RANDOMIZED, OPEN LABEL, PARALLEL-GROUP, TWO-ARM, MULTICENTER STUDY WITH CLINICAL ENDPOINT COMPARING PRESERVATIVE FREE BIMATOPROST OPHTHALMIC SOLUTION 0.1 MG/ML AND LUMIGAN® (BIMATOPROST OPHTHALMIC SOLUTION) 0.1 MG/ML IN PATIENTS WITH CHRONIC OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN ONE OR BOTH EYES. - BIM-001

开始日期2024-04-11

申办/合作机构-

NCT06267274

/ 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]

100 项与贝美前列素相关的临床结果

登录后查看更多信息

100 项与贝美前列素相关的转化医学

登录后查看更多信息

100 项与贝美前列素相关的专利（医药）

登录后查看更多信息

912

项与贝美前列素相关的文献（医药）

2025-01-09·CURRENT ORGANIC SYNTHESIS

Synthesis, Characterization, and Docking Studies of 1,4-dien as a Potential Impurity in Bimatoprost Drug

Article

作者: Guttikonda, Nagarjuna Reddy ; Haridasyam, Sharath Babu ; Venkatanarayana, Muvvala

Introduction::

Bimatoprost synthesis, novel diene impurity, Pd/C, Docking studies, IFD calculations, prostaglandin.

Methods::

This impurity was controlled by employing 30% Pd/C, and the impurity level was brought to the permissible level, i.e., 0.03% (ICH guidelines) in the final drug preparation of Bimatoprost.

Results::

Finally, induced-fit docking calculations were performed to theoretically evaluate the binding efficiencies of these inhibitors in the crystal structure of Prostaglandin F syn-thase (PGFS).

Conclusion::

There are negligible differences in RMSD and docking scores between the two ligands, which amount to only 0.18 Å and 0.313 kcal/mol, respectively. These findings strongly indicate that both ligands are likely to exhibit similar biological functions and effi-ciencies.

2025-01-06·MOLECULAR PHARMACEUTICS

A New Analytical Method for Quantifying Acid-End-Cap PLGA in Sub-Milligram Quantities

Article

作者: Wang, Yan ; Skidmore, Sarah ; Park, Kinam ; Zou, Yuan ; Zhang, Deyi ; Smith, William C. ; Park, Haesun ; Jhon, Young Kuk ; Garner, John ; Overdorf, Gary ; Hadar, Justin

Characterization of PLGA polymers used in FDA-approved drug products is critical for quality control and qualitative/quantitative (Q1/Q2) evaluation of potential generic formulations. Various techniques have been developed and used to characterize the molecular properties of PLGA polymers, such as molecular weight, molecular composition, and molecular structure. Commonly used techniques include gel permeation chromatography (GPC), nuclear magnetic resonance (NMR), semisolvent methods, and GPC-based intrinsic viscosity measurement. It is noted that the existing analytical methods may not be able to separate and quantify PLGA polymers when used as a mixture in a drug product (e.g., Durysta and Ozurdex). In particular, one assay method still lacking is quantitating the PLGA polymer with acid-end-cap (PLGA-A) in the mixture containing PLGA with ester-end-cap (PLGA-E), especially when the sample quantity is below the submilligram level. The total PLGA quantities available in Durysta and Ozurdex formulations are too small (<1 mg) to use existing assay methods to quantify the PLGA-A content. A new assay method was developed to quantitate PLGA-A in the mixture with PLGA-E. The acid end-cap was modified with pyrene methylamine (a UV dye) to enhance the signal and compared with the total PLGA quantity measured with the refractive index (RI) after a sample was run through a GPC. This GPC-UV/RI approach is based on measuring the total acid number (TAN) of PLGA-A and converting it to the PLGA-A quantity to compare with the total PLGA. Unlike conventional methods of measuring TAN, the GPC-UV/RI methods enables TAN measurements of submilligram PLGA quantities. Application of this method to Ozurdex-similar samples showed the expected acid:ester ratio of PLGAs. This new approach provides another powerful tool for characterizing PLGA polymers in FDA-approved drug products. This is especially significant considering that the PLGAs of commercial products are likely to have molecular properties different from those of the raw PLGAs before going through the manufacturing process.

2025-01-01·JOURNAL OF CHROMATOGRAPHY A

Green extraction of prostaglandin analogs in cosmetics using deep eutectic solvents and detection via LC-MS/MS

Article

作者: Park, Chae Gyeong ; Woo, In Suk ; Kim, You Kyung ; Han, Kyoung-Moon ; Choi, Jang Duck ; Kim, Aeseul ; Son, Kyung Hun

Prostaglandin analogs (bimatoprost, travoprost, tafluprost, etc.) have similar effects to prostaglandins and are effective drugs for treating glaucoma. These compounds exhibit abnormal reactions such as causing eyelash growth, with several cases being reported of people purchasing them to increase eyelash growth; however, some cases have reported side effects such as pigmentation and dry eyes. In the Republic of Korea, cosmetics are not medicines for treating diseases; therefore, cosmetics cannot contain drugs or have labels that could mislead people. However, there are cases in which products claim to elongate and enrich eyelashes. Concerns about the abnormal reactions of these products are constantly growing, and the absence of analytical methods for illicit compounds (prostaglandins and their analogs) in cosmetics (eyelash growth serums) renders monitoring challenging. Accordingly, in this study, we sought to develop an LC-MS/MS method for facile and fast analysis of compounds illegally mixed into eyelash growth serums. Green analytical chemistry has recently emerged because of environmental concerns. In line with this trend, we developed an optimal method by comparing the methods mainly used in cosmetic pretreatment (solvent extraction, QuEChERS, and solid phase extraction) with a method using deep eutectic solvents (DESs), which is an eco-friendly solvent. As a result of validation according to the International Conference on Harmonization guidelines, the limit of detection was 0.20-9.34 ng/mL, and the limit of quantification was 0.60-28.31 ng/mL. Recovery, linearity, precision, and accuracy were within acceptable ranges. Additionally, using the Analytical GREEnness calculator and complex green analytical procedure index tools, we confirmed that the method using the DES was greener than the other methods. In this study, we developed an analytical method for illicit compounds contained in eyelash growth serums, offering an eco-friendly approach for the prevention of the distribution of illegal cosmetics.

105

项与贝美前列素相关的新闻（医药）

2024-12-15

·信狐药迅

石药乳腺癌治疗用药2.2类白蛋白紫杉醇纳米制剂提交上市申请|新受理（12.9-12.15）

本周药品注册受理数据，分门别类呈现，一目了然。(12.9-12.15）新药上市申请药品名称企业注册分类受理号SYHX2011石药集团欧意药业有限公司2.2CXHS2400128马来酸噻吗洛尔凝胶北京梅尔森医药技术开发有限公司2.2;2.4CXHS2400129吸附无细胞百(三组分)白破联合疫苗康希诺生物股份公司2.2CXSS2400139 新药临床申请药品名称企业注册分类受理号JYP0015片广州嘉越医药科技有限公司1CXHL2401384JYP0015片广州嘉越医药科技有限公司1CXHL2401383JYP0015片广州嘉越医药科技有限公司1CXHL2401382JYP0015片广州嘉越医药科技有限公司1CXHL2401381JYP0015片广州嘉越医药科技有限公司1CXHL2401380JYP0015片广州嘉越医药科技有限公司1CXHL2401379CXJM-66注射液宜昌人福药业有限责任公司1CXHL2401378QY201片启元生物(杭州)有限公司1CXHL2401377QY201片启元生物(杭州)有限公司1CXHL2401376LT-002-158片领泰生物医药(绍兴)有限公司1CXHL2401375LT-002-158片领泰生物医药(绍兴)有限公司1CXHL2401374注射用ARTS-876安锐生物医药科技(广州)有限公司1CXHL2401373XS-03片江苏星盛新辉医药有限公司1CXHL2401371XS-03片江苏星盛新辉医药有限公司1CXHL2401370XS-03片江苏星盛新辉医药有限公司1CXHL2401369PH-501片原研港(上海)医药有限公司1CXHL2401372SR1375胶囊上海赛默罗生物科技有限公司1CXHL2401367SR1375胶囊上海赛默罗生物科技有限公司1CXHL2401366SR1375胶囊上海赛默罗生物科技有限公司1CXHL2401365HS-10501-2江苏豪森药业集团有限公司1CXHL2401363HS-10501-2江苏豪森药业集团有限公司1CXHL2401362HS-10501-2江苏豪森药业集团有限公司1CXHL2401361HS-10501-2江苏豪森药业集团有限公司1CXHL2401359HS-10501-2江苏豪森药业集团有限公司1CXHL2401358HS-10501-2江苏豪森药业集团有限公司1CXHL2401357注射用HRS-4029北京盛迪医药有限公司1CXHL2401368AP306片上海礼邦医药科技有限公司1CXHL2401355AP306片上海礼邦医药科技有限公司1CXHL2401354AP306片上海礼邦医药科技有限公司1CXHL2401353AP306片上海礼邦医药科技有限公司1CXHL2401352HS-10561胶囊江苏豪森药业集团有限公司1CXHL2401351HS-10561胶囊江苏豪森药业集团有限公司1CXHL2401350HS-10561胶囊江苏豪森药业集团有限公司1CXHL2401349IN10018片应世生物科技(上海)有限公司1CXHL2401348IN10018片应世生物科技(上海)有限公司1CXHL2401347JK0001片深圳嘉科生物科技有限公司1CXHL2401346JK0001片深圳嘉科生物科技有限公司1CXHL2401345SBK013片成都施贝康生物医药科技有限公司1CXHL2401344KPG-818胶囊康朴生物医药技术(合肥)有限公司1CXHL2401343KPG-818胶囊康朴生物医药技术(合肥)有限公司1CXHL2401342ADC189颗粒嘉兴安帝康生物科技有限公司1CXHL2401340SAR107375E 片北京联馨药业有限公司1CXHL2401339SAR107375E 片北京联馨药业有限公司1CXHL2401338CS12088片成都微芯药业有限公司1CXHL2401337CS12088片成都微芯药业有限公司1CXHL2401335HRS-6213注射液天津恒瑞医药有限公司1CXHL2401332ADLS1026注射液真奥金银花药业有限公司2.1;2.2;2.4CXHL2401341RFUS-301注射剂宜昌人福药业有限责任公司2.1;2.2;2.4CXHL2401333注射用N2107(纳米晶)江苏慧聚药业股份有限公司2.2CXHL2401364AD108注射液江苏艾迪药业股份有限公司2.2CXHL2401360BN021208H山东百诺医药股份有限公司2.2CXHL2401356RHYK2015仁合益康集团有限公司2.3CXHL2401336RHYK2015仁合益康集团有限公司2.3CXHL2401334氟替格维吸入气雾剂江西艾施特制药有限公司2.3CXHL2401331冻干二价呼吸道合胞病毒mRNA疫苗武汉瑞佶生物科技有限公司1.2CXSL2400860冻干呼吸道合胞病毒mRNA疫苗苏州艾博生物科技有限公司1.2CXSL2400849冻干呼吸道合胞病毒mRNA疫苗苏州艾博生物科技有限公司1.2CXSL2400848重组呼吸道合胞病毒疫苗(CHO细胞)北京吉诺卫生物科技有限公司1.2CXSL2400847冻干呼吸道合胞病毒mRNA疫苗苏州艾博生物科技有限公司1.2CXSL2400850注射用DXC008杭州多禧生物科技有限公司1CXSL2400868注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2400866注射用SHR-4602苏州盛迪亚生物医药有限公司1CXSL2400865注射用KKD001上饶市康可得生物科技有限公司1CXSL2400864注射用KKD001上饶市康可得生物科技有限公司1CXSL2400863IMM01宜明昂科生物医药技术(上海)股份有限公司1CXSL2400862IMM2510宜明昂科生物医药技术(上海)股份有限公司1CXSL2400861人骨髓间充质干细胞注射液九芝堂美科(北京)细胞技术有限公司1CXSL2400859JMT108注射液上海津曼特生物科技有限公司1CXSL2400858YFQLXB-UC01注射液山东省齐鲁细胞治疗工程技术有限公司1CXSL2400857BN-1001眼用注射液南京贝思奥生物科技有限公司1CXSL2400856BN-1001眼用注射液南京贝思奥生物科技有限公司1CXSL2400855ZX2021注射液江苏中新医药有限公司1CXSL2400851注射用ALK202上海安领科生物医药有限公司1CXSL2400854HC006注射液上海宏成药业有限公司1CXSL2400853注射用Tye1001深圳市泰尔康生物医药科技有限公司1CXSL2400852重组人源化抗Trop2单抗-SN38偶联物上海诗健生物科技有限公司1CXSL24008449MW2821迈威(上海)生物科技股份有限公司1CXSL2400838重组人源化抗BTLA单抗注射液上海君实生物医药科技股份有限公司1CXSL2400842JS015注射液上海君实生物医药科技股份有限公司1CXSL2400841JS007注射液上海君实生物医药科技股份有限公司1CXSL2400840注射用JS207上海君实生物医药科技股份有限公司1CXSL2400837IMD101注射液上海英脉德医疗科技有限公司1CXSL2400843阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400867人干扰素α2b喷雾剂天津未名生物医药有限公司2.2CXSL2400845人干扰素α2b喷雾剂天津未名生物医药有限公司2.2CXSL2400846注射用MK-2870默沙东研发(中国)有限公司2.2CXSL2400839 仿制药申请药品名称企业注册分类受理号小儿复方氨基酸注射液(19AA-I)武汉久安药物研究院有限公司3CYHS2404359头孢泊肟酯干混悬剂石家庄四药有限公司3CYHS2404352己酮可可碱缓释片杭州康恩贝制药有限公司3CYHS2404350复方聚乙二醇电解质散 (II)湖南普道医药技术有限公司3CYHS2404347咪达唑仑口服溶液成都倍特药业股份有限公司3CYHS2404337盐酸纳洛酮注射液海南葫芦娃药业集团股份有限公司3CYHS2404336布比卡因脂质体注射液浙江圣兆药物科技股份有限公司3CYHS2404308布比卡因脂质体注射液浙江圣兆药物科技股份有限公司3CYHS2404307昂丹司琼口溶膜上海上药中西制药有限公司3CYHS2404325昂丹司琼口溶膜上海上药中西制药有限公司3CYHS2404324西格列汀二甲双胍缓释片南京易亨制药有限公司3CYHS2404322盐酸普萘洛尔片石家庄龙泽制药股份有限公司3CYHS2404319腺苷钴胺胶囊南京海纳制药有限公司3CYHS2404316盐酸利多卡因凝胶华润双鹤药业股份有限公司3CYHS2404314注射用乳糖酸红霉素广州艾奇西新药研究有限公司3CYHS2404313维生素B12注射液海南元盈医药科技有限公司3CYHS2404312布美他尼注射液绪必迪药业(沧州)有限公司3CYHS2404331帕拉米韦注射液嘉亨(珠海横琴)医药科技有限公司3CYHS2404329利伐沙班口腔崩解片北京福元医药股份有限公司3CYHS2404328利伐沙班口腔崩解片北京福元医药股份有限公司3CYHS2404327法莫替丁注射液杭州民生药物研究院有限公司3CYHS2404291复合磷酸氢钾注射液石家庄荣雾迪医药科技有限公司3CYHS2404290钠钾镁钙注射用浓溶液苏州朗易生物医药研究有限公司3CYHS2404289碳酸氢钠注射液江苏宝东医药科技有限公司3CYHS2404303硫酸阿托品注射液江苏润恒制药有限公司3CYHS2404301盐酸克林霉素棕榈酸酯颗粒广州大光制药有限公司3CYHS2404260盐酸纳美芬注射液南京正科医药股份有限公司3CYHS2404257盐酸氯胺酮注射液国药集团工业有限公司廊坊分公司3CYHS2404278琥珀酸亚铁片赤峰固得药业有限公司3CYHS2404279门冬氨酸钾注射液海南慧通生物医药科技有限公司3CYHS2404277门冬氨酸钾注射液海南慧通生物医药科技有限公司3CYHS2404276唑来膦酸注射液浙江康吉尔药业有限公司3CYHS2404256硫酸镁钠钾口服用浓溶液湖北唯森制药有限公司4CYHS2404358苹果酸奈诺沙星氯化钠注射液贵州科伦药业有限公司4CYHS2404357溴芬酸钠滴眼液江西马应龙美康药业有限公司4CYHS2404356磷酸特地唑胺片浙江东亚药业股份有限公司4CYHS2404355脂肪乳氨基酸(17)葡萄糖(19)注射液辽宁海思科制药有限公司4CYHS2404354左乙拉西坦口服溶液广东合威制药有限公司4CYHS2404353硫酸氨基葡萄糖胶囊湖南诺纳医药科技有限公司4CYHS2404351盐酸达泊西汀片云南龙津康佑生物医药有限公司4CYHS2404349盐酸达泊西汀片云南龙津康佑生物医药有限公司4CYHS2404348双氯芬酸钠缓释片四川依科制药有限公司4CYHS2404346瑞舒伐他汀依折麦布片(I)江苏德源药业股份有限公司4CYHS2404345瑞舒伐他汀依折麦布片(I)成都倍特药业股份有限公司4CYHS2404344噻托溴铵吸入喷雾剂天津信达制药有限公司4CYHS2404343盐酸氨溴索口服溶液海南斯达制药有限公司4CYHS2404342盐酸氨溴索口服溶液海南斯达制药有限公司4CYHS2404341盐酸氨溴索口服溶液海南斯达制药有限公司4CYHS2404340盐酸氨溴索口服溶液海南斯达制药有限公司4CYHS2404339盐酸氨溴索口服溶液海南斯达制药有限公司4CYHS2404338富马酸依美斯汀滴眼液石家庄四药有限公司4CYHS2404335腺苷注射液广州大光制药有限公司4CYHS2404334钆喷酸葡胺注射液重庆圣华曦药业股份有限公司4CYHS2404333布南色林片合肥英太制药有限公司4CYHS2404318依折麦布片华润赛科药业有限责任公司4CYHS2404315氟伐他汀钠缓释片浙江普洛康裕制药有限公司4CYHS2404326米拉贝隆缓释片浙江普利药业有限公司4CYHS2404323罗沙司他胶囊浙江高跖医药科技股份有限公司4CYHS2404321罗沙司他胶囊浙江高跖医药科技股份有限公司4CYHS2404320二十碳五烯酸乙酯软胶囊甘正(海南)生物药业有限公司4CYHS2404317醋酸兰瑞肽缓释注射液(预充式)四川汇宇制药股份有限公司4CYHS2404311醋酸兰瑞肽缓释注射液(预充式)四川汇宇制药股份有限公司4CYHS2404310醋酸兰瑞肽缓释注射液(预充式)四川汇宇制药股份有限公司4CYHS2404309恩格列净片山东益康药业股份有限公司4CYHS2404306恩格列净片山东益康药业股份有限公司4CYHS2404305比拉斯汀片宁波美诺华天康药业有限公司4CYHS2404304丙戊酸钠缓释片华益药业科技(安徽)有限公司4CYHS2404332培哚普利氨氯地平片(I)杭州和泽坤元药业有限公司4CYHS2404330注射用硫酸艾沙康唑上药东英(江苏)药业有限公司4CYHS2404300二甲双胍恩格列净片(I)河北龙海药业有限公司4CYHS2404299二甲双胍恩格列净片(V)河北龙海药业有限公司4CYHS2404298二甲双胍恩格列净片(VI)河北龙海药业有限公司4CYHS2404297克立硼罗软膏浙江百代医药科技有限公司4CYHS2404296双氯芬酸二乙胺乳胶剂丽彩甘肃西峰制药有限公司4CYHS2404295双氯芬酸二乙胺乳胶剂丽彩甘肃西峰制药有限公司4CYHS2404294富马酸伏诺拉生片海南广升誉制药有限公司4CYHS2404293富马酸伏诺拉生片海南广升誉制药有限公司4CYHS2404292注射用替考拉宁丽珠集团丽珠制药厂4CYHS2404288甲泼尼龙片上海理想制药有限公司4CYHS2404287富马酸伏诺拉生片国大(吉林)制药集团有限公司4CYHS2404286富马酸伏诺拉生片国大(吉林)制药集团有限公司4CYHS2404285吸入用乙酰半胱氨酸溶液山西普恒制药有限公司4CYHS2404284单硝酸异山梨酯缓释片南京华兴医药科技有限公司4CYHS2404283富马酸伏诺拉生片四川迪菲特药业有限公司4CYHS2404282富马酸伏诺拉生片四川迪菲特药业有限公司4CYHS2404281盐酸埃克替尼片昆山龙灯瑞迪制药有限公司4CYHS2404280马来酸阿伐曲泊帕片江苏吴中医药集团有限公司苏州制药厂4CYHS2404302乌帕替尼缓释片重庆华邦制药有限公司4CYHS2404275丙戊酸钠缓释片(I)浙江普洛康裕制药有限公司4CYHS2404274阿昔莫司胶囊海南药谷云生物科技有限公司4CYHS2404273富马酸伏诺拉生片陕西西岳制药有限公司4CYHS2404272富马酸伏诺拉生片陕西西岳制药有限公司4CYHS2404271依折麦布阿托伐他汀钙片南京海纳医药科技股份有限公司4CYHS2404270依折麦布阿托伐他汀钙片南京海纳医药科技股份有限公司4CYHS2404269富马酸伏诺拉生片云鹏医药集团有限公司4CYHS2404268富马酸伏诺拉生片云鹏医药集团有限公司4CYHS2404267盐酸伐地那非片浙江诺得药业有限公司4CYHS2404266富马酸伏诺拉生片山东鲁抗医药股份有限公司4CYHS2404265富马酸伏诺拉生片山东鲁抗医药股份有限公司4CYHS2404264比索洛尔氨氯地平片上海衡山药业有限公司4CYHS2404263乌帕替尼缓释片山东齐都药业有限公司4CYHS2404262利格列汀二甲双胍片(I)北京百奥药业有限责任公司4CYHS2404261夫西地酸乳膏江苏盈科生物制药有限公司4CYHS2404259复方聚乙二醇电解质散(III)江西亿友药业有限公司4CYHS2404258艾地骨化醇软胶囊北京斯利安药业有限公司4CYHS2404255莫匹罗星软膏华润三九医药股份有限公司4CYHS2404254富马酸伏诺拉生片北京北陆药业股份有限公司4CYHS2404253富马酸伏诺拉生片北京北陆药业股份有限公司4CYHS2404252阿达木单抗注射液浙江华海生物科技有限公司3.3CXSS2400138阿齐沙坦氨氯地平片北京百奥药业有限责任公司3CYHL2400259注射用甲磺酸萘莫司他康普药业股份有限公司3CYHL2400257双氯芬酸依泊胺贴四川天道制药有限公司3CYHL2400256复方硫酸钠片广东逸舒制药股份有限公司3CYHL2400255米诺地尔泡沫剂山东致泰医药技术有限公司3CYHL2400254贝美前列素涂剂南京恩泰医药科技有限公司3CYHL2400252贝美前列素涂剂南京恩泰医药科技有限公司3CYHL2400251盐酸美金刚多奈哌齐缓释胶囊四川科瑞德制药股份有限公司3CYHL2400250盐酸美金刚多奈哌齐缓释胶囊四川科瑞德制药股份有限公司3CYHL2400249氟比洛芬凝胶贴膏福元药业有限公司4CYHL2400258洛索洛芬钠凝胶贴膏深圳珐玛易药品科技有限公司4CYHL2400253 进口申请药品名称企业注册分类受理号布瑞哌唑片M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2400064布瑞哌唑片M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2400063布瑞哌唑片M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2400062布瑞哌唑片M/s MSN LABORATORIES PRIVATE LIMITED5.2JYHS2400061替尔泊肽注射液Eli Lilly Nederland B.V.2.4JXHS2400111替尔泊肽注射液Eli Lilly Nederland B.V.2.4JXHS2400110替尔泊肽注射液Eli Lilly Nederland B.V.2.4JXHS2400109替尔泊肽注射液Eli Lilly Nederland B.V.2.4JXHS2400108洛替拉纳滴眼液Tarsus Pharmaceuticals, Inc.5.1JXHS2400107索安非托片AXSOME MALTA LTD.5.1JXHS2400104西诺氨酯片SK Life Science, Inc.5.1JXHS2400106西诺氨酯片SK Life Science, Inc.5.1JXHS2400105Olomorasib胶囊Eli Lilly and Company1JXHL2400289Olomorasib胶囊Eli Lilly and Company1JXHL2400288Sepantronium Bromide注射液Cothera Bioscience, Inc.1JXHL2400287Baxdrostat片AstraZeneca AB1JXHL2400291Baxdrostat片AstraZeneca AB1JXHL2400290Amycretin注射液Novo Nordisk A/S1JXSL2400237注射用M9140Merck Healthcare KGaA1JXSL2400236帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400235 中药相关申请药品名称企业注册分类受理号醒脑益智胶囊唐宁医药科技(济南)有限公司1.1CXZL2400090固本消疹颗粒江苏康缘药业股份有限公司1.1CXZL2400087淫羊藿素软胶囊北京珅诺基医药科技有限公司2.3CXZL2400089淫羊藿总黄酮胶囊江苏康缘阳光药业有限公司2.3CXZL2400088 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市疫苗

2024-12-04

·GlobeNewswire-Health Care

Nicox Announces First Commercial Sale of ZERVIATE in China by Partner Ocumension, Creating a New Recurrent Revenue Stream

Press Release Nicox Announces First Commercial Sale of ZERVIATE in China by Partner Ocumension, Creating a New Recurrent Revenue Stream First commercialized product from the Nicox-Ocumension collaboration Recent acquisitions have enhanced OcuMension's leadership in the ophthalmology field in the China marketProduct made available quickly after approval thanks to a rapid manufacturing campaign at Ocumension’s state-of-the-art factoryMajor milestone for this strong collaboration, which also includes our lead asset, NCX 470, where recruitment was just completed in the Denali Phase 3 trial December 4, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the first commercial sale of ZERVIATE® (cetirizine ophthalmic solution), 0.24% in China by its exclusive Chinese partner Ocumension Therapeutics. ZERVIATE is indicated for ocular itching associated with allergic conjunctivitis and was approved in China in September 2024.ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the U.S. for ocular itching associated with allergic conjunctivitis by Nicox’s exclusive U.S. partner, Harrow, Inc. Ocumension emphasizes that ZERVIATE is suitable for the treatment of allergic conjunctivitis in toddlers and preschoolers, which significantly fills the medical gap in this field and benefits the vast number of children in China.“The first commercial sale of ZERVIATE in China by our partner Ocumension, marks the next significant milestone in this broad collaboration initiated in 2018 and provides a new revenue stream for Nicox. Ocumension has proven itself to be a strong development partner through their work on ZERVIATE and on the recruitment of Chinese patients in the NCX 470 Denali Phase 3 study. They have also been building out commercial operations through organic and external growth, including acquiring products and operations from a leading player in China, ideally placing them to maximise the value of ZERVIATE in the Chinese market. We look forward to continuing to work with them as we advance NCX 470 towards commercialisation as well.” said Gavin Spencer, Chief Executive Officer of Nicox. ZERVIATE is exclusively licensed to Ocumension for development and commercialization in the Chinese and the majority of the Southeast Asian markets. Nicox may potentially receive sales milestones of up to US$17.2 million together with royalties from 5% to 9% on net sales of ZERVIATE by Ocumension. 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 also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from 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 coverageH.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 OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2023” and in section 4 of the “Rapport semestriel financier et d’activité 2024” which are available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_ZERVIATELaunchChina_PR_FINAL

临床3期上市批准并购引进/卖出

2024-11-19

·GlobeNewswire-Health Care

SpyGlass Pharma Completes Enrollment in Phase I/II Study of its Promising Long-Term Drug Delivery Platform for Glaucoma and Ocular Hypertension

SpyGlass prepares for End of Phase II meeting with the FDA to advance its Drug Delivery Platform into Phase III pivotal studiesInnovative platform has the potential to enable all cataract surgeons to treat glaucoma during routine cataract procedures ALISO VIEJO, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a privately-held ophthalmic biotechnology company, today announced completion of enrollment in its Phase I/II, randomized, multi-center, controlled clinical trial (NCT06120842) evaluating SpyGlass’ Drug Delivery Platform in patients with glaucoma or ocular hypertension. The SpyGlass platform is designed to deliver multiple years of bimatoprost to lower intraocular pressure (IOP) and is implanted during routine cataract surgery. “Chronic eye conditions, such as glaucoma, can lead to vision loss and significantly impact quality of life. That’s why SpyGlass is singularly focused on making a difference for those in need,” said Patrick Mooney, SpyGlass Pharma’s Chief Executive Officer. “Completing enrollment in this study is an important milestone in our efforts to bring the SpyGlass technology to millions of patients around the world. We look forward to continued engagement with the FDA as we advance our platform toward two large Phase III trials.” “The SpyGlass technology continues to demonstrate great potential for improving care in glaucoma patients undergoing routine cataract surgery,” said Malik Kahook, M.D., co-founder of SpyGlass Pharma™. “As the SpyGlass platform is implanted using standard surgical techniques, it could significantly expand the integration of glaucoma treatment into routine cataract procedures. This could enhance adoption across a broad spectrum of surgeons and practices, setting our platform apart from currently available glaucoma interventions.” Dr. Kahook added, “We are deeply grateful to the investigators and patients whose participation has been essential to advancing this clinical trial. Their trust and commitment have helped bring us closer to delivering a treatment that could significantly enhance care for glaucoma patients worldwide.” ABOUT SPYGLASS PHARMA The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. SpyGlass will continue to release data from both the first-in-human study, which was recently published with 18-month data, and this Phase I/II study as it becomes available. SpyGlass looks forward to working closely with the U.S. Food and Drug Administration (FDA) to advance the program to commercial approval. SpyGlass Pharma was co-founded by Dr. Malik Y. Kahook, M.D. and Glenn Sussman. The company is focused on the development of the world’s first, IOL-mounted, controlled release drug delivery platform capable of delivering multiple years of therapy. SpyGlass is backed by investors including New Enterprise Associates (NEA), RA Capital, Vensana Capital, Samsara BioCapital and Vertex Ventures HC. The technology was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine and spun off campus post Series A funding. http://www.spyglasspharma.com Media Contact:Angela Salerno-Robin 312-545-9331asalerno-robin@dna-comms.com

临床3期

100 项与贝美前列素相关的药物交易

登录后查看更多信息

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,

后查看更多信息

适应症	国家/地区	公司	日期
青光眼	日本	Senju Pharmaceutical Co., Ltd.	2009-07-07
青光眼	日本	Takeda 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,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
白内障	临床2期	美国	SpyGlass Pharma Inc初创企业	2023-10-13
男性雄激素源性脱发	临床2期	美国	Allergan Ltd. (Ireland)	2013-08-01
脱发	临床2期	美国	Allergan Ltd. (Ireland)	2011-06-01
脱发	临床2期	德国	Allergan Ltd. (Ireland)	2011-06-01
雄激素脱发	临床2期	美国	Allergan Ltd. (Ireland)	2011-06-01
雄激素脱发	临床2期	德国	Allergan Ltd. (Ireland)	2011-06-01

登录后查看更多信息

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


NCT04747808 (BusinessWire) 人工标引	临床2期	青光眼	-	LL-BMT1 32-µg dose	遞積鹽齋艱蓋願製憲艱(蓋夢觸範構觸窪糧積築) = 餘齋製鑰獵艱積醖壓遞願糧繭顧糧廠蓋遞鏇鬱 (齋構壓襯餘艱鑰鏇範獵 ) 更多	积极	2024-11-12
				bimatoprost 0.01%	-
NCT03825380 (CTgov)	临床3期	青光眼	485	Bimatoprost (T4032)	鹽餘鹹鏇築膚鹹窪鹹積(淵衊衊餘網壓簾繭衊廠) = 選淵範蓋願構範糧顧構餘獵壓醖艱艱醖獵獵艱 (選願憲鹽艱簾衊構積壓, 鹹鏇築願構鏇糧鑰遞獵 ~ 淵壓襯糧淵鏇夢憲觸糧) 更多	-	2023-11-21
				Lumigan® (Lumigan®)	鹽餘鹹鏇築膚鹹窪鹹積(淵衊衊餘網壓簾繭衊廠) = 鑰製窪網積膚範觸廠範餘獵壓醖艱艱醖獵獵艱 (選願憲鹽艱簾衊構積壓, 範衊夢餘遞廠築獵鏇鹽 ~ 廠夢遞襯繭積膚繭蓋鏇) 更多
NCT04285580 (CTgov)	临床3期	开角型青光眼	37	Bimatoprost SR (Bimatoprost SR 10 μg)	艱廠衊憲顧鹹鏇廠製觸(窪齋醖壓鏇構繭製獵觸) = 觸鹹醖選窪醖蓋網顧鹽築鹽築夢鏇顧廠憲鏇糧 (獵範廠築憲壓鑰顧觸餘, 顧膚廠艱糧鹽鹹遞壓網 ~ 構網夢顧齋廠願選網簾) 更多	-	2023-06-08
				LUMIGAN (LUMIGAN 0.01%)	艱廠衊憲顧鹹鏇廠製觸(窪齋醖壓鏇構繭製獵觸) = 齋襯窪網餘廠積簾壓構築鹽築夢鏇顧廠憲鏇糧 (獵範廠築憲壓鑰顧觸餘, 憲壓廠遞蓋築壓範壓積 ~ 膚艱壓鏇膚膚醖觸廠衊) 更多
NCT01157364 \| NCT02250651 \| NCT02247804 (Pubmed)	临床3期	高眼压症 \| 开角型青光眼	-	Bimatoprost implant 10 µg	繭獵鏇窪構鹹醖廠選糧(淵繭觸構製衊範網憲範) = 憲簾觸夢鹹衊觸鬱廠窪壓壓製願醖鹹鹽憲衊鬱 (膚製鏇醖鬱構顧繭襯觸 )	-	2022-05-28
				Topical timolol maleate 0.5%	繭獵鏇窪構鹹醖廠選糧(淵繭觸構製衊範網憲範) = 淵壓鹹餘鏇夢膚鏇顧憲壓壓製願醖鹹鹽憲衊鬱 (膚製鏇醖鬱構顧繭襯觸 )
ARVO2022	N/A	青光眼	122	Bimatoprost SR implantation	襯網蓋廠廠顧構衊顧願(築繭簾窪觸糧鹹膚獵築) = 觸齋選壓淵觸壓簾構醖顧襯鏇鑰壓繭遞築範築 (淵顧膚壓觸構觸鹹構艱 )	-	2022-05-01
ARVO2022	N/A	青光眼	122	Bimatoprost SR	醖膚範廠鑰襯願選憲範(築顧獵構顧膚繭糧鹽醖) = 築選鏇襯蓋糧襯範鬱積遞襯艱淵窪壓窪憲範顧 (鹽膚鑰網製鑰糧齋鏇壓 )	-	2022-05-01
NCT03850782 (Phase 3b Study, ARVO2022)	临床3期	低眼压	203	Bimatoprost implant	衊齋窪衊願網觸夢壓廠(構鏇網顧鹽鹽繭繭鹽構) = 構蓋艱積範鏇壓簾簾鹹繭蓋獵鹹艱鹹窪網壓鹽 (醖簾範鏇獵遞製鹹簾夢 )	-	2022-05-01
ARVO2022	N/A	-	-	Bimatoprost free acid	艱獵築蓋淵網網製衊蓋(鹹廠觸糧淵觸窪繭醖顧) = a dose-dependent although non-statistically significant increase in protein expression with a maximal increase of 56% 廠遞鬱獵選壓醖蓋鏇鬱 (願蓋鹹齋鏇觸鬱繭顧齋 ) 更多	-	2022-05-01
NCT03891446 (PO080, AAO2021)	临床3期	开角型青光眼	200	Bimatoprost implant 10μg	膚壓顧願壓簾淵製糧壓(壓構窪顧餘製鬱鏇獵範) = 選構衊獵積艱簾繭鏇範壓繭壓獵窪艱夢艱範願 (膚範艱構醖艱齋憲鹹鑰, 3.6)	积极	2021-11-13
				Bimatoprost implant 15μg	膚壓顧願壓簾淵製糧壓(壓構窪顧餘製鬱鏇獵範) = 願鏇餘簾願遞願鹹簾糧壓繭壓獵窪艱夢艱範願 (膚範艱構醖艱齋憲鹹鑰, 3.2)