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 / Recruiting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]

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100 项与乌地那非相关的专利（医药）

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179

项与乌地那非相关的文献（医药）

2024-01-17·Science translational medicine1区 · 医学

Small-molecule inhibition of glycogen synthase 1 for the treatment of Pompe disease and other glycogen storage disorders

1区 · 医学

Article

作者: Reiton, Daniel ; Fastman, Nathan ; Young, Lyndsay E A ; Tep, Samnang ; Wong, Perryn ; Merritt, Hanne ; Dick, Ryan A ; Ullman, Julie C ; Homburger, Julian R ; DePaoli-Roach, Anna A ; Hurley, Thomas D ; Chandriani, Sanjay J ; O'Regan, Adam ; Morton, Vivian ; Gentry, Matthew S ; Espanol, Bryan ; Lin, Baiwei ; Green, Eric M ; Choy, Rebeca ; Sinz, Christopher ; Sarwaikar, Richa ; Hoek, Maarten ; Blake, Kerrigan ; Yu, Cecile ; Morgans, David J ; Mellem, Kevin T ; Santiago, Pam ; Powers, Hannah ; Lee, Patrick ; Satterfield, Terrence F ; Tzitzilonis, Christos ; Beattie, David T ; Cummings, Beryl B ; Ramanan, Vyas ; Gujral, Tarunmeet ; Situ, Eva ; Sun, Ramon C ; Ganesh, Sandya ; Graham, Robert R ; Xi, Yannan ; Won, Walter ; Roach, Peter J ; Noonberg, Sarah B ; Bainer, Russell

Glycogen synthase 1 (GYS1), the rate-limiting enzyme in muscle glycogen synthesis, plays a central role in energy homeostasis and has been proposed as a therapeutic target in multiple glycogen storage diseases. Despite decades of investigation, there are no known potent, selective small-molecule inhibitors of this enzyme. Here, we report the preclinical characterization of MZ-101, a small molecule that potently inhibits GYS1 in vitro and in vivo without inhibiting GYS2, a related isoform essential for synthesizing liver glycogen. Chronic treatment with MZ-101 depleted muscle glycogen and was well tolerated in mice. Pompe disease, a glycogen storage disease caused by mutations in acid α glucosidase (GAA), results in pathological accumulation of glycogen and consequent autophagolysosomal abnormalities, metabolic dysregulation, and muscle atrophy. Enzyme replacement therapy (ERT) with recombinant GAA is the only approved treatment for Pompe disease, but it requires frequent infusions, and efficacy is limited by suboptimal skeletal muscle distribution. In a mouse model of Pompe disease, chronic oral administration of MZ-101 alone reduced glycogen buildup in skeletal muscle with comparable efficacy to ERT. In addition, treatment with MZ-101 in combination with ERT had an additive effect and could normalize muscle glycogen concentrations. Biochemical, metabolomic, and transcriptomic analyses of muscle tissue demonstrated that lowering of glycogen concentrations with MZ-101, alone or in combination with ERT, corrected the cellular pathology in this mouse model. These data suggest that substrate reduction therapy with GYS1 inhibition may be a promising therapeutic approach for Pompe disease and other glycogen storage diseases.

2023-12-01·Pediatric cardiology

The Fontan Udenafil Exercise Longitudinal Trial: Subgroup Analysis.

Article

作者: Goldberg, David J ; Zak, Victor ; Wagner, Jonathan B ; McCrindle, Brian W ; Almaguer, Marisa ; Yung, Delphine ; Schumacher, Kurt R ; Mackie, Andrew S ; Cartoski, Mark J ; Williams, Richard V ; Ginde, Salil ; Richmond, Marc E ; Pearson, Gail D ; Petit, Christopher J ; Lubert, Adam M ; Davis, Christopher K ; McBride, Michael G ; Rathod, Rahul H ; Yetman, Anji T ; Kim, Gi Beom ; Hill, Kevin D ; Nowlen, Todd T ; Goldstein, Bryan H ; Frischhertz, Benjamin P ; Payne, R Mark ; John, Anitha S ; McHugh, Kimberly E ; Shahanavaz, Shabana ; Hu, Chenwei ; Penny, Daniel J ; Detterich, Jon A ; Paridon, Stephen M ; Yoon, J K ; DiMaria, Michael V

The Pediatric Heart Network's Fontan Udenafil Exercise Longitudinal (FUEL) Trial (Mezzion Pharma Co. Ltd., NCT02741115) demonstrated improvements in some measures of exercise capacity and in the myocardial performance index following 6 months of treatment with udenafil (87.5 mg twice daily). In this post hoc analysis, we evaluate whether subgroups within the population experienced a differential effect on exercise performance in response to treatment. The effect of udenafil on exercise was evaluated within subgroups defined by baseline characteristics, including peak oxygen consumption (VO₂), serum brain-type natriuretic peptide level, weight, race, gender, and ventricular morphology. Differences among subgroups were evaluated using ANCOVA modeling with fixed factors for treatment arm and subgroup and the interaction between treatment arm and subgroup. Within-subgroup analyses demonstrated trends toward quantitative improvements in peak VO₂, work rate at the ventilatory anaerobic threshold (VAT), VO₂ at VAT, and ventilatory efficiency (VE/VCO₂) for those randomized to udenafil compared to placebo in nearly all subgroups. There was no identified differential response to udenafil based on baseline peak VO₂, baseline BNP level, weight, race and ethnicity, gender, or ventricular morphology, although participants in the lowest tertile of baseline peak VO₂ trended toward larger improvements. The absence of a differential response across subgroups in response to treatment with udenafil suggests that the treatment benefit may not be restricted to specific sub-populations. Further work is warranted to confirm the potential benefit of udenafil and to evaluate the long-term tolerability and safety of treatment and to determine the impact of udenafil on the development of other morbidities related to the Fontan circulation.Trial Registration NCT0274115.

2023-06-01·Annals of clinical and translational neurology

A pilot study to explore the effect of udenafil on cerebral hemodynamics in older adults.

Article

作者: Wang, Qi ; Na, Duk L ; Oh, Sun-Young ; Kim, Ko Woon ; Shin, Byoung-Soo ; Shin, Yu Seob

OBJECTIVE:

Phosphodiesterase-5 inhibitors (PDE5Is) enhance vasodilation. We investigated the effects of PDE5I on cerebral hemodynamics during cognitive tasks using functional near-infrared spectroscopy (fNIRS).

METHODS:

This study used a crossover design. Twelve cognitively healthy men participants (mean age, 59 ± 3 years; range, 55-65 years) were recruited and randomly assigned to the experimental or control arm, then the experimental and control arm were exchanged after 1 week. Udenafil 100 mg was administered to participants in the experimental arm once daily for 3 days. We measured the fNIRS signal during the resting state and four cognitive tasks three times for each participant: at baseline, in the experimental arm, and in the control arm.

RESULTS:

Behavioral data did not show a significant difference between the experimental and control arms. The fNIRS signal showed significant decreases in the experimental arm compared to the control arm during several cognitive tests: verbal fluency test (left dorsolateral prefrontal cortex, T = -3.02, p = 0.014; left frontopolar cortex, T = -4.37, p = 0.002; right dorsolateral prefrontal cortex, T = -2.59, p = 0.027), Korean-color word Stroop test (left orbitofrontal cortex, T = -3.61, p = 0.009), and social event memory test (left dorsolateral prefrontal cortex, T = -2.35, p = 0.043; left frontopolar cortex, T = -3.35, p = 0.01).

INTERPRETATION:

Our results showed a paradoxical effect of udenafil on cerebral hemodynamics in older adults. This contradicts our hypothesis, but it suggests that fNIRS is sensitive to changes in cerebral hemodynamics in response to PDE5Is.

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

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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

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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
心脏病	临床3期	-	Mezzion Pharma Co., Ltd.	2023-06-26
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

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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 \| Korean Circ J)	临床2期	肺动脉高压	63	Udenafil 50 mg	糧糧繭願襯糧繭鏇窪構(窪鹽廠繭鬱網膚網夢鑰) = 鹹遞築鬱廠簾膚衊遞構壓壓鹽簾繭範艱艱廠蓋 (築窪艱鹽繭遞鹽蓋艱鑰 ) 更多	-	2019-04-01
				Udenafil 100 mg	糧糧繭願襯糧繭鏇窪構(窪鹽廠繭鬱網膚網夢鑰) = 衊淵鏇憲製願壓餘襯獵壓壓鹽簾繭範艱艱廠蓋 (築窪艱鹽繭遞鹽蓋艱鑰 ) 更多
Pubmed \| J Clin Pharmacol	临床1期	-	-	Udenafil (Healthy young men (21-27 years))	鏇窪艱壓鬱齋膚鬱鏇窪(顧鑰製衊顧積鹽夢獵鹽) = 鹹蓋餘壓遞範齋糧遞選鑰鬱衊膚醖鹹餘願憲鬱 (蓋餘積艱膚齋鹹襯壓壓 ) 更多	-	2016-11-01
				Udenafil (Healthy elderly men (65-78 years))	鏇窪艱壓鬱齋膚鬱鏇窪(顧鑰製衊顧積鹽夢獵鹽) = 齋構選鬱蓋鹽獵簾壓獵鑰鬱衊膚醖鹹餘願憲鬱 (蓋餘積艱膚齋鹹襯壓壓 ) 更多
NCT01280266 (EULAR2014)	临床2/3期	雷诺病	12	Udenafil 100 mg/day	簾壓艱網衊窪齋壓選廠(構襯鹹積蓋鑰遞壓艱窪) = 壓鹽顧範鏇積遞簾夢觸憲範製齋繭觸餘糧鑰襯 (顧夢鏇糧鏇窪顧齋觸淵 ) 更多	-	2014-06-11
NCT01364181 (Pubmed \| COPD)	临床3期	慢性阻塞性肺疾病	23	Udenafil 50 mg	遞積艱顧夢窪蓋選構獵(夢膚願範積製遞膚鹽壓) = 構鬱餘膚艱製顧糧製鏇選鬱淵膚鑰選窪鬱齋齋 (夢鏇衊鏇餘鬱築製獵築 ) 更多	-	2012-08-01
NCT01037244 (CTgov)	临床3期	勃起功能障碍	618	Udenafil (Udenafil 50 mg)	網選鏇齋憲顧選夢簾糧(鬱醖鑰網齋衊顧艱顧醖) = 範簾齋鏇壓簾壓醖餘顧簾糧艱構構廠壓餘築獵 (願範壓構選衊襯鹽觸衊, 淵網醖遞繭餘衊獵蓋觸 ~ 壓鹹鏇製獵築選簾構糧) 更多	-	2011-12-22
				Udenafil (Udenafil 100 mg)	網選鏇齋憲顧選夢簾糧(鬱醖鑰網齋衊顧艱顧醖) = 醖鑰鑰廠顧鑰選觸積憲簾糧艱構構廠壓餘築獵 (願範壓構選衊襯鹽觸衊, 襯顧醖範製憲淵衊鹹願 ~ 構繭艱範窪遞蓋鏇獵選) 更多
NCT01037218 (CTgov)	临床3期	勃起功能障碍	601	Placebo+Udenafil (Udenafil 50 mg)	繭衊觸窪夢窪繭築網網(壓壓艱艱襯製願鏇遞願) = 壓獵衊鹽網構遞選蓋繭製鏇襯築積憲窪構遞鹹 (夢範鑰壓構糧簾夢壓簾, 願選醖鏇鑰廠鬱製壓壓 ~ 壓觸鬱願廠鹽獵憲餘膚) 更多	-	2011-12-22
				Placebo+Udenafil (Udenafil 100 mg)	繭衊觸窪夢窪繭築網網(壓壓艱艱襯製願鏇遞願) = 鹽廠觸觸鬱鏇築築網簾製鏇襯築積憲窪構遞鹹 (夢範鑰壓構糧簾夢壓簾, 廠憲繭窪艱艱顧鹽製積 ~ 構壓構衊衊選築選糧積) 更多