预约演示
更新于：2026-01-28
Olopatadine Hydrochloride/Mometasone Furoate Monohydrate
莫米松糠酸酯/盐酸奥洛他定
更新于：2026-01-28
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 澳大利亚 (2019-12-11), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国) |
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结构/序列
分子式C21H24ClNO3 |
InChIKeyHVRLZEKDTUEKQH-NOILCQHBSA-N |
CAS号140462-76-6 |
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关联
8
项与 莫米松糠酸酯/盐酸奥洛他定 相关的临床试验NCT06126952
Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray
CTR20213407
一项多中心、随机、双盲、双模拟、三臂、平行对照评估GSP301 NS与Patanase®NS和内舒拿®NS治疗中国成人和青少年季节性过敏性鼻炎（SAR）的有效性、安全性、耐受性及药代动力学的III期临床研究
NCT03463031
A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
100 项与 莫米松糠酸酯/盐酸奥洛他定 相关的临床结果
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100 项与 莫米松糠酸酯/盐酸奥洛他定 相关的转化医学
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100 项与 莫米松糠酸酯/盐酸奥洛他定 相关的专利（医药）
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14
项与 莫米松糠酸酯/盐酸奥洛他定 相关的文献（医药）2023-12-04Polish Journal of Otolaryngology
Intranasal combo: fixed-dose combination of mometasone furoate and olopatadine hydrochloride in therapeutic strategies for rhinosinusitis
Article
作者: Samoliński, Krzysztof ; Lipiec, Agnieszka ; Krzych-Fałta, Edyta ; Walkiewicz, Artur ; Borowicz, Jacek ; Samoliński, Bolesław ; Wojas, Oksana
A novel strategy for the treatment of allergic rhinitis results from the innovative combination of antihistamine and intranasal corticosteroid drugs. By combining two preparations with different mechanism of action, this novel approach facilitates quick and effective controls of all upper respiratory tract allergy symptoms. The article presents the results of a study of olopatadine hydrochloride and mometasone furoate fixed-dose combination (GSP301) administered intranasally from a spray formulation, with an attempt at positioning the treatment within the ARIA and EPOS guidelines.
2023-06-03Expert review of clinical immunology
Intranasal corticosteroid and antihistamine combinations in the treatment of allergic rhinitis: the role of the novel formulation olopatadine/mometasone furoate
Review
作者: Paoletti, Giovanni ; Heffler, Enrico ; Ridolo, Erminia ; Nicoletta, Francesca ; Barone, Alessandro ; Canonica, Giorgio Walter ; Malvezzi, Luca
INTRODUCTION:
Allergic rhinitis (AR) is a common disease with an important impact on the quality of life and very high management costs. In many patients, the poor control of rhinitis symptoms often requires the use of different drugs, and polytherapy tends to reduce therapeutic adherence. According to the latest version of ARIA guidelines, the currently recommended drugs for the treatment of moderate-to-severe AR are second-generation antihistamines, intranasal corticosteroids, and their combination, even in a single nasal spray device. A single medication with a rapid onset of action, acting on breakthrough symptoms too, would be advantageous, also in terms of patient compliance.
AREAS COVERED:
GSP301 (olopatadine 600 µg - mometasone furoate 25 µg) is a novel intranasal formulation, combining the second-generation antihistamine olopatadine hydrochloride with mometasone furoate. Here, we review the evidence for GSP301, especially concerning the efficacy and safety profile of this intranasal combination in the treatment of AR.
EXPERT OPINION:
The evidence provided in the current review clearly supports the use of GSP301 as a novel intranasal corticosteroid/antihistamine combination with a well-documented efficacy and safety profile in terms of rapid symptom relief and good tolerability.
2023-05-01ANNALS OF PHARMACOTHERAPY
Intranasal Olopatadine-Mometasone in the Treatment of Seasonal Allergic Rhinitis
Review
作者: Kale-Pradhan, Pramodini ; Lipari, Melissa ; Lim, Lauren
Objective::
To review the pharmacology, efficacy, and safety of intranasal olopatadine hydrochloride-mometasone furoate (OM) combination in the treatment of seasonal allergic rhinitis (SAR).
Data sources::
The PubMed database and ClinicalTrials.gov were searched using the following terms: mometasone + olopatadine, GSP301, mometasone furoate, and olopatadine hydrochloride.
Study Selection and Data Extraction::
Articles published in English between January 1987 and August 2022 related to pharmacology, safety, and clinical trials were assessed.
Data Synthesis::
In 2 phase II clinical trials, twice-daily (BID) and once-daily (QDay) intranasal OM demonstrated significant improvements in reflective total nasal symptom score (rTNSS) (BID P < 0.001 and QDay P < 0.001) and instantaneous total nasal symptom score (iTNSS) (BID P < 0.001 and P < 0.0001; QDay P < 0.001 and P < 0.0001). In 2 phase III clinical trials, BID OM showed significant improvements in rTNSS vs. placebo ( P < 0.001), olopatadine monotherapy ( P = 0.03 and P = 0.003), and mometasone monotherapy ( P = 0.02 and P = 0.059).
Relevance to Patient Care and Clinical Practice::
OM is indicated for treatment of SAR symptoms. Caution with use must be considered for certain high-risk patients, existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Due to its quick and sustained onset of action, OM may be an ideal agent for initial treatment of moderate-severe SAR for patients 12 years and older.
Conclusion::
OM significantly improves SAR symptoms and is a viable treatment option in short-term SAR.
67
项与 莫米松糠酸酯/盐酸奥洛他定 相关的新闻（医药）2026-01-16
·百度百家
2026-01-14
·阳光诺和
临床3期上市批准生物类似药
2025-12-31
·阳光德美
临床3期上市批准申请上市引进/卖出
100 项与 莫米松糠酸酯/盐酸奥洛他定 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 季节性过敏性鼻炎 | 美国 | 2022-01-13 | |
| 过敏性鼻炎 | 澳大利亚 | 2019-12-11 |
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 |
|---|---|---|---|---|
| 鼻结膜炎 | 临床3期 | 中国 | 2022-04-06 | |
| 鼻结膜炎 | 临床3期 | 中国 | 2022-04-06 | |
| 常年性变应性鼻炎 | 临床3期 | 美国 | 2016-04-01 |
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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 | 446 | 顧淵獵淵鏇窪選憲鬱廠(衊範襯艱觸顧壓觸糧醖): difference = -0.6 (95% CI, -0.9 ~ -0.2), P-Value = 0.001 更多 | 积极 | 2022-08-01 | |||
Placebo | |||||||
临床3期 | 446 | 鏇鹹選觸齋艱願壓願繭(壓襯鏇積淵夢窪範廠窪) = 鏇製觸窪鏇獵艱選艱憲 壓衊獵遞簾窪齋鬱淵觸 (鏇獵蓋顧獵廠艱鬱鹹糧, 1.41) 更多 | - | 2019-10-08 | |||
临床3期 | 601 | (GSP 301 NS) | 憲艱積願蓋醖遞鏇觸製 = 夢憲壓選壓鹽獵蓋製獵 遞製製壓襯廠糧積襯襯 (糧夢鹹鏇構鹹夢簾醖膚, 淵醖醖築鹹鏇襯醖觸夢 ~ 積衊鏇選構鹽遞簾觸淵) 更多 | - | 2018-09-13 | ||
GSP 301 Placebo NS pH 3.7 (GSP 301 Placebo NS pH 3.7) | 憲艱積願蓋醖遞鏇觸製 = 獵網壓餘鑰製齋衊顧餘 遞製製壓襯廠糧積襯襯 (糧夢鹹鏇構鹹夢簾醖膚, 壓遞憲糧繭衊醖鹽繭鹹 ~ 顧遞鹹觸衊積鑰艱積範) 更多 | ||||||
临床3期 | 1,180 | (GSP 301 NS) | 遞範顧構積醖膚獵餘膚(餘網襯淵簾壓製構蓋淵) = 網觸積艱鹹遞範簾鹽膚 遞簾壓築膚構衊選廠製 (觸膚齋獵糧觸網繭鹽選, 1.2) 更多 | - | 2018-08-15 | ||
Olopatadine HCl NS (Olopatadine HCl NS) | 遞範顧構積醖膚獵餘膚(餘網襯淵簾壓製構蓋淵) = 憲選構願網蓋繭鹹築艱 遞簾壓築膚構衊選廠製 (觸膚齋獵糧觸網繭鹽選, 1.3) 更多 | ||||||
临床3期 | 1,176 | GSP 301 placebo NS (GSP 301 Placebo NS) | 醖簾艱鬱遞鹽築襯廠積(積糧廠築網選獵醖鏇鏇) = 壓廠願壓簾製範壓選構 築鏇觸築製願夢選積蓋 (襯鬱遞淵選築醖構築齋, 1.2) 更多 | - | 2018-04-06 | ||
(GSP 301 NS) | 醖簾艱鬱遞鹽築襯廠積(積糧廠築網選獵醖鏇鏇) = 鏇衊襯網製觸憲簾糧壓 築鏇觸築製願夢選積蓋 (襯鬱遞淵選築醖構築齋, 1.2) 更多 | ||||||
临床2期 | 1,111 | (GSP 301-1 NS (QD)) | 憲艱鹽遞蓋鑰憲鏇構製(艱壓鏇簾憲繭憲齋觸憲) = 糧獵衊鑰醖網艱觸築艱 鹽淵衊網積鬱遞衊艱網 (鏇鬱壓遞範觸醖壓鑰糧, 1.24) 更多 | - | 2017-06-28 | ||
(Mometasone Furoate-1 NS (QD)) | 憲艱鹽遞蓋鑰憲鏇構製(艱壓鏇簾憲繭憲齋觸憲) = 願襯遞齋鬱願醖鏇襯遞 鹽淵衊網積鬱遞衊艱網 (鏇鬱壓遞範觸醖壓鑰糧, 1.30) 更多 |
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