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更新于：2026-02-27
Bimatoprost/Timolol Maleate
贝美素噻吗洛尔
更新于：2026-02-27
概要
基本信息
药物类型 小分子化药 |
别名 Bimatoprost and Timolol Maleate、Bimatoprost/Timolol、Ganfort + [6] |
作用方式 激动剂、拮抗剂 |
作用机制 前列腺素类受体家族激动剂、β-adrenoceptors拮抗剂(β-肾上腺素能受体家族拮抗剂) |
治疗领域 |
非在研适应症- |
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
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C25H37NO4 |
InChIKeyAQOKCDNYWBIDND-FTOWTWDKSA-N |
CAS号155206-00-1 |
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关联
23
项与 贝美素噻吗洛尔 相关的临床试验CTRI/2021/04/033213
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
NCT04898387
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
CTR20150389
评价贝美素噻吗洛尔滴眼液治疗开角型青光眼或高眼压症且对β-block或前列腺素类似物疗效不佳的中国患者长期安全性
100 项与 贝美素噻吗洛尔 相关的临床结果
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100 项与 贝美素噻吗洛尔 相关的转化医学
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100 项与 贝美素噻吗洛尔 相关的专利（医药）
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18
项与 贝美素噻吗洛尔 相关的文献（医药）2024-01-01Graefe's Archive for Clinical and Experimental Ophthalmology
MERCURY-3: a randomized comparison of netarsudil/latanoprost and bimatoprost/timolol in open-angle glaucoma and ocular hypertension
Article
作者: Lim, Kin Sheng ; Schweitzer, Cédric ; Fichtl, Marek ; Oddone, Francesco ; Belda, Jose I ; Stalmans, Ingeborg ; Laganovska, Guna ; Hommer, Anton ; Holló, Gábor ; Voykov, Bogomil ; Zarnowski, Tomasz
Abstract:
Purpose :
To compare the efficacy and safety of the fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (NET/LAT; Roclanda®) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®) ophthalmic solution in the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).
Methods:
MERCURY-3 was a 6-month prospective, double–masked, randomized, multicenter, active-controlled, parallel-group, non-inferiority study. Patients (≥ 18 years) with a diagnosis of OAG or OHT in both eyes that was insufficiently controlled with topical medication (IOP ≥ 17 mmHg in ≥ 1 eye and < 28 mmHg in both eyes) were included. Following washout, patients were randomized to once-daily NET/LAT or BIM/TIM for up to 6 months; efficacy was assessed at Week 2, Week 4, and Month 3; safety was evaluated for 6 months. Comparison of NET/LAT relative to BIM/TIM for mean IOP at 08:00, 10:00, and 16:00 h was assessed at Week 2, Week 6, and Month 3. Non-inferiority of NET/LAT to BIM/TIM was defined as a difference of ≤ 1.5 mmHg at all nine time points through Month 3 and ≤ 1.0 mmHg at five or more of nine time points through Month 3.
Results:
Overall, 430 patients were randomized (NET/LAT, n = 218; BIM/TIM, n = 212), and all received at least one dose of study medication. Efficacy analyses were performed at Month 3 on 388 patients (NET/LAT, n = 184; BIM/TIM, n = 204). NET/LAT demonstrated non-inferiority to BIM/TIM, with a between-treatment difference in IOP of ≤ 1.5 mmHg achieved at all time points and ≤ 1.0 mmHg at the majority of time points (six of nine) through Month 3. Mean diurnal IOP during the study ranged from 15.4 to 15.6 mmHg and 15.2 to 15.6 mmHg in the NET/LAT and BIM/TIM groups respectively, with no between-group statistically significant difference. No significant differences were observed in key secondary endpoints. No serious, treatment-related adverse events (AEs) were observed, and AEs were typically mild/moderate in severity. The most common treatment-related AEs were conjunctival hyperemia (NET/LAT, 30.7%; BIM/TIM, 9.0%) and cornea verticillata (NET/LAT, 11.0%; BIM/TIM, 0%).
Conclusions:
Once-daily NET/LAT was non-inferior to BIM/TIM in IOP reduction in OAG and OHT, with AEs consistent with previous findings. NET/LAT offers a compelling alternative FDC treatment option for OAG and OHT.
2023-05-04Current medical research and opinion
A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension
Article
作者: Mrukwa-Kominek, Ewa ; Stalmans, Ingeborg ; Garhofer, Gerhard ; Misiuk-Hojlo, Marta ; Csutak, Adrienne
OBJECTIVE:
To compare the efficacy and safety of two fixed combination, preservative-free eye drops (bimatoprost 0.01% in combination with either timolol 0.1% or 0.5%) in a gel formulation, with bimatoprost 0.03%/timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
METHODS:
Phase II, randomized, investigator-masked, multicenter, 3-arm parallel group (Eudract No. 2017-002823-46). Eighty-six patients aged ≥18 years with OAG or OHT, with intraocular pressure (IOP) initially controlled for at least 6 months by a combination therapy of a dual prostaglandin and timolol or insufficiently controlled by first-line monotherapy were included. Patients were randomized to receive T4030a (bimatoprost 0.01%/timolol 0.1%; N = 29), T4030c (bimatoprost 0.01%/timolol 0.5%; N = 29) or bimatoprost 0.03%/timolol 0.5% (N = 28), administered once daily in the evening for 12 weeks. Primary endpoint was defined as change in IOP from day 1 to week 12 measured at 08:00 (±1 h). Further efficacy, safety and pharmacokinetic endpoints were assessed as secondary outcomes.
RESULTS:
The mean change in IOP from baseline to week 12 was -9.8 ± 2.1 mmHg for T4030a, -10.1 ± 2.5 mmHg for T4030c and -10.0 ± 2.8 mmHg for bimatoprost 0.03%/timolol 0.5%. All treatments were well tolerated with no safety issues identified in any group. In patients treated with T4030a, the systemic concentration of timolol was significantly lower after 12 weeks than in patients treated with T4030c or bimatoprost 0.03%/timolol0.5%.
CONCLUSIONS:
These study results suggest that the preservative-free ophthalmic formulation of T4030a (bimatoprost 0.01%/timolol 0.1%) can be regarded as a useful tool in the therapeutic management of OAG and OHT.
2023-02-01Ophthalmology and therapy
Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
Article
作者: Yang, Jingyuan ; Duan, Xuanchu ; Goodkin, Margot L ; Xing, Xiaoli ; Chen, Michelle Y ; Yao, Ke ; Liu, Qinghuai ; Yu, Minbin ; Fang, Aiwu ; Sun, Xinghuai ; Zhang, Hong
INTRODUCTION:
Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort®, Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
METHODS:
In this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks.
RESULTS:
Of 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related.
CONCLUSIONS:
The frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT.
CLINICALTRIALS:
GOV IDENTIFIER:
NCT02571712.
100 项与 贝美素噻吗洛尔 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 |
|---|---|---|---|
| 开角型青光眼 | 欧盟 | 2006-05-19 | |
| 开角型青光眼 | 冰岛 | 2006-05-19 | |
| 开角型青光眼 | 列支敦士登 | 2006-05-19 | |
| 开角型青光眼 | 挪威 | 2006-05-19 | |
| 高眼压症 | 欧盟 | 2006-05-19 | |
| 高眼压症 | 冰岛 | 2006-05-19 | |
| 高眼压症 | 列支敦士登 | 2006-05-19 | |
| 高眼压症 | 挪威 | 2006-05-19 |
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 |
|---|---|---|---|---|
| 青光眼 | 临床3期 | 美国 | 2001-08-01 | |
| 青光眼 | 临床3期 | 加拿大 | 2001-08-01 |
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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 | - | 鏇繭鹹壓蓋膚鹹夢積鑰(廠鹽顧廠鹹窪艱齋遞醖) = 廠獵糧鹽淵獵壓積積鹽 鹹襯繭築齋鬱繭艱願願 (積範糧獵醖積鹹夢艱壓, 3.43) 更多 | 积极 | 2025-10-14 | |||
鏇繭鹹壓蓋膚鹹夢積鑰(廠鹽顧廠鹹窪艱齋遞醖) = 範衊鏇鹽選夢簾衊網衊 鹹襯繭築齋鬱繭艱願願 (積範糧獵醖積鹹夢艱壓, 3.56) 更多 | |||||||
N/A | 90 | Fixed-combination bimatoprost/timolol | 鏇積襯憲願襯衊獵膚觸(齋膚簾積築範餘窪蓋鏇) = 蓋願醖繭廠夢壓艱襯築 簾鏇窪廠廠遞鏇願鏇願 (餘艱構鏇選膚鑰積齋衊 ) 更多 | - | 2014-12-19 | ||
Fixed-combination dorzolamide/brimonidine/timolol | 鏇積襯憲願襯衊獵膚觸(齋膚簾積築範餘窪蓋鏇) = 遞鹽獵襯願網簾鹽衊鬱 簾鏇窪廠廠遞鏇願鏇願 (餘艱構鏇選膚鑰積齋衊 ) 更多 | ||||||
临床3期 | 561 | (Bimatoprost/Timolol Formulation A) | 繭製鹹簾網膚築製窪鏇(築憲選積艱網淵糧鬱觸) = 製鹹襯鹽壓廠鹽鹽鏇齋 願製鹹夢糧鹽餘齋製蓋 (鬱衊壓鹹衊鏇簾鹽鬱鏇, 2.232) 更多 | - | 2013-03-12 | ||
(Bimatoprost/Timolol Fixed Combination Ophthalmic Solution) | 繭製鹹簾網膚築製窪鏇(築憲選積艱網淵糧鬱觸) = 鏇築觸選艱觸淵艱衊鏇 願製鹹夢糧鹽餘齋製蓋 (鬱衊壓鹹衊鏇簾鹽鬱鏇, 2.209) 更多 | ||||||
临床4期 | 81 | (Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution) | 鏇糧獵鹽鬱築繭壓醖壓(遞餘鏇憲積獵膚壓顧鏇) = 構壓願壓觸醖獵齋鬱鬱 廠範顧衊築觸鑰觸餘憲 (蓋鹽製製憲範築築築醖, 3.35) 更多 | - | 2013-02-26 | ||
(Latanoprost 0.005% Ophthalmic Solution) | 鏇糧獵鹽鬱築繭壓醖壓(遞餘鏇憲積獵膚壓顧鏇) = 齋齋觸觸積鑰繭廠鬱鑰 廠範顧衊築觸鑰觸餘憲 (蓋鹽製製憲範築築築醖, 2.57) 更多 | ||||||
N/A | 235 | (0.03% Bimatoprost/0.5% Timolol in Same Bottle) | 鏇簾築廠醖壓願獵夢餘(築餘衊簾範鹽衊選窪顧) = 淵憲築淵淵獵遞糧網淵 餘廠夢齋築選鏇衊遞簾 (艱醖網鏇願積蓋獵艱衊, 3.06) 更多 | - | 2012-01-20 | ||
(0.03% Bimatoprost and 0.5% Timolol in Separate Bottles) | 鏇簾築廠醖壓願獵夢餘(築餘衊簾範鹽衊選窪顧) = 鑰壓簾獵糧餘淵淵築選 餘廠夢齋築選鏇衊遞簾 (艱醖網鏇願積蓋獵艱衊, 3.88) 更多 | ||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 簾艱鏇衊鹹糧積膚窪選(餘衊築糧簾願獵網憲淵) = 顧鏇糧鏇蓋願鏇繭獵築 蓋製願範鬱鑰餘願襯廠 (鏇觸壓餘憲鬱鑰蓋顧窪 ) 更多 | - | 2010-02-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 簾艱鏇衊鹹糧積膚窪選(餘衊築糧簾願獵網憲淵) = 齋繭網廠遞鏇願衊繭鏇 蓋製願範鬱鑰餘願襯廠 (鏇觸壓餘憲鬱鑰蓋顧窪 ) 更多 | ||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 築淵範顧廠鏇窪膚壓窪(壓衊願構衊夢築廠淵繭) = 願選蓋醖餘鬱範選遞膚 鏇憲襯壓顧願鑰鹽夢顧 (鹽鏇衊襯艱顧鏇範襯鑰 ) | - | 2009-04-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 築淵範顧廠鏇窪膚壓窪(壓衊願構衊夢築廠淵繭) = 製顧簾獵鏇憲衊夢鹽餘 鏇憲襯壓顧願鑰鹽夢顧 (鹽鏇衊襯艱顧鏇範襯鑰 ) | ||||||
临床3期 | 1,061 | 膚壓蓋糧積糧膚鹹鑰繭(廠簾網膚鹹鑰糧夢鬱糧) = GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles 鏇壓淵繭鏇遞鹹憲簾願 (鏇齋製淵壓範積艱選夢 ) | 积极 | 2007-05-01 | |||
Bimatoprost |
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