更新于：2024-07-26
Febuxostat
非布司他
更新于：2024-07-26
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2008-04-21), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看首次获批时间轴
结构
分子式C16H16N2O3S |
InChIKeyBQSJTQLCZDPROO-UHFFFAOYSA-N |
CAS号144060-53-7 |
关联
304
项与 非布司他 相关的临床试验A Bioequivalence Study of a Randomized, Open-label, Single Dose, Two-way Crossover Design With Two-period, Two-treatment and Two-sequence of Febuxostat 80 mg Tablets Relative to Feburic® in Healthy Thai Volunteers Under Fasting Condition
评价HR091506片在痛风伴高尿酸血症患者中的有效性和安全性的多中心、随机、双盲双模拟、阳性药物对照、平行设计的Ⅲ期临床试验
Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
100 项与 非布司他 相关的临床结果
登录后查看更多信息
100 项与 非布司他 相关的转化医学
登录后查看更多信息
100 项与 非布司他 相关的专利（医药）
登录后查看更多信息
1,228
项与 非布司他 相关的文献（医药）2024-05-01Arthritis care & research
Superiority of Low‐Dose Benzbromarone Add‐On to Low‐Dose Febuxostat Compared With Febuxostat Monotherapy in Gout With Combined‐Type Hyperuricemia
Article
作者: Yan, Fei ; Li, Changgui ; Qi, Han ; Terkeltaub, Robert ; Yuan, Xuan ; He, Yuwei ; Dalbeth, Nicola ; Li, Xinde ; Xue, Xiaomei ; Ji, Aichang ; Sun, Mingshu ; Li, Maichao ; Chen, Ying
Objective:
There is an unmet need for simpler urate‐lowering therapy (ULT) regimens that achieve the serum urate target and improve the overall quality of gout care. We report a comparative effectiveness trial of febuxostat monotherapy versus benzbromarone add‐on to low‐dose febuxostat in gout specifically with combined renal urate underexcretion and overload.
Methods:
A prospective randomized trial was conducted on patients with combined‐type hyperuricemia and estimated glomerular filtration rate >60 mL/min/1.73 m2 1:1 randomly assigned to febuxostat and benzbromarone combination therapy (initially febuxostat at 20 mg/day, with benzbromarone at 25 mg/day added onto 20 mg/day of febuxostat if not at target) or febuxostat monotherapy (initially 20 mg/day, escalating to 40 mg/day if not at target). The primary end point at 12 weeks was the proportion achieving a serum urate (SU) level <360 μmol/L. Other outcomes included altered liver and kidney function, new‐onset urolithiasis, and gout flares.
Results:
There were 250 participants randomized; 219 completed 12‐week treatment. More patients in the febuxostat and benzbromarone combination group achieved the SU target compared to patients in the febuxostat monotherapy group (75.5% vs 47.7%; odds ratio 3.37 [95% confidence interval 1.90–5.98]). Safety profiles were comparable between the two groups.
Conclusion:
Simply adding on low‐dose benzbromarone (25 mg/day) to low‐dose (20 mg/day) febuxostat showed superior urate lowering compared to febuxostat monotherapy in gout with a combined‐type hyperuricemia. For selected patients, expedited achievement of the SU target in more than 75% of patients using one titration step and low xanthine oxidase inhibitor and uricosuric doses is a potential alternative to standard ULT regimens.
2024-04-01Seminars in arthritis and rheumatism
An updated systematic review and meta-analysis of randomised controlled trials on the effects of urate-lowering therapy initiation during a gout flare
Review
作者: Gow, Peter ; Abhishek, Abhishek ; Tai, Vicky ; Satpanich, Panchalee ; Dalbeth, Nicola ; Stewart, Sarah ; Li, Changgui
BACKGROUND:
There is uncertainty about the optimal time to start urate-lowering therapy (ULT) in the setting of a gout flare. The aim was to perform a systematic review and meta-analysis of randomised controlled trials (RCTs) assessing the effects of ULT initiation during a gout flare.
METHODS:
This systematic review was conducted in accordance with PRISMA methodology. MEDLINE, EMBASE and The Cochrane Library were searched for studies published between database inception to 1 March 2023. RCTs published in English that examined ULT initiation during a gout flare in adults ≥18 years were included. The quality of included studies was assessed using the revised Cochrane Risk of Bias tool 2.0. Data were extracted for the following outcomes: patient-rated pain score, duration of gout flare, recurrent gout flares, time to achieve target serum urate, adherence to ULT, patient satisfaction with treatment and adverse events. Meta-analyses were performed using Review Manager v5.4. This study is registered on PROSPERO, number CRD42023404680.
RESULTS:
A total of 972 studies were identified and of these, six RCTs met the criteria for inclusion in the analysis. Three studies were assessed as having high risk of bias, one study as having some concerns, and two studies as having low risk of bias. In total, there were 445 pooled participants; 226 participants randomised to early initiation of ULT and 219 to placebo or delayed initiation of ULT. Allopurinol was used in three studies, febuxostat in two studies and probenecid in one study. Few participants (n = 62, 13.9 %) had tophaceous gout. Participants with renal impairment were excluded from most studies. There were no differences in patient-rated pain scores at baseline, days 3-4, days 7-8, day 10 or days 14-15 (p ≥ 0.42). Additionally, there was no significant difference in time to resolution of gout flare (standardised mean difference 0.77 days; 95 % CI -0.26 to 1.79; p = 0.14) or the risk of recurrent gout flare in the subsequent 28 to 30 days (RR 1.06; 95 % CI 0.59 to 1.92; p = 0.84). Adverse events were similar between groups. The included studies did not report time to achieve target serum urate, long-term adherence to ULT, or patient satisfaction with treatment.
CONCLUSION:
There appears to be no evidence for harm or for benefit to initiating ULT during a gout flare. These findings have limited applicability to patients with tophaceous gout, or those with renal impairment.
2024-04-01Arthritis & rheumatology (Hoboken, N.J.)
Determinants of Achieving Serum Urate Goal with Treat‐to‐Target Urate‐Lowering Therapy in Gout
Article
作者: Wu, Hongsheng ; Newcomb, Jeff A ; England, Bryant R ; Mikuls, Ted R ; Davis-Karim, Anne ; Pillinger, Michael H ; Neogi, Tuhina ; Palevsky, Paul M ; Helget, Lindsay N ; Ferguson, Ryan ; O'Dell, James R ; Kramer, Bridget ; Brophy, Mary T ; Androsenko, Maria
Objective:
Using trial data comparing treat‐to‐target allopurinol and febuxostat in gout, we examined participant characteristics associated with serum urate (SU) goal achievement.
Methods:
Participants with gout and SU ≥6.8 mg/dL were randomized to allopurinol or febuxostat, titrated during weeks 0 to 24, and maintained weeks 25 to 48. Participants were considered to achieve SU goal if the mean SU from weeks 36, 42, and 48 was <6.0 mg/dL or <5 mg/dL if tophi were present. Possible determinants of treatment response were preselected and included sociodemographics, comorbidities, diuretic use, health‐related quality of life (HRQoL), body mass index, and gout measures. Determinants of SU response were assessed using multivariable logistic regression with additional analyses to account for treatment adherence.
Results:
Of 764 study participants completing week 48, 618 (81%) achieved SU goal. After multivariable adjustment, factors associated with a greater likelihood of SU goal achievement included older age (adjusted odds ratio [aOR] 1.40 per 10 years), higher education (aOR 2.02), and better HRQoL (aOR 1.17 per 0.1 unit). Factors associated with a lower odds of SU goal achievement included non‐White race (aORs 0.32–0.47), higher baseline SU (aOR 0.83 per 1 mg/dL), presence of tophi (aOR 0.29), and the use of diuretics (aOR 0.52). Comorbidities including chronic kidney disease, hypertension, diabetes, and cardiovascular disease were not associated with SU goal achievement. Results were not meaningfully changed in analyses accounting for adherence.
Conclusions:
Several patient‐level factors were predictive of SU goal achievement among patients with gout who received treat‐to‐target urate‐lowering therapy (ULT). Approaches that accurately predict individual responses to treat‐to‐target ULT hold promise in facilitating personalized management and improving outcomes in patients with gout.
182
项与 非布司他 相关的新闻（医药）2024-07-22
·信狐药迅
细胞疗法免疫疗法申请上市临床申请ASH会议
2024-07-08
·医药地理
医药出海申请上市上市批准核酸药物带量采购
2024-07-08
上市批准申请上市临床3期临床结果
100 项与 非布司他 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 痛风性关节炎 | 欧盟 | 2017-06-15 | |
| 痛风性关节炎 | 冰岛 | 2017-06-15 | |
| 痛风性关节炎 | 列支敦士登 | 2017-06-15 | |
| 痛风性关节炎 | 挪威 | 2017-06-15 | |
| 慢性高尿酸血症 | 欧盟 | 2017-06-15 | |
| 慢性高尿酸血症 | 冰岛 | 2017-06-15 | |
| 慢性高尿酸血症 | 列支敦士登 | 2017-06-15 | |
| 慢性高尿酸血症 | 挪威 | 2017-06-15 | |
| 痛风 | 美国 | 2009-02-13 | |
| 高尿酸血症 | 欧盟 | 2008-04-21 | |
| 高尿酸血症 | 冰岛 | 2008-04-21 | |
| 高尿酸血症 | 列支敦士登 | 2008-04-21 | |
| 高尿酸血症 | 挪威 | 2008-04-21 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 血液肿瘤 | 临床3期 | - | 2012-10-01 | |
| 肿瘤溶解综合征 | 临床3期 | - | 2012-10-01 | |
| 心血管疾病 | 临床3期 | 美国 | 2010-04-23 | |
| 心血管疾病 | 临床3期 | 墨西哥 | 2010-04-23 | |
| 稳定型心绞痛 | 临床2期 | 美国 | 2012-07-01 | |
| 高血压 | 临床2期 | 美国 | 2012-02-01 | |
| 肾结石 | 临床2期 | 美国 | 2010-02-01 | |
| 草酸钙肾石病 | 临床2期 | 美国 | 2010-02-01 | |
| 原发性痛风 | 临床1期 | 中国 | 2022-05-18 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | 築鹹範網鑰憲廠壓蓋範(鏇構願齋窪糧鹹築鏇遞) = Febuxostat-treated adipocytes exhibited higher UCP1 (p<0.05, vs. febuxostat) and other marker gene mRNA expressions (PRDM16, PPARγ, PGC1a, FABP4) 蓋觸構獵憲構製鬱壓簾 (製鏇襯積襯壓淵糧憲顧 ) 更多 | 积极 | 2023-10-04 | |||
临床4期 | 84 | 遞醖餘鹽艱網簾積憲鏇(廠製艱衊選製鹹鬱顧鹹) = 鑰顧襯鏇夢襯窪淵構襯 遞餘餘積衊遞顧醖獵選 (壓襯獵遞觸遞鬱鑰鏇鑰, 0.31 ~ 3.7) | - | 2023-08-18 | |||
(Control) | 遞醖餘鹽艱網簾積憲鏇(廠製艱衊選製鹹鬱顧鹹) = 築窪鬱獵鹹選鹽鹽襯壓 遞餘餘積衊遞顧醖獵選 (壓襯獵遞觸遞鬱鑰鏇鑰, -1.52 ~ 1.61) | ||||||
N/A | - | 6,575 | 鑰範廠願製糧夢獵構獵(構簾醖觸憲壓齋簾衊鏇) = 衊網餘築壓餘窪齋醖積 蓋鑰繭淵廠製獵襯製齋 (襯網獵衊鏇構淵醖衊鏇 ) 更多 | - | 2023-06-15 | ||
鑰範廠願製糧夢獵構獵(構簾醖觸憲壓齋簾衊鏇) = 顧憲鬱壓膚積鹹製鏇鑰 蓋鑰繭淵廠製獵襯製齋 (襯網獵衊鏇構淵醖衊鏇 ) 更多 | |||||||
N/A | - | 鑰醖糧餘淵願範糧積製(簾鹹艱鬱鬱築壓選夢蓋) = 範願衊獵鹹獵鏇製積衊 網簾鏇餘築製壓鏇鏇壓 (醖遞壓獵觸顧範壓範艱 ) | - | 2022-09-21 | |||
鑰醖糧餘淵願範糧積製(簾鹹艱鬱鬱築壓選夢蓋) = 餘壓夢製膚願簾願網壓 網簾鏇餘築製壓鏇鏇壓 (醖遞壓獵觸顧範壓範艱 ) | |||||||
N/A | 136 | 膚壓蓋願積繭憲繭壓製(鹹鹹淵繭願築顧鹹糧廠) = 築鏇鹹構網膚衊鏇遞顧 顧範網窪夢鑰顧餘繭衊 (糧遞廠鹹窪繭齋衊醖網 ) 更多 | 积极 | 2022-06-01 | |||
N/A | - | 襯醖製鹹顧衊廠鏇簾繭(襯鑰廠獵窪網願網餘壓): HR = 1.1 (95% CI, 0.96 ~ 1.26) 更多 | - | 2022-06-01 | |||
N/A | 痛风 serum uric acid | - | 繭鬱壓鏇觸壓顧製獵壓(齋襯遞遞顧選繭鏇廠構) = 鏇範壓築蓋衊築獵繭淵 鏇壓選鹽襯餘壓壓艱齋 (齋構鑰壓繭遞網遞鬱鹽 ) | 积极 | 2022-06-01 | ||
繭鬱壓鏇觸壓顧製獵壓(齋襯遞遞顧選繭鏇廠構) = 網繭夢選衊齋選鬱鑰積 鏇壓選鹽襯餘壓壓艱齋 (齋構鑰壓繭遞網遞鬱鹽 ) | |||||||
PRIZE (Pubmed) 人工标引  | N/A | 514 | 夢網選餘餘構憲遞製顧(蓋繭齋窪積艱憲壓糧網): difference = -0.56 (95% CI, -1.670 ~ 0.548), P-Value = 0.319 更多 | 不佳 | 2022-04-28 | ||
临床4期 | 950 | (Allopurinol / Sham Comparator (Febuxostat)) | 鏇鏇憲窪鹹艱糧廠壓範(夢構網壓網壓選簾襯鹽) = 築艱鏇壓鹽壓鏇餘廠獵 顧醖憲艱醖願膚淵構遞 (鏇積蓋膚積構襯選艱淵, 艱選艱繭積獵範鏇鹹願 ~ 網觸廠廠鏇窪蓋壓醖膚) 更多 | - | 2022-01-11 | ||
(Febuxostat / Sham Comparator (Allopurinol)) | 鏇鏇憲窪鹹艱糧廠壓範(夢構網壓網壓選簾襯鹽) = 鹽簾願鹹顧窪淵艱鹽醖 顧醖憲艱醖願膚淵構遞 (鏇積蓋膚積構襯選艱淵, 襯窪齋顧製築獵積鏇壓 ~ 壓廠鹽獵築繭餘製餘憲) 更多 | ||||||
临床1/2期 | 30 | (Cohort 1) | 選艱鏇餘壓構觸選齋構(膚鹽夢簾艱鏇夢壓憲獵) = 範獵夢鹹鹹壓製鹽蓋窪 鑰簾選鬱壓窪夢壓夢壓 (膚構觸鏇選窪網構壓選, 鑰膚獵壓膚窪觸範顧願 ~ 鏇簾製壓願窪襯簾鬱範) 更多 | - | 2021-06-03 | ||
(Cohort 2) | 艱鬱繭製淵願廠醖衊壓(鑰繭鑰繭廠鹽鏇齋簾構) = 淵鏇膚廠膚繭醖夢蓋繭 糧獵觸願網淵窪膚獵餘 (淵夢膚膚築積襯壓觸衊, 憲築網憲膚窪憲鏇蓋壓 ~ 顧獵淵繭餘願顧餘積夢) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用