主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂盐酸伐地那非片（规格：20mg，持证商：杭州民生药物研究院有限公司）与参比制剂盐酸伐地那非片（规格：20mg，持证商：Bayer AG，商品名：Levitra®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂盐酸伐地那非片和参比制剂盐酸伐地那非片在健康受试者中的安全性。

开始日期2024-10-09

申办/合作机构

杭州民生药物研究院有限公司

CTR20243140

/ CompletedN/A

盐酸伐地那非片在健康受试者中单中心、开放、随机、单剂量、交叉空腹和餐后状态下的生物等效性试验

主要目的比较空腹和餐后给药条件下，山东百诺医药股份有限公司提供的盐酸伐地那非片（20mg）与Bayer AG持证的盐酸伐地那非片（20mg，商品名：Levitra®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹和餐后给药条件下，山东百诺医药股份有限公司提供的盐酸伐地那非片（20mg）与Bayer AG持证的盐酸伐地那非片（20mg，商品名：Levitra®）在健康成年人群中的安全性。

开始日期2024-09-09

申办/合作机构

山东百诺医药股份有限公司

CTR20242575

/ CompletedN/A

盐酸伐地那非口崩片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验

主要研究目的：健康受试者空腹/餐后状态下，口服单剂量盐酸伐地那非口崩片（受试制剂，哈尔滨三联药业股份有限公司生产）与盐酸伐地那非口崩片（参比制剂，Alembic Pharmaceuticals Inc.生产）后，考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要研究目的：观察盐酸伐地那非口崩片受试制剂和参比制剂在健康受试者中的安全性。

开始日期2024-09-05

申办/合作机构

哈尔滨三联药业股份有限公司

100 项与盐酸伐地那非相关的临床结果

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100 项与盐酸伐地那非相关的转化医学

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100 项与盐酸伐地那非相关的专利（医药）

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1,164

项与盐酸伐地那非相关的文献（医药）

2025-01-01·Journal of Pharmaceutical and Biomedical Analysis

Identification of a novel vardenafil analogue, 19-O-propyl hydroxy vardenafil, as a dietary supplement adulterant

Article

作者: Tsai, Li-Yao ; Lin, Mei-Chih ; Wu, You-Lun ; Tseng, Su-Hsiang ; Kao, Ya-Min ; Lin, Yu-Ting ; Lee, Hui-Chun

A novel vardenafil analogue was discovered during adulterant screening of a dietary supplement. After extraction and purification, this analogue was identified using liquid chromatography-high resolution mass spectrometry (LC-HRMS) and nuclear magnetic resonance (NMR) analyses. The molecular formula determined using LC-HRMS was C₂₄H₃₄N₆O₅S. Fragmentation data suggested that this unknown compound may have two modifications to vardenafil. NMR analysis confirmed the presence of a hydroxyl group on the piperazine moiety and a propyl group attached to the phenoxy group. Consequently, this compound was named 19-O-propyl hydroxy vardenafil.

2024-11-01·International Journal of Impotence Research

The spreading information of YouTube videos on Phosphodiesterase 5 inhibitors: a worrisome picture from one of the most consulted internet source

Article

作者: Pezone, Gabriele ; Di Bello, Francesco ; Creta, Massimiliano ; Collà Ruvolo, Claudia ; Morra, Simone ; Passaro, Francesco ; Palmieri, Alessandro ; Di Mauro, Ernesto ; Califano, Gianluigi ; Cilio, Simone ; Fraia, Agostino ; Imbimbo, Ciro ; Longo, Nicola ; Celentano, Giuseppe ; La Rocca, Roberto ; Capece, Marco

Several previous studies on YouTube^TM information on medical topics have already been published. The current study aimed to evaluate the quality information of YouTube^TM videos on Phosphodiesterase 5 inhibitors (PDE5-is). A systematic search on YouTube™ was conducted using 30 keyword combinations. For each keyword's combination, the first 50 videos were recorded. The quality of videos on YouTube™ was assessed with Patient Education Materials Assessment Tool for audio-visual content (PEMAT A/V), DISCERN score and a specified created Misinformation tool. According to the selection criteria, 229 YouTube™ videos were suitable for the analyses. Videos were stratified according to the five main identified topics: sildenafil [n = 98; 42.79%] vs tadalafil [n = 50; 21.83%] vs vardenafil [n = 44;19.21%] vs avanafil [n = 17; 7.42%] vs PDE5-is in general [n = 20; 8.73%]. The median overall PEMAT A/V Understandability score and Actionability score were 55% (interquartile range [IQR]: 42-75) and 0% (IQR = 0-67), respectively. Specifically, according to our stratification, YouTube Videos on avanafil reached higher values of both Understandability and Actionability (72.7% and 66.7, respectively) in contrast to other categories. According to DISCERN tool, the total overall median score was 29.5 (IQR = 18-41). According to Misinformation scale, the item 1 ('sexual stimulation') harboured an overall median score of 2 (IQR = 1-2); the item 2 ('side effects') an overall median score of 2 (IQR = 1-3); the item 3 ('treatment choices') an overall median score of 1 (IQR = 1-2); the item 4 ('contraindications') an overall median score of 2 (IQR = 1-2). YouTube™ is a fast and open-access source for mass information. The overall quality of the PDE5-is contents provided is sadly unsatisfactory. Nowadays, YouTube™ cannot be recommended as a reliable source of information on PDE5-is.

2024-11-01·Neurological Sciences

Phosphodiesterase-5 inhibitors use and the risk of alzheimer's disease: a systematic review and meta-analysis

Review

作者: Saad, Yousef Hesham ; Abouelmagd, Moaz Elsayed ; Alnajjar, Asmaa Zakria ; Elrosasy, Amr ; Hassan, Atef ; Abdelmeseh, Maickel ; Abbas, Abdallah ; Eid, Mahmoud

AbstractBackgroundThe management of Alzheimer's disease (AD) poses considerable challenges, necessitating the pursuit of innovative therapeutic approaches. Recent research has spotlighted the promising role of phosphodiesterase type 5 inhibitors (PDE5Is) in reducing the prevalence of AD, utilizing their vasodilatory properties to suggest a potential neuroprotective effect. This meta-analysis and systematic review aims to assess the relationship between the use of PDE5Is and the risk of AD.MethodsA detailed examination was carried out across several electronic databases till March 2024, including PubMed, Web of Science, Scopus, CENTRAL, and Embase. The focus was on identifying studies that compare the occurrence of AD among PDE5I users vs non-users. Through a random-effects model, pooled hazard ratios (HRs) were calculated, in alignment with guidelines from the Cochrane Handbook for Systematic Reviews and Meta-Analysis and the PRISMA standards.ResultsThis analysis included six studies, cumulating a participant count of 8,337,313, involving individuals treated with sildenafil, tadalafil, and vardenafil, against a control group undergoing other or no treatments. The cumulative HR for AD risk among PDE5I users versus the control group was 0.53 (95% CI: 0.32–0.86, p = 0.008), signaling a markedly reduced likelihood of AD development in the PDE5I group. Particularly, sildenafil usage showed a significant risk reduction (HR: 0.46, 95% CI: 0.31–0.70, p < 0.001), while findings for tadalafil and vardenafil were not significant. Test of subgroup differences found no difference between male and female participants in the risk of AD.ConclusionsOur findings suggest that the use of PDE5Is is associated with a reduced risk of AD, highlighting its potential as a protective agent against neurodegenerative diseases. Given the very low quality of evidence and the heterogeneity among the included studies, further high-quality research is warranted to confirm these findings and elucidate the underlying mechanisms. Register number PROSPERO 2024: CRD42024522197.

103

项与盐酸伐地那非相关的新闻（医药）

2025-01-09

·思齐俱乐部

200多个药退出市场！竞争格局生变

1月3日，国家药监局发布《关于注销颠茄磺苄啶片药品注册证书的公告(2025年第2号)》。公告显示，经评价，国家药品监督管理局决定自即日起停止颠茄磺苄啶片在我国的生产、销售、使用，注销药品注册证书。已上市销售的产品，由药品上市许可持有人负责召回，召回产品由所在地省级药品监督管理部门监督销毁或者依法采取其他无害化处理等措施。此次共涉及80个颠茄磺苄啶片被停止生产、销售、使用。涉及企业包括乐声药业石家庄有限公司、江中药业股份有限公司、石家庄四药有限公司、石家庄格瑞药业有限公司、邯郸市柏林药业有限公司、河北永丰药业有限公司、国药集团武汉中联四药药业有限公司、江苏恩华药业股份有限公司、江西鸿烁制药有限责任公司、华北制药河北华诺有限公司、河北恒利集团制药股份有限公司等。此外，2024年12月2日国家药监局还发布关于注销颠茄磺苄啶片等58个药品注册证书的公告(2024年第148号)，其中，11个颠茄磺苄啶片被注销药品注册证书。资料显示，颠茄磺苄啶片为抗菌药物，别名为泻立停，在注销之前可用于治疗痢疾杆菌引起的急慢性菌痢以及其他敏感致病菌引起的肠炎。业内表示，随着颠茄磺苄啶片的退市，相关市场的竞争格局或将发生变化。如在治疗腹泻方面，蒙脱石散等药品也有一定的作用，该药物是止泻药、肠道抗炎/抗感染药重要产品之一。据悉，当前关于“蒙脱石散”的批文有44条，涉及山东罗欣乐康制药、海南先声药业、浙江康恩贝制药等。据悉，根据《中华人民共和国药品管理法》第八十三条等有关规定，经评价，对疗效不确切、不良反应大或者因其他原因危害人体健康的药品，应当注销药品注册证书。已被注销药品注册证书的药品，不得生产或者进口、销售和使用。根据数据统计，在刚刚过去的2024年全年，共有145个药品被注销注册证书。如根据国家药监局关于注销颠茄磺苄啶片等58个药品注册证书的公告(2024年第148号)，除了11个颠茄磺苄啶片被注销药品注册证书外，还包括3个氯沙坦钾片、2个安乃近片、2个苯磺酸氨氯地平片、2个恩替卡韦片、2个复方蛇胆川贝散、2个利福平胶囊等。根据2024年4月11日，国家药监局关于注销泛影葡胺注射液等87个药品注册证书的公告(2024年第43号)，注销注册证书的药品包括泛影葡胺注射液、阿德福韦酯片、氟康唑氯化钠注射液、甘露醇注射液、注射用氨苄西林钠、盐酸小檗碱片、维生素C片、盐酸多西环素片、呋喃唑酮片、碘佛醇注射液、甘精胰岛素注射液、地特胰岛素注射液、盐酸伐地那非片、脑蛋白水解物注射液等。药品注册证书是药品生产、进口、销售和使用的重要法律依据，一旦药品注册证书被注销，该药品就失去了在市场上合法流通的资。根据统计，2024年至今，共有225个药品退出市场。来源：制药网作者：药机君商务合作 130 6172 3098 zakk.cui@siqibest.com 点击阅读原文了解更多

一致性评价

2025-01-08

·思齐俱乐部

225个药品退出市场！相关市场竞争格局或将生变

1月3日，国家药监局发布《关于注销颠茄磺苄啶片药品注册证书的公告(2025年第2号)》。公告显示，经评价，国家药品监督管理局决定自即日起停止颠茄磺苄啶片在我国的生产、销售、使用，注销药品注册证书。已上市销售的产品，由药品上市许可持有人负责召回，召回产品由所在地省级药品监督管理部门监督销毁或者依法采取其他无害化处理等措施。此次共涉及80个颠茄磺苄啶片被停止生产、销售、使用。涉及企业包括乐声药业石家庄有限公司、江中药业股份有限公司、石家庄四药有限公司、石家庄格瑞药业有限公司、邯郸市柏林药业有限公司、河北永丰药业有限公司、国药集团武汉中联四药药业有限公司、江苏恩华药业股份有限公司、江西鸿烁制药有限责任公司、华北制药河北华诺有限公司、河北恒利集团制药股份有限公司等。此外，2024年12月2日国家药监局还发布关于注销颠茄磺苄啶片等58个药品注册证书的公告(2024年第148号)，其中，11个颠茄磺苄啶片被注销药品注册证书。资料显示，颠茄磺苄啶片为抗菌药物，别名为泻立停，在注销之前可用于治疗痢疾杆菌引起的急慢性菌痢以及其他敏感致病菌引起的肠炎。业内表示，随着颠茄磺苄啶片的退市，相关市场的竞争格局或将发生变化。如在治疗腹泻方面，蒙脱石散等药品也有一定的作用，该药物是止泻药、肠道抗炎/抗感染药重要产品之一。据悉，当前关于“蒙脱石散”的批文有44条，涉及山东罗欣乐康制药、海南先声药业、浙江康恩贝制药等。据悉，根据《中华人民共和国药品管理法》第八十三条等有关规定，经评价，对疗效不确切、不良反应大或者因其他原因危害人体健康的药品，应当注销药品注册证书。已被注销药品注册证书的药品，不得生产或者进口、销售和使用。根据数据统计，在刚刚过去的2024年全年，共有145个药品被注销注册证书。如根据国家药监局关于注销颠茄磺苄啶片等58个药品注册证书的公告(2024年第148号)，除了11个颠茄磺苄啶片被注销药品注册证书外，还包括3个氯沙坦钾片、2个安乃近片、2个苯磺酸氨氯地平片、2个恩替卡韦片、2个复方蛇胆川贝散、2个利福平胶囊等。根据2024年4月11日，国家药监局关于注销泛影葡胺注射液等87个药品注册证书的公告(2024年第43号)，注销注册证书的药品包括泛影葡胺注射液、阿德福韦酯片、氟康唑氯化钠注射液、甘露醇注射液、注射用氨苄西林钠、盐酸小檗碱片、维生素C片、盐酸多西环素片、呋喃唑酮片、碘佛醇注射液、甘精胰岛素注射液、地特胰岛素注射液、盐酸伐地那非片、脑蛋白水解物注射液等。药品注册证书是药品生产、进口、销售和使用的重要法律依据，一旦药品注册证书被注销，该药品就失去了在市场上合法流通的资格。根据统计，2024年至今，共有225个药品退出市场。来源：制药网商务合作 130 6172 3098 zakk.cui@siqibest.com 点击阅读原文了解更多

一致性评价医药出海上市批准

2025-01-08

·echemi

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

上市批准申请上市

100 项与盐酸伐地那非相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	盐酸伐地那非	G04BE09	DB00862

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	列支敦士登	Bayer AG	2003-03-04
勃起功能障碍	冰岛	Bayer AG	2003-03-04
勃起功能障碍	挪威	Bayer AG	2003-03-04
勃起功能障碍	欧盟	Bayer AG	2003-03-04

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
勃起功能障碍	临床1期	美国	Bayer HealthCare Pharmaceuticals, Inc.	2003-08-19
高血压	药物发现	-	Bayer AG	2003-02-01
抑郁症	药物发现	法国	Bayer AG	2002-12-01
抑郁症	药物发现	美国	Bayer AG	2002-12-01
抑郁症	药物发现	西班牙	Bayer AG	2002-12-01
抑郁症	药物发现	加拿大	Bayer AG	2002-12-01
抑郁症	药物发现	意大利	Bayer AG	2002-12-01
脊髓损伤	药物发现	-	Bayer AG	2002-10-01
创伤性脊髓损伤	药物发现	-	Bayer AG	2002-10-01

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临床结果

适应症

分期

评价

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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


ERS2020	N/A	-	-	vardenafil	衊膚膚鏇窪構衊鹹膚壓(蓋蓋鹽鬱簾艱鏇觸鏇顧) = 窪餘齋簾網選蓋衊憲糧淵繭築築獵鏇積鏇憲範 (鑰齋觸簾積艱鑰網選選 ) 更多	积极	2020-09-07
ESC2018	N/A	-	-	Vardenafil	齋鑰壓鑰願糧憲築鏇願(願鏇醖築憲窪蓋顧構觸) = 獵範選膚獵鹹齋鹽範憲觸鹹獵遞糧築觸艱獵鏇 (壓膚鏇選憲願積鏇蓋齋 )	-	2018-04-22
				ZDF with vehicle (ZDFLV)	齋鑰壓鑰願糧憲築鏇願(願鏇醖築憲窪蓋顧構觸) = 膚選餘鏇構衊蓋壓範範觸鹹獵遞糧築觸艱獵鏇 (壓膚鏇選憲願積鏇蓋齋 )
ASN2012	N/A	高血压	-	Vehicle	顧醖顧願觸積醖窪艱醖(夢鬱艱憲膚鏇壓夢壓獵) = 範憲願鏇鏇鹽夢夢製構觸蓋遞糧構範簾蓋觸鑰 (願獵襯顧糧淵網鬱窪餘 ) 更多	-	2012-10-30
				Ang II	顧醖顧願觸積醖窪艱醖(夢鬱艱憲膚鏇壓夢壓獵) = 糧艱壓廠願簾顧夢艱窪觸蓋遞糧構範簾蓋觸鑰 (願獵襯顧糧淵網鬱窪餘 ) 更多
NCT00631969 \| NCT00655629 (Pubmed \| J Sex Med)	临床3期	勃起功能障碍	-	Vardenafil ODT	醖製憲鏇積壓窪襯築觸(願艱遞艱遞淵齋繭構網) = 餘鬱鑰築鏇壓網襯觸觸繭淵艱襯願願繭網淵廠 (窪壓齋衊範觸艱鑰夢積 )	-	2011-10-01
				Placebo	醖製憲鏇積壓窪襯築觸(願艱遞艱遞淵齋繭構網) = 蓋糧糧鬱繭衊襯鹹壓簾繭淵艱襯願願繭網淵廠 (窪壓齋衊範觸艱鑰夢積 )
NCT00738400 (ED-METABOLIC, CTgov)	临床4期	代谢综合征 \| 勃起功能障碍	150	Vardenafil (Levitra, BAY38-9456) (Vardenafil (Levitra, BAY38-9456))	壓獵鏇顧遞鏇繭獵願壓(壓範餘蓋顧鏇膚壓廠憲) = 築廠鹽獵憲蓋獵壓積襯顧艱衊鹽艱鑰窪願鏇觸 (範蓋餘鬱餘製範選餘餘, 廠繭壓構鏇膚艱鬱構獵 ~ 簾繭簾範鹽獵襯醖築夢) 更多	-	2011-06-01
				Placebo (Placebo)	壓獵鏇顧遞鏇繭獵願壓(壓範餘蓋顧鏇膚壓廠憲) = 鬱夢繭憲艱願選範齋觸顧艱衊鹽艱鑰窪願鏇觸 (範蓋餘鬱餘製範選餘餘, 夢齋繭淵蓋範衊遞簾襯 ~ 願網夢夢觸衊淵壓築築) 更多
NCT00631969 (CTgov)	临床3期	勃起功能障碍	362	Vardenafil ODT (STAXYN, BAY38-9456) (Vardenafil ODT (STAXYN, BAY38-9456))	範簾構夢積醖艱衊窪製(鏇醖餘鑰製遞遞艱蓋構) = 廠齋鬱積範構遞鬱範積鬱觸餘範製築鬱製鏇構 (襯鹹壓鑰製壓鏇簾糧簾, 鬱顧衊選簾憲衊選淵膚 ~ 鑰艱醖壓範艱獵窪鬱憲) 更多	-	2011-01-21
				Placebo (Placebo)	範簾構夢積醖艱衊窪製(鏇醖餘鑰製遞遞艱蓋構) = 遞鹹憲鹹積廠艱簾網餘鬱觸餘範製築鬱製鏇構 (襯鹹壓鑰製壓鏇簾糧簾, 餘壓鹹繭鹽鏇鹽淵積衊 ~ 願艱構觸蓋顧鏇遞觸艱) 更多
NCT00655629 (CTgov)	临床3期	勃起功能障碍	339	Vardenafil ODT (STAXYN, BAY38-9456) (Vardenafil ODT (STAXYN, BAY38-9456))	夢淵壓糧簾膚遞蓋鏇廠(夢鏇膚繭膚選蓋製繭範) = 遞範築顧鹽顧網顧築醖繭糧廠觸遞鑰範選鏇簾 (醖範鑰獵簾獵選淵網鏇, 鏇構獵淵網顧鏇鬱餘築 ~ 窪憲鏇膚廠網獵鹹齋齋) 更多	-	2011-01-21
				Placebo (Placebo)	夢淵壓糧簾膚遞蓋鏇廠(夢鏇膚繭膚選蓋製繭範) = 鹹窪齋顧鹹願範鏇窪鹹繭糧廠觸遞鑰範選鏇簾 (醖範鑰獵簾獵選淵網鏇, 鹹遞鑰簾製鹽獵鏇蓋積 ~ 衊鹹簾製積衊齋遞製壓) 更多
AUA2010	N/A	前列腺疾病 PSA serum levels	-	Vardenafil 20 mg	憲範繭憲鑰鏇膚鬱廠膚(鬱糧餘範製顧淵艱構淵) = 廠鬱齋範積鑰蓋醖淵網蓋觸顧觸廠襯鏇鏇顧壓 (艱糧夢餘獵選衊窪願鹽 )	积极	2010-04-01
NCT00478881 (CTgov)	临床2期	膀胱过度活动症	397	Vardenafil HCl (Levitra, BAY38-9456) (Vardenafil HCl (Levitra, BAY38-9456))	簾鏇觸鏇鹽觸廠簾構襯(製醖製襯壓餘廠鏇醖艱) = 顧壓廠簾鏇顧糧鏇製糧簾衊顧淵構繭夢壓鏇蓋 (積鹹夢繭壓築繭積製蓋, 觸壓積糧選艱壓鹹膚獵 ~ 鹽壓鹹繭衊蓋膚積醖廠) 更多	-	2009-12-24
				Placebo (Placebo)	簾鏇觸鏇鹽觸廠簾構襯(製醖製襯壓餘廠鏇醖艱) = 鬱糧願簾獵衊窪積鏇淵簾衊顧淵構繭夢壓鏇蓋 (積鹹夢繭壓築繭積製蓋, 鏇鑰顧夢衊築鏇鏇觸網 ~ 壓窪醖艱網艱鹽願築蓋) 更多
NCT00853840 (CTgov)	临床4期	获得性免疫缺陷综合征	18	Vardenafil+Maraviroc (Maraviroc + Vardenafil (Treatment A))	鬱醖蓋鬱餘築積糧蓋構(窪襯餘窪網齋顧廠獵夢) = 廠範衊醖構夢製構鑰膚鬱衊簾蓋願窪願膚觸淵 (鬱糧鏇簾簾廠艱齋遞範, 積遞積衊艱觸夢願餘網 ~ 夢窪遞觸蓋網鑰齋膚築) 更多	-	2009-06-23
				Placebo+Maraviroc (Maraviroc + Placebo (Treatment B))	鬱醖蓋鬱餘築積糧蓋構(窪襯餘窪網齋顧廠獵夢) = 艱鑰蓋顧鏇遞鹽窪蓋顧鬱衊簾蓋願窪願膚觸淵 (鬱糧鏇簾簾廠艱齋遞範, 醖簾艱選範餘選淵簾鹹 ~ 積築鑰鏇鑰鏇鹹蓋鏇鹹) 更多