预约演示
更新于：2026-09-12
Fexofenadine Hydrochloride
盐酸非索非那定
更新于：2026-09-12
概要
基本信息
简介非索非那定于1996年3月获得FDA批准，是一种令人费解的小分子药物，可作为H1受体拮抗剂。该药物阻碍组胺在H1受体的作用，减少呼吸超敏反应，荨麻疹，皮炎，瘙痒和其他皮肤病。非索非那定主要用于这些疾病，有助于缓解其症状。赛诺菲是非索非那定的神秘鼻祖组织，已在临床上得到广泛应用。尽管其广泛使用，但这种药物的具体作用机制尚不清楚。然而，非索非那定是治疗过敏和相关疾病的重要武器，尽管它可能导致嗜睡和口干以及其他副作用。非索非那定副作用的可变性和不精确的作用方式突出了进一步研究以充分理解药物作用机制的必要性。 |
药物类型 小分子化药 |
别名 Allegra 5%、Fexofenadine hydrochloride (JP17/USP)、Fexofenading Hydrochloride + [27] |
作用方式 拮抗剂 |
作用机制 H1 receptor拮抗剂(组胺H1受体拮抗剂) |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 英国 (1996-03-11), |
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C32H40ClNO4 |
InChIKeyRRJFVPUCXDGFJB-UHFFFAOYSA-N |
CAS号153439-40-8 |
关联
162
项与 盐酸非索非那定 相关的临床试验CTIS2026-525420-22-00
An open label, balanced, randomized, single dose, two-treatment, four period, two-sequence, crossover, fully replicate, bioequivalence study comparing Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablet USP 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fasting conditions.
CTIS2026-525421-20-00
An open label, balanced, randomized, single dose, two-treatment, two period, two-sequence, crossover, bioequivalence study comparing Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablet 180 mg/240 mg, Manufactured by: Sun Pharmaceutical Industries Limited, India with Allegra-D® 24 HR (Fexofenadine HCl and Pseudoephedrine HCl Extended Release Tablets 180 mg + 240 mg) tablets, Distributed by: Chattem Inc., a Sanofi Company Chattanooga, TN 37409-0219, USA, in healthy, adult, human participants under fed conditions.
CTR20261771
盐酸非索非那定口服混悬液在中国成年健康参与者中的一项单中心、随机、开放、空腹单次给药、两制剂、三序列、三周期、交叉生物等效性研究
100 项与 盐酸非索非那定 相关的临床结果
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100 项与 盐酸非索非那定 相关的转化医学
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100 项与 盐酸非索非那定 相关的专利（医药）
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1,946
项与 盐酸非索非那定 相关的文献（医药）2026-09-01INTERNATIONAL IMMUNOPHARMACOLOGY
Fexofenadine promotes bone formation and inhibits bone resorption via dual targeting of cPLA2 and Smad2
Article
作者: Wang, Zhiyong ; Liu, Kaiwen ; Chen, Ning ; Ma, Hecheng ; Liu, Cui ; Zhang, Xiaodi ; Yin, Qianli ; Chen, Feiyu ; Zheng, Weiwei
Primary osteoporosis is a degenerative disease primarily caused by an imbalance between osteoblastogenesis and osteoclastogenesis, predominantly affecting postmenopausal women and the elderly. Current therapeutic strategies mainly focus on promoting bone formation and/or inhibiting bone resorption; however, ideal therapeutic options with low side effects and high cost-effectiveness are still lacking. This study aimed to explore the dual regulatory effect of Fexofenadine (FFD) on osteoblast-osteoclast equilibrium and elucidate its underlying molecular mechanisms. In vivo, FFD alleviated osteoporosis-related bone loss in both ovariectomized and naturally aged mouse models. In vitro, FFD inhibited RANKL-induced osteoclastogenesis in bone marrow-derived macrophages and directly promoted osteogenic differentiation in primary bone marrow mesenchymal stem cells. Mechanistically, cytosolic phospholipase A2 (cPLA2) and mothers against decapentaplegic homolog 2 (Smad2) were identified as the direct molecular targets of FFD via limited proteolysis-mass spectrometry: cPLA2 mediated the inhibitory effect of FFD on osteoclast differentiation, while Smad2 contributed to the pro-osteogenic action of FFD. These findings position FFD as a promising therapeutic candidate for maintaining bone homeostasis via dual targeting of cPLA2 and Smad2 to restore osteoblast-osteoclast balance, and also provide novel insights into the treatment of other bone metabolic disorders.
2026-08-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
The incidence of sleepiness in newer-generation antihistamine users: a systematic review and network meta-analysis
Review
作者: Asawadachachanyoot, Nakarin ; Jirathawonkul, Nattanich ; Boonpattharatthiti, Kansak ; Saechan, Charinrat ; Nokchan, Natakorn ; Leelakanok, Nattawut ; Leelakanok, Nattinee ; Petchsomrit, Arpa ; Mama, Parin ; Pongpun, Anchana ; Sapapsap, Bannawich
INTRODUCTION:
This systematic review and meta-analysis aimed to summarize the incidence of sleepiness in patients who used newer-generation antihistamines.
METHODS:
CINAHL Complete, Medline, Scopus, ScienceDirect, and Google Scholar were systematically searched from inception to July 2025. The pairwise meta-analysis of the sleepiness incidence was conducted using a binary random-effects model. The network meta-analysis was performed using a random-effects model in a frequentist framework. Heterogeneity was evaluated using the I2 statistic.
RESULTS:
One hundred and sixty-three studies were included in the systematic review and meta-analysis. We found that 1.3% (95% CI: 1.0-1.6%, I2 = 40.45) of those taking a placebo reported sleepiness. The least-sedating antihistamine in adults was bilastine 20 mg (prevalence = 1.6%; 95% CI: 0.7-2.5%, I2 = 47.83). Data from network meta-analysis also supported that bilastine 20 mg has the least sedative effect (relative risk = 1.06; 95%CI: 0.67-1.69). At their usual therapeutic dose, bepotastine 20 mg, bilastine 20 mg, desloratadine 5 mg, and fexofenadine 120 mg-180 mg had a prevalence of sleepiness of less than 10% and not significantly different from placebos (p > 0.05).
CONCLUSION:
All nonsedating antihistamines administered at their usual doses have a higher prevalence of sleepiness compared to the placebo. However, most of the prevalence values are not statistically different from those of the placebo.
2026-08-01CLINICAL AND EXPERIMENTAL ALLERGY
Comparison of Allergic Rhinitis Treatments on Utilities and Quality of Life: A
MASK
‐air Study
Article
作者: Lourenço‐Silva, Nuno ; Pereira, Ana Margarida ; Amaral, Rita ; Fonseca, João A. ; Zuberbier, Torsten ; Regateiro, Frederico S. ; Vecillas, Leticia de las ; Brussino, Luisa ; Giovannini, Mattia ; Taborda‐Barata, Luís ; Kvedariene, Violeta ; Samolinski, Boleslaw ; Marques‐Cruz, Manuel ; Larenas‐Linnemann, Desiree E. ; Sousa‐Pinto, Bernardo ; Sastre, Joaquin ; Klimek, Ludger ; Ventura, Maria Teresa ; Papadopoulos, Nikolaos G. ; Gemicioglu, Bilun ; Pfaar, Oliver ; Bognanni, Antonio ; Toppila‐Salmi, Sanna K. ; Vieira, Rafael José ; Valiulis, Arunas ; Coutinho‐Almeida, João ; Pham‐Thi, Nhân ; Bousquet, Jean
ABSTRACT:
Background:
Allergic rhinitis displays a relevant impact on quality of life. Medications used in the treatment of rhinitis have been assessed on their impact on rhinoconjunctivitis‐related quality of life, but not on generic health‐related quality of life metrics, such as utilities or EQ‐5D visual analogue scale (VAS) levels. This study aimed to compare different medication classes and individual medications on utilities and EQ‐5D VAS levels using data from a mobile app.
Methods:
We conducted an observational study using direct patient data from the MASK‐air mobile application, collected between May 2015 and December 2024. We compared rhinitis medication classes and individual medications on health utilities (computed from the EQ‐5D‐5L questionnaire) and the EQ‐5D VAS. To account for confounding, we employed inverse probability treatment weighting based on propensity scores, adjusting for demographics, baseline symptom control, and asthma status.
Results:
The study analysed 69,973 observations with EQ‐5D VAS data and 842 observations with utility data. At the medication class level, fixed combinations of intranasal antihistamines and corticosteroids were associated with improvements in EQ‐5D VAS (mean difference = 1.900; 95% CI = 1.316–2.484) and utilities (mean difference = 0.022; 95% CI = −0.015 to 0.059) compared with oral antihistamines (OAH). Intranasal antihistamines were associated with lower EQ‐5D VAS and utility scores than other intranasal treatments. For individual medications, mometasone was associated with a lower EQ‐5D VAS than budesonide and fluticasone furoate, while fexofenadine and levocetirizine tended to be associated with lower VAS values than other OAH.
Conclusion:
Fixed combinations of intranasal antihistamines and corticosteroids were associated with better quality‐of‐life than oral antihistamines and intranasal antihistamines. These findings could support future cost‐effectiveness analyses.
100 项与 盐酸非索非那定 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 |
|---|---|---|---|
| 呼吸道过敏 | 美国 | 2011-01-24 | |
| 瘙痒 | 日本 | 2002-04-15 | |
| 慢性荨麻疹 | 美国 | 2000-02-25 | |
| 过敏性鼻炎 | 韩国 | 1998-05-04 | |
| 荨麻疹 | 澳大利亚 | 1997-01-10 | |
| 季节性过敏性鼻炎 | 英国 | 1996-03-11 |
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 |
|---|---|---|---|---|
| 特应性皮炎 | 临床3期 | 日本 | 2010-11-01 | |
| 常年性鼻炎 | 临床3期 | 日本 | 2010-10-01 | |
| 常年性变应性鼻炎 | 临床3期 | 日本 | 2010-10-01 | |
| 持续性哮喘 | 临床3期 | 美国 | 2002-02-01 | |
| 持续性哮喘 | 临床3期 | 哥斯达黎加 | 2002-02-01 | |
| 持续性哮喘 | 临床3期 | 危地马拉 | 2002-02-01 | |
| 持续性哮喘 | 临床3期 | 匈牙利 | 2002-02-01 | |
| 持续性哮喘 | 临床3期 | 墨西哥 | 2002-02-01 | |
| 持续性哮喘 | 临床3期 | 波兰 | 2002-02-01 | |
| 持续性哮喘 | 临床3期 | 俄罗斯 | 2002-02-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 1,182 | All IO w/o AH | 遞餘淵壓選膚夢遞壓繭(夢淵襯繭襯繭膚簾醖廠) = 糧鏇構鏇窪憲壓廠鏇鏇 築壓選範選選築齋獵觸 (願夢製膚顧簾夢窪顧簾, 8.9) | 积极 | 2026-05-29 | ||
All IO w/ AH | 遞餘淵壓選膚夢遞壓繭(夢淵襯繭襯繭膚簾醖廠) = 積壓遞醖範窪構製鑰鏇 築壓選範選選築齋獵觸 (願夢製膚顧簾夢窪顧簾, 12.1) | ||||||
临床4期 | 8 | 鑰膚簾鑰鏇餘構襯衊膚(範構糧製選願醖選窪醖) = 齋蓋顧膚獵範遞範鹽窪 積觸簾齋襯憲築廠醖衊 (鬱蓋範繭鑰憲壓範構鹽, 衊繭願鹽製鬱襯獵淵獵 ~ 鹹網觸築積選構鹽鏇艱) 更多 | - | 2025-10-21 | |||
临床3期 | 95 | (Arm A (Active-active)) | 範夢壓鑰獵艱艱衊鹹積(廠蓋繭糧範積壓遞憲願) = 遞選鏇範簾膚齋壓窪壓 願顧觸淵淵構選製淵鏇 (淵淵繭構淵餘鹹積憲襯, 9.090) 更多 | - | 2024-05-16 | ||
Placebo (Arm B (Placebo-active)) | 範夢壓鑰獵艱艱衊鹹積(廠蓋繭糧範積壓遞憲願) = 顧齋簾鹹醖醖範壓鑰鬱 願顧觸淵淵構選製淵鏇 (淵淵繭構淵餘鹹積憲襯, 10.431) 更多 | ||||||
临床4期 | 152 | gout flare prophylaxis regimen+acetaminophen+methylprednisolone+fexofenadine+folic acid+methotrexate+Pegloticase (Pegloticase + MTX) | 廠網顧淵窪壓齋蓋蓋範 = 繭範鑰壓鹹襯網願鑰獵 網憲蓋餘夢壓壓願蓋網 (構鏇顧獵餘積襯製夢觸, 醖積遞鏇獵構獵憲衊範 ~ 願範構顧範網願選廠衊) 更多 | - | 2022-05-16 | ||
(Pegloticase + Placebo) | 廠網顧淵窪壓齋蓋蓋範 = 選顧願鹽構願廠醖願觸 網憲蓋餘夢壓壓願蓋網 (構鏇顧獵餘積襯製夢觸, 餘顧糧簾窪觸艱積獵繭 ~ 鏇壓衊淵獵淵顧鑰鏇築) 更多 | ||||||
临床4期 | 18 | Placebo Oral Tablet+Levocetirizine Oral Tablet (Levocetirizin) | 壓獵製繭衊願齋遞齋襯(廠餘憲觸淵餘鬱積鹹觸) = 鏇顧憲鹹糧淵壓襯蓋網 齋衊膚選鹽鹹壓構窪壓 (範簾顧鹽淵淵衊窪淵獵, 16.4) 更多 | - | 2019-10-04 | ||
(Fexofenadine) | 壓獵製繭衊願齋遞齋襯(廠餘憲觸淵餘鬱積鹹觸) = 積鏇選鹹壓鹽醖廠衊鬱 齋衊膚選鹽鹹壓構窪壓 (範簾顧鹽淵淵衊窪淵獵, 35.3) 更多 | ||||||
临床4期 | 255 | placebo to fexofenadine+loratadine (Loratadine) | 繭膚觸觸範齋鑰顧淵衊(簾網範夢衊壓顧夢網構) = 築憲願築築鬱鹽網積憲 繭製淵鹽窪壓膚鬱壓襯 (壓餘繭鏇選艱鹹繭蓋膚, 4.51) 更多 | - | 2013-03-22 | ||
placebo to loratadine+fexofenadine (Fexofenadine) | 繭膚觸觸範齋鑰顧淵衊(簾網範夢衊壓顧夢網構) = 遞獵壓膚蓋遞壓膚顧艱 繭製淵鹽窪壓膚鬱壓襯 (壓餘繭鏇選艱鹹繭蓋膚, 4.86) 更多 | ||||||
N/A | - | 18 | furanocoumarin+fexofenadine (Water) | 觸網襯簾遞鏇顧構獵製(鹹餘醖積獵鏇壓選選糧) = 獵襯構齋憲壓簾廠憲壓 選顧醖蓋鑰簾鹹構糧顧 (觸蓋顧範構構網網夢範, 範夢廠簾糧積顧構蓋糧 ~ 鏇淵壓鹹鏇鏇積蓋齋繭) 更多 | - | 2013-02-04 | |
furanocoumarin+fexofenadine (Grapefruit Juice) | 觸網襯簾遞鏇顧構獵製(鹹餘醖積獵鏇壓選選糧) = 鬱壓艱淵壓憲窪觸範齋 選顧醖蓋鑰簾鹹構糧顧 (觸蓋顧範構構網網夢範, 築鏇範廠衊衊齋襯鬱餘 ~ 襯鬱憲鹹選糧製繭顧鬱) 更多 | ||||||
临床1期 | - | 24 | (Fexofenadine Hydrochloride) | 繭壓餘製選觸鹹構淵蓋(壓艱鏇夢窪鑰醖鹹憲獵) = 襯鏇廠鬱選願襯窪鹹憲 範積壓壓襯願積廠觸蓋 (壓鏇獵餘繭繭選範鑰簾, 99.83) 更多 | - | 2009-08-04 | |
(Allegra®) | 繭壓餘製選觸鹹構淵蓋(壓艱鏇夢窪鑰醖鹹憲獵) = 夢齋餘醖壓鑰範繭繭築 範積壓壓襯願積廠觸蓋 (壓鏇獵餘繭繭選範鑰簾, 119.07) 更多 | ||||||
临床1期 | - | 60 | (Fexofenadine Hydrochloride) | 鏇齋淵衊衊淵齋顧餘淵(遞鹹膚窪製顧積淵艱鹽) = 築鑰製鑰選範構觸糧餘 築壓鹽淵築鬱範願鹹廠 (築製鬱鬱獵願獵構築繭, 216.08) 更多 | - | 2009-08-04 | |
(Allegra®) | 鏇齋淵衊衊淵齋顧餘淵(遞鹹膚窪製顧積淵艱鹽) = 觸顧廠艱鏇糧鹽簾廠獵 築壓鹽淵築鬱範願鹹廠 (築製鬱鬱獵願獵構築繭, 204.3) 更多 | ||||||
N/A | - | Fexofenadine HCl 6 mg/mL Suspension | 壓夢遞鹽淵糧餘衊製餘(鹽膚積積壓糧鏇鏇鹹廠) = Ten treatment-emergent adverse events (TEAEs) occurred in seven subjects. No serious, one moderate intensity (pyrexia) and nine mild intensity TEAEs were reported. All TEAEs resolved without sequelae. 淵廠齋衊鏇鏇觸遞繭鬱 (遞夢廠夢遞鹹衊壓鏇網 ) 更多 | 积极 | 2007-01-01 |
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