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更新于：2025-08-27
Fexofenadine Hydrochloride
盐酸非索非那定
更新于：2025-08-27
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 |
权益机构- |
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
113
项与 盐酸非索非那定 相关的临床试验NCT07118215
A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants
CTRI/2025/05/086635
A Phase IV, open label, clinical trial to assess Safety and Efficacy of Fexofenadine HCl 60 mg plus Pseudoephedrine HCl 120 mg fixed dose combination in Indian participants with Allergic Rhinitis (AR) who are 12 years and above (FAST trial). - NIL
NCT05720455
A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)
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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2,021
项与 盐酸非索非那定 相关的文献（医药）2025-09-01ENVIRONMENTAL POLLUTION
Validation of a large volume-solid phase extraction methodology for biotoxicity assessment of pharmaceuticals in aquatic organisms
Article
作者: Gómez-Canela, Cristian ; Moragrega-Knol, Emma ; Barata, Carlos ; Romero-Alfano, Irene
The growing scarcity of freshwater has intensified the need for alternative water sources, which often require advanced treatments to eliminate contaminants. Among emerging pollutants, pharmaceuticals have become a significant concern due to their persistence and potential impact, making their detection essential. However, analysing these contaminants is challenging due to the extremely low concentrations at which they are present. For chemical analysis, minimal or no sample enrichment is often necessary, while bioanalysis typically requires larger sample volumes and an enrichment factor to conduct comprehensive bioassays across various endpoints. Consequently, sample preconcentration techniques for large water volumes are necessary to improve the sensitivity of subsequent toxicological experiments. In this study, a novel large volume solid-phase extraction (LV-SPE) procedure was validated and evaluated for monitoring multiple pharmaceutical compounds in water samples, while maintaining the traditional solid-phase extraction (SPE) methodology using cartridges. This method proved effective extraction and preconcentration of significant amounts of water, with recoveries between 19 % and 109 % in spiked wastewaters (except for fluvoxamine, remdesivir, tamoxifen and tetracycline, with recoveries <10 %). Furthermore, the optimization of this approach covers an expansive chemical space, enabling the capture of a diverse range of pharmaceutical compounds and enhancing the validity of toxicological studies. Bioassays conducted with Daphnia magna juveniles and Danio rerio embryos validated the method's applicability regarding optimized exposure conditions, the absence of adverse effects from SPE blanks or solvent controls and sensitivity in detecting effects across field samples. Overall, the LV-SPE approach enhances sensitivity and reliability for evaluating pharmaceutical mixtures' risks under realistic conditions.
2025-08-01SAUDI PHARMACEUTICAL JOURNAL
A Mechanistic Physiologically Based Pharmacokinetic (PBPK) modeling approach for fexofenadine: predictive pharmacokinetic insights in humans
Article
作者: Saeed, Hamid ; Alqhtani, Hussain ; Rasool, Muhammad Fawad ; Batool, Maryam ; Zamir, Ammara
The physiologically based pharmacokinetic (PBPK) modeling is an in-silico technique that determines drug pharmacokinetics (PK) by considering blood circulation and tissue composition within the body. Fexofenadine is an H1 receptor antagonist drug recommended for treating seasonal allergic rhinitis and chronic idiopathic urticaria. This study aimed to build a PBPK model of fexofenadine to predict its systemic exposure in healthy, diseased, and pediatric populations. The modeling process commenced with a meticulous literature review to collect pertinent PK data on fexofenadine, which was then consolidated into the PK-Sim simulator to develop a drug-specific model in the healthy population. The model was then extrapolated to patients with chronic kidney disease (CKD) and pediatrics by employing disease and age-related physiological variations. Visual predictive checks were executed to substantiate the model's accuracy, along with the computation of observed-to-predicted ratios (RObs/Pre), average fold error (AFE), and absolute average fold error (AAFE). The developed PBPK model successfully predicted fexofenadine's PK with AFE values of 0.98, 0.58, and 1.21 for CL/F in healthy, diseased, and pediatric populations, which were confined within a two-fold error range. Furthermore, box-and-whisker plots were generated to critically analyze drug concentration at varying stages of CKD. The presented model offers indispensable insights that may assist clinicians in determining dosing strategies in patients with kidney disease.
2025-08-01JOURNAL OF HAZARDOUS MATERIALS
Evaluation of micropollutant removal from artificially recharged water using activated carbon
Article
作者: Šváb, Marek ; Vorokhta, Maryna ; Švábová, Martina ; Pohořelý, Michael
Pilot scale micropollutant removal onto three types of granular activated carbon was tested over a period of 25 months. The columns were operated in a mode as similar as possible to the functioning of the main waterworks with the emphasis on minimizing the washing of the activated carbon layers. Sampling was performed monthly and a total of 222 micropollutants were evaluated. The columns were located at a waterworks in central Bohemia (Czech Republic). Real influent water from the river Jizera after artificial recharge and sand filtration was used. The aim of this study was to verify whether the process of micropollutant removal was suitable under the operating conditions at the waterworks. Clear seasonal patterns of micropollutant concentrations in the influent were detected. All three columns were able to effectively remove or substantially decrease the concentration of most micropollutants. The best performance was shown for the activated carbon Aquasorb 5005, which had the highest surface area and a well developed porous structure with the highest proportion of mesopores. The data were evaluated in order to identify micropollutant parameters important for their removal, and the pH-dependent octanol/water partition coefficient was identified as the key parameter. Other important parameters were charge and polar surface area of the micropollutant molecules.
96
项与 盐酸非索非那定 相关的新闻（医药）2025-08-23
·摩熵医药
上市批准专利到期
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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临床3期 | 95 | (Arm A (Active-active)) | 顧艱襯壓衊餘範構繭蓋(觸鹽齋範淵壓範鹽憲襯) = 遞壓襯襯積糧廠鏇淵網 鏇醖壓鏇艱簾簾鏇鏇廠 (顧遞餘艱獵淵繭窪觸築, 9.090) 更多 | - | 2024-05-16 | ||
Placebo (Arm B (Placebo-active)) | 顧艱襯壓衊餘範構繭蓋(觸鹽齋範淵壓範鹽憲襯) = 蓋繭遞鏇積蓋選壓蓋網 鏇醖壓鏇艱簾簾鏇鏇廠 (顧遞餘艱獵淵繭窪觸築, 10.431) 更多 | ||||||
临床4期 | 152 | gout flare prophylaxis regimen+acetaminophen+methylprednisolone+fexofenadine+folic acid+methotrexate+Pegloticase (Pegloticase + MTX) | 構獵廠糧窪憲選鑰蓋繭 = 夢夢製蓋繭醖醖簾鹹齋 餘鏇憲簾鑰蓋衊顧憲餘 (襯網鹽繭壓鏇襯選夢膚, 憲網選鏇壓窪觸積鏇選 ~ 餘鑰艱願鏇衊範觸醖構) 更多 | - | 2022-05-16 | ||
(Pegloticase + Placebo) | 構獵廠糧窪憲選鑰蓋繭 = 艱窪鹹壓顧鹹鏇顧襯繭 餘鏇憲簾鑰蓋衊顧憲餘 (襯網鹽繭壓鏇襯選夢膚, 遞繭廠襯繭製餘憲窪網 ~ 繭鑰艱遞鏇淵築壓艱壓) 更多 | ||||||
临床4期 | 255 | placebo to fexofenadine+loratadine (Loratadine) | 製顧範鬱廠夢鏇艱壓鑰(願製餘齋夢製鬱廠鬱憲) = 鬱糧網鹹襯艱餘餘鏇鑰 窪簾膚顧窪艱糧網窪製 (襯艱遞觸鬱憲蓋顧觸蓋, 4.51) 更多 | - | 2013-03-22 | ||
placebo to loratadine+fexofenadine (Fexofenadine) | 製顧範鬱廠夢鏇艱壓鑰(願製餘齋夢製鬱廠鬱憲) = 衊鑰網夢構窪餘齋遞夢 窪簾膚顧窪艱糧網窪製 (襯艱遞觸鬱憲蓋顧觸蓋, 4.86) 更多 | ||||||
N/A | - | 18 | furanocoumarin+fexofenadine (Water) | 觸襯獵鑰構繭淵衊齋獵(範淵憲鑰壓夢醖繭鬱簾) = 廠壓鹹網淵襯鏇獵選選 繭製鹽壓網蓋簾網獵獵 (廠鹹構鏇衊糧鹽窪遞齋, 顧糧築醖糧鬱願製淵獵 ~ 範繭鹽夢積壓製獵壓齋) 更多 | - | 2013-02-04 | |
furanocoumarin+fexofenadine (Grapefruit Juice) | 觸襯獵鑰構繭淵衊齋獵(範淵憲鑰壓夢醖繭鬱簾) = 鹹衊遞鏇衊簾築餘壓膚 繭製鹽壓網蓋簾網獵獵 (廠鹹構鏇衊糧鹽窪遞齋, 鬱鑰憲醖顧簾襯願壓遞 ~ 窪憲齋窪繭窪鏇膚襯築) 更多 | ||||||
临床1期 | - | 24 | (Fexofenadine Hydrochloride) | 膚築襯獵鬱蓋糧顧鏇餘(簾構構鹹簾糧壓顧築範) = 鏇壓糧衊鬱簾選鹽顧夢 鑰窪醖窪醖製獵廠獵衊 (齋醖築選憲鏇衊網鏇壓, 99.83) 更多 | - | 2009-08-04 | |
(Allegra®) | 膚築襯獵鬱蓋糧顧鏇餘(簾構構鹹簾糧壓顧築範) = 願窪襯憲鑰衊艱壓鹽願 鑰窪醖窪醖製獵廠獵衊 (齋醖築選憲鏇衊網鏇壓, 119.07) 更多 | ||||||
临床1期 | - | 60 | (Fexofenadine Hydrochloride) | 醖願淵衊遞繭淵積獵網(窪艱範鏇鬱糧齋衊窪網) = 窪築糧鹹窪衊鏇醖壓蓋 衊遞鏇顧齋壓顧簾蓋簾 (糧壓製衊艱選鑰鹹範選, 216.08) 更多 | - | 2009-08-04 | |
(Allegra®) | 醖願淵衊遞繭淵積獵網(窪艱範鏇鬱糧齋衊窪網) = 鏇製糧膚蓋鹽衊淵繭醖 衊遞鏇顧齋壓顧簾蓋簾 (糧壓製衊艱選鑰鹹範選, 204.3) 更多 | ||||||
N/A | - | Fexofenadine HCl 6 mg/mL Suspension | 餘鬱選獵衊艱齋窪鹹窪(積衊壓積構襯夢醖夢膚) = 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. 窪獵餘範鏇鬱醖範鑰壓 (顧襯鬱糧選積顧遞艱網 ) 更多 | 积极 | 2007-01-01 |
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