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更新于：2025-02-19
Tadalafil
他达拉非
更新于：2025-02-19
概要
基本信息
简介他达拉非（Tadalafil）是一种磷酸二酯酶5型（PDE5）抑制剂药物，商标名为“Cialis”，与西地那非（Viagra）和伐地那非（Levitra）同属一类药物。他达拉非于2003年11月21日首次获得FDA批准用于治疗勃起功能障碍（ED）。它由ICOS Corporation制药公司开发，由Eli Lilly and Company销售。除了获得勃起功能障碍的批准外，他达拉非还获得了FDA批准用于治疗良性前列腺增生症（BPH）和肺动脉高压（PAH）。 |
药物类型 小分子化药 |
别名 Tadalafil (JAN/USP/INN)、他达那非、GF-196960 + [29] |
靶点 |
作用机制 PDE5A抑制剂(磷酸二酯酶-5A抑制剂) |
最高研发阶段批准上市 |
首次获批日期 澳大利亚 (2002-10-23), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构/序列
分子式C22H19N3O4 |
InChIKeyWOXKDUGGOYFFRN-IIBYNOLFSA-N |
CAS号171596-29-5 |
关联
503
项与 他达拉非 相关的临床试验NCT04762082
A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
NCT06805513
Actual Use Trial to Switch Tadalafil 5 mg Tablets From Prescription to Over-the-Counter
IRCT20241027063519N1
Comparison of the effect of different doses of tadalafil on urinary symptoms and urodynamic findings in Benign Prostatic Hyperplasia patients
100 项与 他达拉非 相关的临床结果
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100 项与 他达拉非 相关的转化医学
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100 项与 他达拉非 相关的专利（医药）
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3,705
项与 他达拉非 相关的文献（医药）2025-03-01AMERICAN JOURNAL OF MEDICINE
Benefits of Tadalafil and Sildenafil on Mortality, Cardiovascular Disease, and Dementia
Article
作者: Paul, Krishna K. ; Uddin, Hamza ; Michler, Obadiah D ; Gaalema, Diann ; Paul, Krishna K ; Sunesra, Raheed ; Hayek, Salim ; Jneid, Hani ; Blackwell, Thomas A. ; Joglar, Alejandro A. ; Jehle, Dietrich von Kuenssberg ; Blackwell, Thomas A ; Joglar, Alejandro A ; Michler, Obadiah D.
BACKGROUND:
Erectile dysfunction and lower urinary tract symptoms, from benign prostatic hyperplasia and bladder neck obstructions, are prevalent in men and associated with an increased risk of cardiovascular diseases. Phosphodiesterase-5 (PDE-5) inhibitors, such as tadalafil and sildenafil, are used to treat erectile dysfunction and may also offer cardiovascular benefits due to their vasodilatory effects. This study evaluates the impact of these PDE-5 inhibitors on all-cause mortality, cardiovascular disease, and dementia in middle-aged men with erectile dysfunction and lower urinary tract symptoms over a 3 year follow-up period.
METHODS:
This longitudinal study analyzed data from 50 million US men using the TriNetX database. Men at least 40 years of age prescribed tadalafil or sildenafil after an erectile dysfunction diagnosis, or tadalafil after lower urinary tract symptom diagnoses, from 2004 to 2021 were included. Three-year outcomes assessed included all-cause mortality, cardiovascular disease, and dementia, comparing men on PDE-5 inhibitors to those not on these medications. Propensity matching was performed for demographics and eight pre-existing conditions.
RESULTS:
The final cohort included 509,788 men with erectile dysfunction and 1,075,908 with lower urinary tract symptoms. Tadalafil and sildenafil were associated with significantly reduced risks of all-cause mortality (RR 0.66/0.76), myocardial infarction (0.73/0.83), stroke (0.66/0.78), venous thromboembolism (0.79/0.80), and dementia (0.68/0.75) in erectile dysfunction patients, with tadalafil showing more significant benefits. In lower urinary tract symptom patients, tadalafil was similarly associated with reduced mortality, cardiovascular disease, and dementia.
CONCLUSIONS:
In conclusion, tadalafil and sildenafil use in erectile dysfunction patients reduced mortality, cardiovascular disease, and dementia risks, with tadalafil providing more benefits. Tadalafil also conferred similar benefits to patients with lower urinary tract symptoms.
2025-02-10The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians4区 · 医学
Assessment of the value of measuring soluble fms-like tyrosine kinase-1 and placental growth factor levels following administration of tadalafil to treat fetal growth restriction
4区 · 医学
Article
作者: Takakura, Sho ; Tanaka, Hiroaki ; Koide, Keiko ; Ikeda, Tomoaki ; Katsuragi, Shinji ; Nakamura, Masamitsu ; Maki, Shintaro ; Sekizawa, Akihiko ; Enomoto, Naosuke ; Tanaka, Kayo
PURPOSE:
The aim of this study was to measure the blood levels of soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF) before and after tadalafil treatment in patients with fetal growth restriction.
MATERIALS AND METHODS:
Maternal blood was collected from 13 women before and 2 weeks after tadalafil administration in the TADAFER II trial. The tadalafil treatment was conducted in addition to the conventional FGR treatment. As a control, maternal blood was also collected from 11 women before and 2 weeks after conventional treatment for fetal growth restriction. Blood sFlt-1 and PlGF were measured and the sFlt-1/PlGF ratio was calculated. Student's t-test was used to statistically analyze differences in the sFlt-1 and PlGF levels, and in the sFlt-1/PlGF ratios.
RESULTS:
In both treatment groups, the levels of sFlt-1 and PlGF before and after treatment were not significantly different from each other. The sFlt-1/PlGF ratio was 2.0 ± 1.0 before and 17.6 ± 11.3 after treatment in the control group (p=.04). The sFlt-1/PlGF ratio was 2.2 ± 1.1 before and 22.2 ± 10.6 after tadalafil treatment in the tadalafil group (p=.06). The sFlt-1/PlGF ratios before and after tadalafil treatment were significantly increased in the control group. In both treatment groups, the sFlt-1/PlGF ratios before and after treatment were less than 38.
CONCLUSIONS:
We conclude that the levels of sFlt-1 and PlGF were not significantly different as a result of tadalafil treatment. Further studies are needed to understand the mechanism of action of tadalafil in the treatment of fetal growth restriction.
2025-02-01RESPIRATORY MEDICINE
The minimally important difference in the six-minute walk test predicts clinical worsening in pulmonary arterial hypertension
Article
作者: Rao, Youlan ; Tharwani, Arsal ; Heresi, Gustavo A ; Minai, Omar ; Kim, Hyoshin
BACKGROUND:
The minimally important difference (MID) in the 6-min walk test (6MWT) for pulmonary arterial hypertension (PAH) is estimated to be 33 m using distributional and anchor-based methods. Quality of life was used as the anchor. Here, we sought to determine whether the MID is predictive of clinical worsening.
METHODS:
This was a post hoc analysis of the pivotal clinical trial of tadalafil in PAH (n = 405) and its extension phase (n = 161). The 6MWT was determined at the end of the placebo-controlled phase of 16 weeks and dichotomized as < 33 or ≥33 m. Primary outcome was clinical worsening ascertained at 16 weeks and at 68 weeks of follow up. Cox proportional hazard analysis was used to determine the association between 6MWT and clinical worsening.
RESULTS:
Mean age for patients in the pivotal trial of tadalafil was 54 years old ( ± 15.5 yrs). There were 317 (78.3 %) female patients and 61 % with idiopathic PAH. 53 % of the patients were on background bosentan therapy. A 6MWT <33 m was associated with an increased risk of clinical worsening at 16 and 68 weeks. These results were unchanged after adjusting for age, sex, background therapy with bosentan, and tadalafil dose. There were no PAH hospitalizations during short-term and long-term follow up in patients achieving a 6MWT ≥33 m CONCLUSIONS: The 6MWT MID of 33 m is predictive of short- and long-term clinical worsening. These results further validate 33 m as a relevant MID for the 6MWT.
100 项与 他达拉非 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 |
|---|---|---|---|
| 前列腺增生症 | 美国 | 2011-10-06 | |
| 家族性肺动脉高压 | 欧盟 | 2008-10-01 | |
| 家族性肺动脉高压 | 冰岛 | 2008-10-01 | |
| 家族性肺动脉高压 | 列支敦士登 | 2008-10-01 | |
| 家族性肺动脉高压 | 挪威 | 2008-10-01 | |
| 肺动脉高压 | 欧盟 | 2008-10-01 | |
| 肺动脉高压 | 冰岛 | 2008-10-01 | |
| 肺动脉高压 | 列支敦士登 | 2008-10-01 | |
| 肺动脉高压 | 挪威 | 2008-10-01 | |
| 勃起功能障碍 | 澳大利亚 | 2002-10-23 |
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 |
|---|---|---|---|---|
| 杜氏肌营养不良症 | 临床3期 | 美国 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 日本 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 阿根廷 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 比利时 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 加拿大 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 法国 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 德国 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 意大利 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 荷兰 | 2013-09-01 | |
| 杜氏肌营养不良症 | 临床3期 | 波多黎各 | 2013-09-01 |
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临床结果
临床结果
适应症
分期
评价
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FDA_CDER 人工标引  | N/A | 606 | Placebo | 願網網遞築蓋網醖廠壓(構範獵觸蓋壓顧憲構範) = 鑰糧繭獵餘鑰醖淵壓鹽 選網淵鹹選願廠廠獵夢 (繭選鏇獵壓襯夢鹹蓋淵 ) 更多 | 积极 | 2024-06-28 | |
Tadalafil 5 mg | 願網網遞築蓋網醖廠壓(構範獵觸蓋壓顧憲構範) = 顧襯鬱獵構糧糧壓衊齋 選網淵鹹選願廠廠獵夢 (繭選鏇獵壓襯夢鹹蓋淵 ) 更多 | ||||||
FDA_CDER 人工标引 | N/A | - | Placebo (Study J) | 製鏇構獵簾襯艱遞選網(齋構鏇膚鏇繭範壓獵鑰) = 鑰積觸簾襯衊構夢鑰築 淵遞鑰選繭獵蓋範齋網 (鹽餘繭艱醖鹹鬱鑰鹹襯 ) | 积极 | 2024-06-28 | |
Tadalafil 5 mg (Study J) | 製鏇構獵簾襯艱遞選網(齋構鏇膚鏇繭範壓獵鑰) = 襯齋鏇鹽製夢襯鹹觸鏇 淵遞鑰選繭獵蓋範齋網 (鹽餘繭艱醖鹹鬱鑰鹹襯 ) | ||||||
FDA_CDER 人工标引 | N/A | 1,112 | Placebo (Outside the US) | 願糧廠築醖鏇餘醖廠築(艱襯網夢夢艱衊選築鹹) = 鹹衊鑰夢糧網窪餘築艱 衊糧壓襯鬱構鑰顧窪製 (鹹壓廠壓膚構範鬱獵廠, 0.7) 更多 | 积极 | 2024-06-28 | |
Tadalafil 5 mg (Outside the US) | 願糧廠築醖鏇餘醖廠築(艱襯網夢夢艱衊選築鹹) = 鑰簾憲襯築製淵獵觸襯 衊糧壓襯鬱構鑰顧窪製 (鹹壓廠壓膚構範鬱獵廠, 4.0) 更多 | ||||||
FDA_CDER 人工标引 | N/A | 696 | 範醖獵繭廠鏇醖獵願構(選積鹹製獵觸夢壓獵衊) = 網製夢艱鹽獵鹹顧膚糧 餘蓋壓餘繭繭鏇鏇範鹹 (艱鑰積鹹鹽憲範廠願顧 ) 更多 | 积极 | 2024-06-28 | ||
範醖獵繭廠鏇醖獵願構(選積鹹製獵觸夢壓獵衊) = 膚鹹醖願構齋衊鬱憲蓋 餘蓋壓餘繭繭鏇鏇範鹹 (艱鑰積鹹鹽憲範廠願顧 ) 更多 | |||||||
FDA_CDER 人工标引 | N/A | 402 | Placebo (Study A + US Trials) | 糧鹹淵窪襯蓋積簾餘廠(憲糧廠鹽繭積顧蓋衊繭) = 鑰齋夢醖膚蓋鑰鬱顧選 憲築願憲衊積蓋窪網築 (簾壓衊艱淵獵糧獵鏇襯 ) 更多 | 积极 | 2024-06-28 | |
Tadalafil 20 mg (Study A + US Trials) | 糧鹹淵窪襯蓋積簾餘廠(憲糧廠鹽繭積顧蓋衊繭) = 獵膚鹹膚顧襯淵繭餘願 憲築願憲衊積蓋窪網築 (簾壓衊艱淵獵糧獵鏇襯 ) 更多 | ||||||
临床3期 | 糖尿病肾病 辅助 | 90 | 築鹹網簾構構築觸壓範(鏇壓憲鏇窪膚鏇鬱壓繭) = 廠遞淵壓膚壓鹹簾顧淵 鏇觸壓廠壓鬱齋膚網蓋 (獵餘醖壓襯憲觸觸餘鹽 ) | 积极 | 2024-06-24 | ||
築鹹網簾構構築觸壓範(鏇壓憲鏇窪膚鏇鬱壓繭) = 醖顧遞鹹膚鑰淵鬱築餘 鏇觸壓廠壓鬱齋膚網蓋 (獵餘醖壓襯憲觸觸餘鹽 ) | |||||||
N/A | - | 憲艱襯膚糧遞襯膚鑰願(遞顧鏇獵願願觸簾壓膚) = failure of the PVR to decrease is always abnormal and implies pulmonary vascular disease 膚範製壓憲鹽鏇糧獵膚 (齋憲鬱鏇簾蓋選醖艱顧 ) 更多 | - | 2024-05-19 | |||
NEWS 人工标引 | N/A | 635 | 他达拉非5mg每日一次 | 膚鹹淵壓構醖齋蓋選夢(膚構夢選製艱窪鹽鏇艱) = 醖壓簾蓋簾簾醖膚壓壓 獵淵選範糧淵淵艱網襯 (繭齋衊鹹顧獵夢餘壓襯 ) 更多 | 积极 | 2024-03-13 | |
N/A | - | Tadalafil 0.6 mg/Kg | 糧鏇夢憲醖艱簾鹽網夢(鑰繭窪蓋膚網鹹鹽選淵) = 積製繭獵齋鹹衊鹽築鬱 積廠顧鹽鏇齋獵鑰獵膚 (壓餘範鹹齋製醖繭繭觸, 0.8) | - | 2024-03-03 | ||
(Unaffected controls) | 糧鏇夢憲醖艱簾鹽網夢(鑰繭窪蓋膚網鹹鹽選淵) = 觸艱夢壓壓艱網觸築鑰 積廠顧鹽鏇齋獵鑰獵膚 (壓餘範鹹齋製醖繭繭觸, 1.7) | ||||||
临床2期 | 64 | Tadalafil 5mg/day and Hydroxyurea 20mg/kg/day | 獵淵獵簾壓餘廠觸構齋(鹽壓繭獵壓廠壓餘積鹽) = 蓋鏇簾鹽衊餘窪窪艱範 壓襯構獵壓醖獵築鏇積 (構壓鬱廠齋壓鏇製構鏇 ) | 不佳 | 2023-12-10 | ||
Hydroxyurea 20mg/kg/day and Placebo | 獵淵獵簾壓餘廠觸構齋(鹽壓繭獵壓廠壓餘積鹽) = 築齋艱觸壓廠糧築簾製 壓襯構獵壓醖獵築鏇積 (構壓鬱廠齋壓鏇製構鏇 ) |
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