奈帕芬胺(Nepafenac) - 药物靶点：COX_在研适应症：黄斑水肿，术后炎症，眼部炎症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

2-amino-3-benzoylbenzeneacetamide、Ilevro、Nepafenac (JAN/USAN/INN)

+ [7]

靶点

COX

作用机制

COX抑制剂(环氧化酶抑制剂)

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [3]

在研适应症

黄斑水肿术后炎症眼部炎症+ [4]

非在研适应症

白内障细菌性结膜炎眼睛疼痛+ [1]

原研机构

Alcon AG

在研机构

Novartis Europharm Ltd.Novartis Pharmaceuticals Australia Pty Ltd.

Novartis Pharma KK

+ [2]

非在研机构

Alcon Research Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2005-08-19),

炎症疼痛

最高研发阶段(中国)无进展

特殊审评-

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结构/序列

分子式C15H14N2O2

InChIKeyQEFAQIPZVLVERP-UHFFFAOYSA-N

CAS号78281-72-8

关联

59

项与奈帕芬胺相关的临床试验

CTRI/2024/05/066781

/ Not yet recruitingN/A

Impact Of 0.1% nepafenac on macular and choroidal thickness after uncomplicated Phacoemulsification surgery - nil

开始日期2024-05-14

申办/合作机构-

CTRI/2023/03/050910

/ Not yet recruitingN/AIIT

Assessment of the effects of topical post operative administration of nepafenac 0.1% eye drops on occurrence of macular edema in patients undergoing manual small incision cataract surgery-a triple blinded randomisation control trail

开始日期2023-03-31

申办/合作机构-

CTRI/2023/03/050650

/ Not yet recruitingN/A

Effect of perioperative topical nepafenac 0.3% on central macular thickness after cataract surgery in patients with diabetes: A randomized controlled trial

开始日期2023-03-16

申办/合作机构

Pondicherry Institute of Medical Sciences

100 项与奈帕芬胺相关的临床结果

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100 项与奈帕芬胺相关的转化医学

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100 项与奈帕芬胺相关的专利（医药）

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271

项与奈帕芬胺相关的文献（医药）

2024-12-01·Ophthalmology and Therapy

Postoperative Pain Comparison Between Alcohol-Assisted and Transepithelial Photorefractive Keratectomy Using Nepafenac Treatment: A Novel Study

Article

作者: Achiron, Asaf ; Levinger, Eliya ; Gomel, Nir ; Levinger, Nadav ; Sorkin, Nir ; Hirsch, Ami ; Levinger, Shmuel ; Shemesh, Nadav

INTRODUCTION:

The study aimed to compare postoperative pain between alcohol-assisted and transepithelial photorefractive keratectomy in patients who received the novel analgesic preoperative nepafenac treatment 2 days preoperatively and 3 days postoperatively. Pain, stinging, tearing, light sensitivity, and stress levels were evaluated.

METHODS:

The study included a retrospective analysis of 55 patients divided into two groups: bilateral alcohol-assisted photorefractive keratectomy (aa-PRK) and transepithelial photorefractive keratectomy (transepithelial-PRK). Nepafenac was administered for pain control for all patients, with patients receiving four drops for 2 days before the surgery and 3 days postoperatively per clinical instructions. Patients completed questionnaires on the day of the surgery and for the first 5 days postoperatively. Statistical analysis was performed using XLSTAT (version 2023.1.2). t-Test was used to analyze and compare pain and symptom levels and Fisher's exact test for categorical data. p-Values less than 0.05 were considered statistically significant.

RESULTS:

The study examined 55 patients (49% female) with a mean age of 25.11 ± 6.81 years who had undergone bilateral surface refractive surgery to correct myopic errors. The mean baseline standard error (SE) was -3.16 ± 2.20 D. Among these patients, 27 patients underwent aa-PRK and 28 patients underwent transepithelial-PRK. Higher levels of pain were significant in the aa-PRK group (p = 0.003). However, there was no significant difference between the groups in the average levels of stinging, tearing, or light sensation. Additionally, stress levels decreased over time in both groups, with levels becoming almost equal after 5 days, and there was no significant difference in the average stress levels between the two groups.

CONCLUSIONS:

The study found that patients who underwent the transepithelial-PRK procedure had significantly lower pain levels compared with those who underwent aa-PRK after being treated with nepafenac per protocol. However, there was no significant difference between the two groups in terms of stinging, tearing, light sensation, and stress levels.

2024-12-01·EYE

Topical NSAIDs impact on macular oedema and visual outcome after phacoemulsification: systematic review of RCTs with network meta-analysis

Review

作者: Gavris, Iulia ; Almasri, Malaz ; Nicoara, Simona Delia ; Leucuta, Daniel-Corneliu ; Gavris, Monica M ; Ismaiel, Abdulrahman

Abstract:

The aim of this Network Meta-analysis was to compare the efficacy of the different topical Nonsteroidal anti-inflammatory drugs (NSAIDs) when added or not to topical steroids in preventing the thickening of the macula and their impact on visual acuity and intraocular pressure after phacoemulsification. Five electronic databases were searched, including PubMed, Embase, Scopus, Cochrane Library, and ClinicalTrials.gov. Our primary outcome was one-month post-surgery visual outcome. We also considered change in Foveal thickness (FT) and Intraocular pressure (IOP) at one-month post-surgery. We summarized our analyses by calculating the mean differences (MD) with associated 95% confidence intervals (CI) using restricted maximum likelihood in random effects models for continuous outcomes. The methodological quality of the studies was assessed with Cochrane Collaboration’s tool. The network meta-analysis was conducted using frequentist approach considering Nepafenac 0.1% as a reference medication. Eleven Randomized controlled trials (RCTs) including 2175 subjects were selected for quantitative analysis. At one-month post-surgery, Bromfenac had statistically significant better visual acuity compared to Nepafenac 0.1% (p < 0.001), regarding FT, Nepafenac 0.3% had the least increase in FT compared to Nepafenac 0.1% (p = 0.09), regarding IOP, Diclofenac had the lowest IOP. No significant results regarding FT and IOP. Interestingly Ketorolac had the worst results regarding BCVA and IOP, and came last but one for FT. Overall, our network meta-analysis demonstrated that Bromfenac was associated with a significant improvement in visual acuity compared to Nepafenac 0.1% at one-month following cataract surgery, while Nepafenac 0.3% was associated with the least increase in foveal thickness.

2024-09-01·Retinal cases & brief reports

MEDICAL THERAPY FOR LARGE IDIOPATHIC FULL-THICKNESS MACULAR HOLES

Article

作者: Sheng, Young ; Narayanan, Raja ; Jain, Mukesh ; Stewart, Michael W. ; Reddy, Nikitha ; Sahoo, Niroj ; Narula, Ritesh ; Tyagi, Mudit

Purpose::

To describe the characteristics and outcomes of eyes with idiopathic full-thickness macular holes that underwent initial medical management.

Methods::

This retrospective study included eyes with full-thickness macular holes that were initially managed with 1 month of topical therapy. Eligible subjects were treated with dorzolamide 2% three times a day, nepafenac 0.1% twice a day, and prednisolone acetate 1% four times a day. The primary end points was hole closure at one month and secondary end point was change in best-corrected visual acuity.

Results::

Ten subjects (mean age: 62.80 years; female: 50%) with unilateral full-thickness macular holes were studied. The mean basal diameter of the entire cohort at baseline was 824.1 µm (median 828 µm). Four (40%) of the smaller holes (mean 698 µm; median 698.50 µm) closed after 1 month of topical therapy, whereas larger holes (mean 908.17 µm; median 889.50 µm) did not close. In one eye, the hole reopened 4 months after stopping the medication but closed again at 1 month after restarting the topical treatment. Median best-corrected visual acuity improved from 0.35 logMAR at baseline to 0.05 logMAR in eyes that closed but remained at 0.70 logMAR at 1 month in eyes that did not close.

Conclusion::

Topical corticosteroid, nonsteroidal antiinflammatory, and carbonic anhydrase inhibitor therapy may promote closure of small full-thickness macular holes, but large holes are less likely to respond. One month of topical therapy might avoid subjecting some patients to complex vitreoretinal surgery without compromising visual outcomes. Macular hole may reopen after stopping the topical therapy.

11

项与奈帕芬胺相关的新闻（医药）

2024-11-19

·药事纵横

从上市产品看纳米晶药物的开发策略

纳米晶体药物（nanocrystal，NC）是通过自上而下、自下而上或两者结合的方式制备的纯药物纳米颗粒，通过稳定剂的稳定作用，分散在水中形成稳定混悬体系。与其他药物递送系统相比，NC具有许多优势。这些优势可以总结如下： 1.NC通过增加活性物质的溶解度，以及增加对细胞表面膜的粘附，提高药物的生物利用度，且生物利用度变异较小。2. 生产简单、成本低，无明显规模效应。3.药物含量很高，在治疗中使用的剂量少。此外，除口服途径外，NC还可以用于肠外、肺、局部和眼科给药途径。因此，纳米晶药物成为近年来药物递送系统开发热点，本文通过已上市纳米晶药物分析纳米晶药物开发策略。一、口服药物开发口服药物开发纳米晶形式一般是为了增强难溶性药物溶解度，从而提高生物利用度。或减少药物使用剂量。通过Bottom up或Top Down方法所制得的纳米晶药物一般以液态形式存在，已上市药物中除Megace ES甲地孕酮直接以混悬液形式给药外，其余产品均转化为片剂或胶囊剂，从而提高药物的稳定性，和患者用药的依从性。喷雾干燥、流化床顶喷制粒及包衣技术是常用制成固体的手段。湿法制粒，需要关注纳米晶药物聚集对粒径的影响，压片机压力影响晶体结构等。因此一些产品将纳米结晶中间体以包衣形式包裹在空白片芯表面而完全避免压力的产生。例如：按照专利US5989591 Wyeth公司开发西罗莫司片工艺为湿法研磨制备平均粒径通常小于约400 nmAPI/泊洛沙姆 188分散体。将蔗糖添加到分散体中，并混合直至溶解。添加聚维酮并混合直至充分润湿。将混合物剧烈混合以溶解。加入微晶纤维素并充分混合直至润湿。加入水（约 2-55 毫克），充分混合，将混合物喷涂到空白片芯上（片芯含有乳糖、微晶纤维素、PEG-6000和其他粘合剂和填充剂）。药代动力学研究表明与口服溶液相比，服用片剂后西罗莫司的平均生物利用度可提高约27%。以下列举部分纳米晶上市口服制剂。二、注射药物开发与传统的注射剂相比，NC具有载药量高、辅料含量较少以及安全性较高等显著优势。静脉注射是NC起效最快、生物利用度最高的给药方式。肌内注射NC后会在注射部位形成一个药物储库，药物从中缓慢释放。在开发用于肠外给药的新型药物递送系统时，递送系统不应被网状内皮系统和肝脏中的 Kupffer 细胞吞噬。因此，NC 的粒径是影响其肠外给药后药动学行为的一个重要质量属性。此外，稳定剂的种类和浓度是肠外给药NC 开发的关键，对其在体内的安全性和释放行为具有重要影响。 2020，Anjes首个每日一次的静脉止痛剂作为静脉注射的纳米晶产品上市，为美洛昔康纳米混悬液。与口服制剂相比起效快，可以为急性疼痛提供快速和持续的治疗。每 mL 水性分散体中含有 30 mg 美洛昔康，9 mg聚维酮、3 mg脱氧胆酸钠、60毫克蔗糖。采用研磨工艺，平均粒径为130nm左右。与口服美洛昔康片相比，Anjeso的达峰时间缩短50多倍，药峰浓度增加4.6倍，生物利用度提高约1倍，通过增加载药量止痛时间可以延长至24h。遗憾的是该药于2022年撤市。 2021年，Janssen的Invega Hafyera上市，为每6个月肌注一次的棕榈酸帕利哌酮纳米晶，非活性成分为聚山梨醇酯 20、聚乙二醇 4000、柠檬酸一水合物、磷酸二氢钠一水合物、氢氧化钠。与口服药物相比，本品在精神分裂症治疗中具有许多优势，包括提高患者的依从性、避免反复提醒患者用药、降低意外或过量服药风险等。半年给药一次长效针剂能更好地支持疾病管理，助力患者实现回归家庭和社会的终极目标。部分上市的纳米晶注射制剂如下表。三、眼部药物开发 NC 可以通过延长药物在眼表的滞留时间以及促进药物角膜渗透，进而提高眼部生物利用度，降低全身不良反应。此外，生理条件下角膜上皮细胞荷负电，故带正电的NC 可与其发生静电相互作用，有助于它们粘附在角膜上从而延长制剂的滞留时间。NC 可以解决与药物溶液引流、泪液周转、稀释或流泪相关的主要问题。2012 年，FDA 批准了首个眼用纳米晶体制剂奈帕芬胺滴眼液（Ilevro®），用于治疗眼部术后的疼痛和炎症。处方含有：硼酸、丙二醇、卡波姆974P、氯化钠、瓜尔胶、羧甲基纤维素钠、醋酸二钠、苯扎氯铵0.005%（防腐剂）、氢氧化钠和/或调节pH值的盐酸和纯净水。2018年Kala Pharmaceuticals Inc，推出Inveltys®（氯替泼诺纳米晶体混悬液1%）每日2次用于治疗眼科手术后炎症和疼痛的皮质类固醇药物。它设计为早上和晚上使用，作用可持续长达 12 小时。2021年又推出EYSUVIS（氯替泼诺纳米晶体混悬液2.5%）用于短期（最多两周）治疗干眼症的体征和症状。是首个也是唯一一个获FDA批准的用于治疗干眼症的皮质类固醇激素药物。两者辅料均为甘油、柠檬酸二水合物、泊洛沙姆407、氯化钠、乙二胺四乙酸二钠二水合物、柠檬酸、苯扎氯铵0.01%。四、经皮给药 NC可以改善药物溶解度并延长药物在皮肤部位的滞留时间，有望提高药物的皮肤渗透性和生物利用度。NC 饱和溶解度的增加使其与角质层之间的浓度梯度增大，从而加快药物的被动扩散速率。NC 的亚微米尺寸会使其与皮肤的接触面积扩大，黏附性增强，从而延长在皮肤上的滞留时间。此外，通过在 NC的结构中选择带正电荷的聚合物，可以增加对带负电荷的角质层的渗透。2005 年6 月由UMeWorldLtd开发的Indaflex cream® 是含有2.5% 吲哚美辛NC以改善吲哚Indaflex cream® 美辛的渗透性和全身不良反应。在墨西哥治疗关节炎上市。尽管NC 在经皮给药中具有其独特优势，但目前市场上这种制剂产品较少。可能是因为透皮制剂需要载入合适的基质或载体制成膏剂、凝胶剂等，这一过程增加了制备工艺的复杂性和生产成本。目前开发较为热门的微针制剂可以直接以液体给药或许可以为NC药物经皮给药打开新的思路。总结：纳米晶体技术使大量难溶性药物成药可能性增加，并为需要延长给药时间、提高临床顺应性的疾病提供了一种新的选择。目前已有多种NC药物上市，通过不同给药方式发挥治疗作用。此外，也有多种药物进入临床，在更多的给药途径中发挥作用。如2020 年6 月，FDA 批准了用于治疗NSCLC 的NanoPac®的IND 申请，这是一种紫杉醇NC，雾化后经肺部吸入给药，持续地将高浓度药物运送到肿瘤病灶区。相信随着纳米晶体技术不断成熟，审评指导原则的不断完善，越来越多的纳米晶药物可以进入临床，推向市场。参考文献： 1. US5989591 2.US11666697 3. Pınar, S.G.; Oktay, A.N.; Karaküçük, A.E.; Çelebi, N. Formulation Strategies of Nanosuspensions for Various Administration Routes. Pharmaceutics 2023, 15, 1520. https://doi.org/10.3390/pharmaceutics15051520 4.各产品说明书药事纵横征稿启事

2024-02-02

·药通社

南京润瞳畅达——专业从事新药研发、药品注册等技术服务| 直击MAH&DDS制剂合作大会

2024.3.1-2 • 中国南京2023MAH&DDS制剂合作大会展位号：M15号展位分布▼ 企业简介南京润瞳畅达医药科技有限公司（原双科医药）是一家专业从事新药研发、药品注册等技术服务的CRO公司。成立于1995年12月，位于南京市江宁CBD中心，拥有3000多平的实验室，团队具有20多年新药研发经验，配备HPLC、GC、LC-MS、GC-MS、ICP-MS、AAS等多元化的高端精密仪器（总价值超过2000万）。主要业务聚焦于高变异口服固体制剂、眼用制剂（溶液型、混悬型）的开发。主营业务 CRO服务3000平的药学研发实验室20多年药品研发经验的技术团队专业的临床CRO服务专属的I期临床研究机构注册咨询前期立项调研药品注册问题咨询B证代持“海南润瞳”为MAH公司具有完善的质量体系，提供B证短期或长期代持服务，依托海南政策优势，可享品种落地补助及税收优惠。第三方审计原辅包供应商审计委托生产企业审计委托检测、研发审计临床相关机构审计研发优势 01品种优势我公司核心优势品种：高变异口服固体制剂（替米沙坦片及其相关复方制剂、奥美拉唑肠溶胶囊）、高难度眼用制剂奈帕芬胺混悬滴眼液等。① 高变异口服固体制剂替米沙坦片和奥美拉唑肠溶胶囊均为业界公认的仿制难度较高的品种，在人体内的变异系数都比较高，许多企业委托我公司开发（见下表），其中不乏综合实力比较强的知名药企和上市公司，如上海信谊天平、上海现代制药、万杰制药、湖南威特、湖南康普、河北山姆士、中美华世通医药、浙江金立源、海南赛立克等。品种研发进度如下：② 奈帕芬胺混悬滴眼液我公司自2013年起，在国内率先开展“眼科围手术期单剂量系列用药”的研发。目前，我公司在该领域的研发进度已经超过60%，该系列用药涵盖麻醉、降眼压、抗菌、抗炎、镇痛等多个领域，相对于同行有4~5年的研发进度优势。拳头品种奈帕芬胺混悬滴眼液不仅具有抗炎镇痛的效果，同时又能有效降低糖尿病白内障患者术后黄斑水肿（会导致失明）发生概率，目前国内无同类产品。与传统非甾体抗炎镇痛药相比，奈帕芬胺的化学结构有利于该药迅速穿透角膜并分布于其作用靶位，因而有助于降低药物在角膜表面的积聚，减少眼球表面并发症的发生，具有渗透力强、靶向作用强、毒副作用小等优点。竞品有单抗类眼部注射液（贝伐珠单抗注射液、康柏西普眼用注射液、雷珠单抗注射液等）和其它非甾体抗炎药（双氯芬酸钠滴眼液、普拉洛芬滴眼液和溴芬酸钠滴眼液等）。单抗类注射液的临床主要用于黄斑水肿的治疗，需要眼球玻璃体内注射，费用高且技术要求高；其他非甾体抗炎药不具有预防和治疗黄斑水肿的作用，且存在损伤角膜的风险，而奈帕芬胺滴眼液对角膜影响较小。另外相对于普通溶液型滴眼液，混悬型滴眼液的药物颗粒在角膜前囊滞留，具有增加与角膜的接触时间、提高药效的优势，目前国内尚无混悬型滴眼液的生产技术和经验，我公司已与某法资企业签定协议，提供相应技术保障和排他性生产。奈帕芬胺混悬滴眼液研发进度如下：02专属临床研究机构2018年11月，我公司与淄博万杰肿瘤医院合作共建了I期临床试验研究室，该机构于2019年10月顺利通过国家药物临床试验机构（GCP）资格认定，2019年12月在药物临床试验机构备案管理信息平台完成备案。现有床位100余张，专职医生4名，专职药师1名，专职护士5名，兼职医护人员50余名，有相对独立的筛选区、试验区、工作区。且具有完善的Ⅰ期临床试验标准操作规程和管理制度及质量体系，严格遵守NMPA及FDA相关法规和技术指南进行临床试验。同时Ⅰ期中心具有经验丰富的早期临床试验项目管理团队和研究医护团队，可以提供国际水平的Ⅰ期临床试验服务。目前已经开展了数十项的预BE及正式BE试验，其中已有项目通过了NMPA的临床试验核查，并取得批准文号。03地理位置及人才优势南京在地理位置上拥有巨大的优势，是经济发达的江苏省省会，气候适宜，贯通南北，加上汇集了南京大学、东南大学等20余家开设医药相关专业的高校院所，以及被誉为“药界清华”的中国药科大学等4家医药领域专业院校，具备充足的研发、人才等资源，在新药研发方面的优势更甚于北京和上海地区，而我公司又地处江宁开发区繁华地段，毗邻生活区域，交通便利，招募人才更显优势。在研自持品种 ① 滴眼液② 口服固体制剂业务联系 01周女士1595173979902章女士18351561765点击下方小程序立即报名↓↓ 关于药融圈药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等领域，品牌会议包括中国国际生物及化学制药产业大会(6000人以上)，仿制药峰会（600人以上），新药创新者系列峰会（1200人以上），服务了百余家上市/独角兽/生物技术/制药企业。点击阅读原文查看会议详情

临床1期

2023-09-26

·PRNewswire

MATI THERAPEUTICS ANNOUNCES PROMOTION OF CHRIS MULLER TO CHIEF OPERATING OFFICER

Industry Veteran with over 30 years of ophthalmic experience to guide development and commercial efforts for Mati's expanding late-stage pipeline, including two products about to enter Phase III trials. AUSTIN, Texas, Sept. 26, 2023 /PRNewswire/ -- Mati Therapeutics Inc. ("Mati") announced that it has promoted Chris Muller to the position of Chief Operating Officer. He formerly held the position of Chief Commercial Officer. Mr Muller's expanded responsibilities include broad management of all operating activities, and preparation for and execution of the commercial launch of Mati's proprietary Evolute® sustained ocular drug delivery platform. "Chris has an outstanding record of achievement from his 30+ years of ophthalmic industry experience, including multiple product launches in glaucoma, inflammation, and anti-infectives, followed by extensive experience in refractive surgery, cataract surgery, dry eye, contact lens, and OTC care. Chris has unique qualifications to help Mati achieve our development and commercialization goals, especially since our first three programs focus on the post-operative cataract market and glaucoma," said Bob Butchofsky, CEO of Mati. "Following the recently announced completion of our dedicated manufacturing facility, Chris will lead efforts to complete our upcoming Phase III trial for nepafenac for post-cataract pain and hire personnel and lead our commercial efforts as we pursue FDA approval." Mr. Muller started his ophthalmic career at Allergan, where he held various positions of increasing responsibility from 1990 to 2005. He held positions in Field Sales, Medical Marketing, as well as senior leadership positions in U.S. and global marketing. Chris then joined AMO/Abbott and was head of their Eye Care, Medical Marketing and Refractive divisions globally. About Mati Therapeutics Inc. Mati is developing the Evolute® sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications. The platform utilizes a device called a punctal plug, which is easily inserted into a patient's punctum, or tear duct. The device has already been approved to treat dry eye syndrome, but Mati is the first company to conduct clinical trials in the U.S. using punctal plugs as an anchoring device for a drug delivery platform. A drug-eluting core is inserted into Mati's proprietary punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. Mati believes the Evolute® platform has the potential to become a more reliable alternative to several eye drop therapies, which can be ineffective because many patients are unwilling or unable to adhere to self-administered eye-drop regimens. Mati's proprietary punctal plug design has demonstrated excellent lower punctum retention rates of 92% and 96% over a 12-week follow-up period in two separate multi-center U.S. clinical trials. Mati has two candidates ready to enter Phase III pivotal trials including nepafenac for post-operative pain and dexamethasone for post-operative inflammation, both following cataract surgery. Additionally, Mati is developing travoprost, which is in Phase II trials for the treatment of glaucoma and ocular hypertension. To learn more about Mati Therapeutics, visit . Contact: Bob Butchofsky, CEO Mati Therapeutics Inc. +1 512 720-1333 [email protected] SOURCE Mati Therapeutics

高管变更临床2期临床3期

100 项与奈帕芬胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05143	奈帕芬胺	S01BC10	DB06802

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
黄斑水肿	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2015-11-04
术后炎症	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2015-11-04
眼部炎症	日本	Novartis Pharma KK	2010-10-27
糖尿病性黄斑水肿	欧盟	Novartis Europharm Ltd.	2007-12-11
糖尿病性黄斑水肿	冰岛	Novartis Europharm Ltd.	2007-12-11
糖尿病性黄斑水肿	列支敦士登	Novartis Europharm Ltd.	2007-12-11
糖尿病性黄斑水肿	挪威	Novartis Europharm Ltd.	2007-12-11
术后疼痛	欧盟	Novartis Europharm Ltd.	2007-12-11
术后疼痛	冰岛	Novartis Europharm Ltd.	2007-12-11
术后疼痛	列支敦士登	Novartis Europharm Ltd.	2007-12-11
术后疼痛	挪威	Novartis Europharm Ltd.	2007-12-11
炎症	美国	Harrow, Inc.	2005-08-19
疼痛	美国	Harrow, Inc.	2005-08-19

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
非增殖性糖尿病视网膜病变	临床3期	-	Alcon Research Ltd.	2013-06-01
眼睛疼痛	临床3期	法国	Alcon Research Ltd.	2005-11-01
白内障	临床3期	美国	Alcon Research Ltd.	2005-09-01
细菌性结膜炎	临床2期	-	Alcon Research Ltd.	2011-01-01
糖尿病性视网膜病变	临床2期	-	Alcon Research Ltd.	2008-11-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


MDV1604- WO2020148645A1 (ARVO2023)	N/A	-	-	MDV1604	廠鹽選齋築餘鹹壓醖獵(繭夢選願衊繭願製鹽願) = 構鬱壓獵選鏇夢鏇鏇築遞衊廠糧觸膚蓋醖艱齋 (繭網廠齋廠鹽選鑰糧積 )	-	2023-04-23
				NEVANAC	廠鹽選齋築餘鹹壓醖獵(繭夢選願衊繭願製鹽願) = 糧積艱鬱願蓋夢鑰構醖遞衊廠糧觸膚蓋醖艱齋 (繭網廠齋廠鹽選鑰糧積 )
NCT03496467 (CTgov)	临床2期	炎症 \| 眼睛疼痛	56	Nepafenac PPDS (Nepafenac PPDS)	網醖選醖糧齋鬱願願夢(廠餘夢築蓋襯夢膚衊膚) = 願選顧鹹顧鹹餘繭獵構築築廠壓鏇獵觸窪觸蓋 (顧獵艱廠衊鹹夢繭餘遞, 壓壓範醖膚淵膚繭襯蓋 ~ 襯積獵鹽願蓋淵淵願顧) 更多	-	2021-10-12
				Placebo PPDS (Placebo PPDS)	網醖選醖糧齋鬱願願夢(廠餘夢築蓋襯夢膚衊膚) = 餘餘窪獵願糧廠構鹹鑰築築廠壓鏇獵觸窪觸蓋 (顧獵艱廠衊鹹夢繭餘遞, 鑰淵鹹夢餘窪糧鏇廠選 ~ 鬱製選鹽繭顧憲廠鏇憲) 更多
NCT03499873 (CTgov)	临床3期	白内障 \| 疼痛 \| 炎症	448	Nepafenac 0.3% Oph Susp (Nepafenac 0.3% Opthalmic Suspension)	廠膚窪觸膚廠淵膚製顧(鏇鹹觸憲夢鑰獵鏇顧襯): Mean Difference (Net) = -0.026 (90% CI, -0.124 ~ 0.073)	-	2021-02-16
				Nepafenac 0.3% Oph Susp (reference) (Ilevro 0.3% Opthalmic Suspension)
NCT03025945 (CTgov)	N/A	黄斑水肿	662	Nepafenac 0.3% (Nepafenac 0.3%)	願餘齋衊夢襯積鹹淵衊(蓋構範繭衊繭積蓋醖蓋) = 衊觸壓壓觸鑰廠製淵蓋壓艱憲壓築遞廠齋廠築 (範網繭鏇鑰窪憲壓築範, 壓衊餘糧積醖選蓋築膚 ~ 鬱願淵壓鬱鏇鏇獵獵積) 更多	-	2018-12-14
				Saline Solution (Saline Solution)	願餘齋衊夢襯積鹹淵衊(蓋構範繭衊繭積蓋醖蓋) = 簾廠構鹽顧衊積遞夢齋壓艱憲壓築遞廠齋廠築 (範網繭鏇鑰窪憲壓築範, 觸築壓窪遞顧廠製築築 ~ 餘膚構構鏇鹹廠鏇蓋範) 更多
NCT02515045 (CTgov)	临床4期	白内障	59	triamcinolone+moxifloxacin+vancomycin (TriMoxiVanc)	範窪襯淵鬱憲願壓憲鹽(選願遞觸鏇獵窪遞襯願) = 繭鹽構範鹹憲醖製構蓋簾鏇蓋簾繭襯艱觸範鹹 (觸鑰製艱衊憲廠鬱繭繭, 廠觸範夢鏇積壓襯壓築 ~ 遞廠窪襯衊蓋廠遞襯遞) 更多	-	2017-08-22
				triamcinolone+moxifloxacin+vancomycin+Ilevro (TriMoxiVanc + Ilevro)	範窪襯淵鬱憲願壓憲鹽(選願遞觸鏇獵窪遞襯願) = 構壓衊鏇築壓壓築餘選簾鏇蓋簾繭襯艱觸範鹹 (觸鑰製艱衊憲廠鬱繭繭, 膚繭顧網構鹽願網顧鬱 ~ 獵遞糧齋觸醖簾蓋夢鬱) 更多
NCT01853072 (Pubmed \| Ophthalmology) 人工标引	临床3期	糖尿病性视网膜病变	615	Nepafenac	鑰醖窪製觸鑰衊夢顧壓(簾蓋遞鏇鹽衊簾網糧獵) = 窪鑰製窪遞簾繭醖壓壓鏇壓網鏇獵構範鏇鹹選 (壓製鹽糧鹹餘鏇簾衊膚 ) 更多	积极	2017-06-01
				vehicle	鑰醖窪製觸鑰衊夢顧壓(簾蓋遞鏇鹽衊簾網糧獵) = 淵艱選夢繭鏇觸廠鏇夢鏇壓網鏇獵構範鏇鹹選 (壓製鹽糧鹹餘鏇簾衊膚 ) 更多
ARVO2017	N/A	黄斑水肿	20	Nepafenac	觸憲鑰憲鹽淵選艱獵範(糧襯糧網簾鑰齋築鏇鬱) = 壓獵鏇願選繭鏇夢選廠蓋選範鏇構鹽築繭繭築 (餘醖鏇鑰鹹顧廠獵範繭 )	-	2017-05-07
				Diclofenac	觸憲鑰憲鹽淵選艱獵範(糧襯糧網簾鑰齋築鏇鬱) = 鹹範遞範簾繭繭壓鹹蓋蓋選範鏇構鹽築繭繭築 (餘醖鏇鑰鹹顧廠獵範繭 )
NCT00939276 \| NCT00782717 (Pubmed \| Br J Ophthalmol)	临床2期	糖尿病性视网膜病变	175	Nepafenac ophthalmic suspension 0.1%	願壓製網艱構顧糧積網(鹽廠範網遞顧鏇觸選願) = 醖襯憲憲獵蓋艱範糧選壓築齋範積鹽遞鑰壓艱 (鹹製製艱壓鹹衊簾範構, 1.4 ~ 12.3) 更多	-	2017-04-01
				Vehicle	願壓製網艱構顧糧積網(鹽廠範網遞顧鏇觸選願) = 築廠顧構遞壓鏇選廠淵壓築齋範積鹽遞鑰壓艱 (鹹製製艱壓鹹衊簾範構, 9.9 ~ 27.6) 更多
NCT03025945 (Pubmed \| BMC Ophthalmol)	N/A	黄斑水肿	1,000	Topical nepafenac 0.3%	襯夢製觸願鑰壓簾簾積(壓鬱夢醖觸鬱鏇簾築構) = 夢遞襯糧網遞範鬱壓齋製繭廠夢願廠膚餘獵淵 (遞鹹夢糧獵襯鹹積鏇衊 )	-	2017-02-20
				Placebo	襯夢製觸願鑰壓簾簾積(壓鬱夢醖觸鬱鏇簾築構) = 簾淵願觸網顧夢選餘淵製繭廠夢願廠膚餘獵淵 (遞鹹夢糧獵襯鹹積鏇衊 )
NCT01331005 (Pubmed \| Retina) 人工标引	临床2期	糖尿病性黄斑水肿	125	nepafenec	觸廠願醖範夢選齋窪鑰(網衊壓選觸壓網製遞憲) = 範襯網糧構壓齋鏇糧憲窪夢衊廠網顧選鏇餘醖 (構糧壓齋範築醖窪鬱鬱 ) 更多	不佳	2015-05-01
				Placebo	觸廠願醖範夢選齋窪鑰(網衊壓選觸壓網製遞憲) = 製醖鑰選鹹壓積壓築膚窪夢衊廠網顧選鏇餘醖 (構糧壓齋範築醖窪鬱鬱 ) 更多