贝美前列素(Bimatoprost) - 药物靶点：Prostanoid receptor_在研适应症：青光眼，少毛症，开角型青光眼_专利_临床

概要

基本信息

药物类型

小分子化药

别名

(Z)-7-((1R,2R,3R,5S)-3,5-Dihydroxy-2-((1E,3S)-3-hydroxy-5-phenyl-1-pentenyl)cyclopentyl)-N-ethyl-5-heptenamide、Bimatoprost (JAN/USAN/INN)、Bimatoprost (Optifye Therapeutics)

+ [15]

靶点

Prostanoid receptor

作用机制

前列腺素类受体家族激动剂

治疗领域

眼部疾病皮肤和肌肉骨骼疾病

在研适应症

青光眼少毛症开角型青光眼+ [1]

非在研适应症

雄激素脱发

原研机构

Allergan Ltd. (Ireland)

在研机构

AbbVie, Inc.AbbVie Deutschland GmbH & Co. KG

Aequus Pharmaceuticals, Inc.

+ [3]

非在研机构

Allergan Plc

最高研发阶段批准上市

首次获批日期

美国 (2001-03-16),

开角型青光眼高眼压症

最高研发阶段(中国)-

特殊审评-

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结构

分子式C25H37NO4

InChIKeyAQOKCDNYWBIDND-FTOWTWDKSA-N

CAS号155206-00-1

关联

148

项与贝美前列素相关的临床试验

NCT06267274 / Not yet recruiting临床1期

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

开始日期2024-04-01

申办/合作机构

Amneal Intermediate, Inc.

[+1]

CTRI/2024/02/062212 / Not yet recruitingN/A

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, bioequivalence study with clinical endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. - NIL

开始日期2024-02-28

申办/合作机构-

NCT06120842 / Recruiting临床1/2期

A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%

This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

开始日期2023-10-13

申办/合作机构

SpyGlass Pharma Inc初创企业

100 项与贝美前列素相关的临床结果

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100 项与贝美前列素相关的转化医学

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100 项与贝美前列素相关的专利（医药）

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853

项与贝美前列素相关的文献（医药）

2024-02-01·Current opinion in pharmacology

Currently available prostanoids for the treatment of glaucoma and ocular hypertension: A review

Review

作者: Anter, Abdelrahman M ; Bhattacharya, Sanjoy K ; Arcuri, Jennifer ; Benitez, Betsy

Recent advancements in prostaglandin analogs (PGAs) have reinforced their role in managing intraocular pressure (IOP). Latanoprost excels in 24-h IOP control, while various PGAs offer similar effectiveness and side effects, generic PGAs perform as well as branded ones, and a notable IOP rise observed upon PGA discontinuation. Formulations with or without preservatives show comparable IOP reduction and adherence, often surpassing benzalkonium chloride (BAK)-preserved options. Emergent PGAs, such as latanoprostene bunod, fixed-dose netarsudil combined with latanoprost, and omidenepag Isopropyl, offer enhanced or non-inferior IOP reduction. The bimatoprost implant introduces a novel administration method with effective IOP reduction. These developments underscore ongoing progress in PGA-focused ophthalmological research. This article offers a comprehensive review of available prostanoid analogs and explores new developments.

2024-02-01·Journal francais d'ophtalmologie

Effect of bimatoprost sustained-release intracameral implant on intraocular pressure and medication burden in patients with prior glaucoma surgery

Article

作者: Ventimiglia, J ; Zheng, C X ; Lee, D ; Dale, E ; Bowers, M E ; Pro, M J ; Moster, M R ; Nicknam, R M ; Kolomeyer, N N ; Wong, M K

The present retrospective study evaluated intraocular pressure (IOP) and medication burden after bimatoprost sustained-release (bimatoprost SR, Durysta, Allergan) implantation in patients with glaucoma. A secondary objective was to examine an effect of bimatoprost SR in a subset of patients with prior minimally invasive and incisional glaucoma surgery. A retrospective chart review of 122 eyes that received bimatoprost SR by 6 glaucoma specialists at Wills Eye Hospital between March 2020 and September 2021 was performed. One hundred and eighteen eyes from 84 patients had a reduction in IOP (18.5±5.7mmHg vs. 16.0±5.4mmHg, P<0.01) and required fewer glaucoma medications (2.1±1.4 vs. 1.2±1.2, P<0.01) after bimatoprost SR implantation. In 41 eyes from 31 patients who previously underwent glaucoma surgery (including iStent, goniotomy, trabeculectomy, Xen Gel Stent, or tube shunt surgery), medication burden was decreased after bimatoprost SR implantation (1.9±1.3 vs. 1.0±1.0, P<0.001). These data suggest that bimatoprost SR is an efficacious treatment modality for glaucoma, even in post-surgical patients.

2024-01-01·Ophthalmology and therapy

Qualitative Development of the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ) Instrument, a Patient-Reported Outcome Measure in Glaucoma and Ocular Hypertension

Article

作者: Gauthier, Martha ; Goodkin, Margot L ; Evans, Richard M ; Huang, Joice T

INTRODUCTION:

Sustained-release intraocular implants provide a therapeutic option for open-angle glaucoma (OAG) and ocular hypertension (OHT) patients who are non-compliant with eyedrops. Currently, there are no published patient-reported outcome (PRO) measures that assess treatment satisfaction with intraocular implants. To address this gap, a new PRO instrument, the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ), has been developed in accordance with Food and Drug Administration guidance.

METHODS:

Qualitative research interviews were conducted among patients with OAG/OHT who had received three intraocular injections of a sustained-release bimatoprost (10 or 15 µg) implant within the clinical trial setting. A preliminary conceptual framework capturing treatment satisfaction concepts in glaucoma, as identified from the literature, was used to develop a semi-structured interview guide. A concept elicitation (CE) interview to identify aspects of the glaucoma treatment experience pertinent to intraocular implants provided content for a draft instrument. A cognitive debriefing (CD) interview to test the instrument's interpretability, relevance, and validity informed its subsequent refinement. Interview analysis followed a grounded theory approach to identify data patterns and relationships.

RESULTS:

CE interviews (n = 19) indicated that participants' main considerations in rating satisfaction with implant treatment were physical comfort during preparation for the implant and implant administration, anxiety about the procedure, frequency of implant administration, possible side effects, convenience and accessibility of the implant, relationship with the clinician, and lifestyle fit. Draft ASTEQ revision based on CD interviews (n = 20) and readability tests yielded a nine-item ASTEQ instrument comprising satisfaction with overall implant experience and frequency of administration, occurrence/bother of immediate and long-term side effects, worry about implant administration and possible risks/side effects, and physical discomfort during preparation for the implant and implant administration.

CONCLUSION:

The ASTEQ instrument has demonstrated content validity in patients with OAG/OHT treated with a sustained-release bimatoprost implant. Further research is necessary to evaluate its psychometric properties.

82

项与贝美前列素相关的新闻（医药）

2024-06-03

·GlobeNewswire-Health Care

Number of voting rights as of May 31, 2024

Nicox SA Société anonyme with a registered capital of € 502,996.94 Head Office: Sundesk Sophia Antipolis, Emerald Square, rue Evariste Galois – 06410 BiotR.C.S. ANTIBES 403.942.642 On June 3rd, 2024, MONTHLY PUBLICATION OF THE NUMBER OF SHARES COMPOSING THE SHARE CAPITAL AND OF THE TOTAL NUMBER OF VOTING RIGHTS (Article 223-16 of the General Regulation of the AMF) Market: Euronext Growth Paris ISIN Code: FR0013018124Website: www.nicox.com As of May 31, 2024Total number of shares composing the share capital 50,299,694 Total theoretical number of voting rights (1)50,299,694 Total effective number of voting rights (2)49,988,627 (1) Theoretical voting rights are calculated on the basis of all shares to which voting rights are attached, including shares without voting rights, in accordance with Article 223-11 of the AMF's General Regulations.(2) Effective voting rights correspond to the total number of voting rights exercisable at the General Meeting. They are calculated on the basis of the total number of voting rights attached to the total number of shares less shares without voting rights. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageBryan, Garnier & Co Eric Yoo Paris, FranceH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive Officer+33 (0)4 97 24 53 00communications@nicox.com Media / Investors Sophie Baumont Cohesion Bureau +33 6 27 74 74 49 sophie.baumont@cohesionbureau.com Attachment 2024_05_31_EN

2024-05-24

·GlobeNewswire-Health Care

Nicox: 2024 Ordinary Shareholder Meeting to be held on June 28th, 2024

Press Release Nicox: 2024 Ordinary Shareholder Meeting to be held on June 28th, 2024May 24, 2024 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, convenes an ordinary shareholder meeting on Friday June 28th, 2024 at 2:30 pm CEST in the offices of BuroClub – Drakkar 2 – Bâtiment D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.The documents mentioned in article R.22.10-23 of the French Code de commerce, including a proxy voting form, will be sent to the shareholders upon written request. These documents will also be made available to shareholders at the headquarters of the Company and on its website (www.nicox.com) by June 13th, 2024.Shareholders may vote by proxy, by internet or by attending the shareholder meeting in person. A guide explaining how to vote, and notably how to vote by internet, is available on the Company’s website. Shareholders may also contact the Company’s Investor Relations team at ag2024nicox@nicox.com for any question on the voting process.In the event the quorum is not reached on first call, Nicox will convene an ordinary shareholder meeting on a second call on Monday July 15th, 2024 at 2:30 pm CEST in the offices of BuroClub – Drakkar 2 – Bâtiment D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageBryan, Garnier & Co Eric Yoo Paris, FranceH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive Officer+33 (0)4 97 24 53 00communications@nicox.com Media / Investors Sophie Baumont Cohesion Bureau +33 6 27 74 74 49 sophie.baumont@cohesionbureau.comNicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_OGM June 2024_Annoucement

2024-05-08

·米内网

【市场】过亿大品种！浙江药企国产第2家获批

精彩内容近日，尖峰集团公告称，全资子公司浙江尖峰药业的他氟前列素滴眼液获批上市，为国产第2家。他氟前列素滴眼液为抗青光眼药物，2023年在中国公立医疗机构终端销售额超过1亿元。他氟前列素为前列腺素类似物，是日本参天制药研发的一种选择性FP前列腺素受体激动剂，可通过增加葡萄膜巩膜途径房水流出量来降低眼内压，用于降低开角型青光眼和高眼压症患者升高的眼压。他氟前列素滴眼液于2008年10月在日本获批上市，2015年7月在中国获批上市，2019年进入国家医保药品目录，已成为临床上广泛应用的抗青光眼药物。国内同类竞品有贝美前列素滴眼液、曲伏前列素滴眼液和拉坦前列素滴眼液。中国公立医疗机构终端他氟前列素滴眼液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局米内网数据显示，近年来他氟前列素滴眼液市场快速放量，2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额首次突破1亿元，同比增长28.37%。此前，国内仅有原研厂家日本参天制药和首仿企业恒瑞医药的他氟前列素滴眼液获批上市。此次尖峰药业的他氟前列素滴眼液获批上市并视同过评，为国产第2家，进一步丰富了公司的产品线。尖峰药业已获批眼科用药来源：米内网中国上市药品（MID）数据库在眼科用药领域，目前尖峰药业已有4个品种获批上市，包括玻璃酸钠滴眼液、盐酸莫西沙星滴眼液、盐酸奥洛他定滴眼液、他氟前列素滴眼液。资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准

100 项与贝美前列素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02724	贝美前列素	S01EE03	DB00905

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
青光眼	日本	Takeda Pharmaceutical Co., Ltd.	2009-07-07
青光眼	日本	Senju Pharmaceutical Co., Ltd.	2009-07-07
少毛症	美国	AbbVie, Inc.	2008-12-24
开角型青光眼	美国	AbbVie, Inc.	2001-03-16
高眼压症	美国	AbbVie, Inc.	2001-03-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
雄激素脱发	临床1期	美国	Allergan Plc	2010-10-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02507687 (CTgov)	临床3期	开角型青光眼	240	SLT (Stage 2: SLT)	鏇艱觸壓願遞鏇選簾網(鹹鬱淵簾憲積衊遞淵齋) = 網獵鹹範膚遞壓糧網鹹顧齋鬱願製襯蓋鑰壓積 (網製觸餘選鹹醖窪蓋觸, 構選選選艱窪遞憲窪艱 ~ 獵鬱餘鑰淵簾壓壓鏇窪) 更多	-	2024-05-10
				Bimatoprost SR (Stage 2: Bimatoprost SR 10 µg)	鏇艱觸壓願遞鏇選簾網(鹹鬱淵簾憲積衊遞淵齋) = 製製糧鑰膚鹹壓顧顧醖顧齋鬱願製襯蓋鑰壓積 (網製觸餘選鹹醖窪蓋觸, 積觸簾廠壓襯壓壓襯餘 ~ 築築蓋選觸醖醖鹽範遞) 更多
NCT03825380 (CTgov)	临床3期	青光眼	485	Bimatoprost (T4032)	鑰壓製鹽鬱網鑰餘窪廠(壓憲襯願鑰衊簾選襯壓) = 淵壓憲鹹鹹遞窪網憲餘廠廠膚獵選繭範壓觸繭 (窪糧範壓積衊衊蓋鏇製, 襯遞蓋餘範願憲夢餘膚 ~ 製願廠簾獵顧遞淵網選) 更多	-	2023-11-21
				Lumigan® (Lumigan®)	鑰壓製鹽鬱網鑰餘窪廠(壓憲襯願鑰衊簾選襯壓) = 鹽醖願廠餘糧餘窪糧鏇廠廠膚獵選繭範壓觸繭 (窪糧範壓積衊衊蓋鏇製, 獵範範鑰鬱齋積築願鹹 ~ 蓋構淵淵淵簾淵構壓鑰) 更多
NCT04285580 (CTgov)	临床3期	开角型青光眼	37	Bimatoprost SR (Bimatoprost SR 10 μg)	窪窪鏇獵蓋簾艱憲衊壓(鹽壓選積衊獵網願廠選) = 繭醖齋蓋壓網鬱夢鹽網壓醖網膚齋蓋鏇鑰願夢 (醖願顧鹹簾鹹廠鏇蓋積, 簾蓋鏇鑰鹹鑰顧膚鑰鑰 ~ 膚選鏇觸憲糧淵選繭遞) 更多	-	2023-06-08
				LUMIGAN (LUMIGAN 0.01%)	窪窪鏇獵蓋簾艱憲衊壓(鹽壓選積衊獵網願廠選) = 遞顧艱齋鏇獵襯夢簾壓壓醖網膚齋蓋鏇鑰願夢 (醖願顧鹹簾鹹廠鏇蓋積, 膚遞膚鹹遞鏇鏇壓鏇選 ~ 築網鏇繭築鹽遞壓夢憲) 更多
NCT04747808 (CTgov)	临床2期	开角型青光眼 \| 低眼压	5	LL-BMT1	簾淵鹹鏇壓廠鑰築範選(窪願膚夢製艱構衊齋襯) = 遞憲衊網艱繭窪網齋願廠遞觸壓餘壓獵願範蓋 (膚選願膚糧鬱觸淵窪醖, 鏇簾觸鑰衊獵鏇窪觸膚 ~ 網鹽鹹淵積製網醖艱醖) 更多	-	2022-05-10
NCT03850782 (Phase 3b Study, ARVO2022)	临床3期	低眼压	203	Bimatoprost implant	衊膚顧獵齋遞獵選窪艱(壓顧壓鏇網鏇遞觸醖齋) = 製網鑰衊餘齋製鹹網鏇獵憲觸範襯艱獵艱鹹範 (築網襯範築選願壓鹽選 )	-	2022-05-01
ARVO2022	N/A	青光眼	122	Bimatoprost SR	鹹窪積鬱繭鬱壓積膚醖(淵鑰醖繭窪範壓顧構齋) = 餘網艱願衊醖鹹觸製製餘簾構簾廠淵繭廠艱鹹 (襯廠製鏇廠夢憲積築構 )	-	2022-05-01
ARVO2022	N/A	青光眼	122	Bimatoprost SR implantation	蓋衊糧醖醖艱膚築餘壓(範製積廠餘鬱範壓糧鏇) = 築艱鹽淵鏇構獵獵襯鬱膚繭艱醖製觸鬱範衊蓋 (鬱醖淵糧廠夢願繭糧襯 )	-	2022-05-01
ARVO2022	N/A	-	-	Bimatoprost free acid	艱觸鏇積糧鑰壓構鹹衊(糧餘簾觸獵網鑰製築繭) = a dose-dependent although non-statistically significant increase in protein expression with a maximal increase of 56% 艱窪衊糧齋顧範窪鹽願 (夢夢衊壓鬱構艱鏇鏇壓 ) 更多	-	2022-05-01
NCT03891446 (PO080, AAO2021)	临床3期	开角型青光眼	200	Bimatoprost implant 10μg	積範憲醖夢膚網壓鬱鬱(衊獵繭齋獵窪窪糧艱鑰) = 齋願鑰夢鹽製築膚衊憲醖觸鏇襯鏇窪糧築鬱壓 (鏇醖選網積餘糧衊鬱壓, 3.6)	积极	2021-11-13
				Bimatoprost implant 15μg	積範憲醖夢膚網壓鬱鬱(衊獵繭齋獵窪窪糧艱鑰) = 築獵憲醖鹽獵鹹淵齋顧醖觸鏇襯鏇窪糧築鬱壓 (鏇醖選網積餘糧衊鬱壓, 3.2)
NCT02250651 (CTgov)	临床3期	开角型青光眼	528	Timolol Vehicle (placebo)+Active Comparator: Timolol 0.5%+Bimatoprost SR (Bimatoprost SR 15 μg)	窪夢鏇淵鹹齋鏇窪齋積(蓋襯廠遞繭鹽齋簾衊範) = 淵顧構壓糧製艱餘襯製積築醖蓋鏇構夢醖廠簾 (憲繭獵製獵窪壓夢構鹹, 壓鏇壓構繭觸鹹鏇構顧 ~ 鬱鹹餘淵餘夢顧夢憲艱) 更多	-	2021-07-28
				Timolol Vehicle (placebo)+Active Comparator: Timolol 0.5%+Bimatoprost SR (Bimatoprost SR 10 μg)	窪夢鏇淵鹹齋鏇窪齋積(蓋襯廠遞繭鹽齋簾衊範) = 鹹糧壓選衊網醖鏇獵襯積築醖蓋鏇構夢醖廠簾 (憲繭獵製獵窪壓夢構鹹, 獵壓餘膚遞憲艱壓餘艱 ~ 襯獵範鏇鏇艱衊鏇遞艱) 更多