药）

2025-04-01·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

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.

2024-09-01·EXPERT OPINION ON INVESTIGATIONAL DRUGS

An overview of conventional and investigational phosphodiesterase 5 inhibitors for treating erectile dysfunction and other conditions

Review

作者: El-Sakka, Ahmed I. ; Ismail, Ezzat A.

INTRODUCTION:

There is a rising concern about developing innovative, efficacious PDE5I molecules that provide better safety, efficacy, and tolerability with less adverse effects. Innovative PDE5I with dual targets have also been defined in the literature. Additionally, some of PDE5I are able to selectively inhibit other enzymes such as histone deacetylase, acetylcholine esterase, and cyclooxygenase or act as nitric oxide donors. This review presents knowledge concerning the advanced trends and perspectives in using PDE5I in treatment of ED and other conditions.

AREAS COVERED:

Pre-clinical and early clinical trials that investigated the safety, efficacy, and tolerability of novel PDE5I such as Udenafil, Mirodenafil, Lodenafil, Youkenafil, Celecoxib, and TPN729 in treatment of ED and other conditions.

EXPERT OPINION:

Preclinical and limited early clinical studies of the new molecules of PDE5I have demonstrated encouraging results; however, safety, efficacy, and tolerability are still issues that necessitate further long-term multicenter clinical studies to ensure justification of their uses in treatment of ED and other conditions. Progress in molecular delivery techniques and tailored patient-specific management and additional therapeutic technology will dramatically improve care for ED and other conditions. The dream of ED and many other conditions becoming more effectively managed may be feasible in the near future.

2024-09-01·Neurourology 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 ; Megahed, Heba ; Ghafouri, Ardalan ; Arafa, Mohamed ; 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.

项与乌地那非相关的新闻（医药）

2024-03-01

·PRNewswire

Mezzion Pharmaceuticals Announces Dr. Rahul Rathod of Boston Children's Hospital and Harvard Medical School as the Global Principal Investigator for the Confirmatory Pivotal Phase 3 Trial FUEL-2

FORT LEE, N.J., March 1, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr. Rahul Rathod, a pediatric cardiology specialist and leader with over 20 years of experience at Boston Children's Hospital, as the Global Principal Investigator of FUEL-2. Continue Reading FUEL-2 Dr. Rathod currently serves as the Associate Chair of Cardiology, Director of the Single Ventricle Program, and Director of the Fontan Clinic at Boston Children's Hospital as well as Associate Professor of Pediatrics at Harvard Medical School. He is an internationally recognized medical expert, researcher, and key opinion leader in the single ventricle heart disease space and Fontan circulation—with more than 80 peer-reviewed publications. Dr. Rathod is the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE). The FORCE Registry is a tech-enabled research platform dedicated to improving the quality and longevity of life for single ventricle patients by aggregating global Fontan data, advancing cardiac imaging through big data and analytics, and utilizing machine learning to improve workflows and patient outcomes. FORCE is the largest Fontan dataset in the world. As the Global Principal Investigator for FUEL-2, Dr. Rathod will lead the clinical trial, overseeing clinical protocol, conduct, and operations at all study sites. He will also lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA). "FUEL-2 represents a pivotal moment in Fontan research pioneering advancements for our patients. This landmark study delves into the potential of udenafil to empower individuals to reclaim vitality in their daily lives," said Dr. Rathod about the trial. "The Fontan population is one with significant medical complexities and unmet needs; this trial offers the promise of tangible solutions and a powerful tool that can redefine the treatment landscape for Fontan patients." "Dr. Rathod is a preeminent expert in Fontan physiology and the ideal clinical leader to serve as the Global Principal Investigator of FUEL-2. Mezzion is very proud and encouraged to have him as our partner as this pivotal clinical trial progresses," said Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion. Dr. Hariadi recently joined Mezzion from Johnson & Johnson, where he was senior director for global regulatory affairs. He previously served in several senior medical leadership roles at the FDA and the United States Department of Homeland Security. He will serve as Mezzion's primary liaison to the FUEL-2 clinical research organization, study sites, and investigators. FUEL-2 is a Mezzion Pharmaceuticals-sponsored clinical trial investigating the clinical efficacy and safety of udenafil in teenagers 12-18 years of age who have undergone the Fontan procedure. It is poised to be the world's largest Fontan clinical trial and is set to enroll 438 patients globally. Currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks. The latest site information for FUEL-2 can be found here. Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor and was previously studied in some adolescents with Fontan physiology. PDE5 inhibitors relax the blood vessels and may increase the blood flow to the lungs. This may mean higher blood oxygen levels; if so, individuals may be less tired when exercising or during everyday activities. For more information about the study, please visit FUEL2study.com. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., has an administrative office in Fort Lee, New Jersey. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media Contacts: PR Contact – Philicia Thompson, [email protected], 7047749643 Medical Contact – John Hariadi, [email protected], (443) 699-6746 Mezzion Pharma Co. Ltd. Contact – S.I. Noh, [email protected], +82 2 560 8000 SOURCE Mezzion Pharmaceuticals, Inc

临床3期高管变更

2023-10-07

·CPHI制药在线

新药 | ED市场有望再添新成员，旺山旺水斯美瑞非申报上市

关注并星标CPHI制药在线近日，苏州旺山旺水生物医药股份有限公司1类新药「斯美瑞非片」的上市申请获CDE受理。斯美瑞非（TPN171）是经过大量筛选和结构优化后获得的具有自主产权的高活性、高选择性PDE5抑制剂，被开发用于治疗勃起功能障碍(ED)和肺动脉高压（PAH）。体外和动物试验以及1期临床研究结果显示：斯美瑞非有效性和安全性良好。笔者推测此次斯美瑞非申报的适应症为ED。已公布的斯美瑞非治疗ED的2期临床研究结果显示：斯美瑞非5、10、20mg三个剂量组均达到试验预设的主要终点，可显著改善受试者的勃起功能，主要疗效指标IIEF-EF、SEP2和SEP3的改变与安慰剂相比，均具有显著的统计学意义。 ED是男性最常见的性功能障碍疾病之一，据WHO统计大约影响全球超1.8亿男性患者。5型磷酸二酯酶（PDE5）抑制剂通过抑制降解cGMP的PDE5活性增加细胞内cGMP浓度，导致平滑肌松弛，使阴茎海绵体内动脉血流增加而发挥作用，是公认的ED一线治疗药物。目前全球获批治疗ED的PDE5抑制剂有8种，即西地那非、他达拉非、伐地那非、优地那非、洛地那非、米罗那非、阿伐那非和爱地那非。其中爱地那非是我国首个自主研发，用于治疗ED的PDE5抑制剂，2021年12月在国内获批。值得一提的是，今年6月ED领域还迎来一种新疗法，即Futura Medical的Eroxon（MED3000）。该药是利用公司独特的DermaSys技术开发的一款硝酸甘油透皮凝胶制剂，其通过含有挥发性溶剂来发挥作用。溶剂蒸发产生的发热效果，从而刺激高度敏感的神经促进NO反应的产生，NO可以促进平滑肌松弛和促进海绵体血液流动，从而有效改善勃起功能。与PDE5抑制剂不同，Eroxon无需口服，涂抹在相应位置即可，是FDA批准的第一款ED外用制剂，也是FDA批准的首个治疗ED的非处方药（OTC）。旺山旺水研发管线分析旺山旺水是中科院上海药物所苏州成果转化中心在苏州孵化的第一家高新技术企业，产品领域涵盖中枢神经系统药物、心脑血管药物、抗肿瘤药物以及抗病毒药物。自2013年成立以来，旺山旺水与君实生物合作开发的抗病毒药物氢溴酸氘瑞米德韦片（研发代号：VV116；商品名：民得维）已于2023年1月在国内获NMPA附条件批准，用于治疗轻中度COVID-19感染的成年患者。该药是一款新型口服核苷类抗病毒药物，能够以核苷三磷酸形式非共价结合到新冠病毒RNA依赖性RNA聚合酶（RdRp）的活性中心，直接抑制病毒RdRp的活性，阻断病毒的复制，从而发挥抗病毒的作用。此外，氢溴酸氘瑞米德韦还被开发用于治疗呼吸道合胞病毒（RSV）感染。今年5月，氢溴酸氘瑞米德韦干混悬剂在国内获批临床，治疗RSV感染。除了VV116，旺山旺水与君实生物还合作开发了另外一款抗COVID-19药物，即VV993。该药是一款靶向3CL蛋白酶的口服抗COVID-19新药，目前处于临床前阶段。在COVID-19感染的细胞模型实验中，VV993可以有效抑制新冠病毒复制。在COVID-19的小鼠模型中，VV993不仅可以有效降低病毒复制，还能显著改善由新冠病毒感染造成的肺部病理改变。而且，VV993安全性较好，目前没有发现心脏毒性和神经毒性作用。斯美瑞非是旺山旺水进展较快的药物，目前已申报上市。除了治疗ED，斯美瑞非治疗肺动脉高压的临床试验处于2期阶段。在健康志愿者中完成的1期临床研究结果表明：TPN171安全性和耐受性良好，药代性质满足每日口服一次的临床需求。此外，目前旺山旺水还有几款新药处于1期临床试验阶段，如LV232、VV119、TPN672、TPN102。其中VV119是一款抗精神分裂症药物，LV232是一种抗抑郁药物，先后于今年9月在国内获批临床。TPN672也是一款抗分裂症药物，2017年5月在国内获批临床。TPN102是一种新型抗癫痫候选药物，临床前研究结果表明其在多种癫痫模型，特别是难治性癫痫动物模型上均表现出显著药效。同时，TPN102具有安全性好、药代动力学性质优良等特点。扫码参与制药在线周年庆游园会来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

申请上市

2023-04-25

·PRNewswire

Mezzion Pharma Raises Nearly $40M to Advance a First-to-Market Treatment Option for Fontan Patients

SEOUL, South Korea, April 25, 2023 /PRNewswire/ -- Mezzion Pharma ("Mezzion"), a rare disease focused pharmaceutical company, announced that it has secured nearly $40M USD to fund FUEL-2, their confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries including Europe. Mezzion is looking to bring to market JURVIGO® (udenafil), a highly selective, unique and potent phosphodiesterase type 5 inhibitor ("PDE-5 inhibitor"), for specific use in the estimated global 70K single ventricle congenital heart disease ("SV-CHD") patients with ages of twelve and above who have undergone Fontan surgical palliation. The average life expectancy for a Fontan patient is 35-45 and apart from JURVIGO®, there are currently no other pharmacotherapies undertaking clinical development directed to the Fontan patient population. The primary aim of JURVIGO® treatment in Fontan subject is to (1) improve their exercise capacity, (2) improve their ability to perform everyday physical activities with less effort, and (3) potentially improve their life expectancy and quality of life. Another potential benefit associated with JURVIGO® treatment may be the slowing of the progression of Fontan-associated liver disease in the Fontan subjects. Founder and CEO, Mr. Dong-Hyun Park, shared, "We have secured the funds necessary for stable and aggressive progress of FUEL-2 and for submitting to regulatory authorities in other countries including Europe. We submitted the FUEL-2 protocol to the FDA and partnered with a leading global CRO for what will be the largest clinical trial ever conducted in Fontan patients. In addition, we are expanding on global partnerships with hospital systems, advocacy groups, provider networks, and industry leaders dedicated to improving outcomes for those with SV-CHD. Our hope is that by continuing to invest in and support the Fontan patients, others will be inspired to do the same." The investment is a paid-in capital increase from BRV Capital Management ("BRV Capital"), a global growth investment platform of BlueRun Ventures, a Silicon Valley-based institutional investment firm known for its early lead investment in PayPal and Waze, the core technology behind Google Maps. Within their healthcare segment, BRV Capital invests in promising biotech companies that can dominate the global market based on differentiated products. BRV has made successful investments/exit into ST Pharm and Arvelle Therapeutics. Mr. Yoon Kwan, CIO of BRV Capital, stated, "BRV Capital participated in the Cardiology Conference by Children's Hospital of Philadelphia (CHOP) in Puerto Rico at the end of February of this year and met many doctors and heart disease related professionals in person as part of its diligence effort. And also, we've been thoroughly reviewing Mezzion's FUEL-1 data and the U.S. FDA's response letters and comments carefully for a long time. As a result, the possibility of new drug approval based on the FUEL-2 Protocol was evaluated very high, so the head office decided to invest in Mezzion." Mr. Kwan continued with, "The future market value was estimated considering attainable drug price after commercialization. BRV, as an institutional investor that focuses not on short-term profits, but on differentiated technology-based investments that can substantially grow, we would like to provide support from the new drug approval of udenafil to the success of global commercialization with strong partnership. We also subscribe to Mezzion's corporate philosophy of helping all the patients around the World who are suffering from congenital diseases to open-up a new life." About BRV Capital Management : BRV Capital is a tech-focused growth equity arm of BlueRun Ventures, with a highly localized presence in Asia. BRV Capital helps to create unique long-term growth by backing category winners in their respective industries and maximizing their potential through leveraging over 20 years of deep industry insight and global expertise in applying technological innovations. Founded in 1998, BlueRun Ventures has identified and led several iconic technology investments as the first institutional investor, including PayPal (PYPL), Waze (GOOG), Coupa (COUP), Kabbage (AMEX), Topsy (AAPL), and Chomp (AAPL). BRV Capital in parallel focuses on technology-powered growth opportunities in Asia, and its current select investments include Ecopro Materials (leading EV battery component technology provider in Korea), LINE MAN Wongnai (top O2O platform in Thailand), and Green Labs (leading agricultural technology company pioneering digitalization of the entire agriculture value chain). BRV Capital closed its third Asia-focused fund, BRV Lotus Fund III, in 2021 and will continue to focus on cross-border value creation leveraging BRV's deep and long investment insight into mobility. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media Contact: Dr. James Yeager, Deerfield, Illinois, USA, Tel: +1-847-2122679 Email: [email protected] Mr. S.I. Noh, Seoul, Korea, Tel: +82 2 560 8000 Email: [email protected] SOURCE Mezzion Pharma Co. Ltd.

临床3期

100 项与乌地那非相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10027	乌地那非	G04BE11	DB06267

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
勃起功能障碍	韩国	Dong-A Pharmaceutical Co., Ltd.	2005-11-29

未上市

10 条进展最快的记录,

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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	Mezzion Pharma Co., Ltd.	2017-01-01
单心室心脏	临床3期	加拿大	Mezzion Pharma Co., Ltd.	2017-01-01
单心室心脏	临床3期	韩国	Mezzion Pharma Co., Ltd.	2017-01-01
肺动脉高压	临床3期	韩国	Dong-A ST Co., Ltd.	2014-04-01
阿尔茨海默症	临床3期	韩国	Dong-A Pharmaceutical Co., Ltd.	2013-09-01
射血分数保留型心力衰竭	临床3期	韩国	Dong-A Pharmaceutical Co., Ltd.	2012-10-01
舒张期心力衰竭	临床3期	韩国	Dong-A Pharmaceutical Co., Ltd.	2012-10-01
特发性肺动脉高压	临床3期	韩国	Dong-A Pharmaceutical Co., Ltd.	2012-09-01
慢性收缩性心力衰竭	临床3期	韩国	Dong-A Pharmaceutical Co., Ltd.	2011-12-01
雷诺病	临床3期	韩国	Dong-A Pharmaceutical Co., Ltd.	2011-01-01

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01553721 (Pubmed \| Clin Ther)	临床2期	肺动脉高压	63	Udenafil 50-mg	範夢壓壓鑰簾築淵醖網(網鹽蓋餘鹹衊蓋夢鹹選) = 鏇願遞廠繭獵鹽積齋顧壓獵鹽選窪襯夢艱範膚 (憲範遞繭鬱襯夢製獵壓 )	积极	2019-08-01
NCT01553721 (Pubmed \| Korean Circ J)	临床2期	肺动脉高压	63	Udenafil 50 mg	艱顧衊繭積壓鏇顧願餘(醖艱窪夢觸構膚齋網鹹) = 簾膚願網襯襯觸壓觸衊憲壓壓觸鏇築觸願鏇齋 (廠觸膚壓齋網廠網簾醖 ) 更多	-	2019-04-01
				Udenafil 100 mg	艱顧衊繭積壓鏇顧願餘(醖艱窪夢觸構膚齋網鹹) = 鬱製鑰簾壓鹹築鏇製壓憲壓壓觸鏇築觸願鏇齋 (廠觸膚壓齋網廠網簾醖 ) 更多
KCT0001436 (Pubmed \| J Clin Pharmacol)	临床1期	-	-	Udenafil (Healthy young men (21-27 years))	鏇餘獵網顧顧遞餘蓋繭(繭鬱顧壓顧醖觸膚餘選) = 壓顧製夢夢範鹹鏇壓齋鏇夢願繭觸艱築網範構 (願鑰網網遞遞鹹膚鹹鑰 ) 更多	-	2016-11-01
				Udenafil (Healthy elderly men (65-78 years))	鏇餘獵網顧顧遞餘蓋繭(繭鬱顧壓顧醖觸膚餘選) = 膚廠襯構鹹餘積繭製繭鏇夢願繭觸艱築網範構 (願鑰網網遞遞鹹膚鹹鑰 ) 更多
NCT01280266 (EULAR2014)	临床2/3期	雷诺病	12	Udenafil 100 mg/day	遞襯鏇鹹壓餘簾構衊醖(顧夢鹽遞選夢壓窪憲築) = 膚願鏇鹽簾蓋齋鹽觸壓壓襯蓋夢齋窪膚餘夢鹽 (憲夢築鹹膚願簾積憲鹹 ) 更多	-	2014-06-11
NCT01364181 (Pubmed \| COPD)	临床3期	慢性阻塞性肺疾病	23	Udenafil 50 mg	窪選選鏇簾鑰獵艱餘繭(醖觸蓋獵淵醖簾選製網) = 鏇窪簾鏇鹽夢憲衊齋鹹簾襯願鑰醖糧構艱築衊 (壓憲遞夢糧衊築簾膚齋 ) 更多	-	2012-08-01
NCT01037218 (CTgov)	临床3期	勃起功能障碍	601	Placebo+Udenafil (Udenafil 50 mg)	窪鏇鬱窪襯艱網衊鹹繭(衊餘壓蓋夢範醖願鑰願) = 選製積淵齋淵鬱選廠鏇夢選積遞鬱艱憲積選選 (顧憲廠遞窪鹹膚鹽廠糧, 遞鏇齋蓋鑰積築繭獵鬱 ~ 衊窪淵蓋觸鏇鑰鏇顧鏇) 更多	-	2011-12-22
				Placebo+Udenafil (Udenafil 100 mg)	窪鏇鬱窪襯艱網衊鹹繭(衊餘壓蓋夢範醖願鑰願) = 簾鬱壓廠壓窪壓醖顧選夢選積遞鬱艱憲積選選 (顧憲廠遞窪鹹膚鹽廠糧, 夢鹹憲獵繭構鬱憲獵襯 ~ 獵網蓋願艱鬱鬱襯襯壓) 更多
NCT01037244 (CTgov)	临床3期	勃起功能障碍	618	Udenafil (Udenafil 50 mg)	壓鑰衊鹽鏇糧衊選願齋(鹹範醖蓋膚艱網齋廠顧) = 積鏇顧鹹顧鑰廠鏇糧廠鹽製觸淵獵衊醖壓遞選 (糧鬱積醖餘積糧壓簾鏇, 簾顧襯範廠襯範膚顧構 ~ 衊壓選觸憲遞憲膚餘築) 更多	-	2011-12-22
				Udenafil (Udenafil 100 mg)	壓鑰衊鹽鏇糧衊選願齋(鹹範醖蓋膚艱網齋廠顧) = 遞獵窪廠廠艱齋構獵選鹽製觸淵獵衊醖壓遞選 (糧鬱積醖餘積糧壓簾鏇, 願廠衊鑰網憲夢鏇餘廠 ~ 願築選齋簾壓製遞築構) 更多