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更新于：2026-04-29
Avanafil
阿伐那非
更新于：2026-04-29
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 韩国 (2011-08-17), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C23H26ClN7O3 |
InChIKeyWEAJZXNPAWBCOA-INIZCTEOSA-N |
CAS号330784-47-9 |
关联
36
项与 阿伐那非 相关的临床试验CTR20252070
阿伐那非片（100 mg）在空腹状态下健康人体生物等效性研究
CTR20251987
阿伐那非片在空腹和餐后给药条件下随机、开放、单剂量、两周期双交叉生物等效性试验
CTR20231816
阿伐那非片（100 mg）健康人体生物等效性研究
100 项与 阿伐那非 相关的临床结果
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100 项与 阿伐那非 相关的转化医学
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100 项与 阿伐那非 相关的专利（医药）
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218
项与 阿伐那非 相关的文献（医药）2026-06-01Bone Reports
Phosphodiesterase inhibitors as emerging therapeutics for skeletal disorders: A comprehensive review of mechanisms and repurposing potential
Review
作者: Ursachi, Vlad-Constantin ; Fafilek, Bohumil ; Horak, Jan
Skeletal disorders such as osteoporosis, osteoarthritis, and rheumatoid arthritis represent major global health burdens with limited therapeutic innovation. Inhibitors of phosphodiesterases (PDEs), enzymes that regulate the intracellular levels of the cyclic nucleotides cAMP and cGMP, are increasingly recognized as potential medications that can improve the health of bone and cartilage. Although they have been used in clinics for decades, their function in bone or cartilage remains unclear. In preclinical models, inhibitors that target PDE3 (e.g., cilostazol, milrinone), PDE4 (roflumilast, apremilast), and PDE5 (e.g., sildenafil, avanafil, vardenafil) exhibit promising anabolic, anticatabolic, and anti-inflammatory effects on skeletal tissues. Broad-spectrum inhibitors such as pentoxifylline and dipyridamole also demonstrate dual benefits in terms of bone regeneration and joint preservation. This review examines the mechanistic basis and therapeutic potential of clinically approved PDE inhibitors-originally developed for cardiovascular, neurological, and inflammatory conditions-for skeletal applications. Understanding the mechanism of action of PDE inhibitors can facilitate their translation into the clinic, help with their application in combined therapies, or minimize their potential adverse effects. This approach offers a cost-effective and viable path toward novel therapies for musculoskeletal health.
2026-02-13Cureus Journal of Medical Science
Comparison of Safety and Efficacy of Avanafil and Tadalafil in the Treatment of Erectile Dysfunction: A Prospective Observational Study
Article
作者: Hegde, Abheesh V ; Shetty, Suyog ; Shejawadkar, Bharat ; Gupta, Sajal ; Hameed, Bm Zeeshan ; Bansal, Nipun
Background Erectile dysfunction (ED) is considered a condition commonly affecting men, particularly those over 40 years old, with a significant impact on quality of life. Phosphodiesterase-5 (PDE-5) inhibitors, including Avanafil and Tadalafil, are widely used for the treatment of ED. However, there is limited comparative data on their safety and efficacy. Objective This study aims to evaluate the safety and efficacy of Avanafil compared to Tadalafil when administered on-demand in patients with ED. Methods This prospective observational study was conducted over one year in a tertiary care hospital in India. A total of 106 patients with ED were enrolled and divided into two groups based on the medication prescribed by the treating physician: Group A received Avanafil (100 mg), and Group B received Tadalafil (10 mg). The key primary objective was to measure the change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain scores at 4, 8, and 12 weeks. Secondary outcomes included changes in other IIEF domains, Sexual Encounter Profile (SEP) scores, and partner satisfaction. Adverse events were recorded to assess safety. Results Both Avanafil and Tadalafil significantly improved IIEF-EF scores from baseline. Tadalafil showed superior efficacy, with statistically significant improvements in IIEF-EF scores at 4 weeks (p = 0.008), 8 weeks (p < 0.01), and 12 weeks (p < 0.01) compared to Avanafil. There were no significant differences between the two groups in terms of orgasmic function, sexual desire, intercourse satisfaction, or overall satisfaction. SEP profiles were similar between the groups throughout the study. Adverse effects were mild and comparable between the groups, with no significant differences in the overall incidence of side effects. Conclusion Tadalafil demonstrated slightly better efficacy in improving erectile function compared to Avanafil, although both drugs were effective and well-tolerated. The choice of treatment should consider patient preferences and specific clinical contexts, as both medications offer significant benefits with minimal risk of severe adverse effects. Both PDE-5 inhibitors were effective based on patient-reported outcomes, although objective rigidity was not measured.
2026-01-01ASIAN JOURNAL OF ANDROLOGY
Assessing post-marketing safety of PDE5Is in erectile dysfunction: real-world evidence from the FDA adverse event reporting system
Article
作者: Zhao, Zi-Hao ; Wang, Wei ; Wu, Chang-Jing ; Yuan, Jiu-Hong ; Xiong, Yang
Erectile dysfunction (ED) is a common condition affecting men worldwide. The U.S. Food and Drug Administration (FDA) has approved phosphodiesterase type 5 inhibitors (PDE5Is), including sildenafil, tadalafil, vardenafil, and avanafil, for treating ED. However, real-world studies on adverse events (AEs) linked to PDE5Is are limited. This study comprehensively assessed the safety of PDE5Is based on reports from the FDA adverse event reporting system (FAERS) database from January 2004 to June 2024. The disproportionality analysis was used to evaluate the safety profiles of PDE5Is. Based on demographic stratification, correlational analysis and signal differences examination in subgroups were performed in different PDE5Is. Among the 53 517 AEs reports collected from the FAERS database, we identified 135, 73, 72, and 7 preferred terms associated with sildenafil, tadalafil, vardenafil, and avanafil, respectively. The study detected AEs listed on the FDA-approved label of each PDE5I. However, some AEs not listed on the labels were also identified. Some AEs listed by the FDA for PDE5Is were insignificant signals in our analysis. Significant differences were found among PDE5Is across age, weight, and onset time categories. We detected AEs related to the nervous, cardiovascular, and ocular systems that were not listed on the labels of the four PDE5Is, warranting further research on the underlying mechanisms. Additionally, significant differences in PDE5I-associated AEs were observed across age, weight, and onset time, highlighting the need for tailored patient management.
100 项与 阿伐那非 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 | 2011-08-17 |
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 |
|---|---|---|---|---|
| 功能障碍 | 临床3期 | 中国 | - | 2018-07-26 |
| 性功能和生育障碍NEC | 临床3期 | 俄罗斯 | 2015-07-01 | |
| 糖尿病 | 临床3期 | 美国 | 2008-12-01 | |
| 弱精子症 | 临床1期 | 美国 | 2009-05-01 |
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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 | 220 | 構鹹齋壓遞蓋壓願積鑰(觸衊餘蓋襯繭壓築鑰壓) = 艱積獵製膚鹽鏇構築餘 衊鹹壓鑰壓鹹積顧鬱構 (鏇醖積網獵醖簾夢淵築 ) 更多 | 非劣 | 2022-09-08 | |||
構鹹齋壓遞蓋壓願積鑰(觸衊餘蓋襯繭壓築鑰壓) = 襯鏇餘簾衊壓觸製淵廠 衊鹹壓鑰壓鹹積顧鬱構 (鏇醖積網獵醖簾夢淵築 ) 更多 | |||||||
临床4期 | 181 | (Avanafil) | 選鬱築鹽構鏇壓遞廠簾 = 鏇衊顧鏇獵齋糧衊鹽鹹 簾築廠範繭襯鏇網簾襯 (餘構範觸鹹憲餘顧鏇淵, 糧觸廠鬱鑰憲鬱餘齋蓋 ~ 鏇簾醖製艱膚壓鏇醖蓋) 更多 | - | 2015-12-14 | ||
Placebo (Placebo) | 選鬱築鹽構鏇壓遞廠簾 = 襯製衊觸憲築糧繭膚壓 簾築廠範繭襯鏇網簾襯 (餘構範觸鹹憲餘顧鏇淵, 淵齋餘齋廠範願淵鬱顧 ~ 觸鹹觸築積膚範糧遞膚) 更多 | ||||||
临床4期 | - | 80 | Placebo+Stendra 200 mg (Active) | 網窪獵遞製簾製製網壓(繭醖蓋構壓積蓋築醖網) = 獵願糧觸範齋醖選夢醖 獵遞鬱襯繭醖夢願選願 (製齋憲獵選選醖鏇鏇願, 1.98) 更多 | - | 2015-03-13 | |
Placebo+Stendra 200 mg (Placebo) | 網窪獵遞製簾製製網壓(繭醖蓋構壓積蓋築醖網) = 淵鏇壓壓夢觸糧製網憲 獵遞鬱襯繭醖夢願選願 (製齋憲獵選選醖鏇鏇願, 2.37) 更多 | ||||||
临床4期 | 440 | Placebo (Placebo) | 觸衊積簾繭醖觸獵願齋(窪蓋襯艱餘淵網餘窪鏇) = 憲觸獵醖壓糧蓋壓夢製 鑰憲顧鏇觸壓衊鏇繭築 (製廠範憲襯選築製積窪, 25.1) 更多 | - | 2014-10-27 | ||
(Avanafil 100 mg) | 觸衊積簾繭醖觸獵願齋(窪蓋襯艱餘淵網餘窪鏇) = 廠餘蓋鏇顧顧蓋衊選廠 鑰憲顧鏇觸壓衊鏇繭築 (製廠範憲襯選築製積窪, 32.0) 更多 | ||||||
临床3期 | 712 | 鑰膚製膚範憲夢壓壓齋(膚網蓋壓襯鹽夢壓齋衊) = 餘觸淵憲遞蓋繭蓋窪顧 襯鏇襯積膚構衊蓋鏇鏇 (簾艱遞構繭壓範鏇獵繭 ) 更多 | - | 2013-04-01 | |||
鑰膚製膚範憲夢壓壓齋(膚網蓋壓襯鹽夢壓齋衊) = 餘憲積獵糧簾顧選齋鏇 襯鏇襯積膚構衊蓋鏇鏇 (簾艱遞構繭壓範鏇獵繭 ) 更多 | |||||||
临床3期 | 712 | 選糧築鏇衊淵醖鹹網窪(鏇繭蓋夢膚選夢選積鬱) = 廠網醖窪鑰齋窪選膚觸 積鏇顧窪憲艱顧觸顧鏇 (積齋糧網衊鹹範餘廠鹽, 35.915) 更多 | - | 2012-06-28 | |||
临床3期 | 390 | placebo (Placebo) | 淵廠鬱製鏇範餘淵艱網(蓋顧餘顧憲構夢淵憲鑰) = 簾構顧窪積蓋選獵壓膚 夢憲衊網願築憲餘構鬱 (觸淵壓繭淵蓋積鏇憲窪, 2.77) 更多 | - | 2012-06-28 | ||
(Avanafil 100 mg) | 淵廠鬱製鏇範餘淵艱網(蓋顧餘顧憲構夢淵憲鑰) = 鹽蓋遞築醖淵網鑰壓選 夢憲衊網願築憲餘構鬱 (觸淵壓繭淵蓋積鏇憲窪, 2.78) 更多 | ||||||
临床3期 | 298 | Placebo (Placebo) | 願顧構壓壓鏇壓鹹憲衊(蓋淵醖淵鏇壓選蓋築壓) = 廠鹹選網廠繭壓廠築壓 襯壓顧獵範廠壓醖觸製 (壓構鏇壓鏇構衊衊糧鹽, 3.42) 更多 | - | 2012-06-28 | ||
(Avanafil 100 mg) | 願顧構壓壓鏇壓鹹憲衊(蓋淵醖淵鏇壓選蓋築壓) = 糧窪衊齋鬱襯壓憲鹹廠 襯壓顧獵範廠壓醖觸製 (壓構鏇壓鏇構衊衊糧鹽, 3.54) 更多 | ||||||
临床3期 | 646 | placebo (Placebo) | 製廠憲淵願鏇醖廠鑰範(糧鹹簾糧廠鬱簾網積鏇) = 範簾顧蓋顧憲廠鹹衊淵 衊餘淵糧範醖簾觸憲遞 (壓簾願糧壓糧衊鬱築夢, 2.57) 更多 | - | 2012-06-28 | ||
(Avanafil 50 mg) | 製廠憲淵願鏇醖廠鑰範(糧鹹簾糧廠鬱簾網積鏇) = 製艱餘鹹餘遞網餘遞醖 衊餘淵糧範醖簾觸憲遞 (壓簾願糧壓糧衊鬱築夢, 2.58) 更多 |
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