The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in bacterial burden from pre- to post-intervention, quantified by culture of abscess aspirates.

开始日期2025-01-01

申办/合作机构

University of Rochester

CTRI/2024/12/077795

/ Not yet recruiting临床4期IIT

Methylene Blue as an early Adjunctive treatment for septic shock-ARandomized Controlled Trial

开始日期2024-12-11

申办/合作机构-

TCTR20241115004

/ Not yet recruiting临床3期IIT

Methylene blue as an adjunctive therapy in septic shock: A Pilot Randomized Controlled Trial

开始日期2024-11-18

申办/合作机构-

100 项与亚甲蓝相关的临床结果

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100 项与亚甲蓝相关的转化医学

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100 项与亚甲蓝相关的专利（医药）

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9,186

项与亚甲蓝相关的文献（医药）

2025-12-01·Techniques in Coloproctology

The use of a methylene blue and glyceryl trinitrate-based cream for the treatment of chronic anal fissures: a phase II randomized pilot trial from a referral coloproctological unit

Article

作者: Laforgia, R ; Lobascio, P ; Pezzolla, A ; Tomasicchio, G ; Cassetta, N ; Altomare, D F ; Gallo, G

BACKGROUND:

Chronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.

METHODS:

A phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.

RESULTS:

Nine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.

CONCLUSION:

Methylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.

2025-06-01·Journal of Environmental Sciences

Facile synthesis of boron-doped porous biochar as a metal-free adsorbent for efficient removal of aqueous tetracycline antibiotics

Article

作者: Xu, Lu ; Qi, Yuetong ; Wang, Chengzhi ; Jin, Xin ; Wang, Kai ; He, Shaolei ; Wang, Qize ; Jin, Pengkang

This study introduced a microwave-assisted pyrolysis method for the rapid and efficient preparation of boron-doped porous biochar. The resulting biochar exhibited a large specific surface area (933.39 m²/g), a rich porous structure (1.044 cm³/g), and abundant active sites. Consequently, the prepared boron-doped porous biochar exhibited higher efficiency in adsorbing tetracycline with a maximum adsorption capacity of 413.223 mg/g, which significantly exceeded that of unmodified biochar and most commercial and reported adsorbents. The correlation analysis between the adsorption capacity and adsorbent characteristics revealed that the formation of the -BCO₂ group enhanced π-π electron donor-acceptor interactions between boron-doped porous biochar and tetracycline. This mechanism mainly contributed to the enhanced adsorption of tetracycline by boron-doped porous biochar. Additionally, the as-prepared boron-doped porous biochar exhibited broad applications in removing antibiotics (tetracycline), phenolics (bisphenol A), and dyes (methylene blue and rhodamine B). Moreover, the boron-doped porous biochar exhibited satisfactory stability, and its adsorption capacity can be nearly completely regenerated through simple heat treatment. This study provides new insights into the effectiveness of boron-doped carbonaceous materials in removing antibiotic contaminants.

2025-05-01·Journal of Environmental Sciences

Efficient activation of peroxymonosulfate for catalytic degradation of organic pollutants by simultaneously using low-level cobalt ions and calcium carbonate micro-particles

Article

作者: Zhou, Yu ; Wang, Xiaobo ; Huang, Shuangshuang ; Wang, Nan ; Zhu, Lihua

An efficient catalytic system was developed to remove various organic pollutants by simultaneously using low-level cobalt ions, calcium carbonate micro-particles and peroxymonosulfate (PMS). A simple base-induced precipitation was used to successfully loaded Co-centered reactive sites onto the surface of CaCO₃ microparticles. Under optimal conditions at 25 °C, 10 mg/L methylene blue (MB) could be completely degraded within 10 min with 480 µg/L Co²⁺, 0.4 g/L CaCO₃ microparticles (or 0.4 g/L Co@CaCO₃) and 0.1 g/L PMS. The MB degradation followed the pseudo first order kinetics with a rate constant of 0.583 min^-1, being 8.3, 11.5 and 53.0 times that by using Co-OH (0.07 min^-1), Co²⁺ (0.044 min^-1) and CaCO₃ (0.011 min^-1) as the catalyst, respectively. It was confirmed that there was a synergistic effect in the catalytic activity between Co species and the CaCO₃ particles but the major contributor was the highly dispersed Co species. When Co²⁺-containing simulated electroplating wastewater was used as the Co²⁺ source, not only the added MB was also completely degraded within 5 min in this catalytic system, but also the coexisting heavy metal ions were substantially removed. The presently developed method was applied to simultaneously treat organic wastewater and heavy metals wastewater. The present method was also successfully used to efficiently degrade other organic pollutants including bisphenol A, sulfamethoxazole, rhodamine B, tetrabromobisphenol A, ofloxacin and benzoic acid. A catalytic mechanism was proposed for the PMS activation by Co@CaCO₃. The surface of CaCO₃ particles favors the adsorption of Co²⁺. More importantly, the surface of CaCO₃ particles provides plentiful surface -OH and -CO₃²⁺, and these surface groups complex with Co²⁺ to produce more catalytically active species such as surface [CoOH]^-, resulting in rapid Co²⁺/Co³⁺ cycling and electron transfer. These interactions cause the observed synergistic effect between Co species and CaCO₃ particles in PMS activation. Due to good cycle stability, strong anti-interference ability and wide universality, the new method will have broad application prospects.

项与亚甲蓝相关的新闻（医药）

2025-01-19

·药筛

国产第5个DPP4新药，石药欧意普卢格列汀获批，全球首款狂犬病双抗，斯乐韦米单抗上市申请（1.12-1.19）

统计每周新药申报、上市申请（1.12-1.19） 1、新药上市申请获批药品名称企业名称分类受理号艾沙妥昔单抗注射液Sanofi Winthrop Industrie3.1JXSS2300090艾沙妥昔单抗注射液Sanofi Winthrop Industrie3.1JXSS2300091奥拉帕利片Natco Pharma Limited5.2JYHS2300075奥拉帕利片Natco Pharma Limited5.2JYHS2300074贝伐珠单抗注射液上海生物制品研究所有限责任公司3.3CXSS2300058厄达替尼片Janssen Biotech, Inc.5.1JXHS2300125厄达替尼片Janssen Biotech, Inc.5.1JXHS2300124厄达替尼片Janssen Biotech, Inc.5.1JXHS2300123帕博利珠单抗注射液Merck Sharp & Dohme LLC3.1JXSS2400034普卢格列汀片石药集团欧意药业有限公司1CXHS2300048赛沃替尼片和记黄埔医药（上海）有限公司;上海合全医药有限公司2.4CXHS2400022赛沃替尼片和记黄埔医药（上海）有限公司;上海合全医药有限公司2.4CXHS2400021注射用瑞卡西单抗广东恒瑞医药有限公司;苏州盛迪亚生物医药有限公司1CXSS2300046注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白杭州博之锐生物制药有限公司3.4CXSS2300055 注：灰色字体部分受理号结论为不批准。 2、新药上市申请受理药品名称企业名称分类受理号艾曲帕米鼻喷雾剂Milestone Pharmaceuticals Inc.1JXHS2500007黄体酮注射液IBSA Institut Biochimique SA5.1JXHS2500008斯乐韦米单抗注射液重庆智翔金泰生物制药股份有限公司1CXSS2500004呫诺美林曲司氯铵胶囊（I）Bristol-Myers Squibb Company5.1JXHS2500009呫诺美林曲司氯铵胶囊（II）Bristol-Myers Squibb Company5.1JXHS2500010呫诺美林曲司氯铵胶囊（III）Bristol-Myers Squibb Company5.1JXHS2500011亚甲蓝注射液Provepharm SAS5.1JXHS2500006亚甲蓝注射液Provepharm SAS5.1JXHS2500005盐酸吡昔替尼胶囊Daiichi Sankyo Korea Co., Ltd5.1JXHS2500004盐酸奎扎替尼片Daiichi Sankyo Korea Co., Ltd5.1JXHS2500012盐酸奎扎替尼片Daiichi Sankyo Korea Co., Ltd5.1JXHS2500013注射用美罗培南韦博巴坦Menarini International Operations Luxembourg S.A.5.1JXHS2500003注射用重组人凝血因子Ⅶa成都蓉生药业有限责任公司3.4CXSS2500005宗格替尼片Boehringer Ingelheim International GmbH1JXHS2500002 数据来源：摩熵医药

上市批准

2025-01-19

·信狐药迅

全球首款！智翔金泰狂犬病被动免疫双抗斯乐韦米单抗注射液提交上市申请|新受理（1.13-1.19）

本周药品注册受理数据，分门别类呈现，一目了然。(1.13-1.19）新药上市申请药品名称企业注册分类受理号斯乐韦米单抗注射液重庆智翔金泰生物制药股份有限公司1CXSS2500004 新药临床申请药品名称企业注册分类受理号DNV001注射液杭州鼎乐新为生物科技有限公司1CXHL2500095HRS-6719片山东盛迪医药有限公司1CXHL2500094奥格特韦钠胶囊浙江艾森药业有限公司1CXHL2500093HRS-6719片山东盛迪医药有限公司1CXHL2500092SYH2046片上海翊石医药科技有限公司1CXHL2500091SYH2046片上海翊石医药科技有限公司1CXHL2500090GW5282片格物生物技术(江苏)有限公司1CXHL2500085GW5282片格物生物技术(江苏)有限公司1CXHL2500084GenSci128片长春金赛药业有限责任公司1CXHL2500081GenSci128片长春金赛药业有限责任公司1CXHL2500080GenSci128片长春金赛药业有限责任公司1CXHL2500079RN1871 注射液大睿生物医药科技(上海)有限公司1CXHL2500078IMP1707片上海瑛派药业有限公司1CXHL2500089IMP1707片上海瑛派药业有限公司1CXHL2500088HSK41959片上海海思盛诺医药科技有限公司1CXHL2500077HSK41959片上海海思盛诺医药科技有限公司1CXHL2500076HB-48片谷冲医药(北京)有限公司1CXHL2500071MRANK-106胶囊杭州德睿智药科技有限公司1CXHL2500073MRANK-106胶囊杭州德睿智药科技有限公司1CXHL2500072HRS-7058胶囊山东盛迪医药有限公司1CXHL2500058注射用HRS-9190江苏恒瑞医药股份有限公司1CXHL2500065BG-68501片百济神州(苏州)生物科技有限公司1CXHL2500064BG-68501片百济神州(苏州)生物科技有限公司1CXHL2500063BG-68501片百济神州(苏州)生物科技有限公司1CXHL2500062HRS-7058片山东盛迪医药有限公司1CXHL2500061HRS-7058片山东盛迪医药有限公司1CXHL2500060HRS-7058胶囊山东盛迪医药有限公司1CXHL2500059BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2500069BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2500068BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2500066MIRSRT缓释片吉林天衡药业有限公司2.2CXHL2500098MIRSRT缓释片吉林天衡药业有限公司2.2CXHL2500097MIRSRT缓释片吉林天衡药业有限公司2.2CXHL2500096RHYK2021仁合益康集团有限公司2.2CXHL2500087RHYK2021仁合益康集团有限公司2.2CXHL2500086ASKC635干混悬剂江苏奥赛康药业有限公司2.2CXHL2500083布瑞哌唑口溶膜甘肃普安制药股份有限公司2.2CXHL2500082磷酸奥司他韦微片北京微智瑞医药科技有限公司2.2CXHL2500070注射用全反式维甲酸脂质体杭州高田生物医药有限公司2.2CXHL2500067谷美替尼片上海海和药物研究开发股份有限公司2.4CXHL2500075吡非尼酮胶囊北京康蒂尼药业股份有限公司2.4CXHL2500074带状疱疹mRNA疫苗上海生物制品研究所有限责任公司1.2CXSL2500040靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液上海邦耀生物科技有限公司1CXSL2500053注射用ZL-1310再鼎医药(上海)有限公司1CXSL2500052EA5注射液上海览屹医药科技有限公司1CXSL2500051注射用DB-2304映恩生物科技(上海)有限公司1CXSL2500050注射用LY4052031礼来苏州制药有限公司1CXSL2500049注射用TQB2934正大天晴药业集团南京顺欣制药有限公司1CXSL2500044注射用HS-20108上海翰森生物医药科技有限公司1CXSL2500048HDM3019杭州中美华东制药有限公司1CXSL2500046SHR-3792注射液苏州盛迪亚生物医药有限公司1CXSL2500045注射用HS-20122上海翰森生物医药科技有限公司1CXSL2500047注射用SHR-1826苏州盛迪亚生物医药有限公司1CXSL2500039TQC2938注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2500038注射用重组人TNK组织型纤溶酶原激活剂石药集团明复乐药业(广州)有限公司2.2CXSL2500054贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500042阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500041注射用重组A型肉毒毒素北京博特维克生物技术有限公司2.4CXSL2500043 仿制药申请药品名称企业注册分类受理号盐酸纳美芬注射液浙江赛默制药有限公司3CYHS2500353甲硝唑阴道凝胶杭州上禾健康科技有限公司3CYHS2500352西格列汀二甲双胍缓释片南京易亨制药有限公司3CYHS2500350叶酸片江苏贝佳制药有限公司3CYHS2500342柳氮磺吡啶口服混悬液上海信谊金朱药业有限公司3CYHS2500341盐酸美金刚口服溶液常州四药制药有限公司3CYHS2500337吡拉西坦注射液石药银湖制药有限公司3CYHS2500336布美他尼注射液浙江赛默制药有限公司3CYHS2500331布美他尼注射液浙江赛默制药有限公司3CYHS2500330富马酸酮替芬滴眼液石家庄格瑞药业有限公司3CYHS2500329富马酸酮替芬滴眼液石家庄格瑞药业有限公司3CYHS2500328苯溴马隆片广州一品红制药有限公司3CYHS2500326苯溴马隆片沐源(安徽)药业有限公司3CYHS2500325唑来膦酸注射液四川太平洋药业有限责任公司3CYHS2500323氟尿嘧啶注射液海南倍特药业有限公司3CYHS2500317氟尿嘧啶注射液海南倍特药业有限公司3CYHS2500316腺苷钴胺胶囊合肥康惠医药技术有限公司3CYHS2500313己酮可可碱缓释片浙江普洛康裕制药有限公司3CYHS2500327盐酸异丙肾上腺素注射液海南倍特药业有限公司3CYHS2500305盐酸异丙肾上腺素注射液海南倍特药业有限公司3CYHS2500304盐酸非索非那定干混悬剂桂林华信制药有限公司3CYHS2500300盐酸非索非那定干混悬剂桂林华信制药有限公司3CYHS2500298氨酚羟考酮片河北奥星集团药业有限公司3CYHS2500297碳酸氢钠注射液江西泰吉立生物医药科技有限公司3CYHS2500296碳酸氢钠注射液江西泰吉立生物医药科技有限公司3CYHS2500295硫酸沙丁胺醇口服溶液辽宁海一制药有限公司3CYHS2500292己酮可可碱缓释片福建海西新药创制股份有限公司3CYHS2500310氨溴特罗口服溶液江苏神华药业有限公司3CYHS2500307吗替麦考酚酯干混悬剂昆明贝克诺顿制药有限公司3CYHS2500271硫糖铝片新乡市常乐制药有限责任公司3CYHS2500284别嘌醇片安徽圣鹰药业有限公司3CYHS2500282酒石酸阿福特罗吸入溶液江苏长泰药业股份有限公司3CYHS2500279西格列汀二甲双胍缓释片华中药业股份有限公司3CYHS2500276美索巴莫片石家庄四药有限公司3CYHS2500273维生素B12注射液南京赛瑞谱顿制药有限公司3CYHS2500265阿昔莫司胶囊天津掌心医药科技有限公司4CYHS2500359二十碳五烯酸乙酯软胶囊北京诚济制药股份有限公司4CYHS2500358ω-3鱼油中/长链脂肪乳注射液贝朗医疗(苏州)有限公司4CYHS2500357ω-3鱼油中/长链脂肪乳注射液贝朗医疗(苏州)有限公司4CYHS2500356洛索洛芬钠贴剂前沿生物药业(南京)股份有限公司4CYHS2500355洛索洛芬钠贴剂前沿生物药业(南京)股份有限公司4CYHS2500354硫酸特布他林雾化吸入用溶液复星医药(徐州)有限公司4CYHS2500351注射用磷酸特地唑胺浙江尖峰药业有限公司4CYHS2500344比索洛尔氨氯地平片海南广升誉制药有限公司4CYHS2500343米库氯铵注射液江西远超医药科技有限公司4CYHS2500340米库氯铵注射液江西远超医药科技有限公司4CYHS2500339聚乙二醇钠钾散郑州泰丰制药有限公司4CYHS2500338注射用硫酸艾沙康唑湖南赛隆药业(长沙)有限公司4CYHS2500335聚乙二醇钠钾散湖北唯森制药有限公司4CYHS2500334米库氯铵注射液四川美大康佳乐药业有限公司4CYHS2500333米库氯铵注射液四川美大康佳乐药业有限公司4CYHS2500332富马酸依美斯汀滴眼液广州大光制药有限公司4CYHS2500349注射用硫酸艾沙康唑桂林南药股份有限公司4CYHS2500348注射用培美曲塞二钠湖南赛隆药业(长沙)有限公司4CYHS2500347注射用培美曲塞二钠湖南赛隆药业(长沙)有限公司4CYHS2500346双醋瑞因胶囊江苏永安制药有限公司4CYHS2500345比拉斯汀片江苏联环药业股份有限公司4CYHS2500324利丙双卡因乳膏江苏吴中医药集团有限公司苏州制药厂4CYHS2500322聚乙烯醇滴眼液南京恒道医药科技股份有限公司4CYHS2500321蒙脱石混悬液合肥远志医药科技开发有限公司4CYHS2500320聚多卡醇注射液海南合瑞制药股份有限公司4CYHS2500319聚多卡醇注射液海南合瑞制药股份有限公司4CYHS2500318阿司匹林肠溶片华中药业股份有限公司4CYHS2500315注射用磷酸特地唑胺珠海优润医药科技有限公司4CYHS2500314二十碳五烯酸乙酯软胶囊浙江创新生物有限公司4CYHS2500312玻璃酸钠滴眼液修正药业集团长春高新制药有限公司4CYHS2500306罗沙司他胶囊华北制药金坦生物技术股份有限公司4CYHS2500303罗沙司他胶囊华北制药金坦生物技术股份有限公司4CYHS2500302注射用亚胺培南西司他丁钠珠海优润医药科技有限公司4CYHS2500301注射用亚胺培南西司他丁钠珠海优润医药科技有限公司4CYHS2500299精氨酸布洛芬片海南赛立克药业有限公司4CYHS2500294枸橼酸西地那非口腔崩解片东莞松山湖美健生物技术有限公司4CYHS2500293吸入用乙酰半胱氨酸溶液重庆莱美药业股份有限公司4CYHS2500291艾拉莫德片宁夏康亚药业股份有限公司4CYHS2500290培哚普利氨氯地平片(I)杭州和泽坤元药业有限公司4CYHS2500289硫酸氢氯吡格雷片华泰民康(沈阳)科技有限公司4CYHS2500311帕拉米韦氯化钠注射液湖南九维生物医药有限公司4CYHS2500309帕拉米韦氯化钠注射液湖南九维生物医药有限公司4CYHS2500308枸橼酸西地那非口腔崩解片南京康川济医药科技有限公司4CYHS2500283布瑞哌唑片浙江华义制药有限公司4CYHS2500281布瑞哌唑片浙江华义制药有限公司4CYHS2500280富马酸伏诺拉生片浙江华海药业股份有限公司4CYHS2500278富马酸伏诺拉生片浙江华海药业股份有限公司4CYHS2500277碘佛醇注射液山东齐都药业有限公司4CYHS2500275脂肪乳氨基酸(17)葡萄糖(19%)注射液四川太平洋药业有限责任公司4CYHS2500274草酸艾司西酞普兰片山东普瑞曼药业有限公司4CYHS2500272双氯芬酸二乙胺乳胶剂福建品腾药业有限公司4CYHS2500270糠酸莫米松乳膏江苏知原药业股份有限公司4CYHS2500288盐酸二甲双胍片石家庄四药有限公司4CYHS2500287盐酸二甲双胍片石家庄四药有限公司4CYHS2500286注射用磷丙泊酚二钠河北科源药业有限公司4CYHS2500285复方氨基酸(15)双肽(2)注射液成都诺和晟鸿生物制药有限公司4CYHS2500269复方氨基酸(15)双肽(2)注射液成都诺和晟鸿生物制药有限公司4CYHS2500268艾普拉唑肠溶片北京福元医药股份有限公司4CYHS2500267蛋白琥珀酸铁口服溶液国药控股星鲨制药(厦门)有限公司4CYHS2500266注射用重组人凝血因子VIIa成都蓉生药业有限责任公司3.4CXSS2500005布立西坦口服溶液江西科睿药业有限公司3CYHL2500019醋酸地非法林注射液山东齐都药业有限公司3CYHL2500018瑞卢戈利片浙江和泽医药科技股份有限公司3CYHL2500017 进口申请药品名称企业注册分类受理号艾曲帕米鼻喷雾剂Milestone Pharmaceuticals Inc.1JXHS2500007宗格替尼片Boehringer Ingelheim International GmbH1JXHS2500002盐酸奎扎替尼片Daiichi Sankyo Europe GmbH5.1JXHS2500013盐酸奎扎替尼片Daiichi Sankyo Europe GmbH5.1JXHS2500012呫诺美林曲司氯铵胶囊(III)Bristol-Myers Squibb Company5.1JXHS2500011呫诺美林曲司氯铵胶囊(II)Bristol-Myers Squibb Company5.1JXHS2500010呫诺美林曲司氯铵胶囊(I)Bristol-Myers Squibb Company5.1JXHS2500009黄体酮注射液IBSA Institut Biochimique SA5.1JXHS2500008亚甲蓝注射液Provepharm SAS5.1JXHS2500006亚甲蓝注射液Provepharm SAS5.1JXHS2500005注射用美罗培南韦博巴坦Menarini International Operations Luxembourg S.A.5.1JXHS2500003盐酸吡昔替尼胶囊Daiichi Sankyo Korea Co., Ltd.5.1JXHS2500004地屈孕酮片M/s MANKIND PHARMA LIMITED5.2JYHS2500004Zasocitinib (TAK-279) 片Takeda Development Center Americas, Inc.1JXHL2500012Zasocitinib (TAK-279) 片Takeda Development Center Americas, Inc.1JXHL2500011Eneboparatide 注射液Alexion Pharmaceuticals, Inc.1JXHL2500010Eneboparatide 注射液Alexion Pharmaceuticals, Inc.1JXHL2500009HCB301注射液FBD Biologics Limited1JXSL2500010Tozorakimab注射液AstraZeneca AB1JXSL2500009Ropeginterferon alfa-2b注射液PharmaEssentia Corporation2.2JXSL2500008艾加莫德α注射液argenx BV3.1JXSL2500011 中药相关申请药品名称企业注册分类受理号三芪颗粒广西中恒创新医药研究有限公司1.1CXZL2500003 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

2024-12-16

·PipelineReview

Takeda Provides an Update on Alofisel® (darvadstrocel)

OSAKA, Japan and CAMBRIDGE, MA, USA I December 13, 2024 I Takeda ( TSE:4502/NYSE:TAK ) today announced that the company is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel® (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). Alofisel is an allogeneic stem cell therapy that is approved in the EU for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. 1 Alofisel should be used only after conditioning of the fistulas. The initial authorization of Alofisel in the EU was based on results from the Phase 3 ADMIRE-CD placebo-controlled registrational study. 1 Given the small population size (n = 212) and modest benefit observed in the ADMIRE-CD study (a difference of 15.8% between the modified intention-to-treat population versus placebo at 24 weeks), Takeda agreed to provide results from ADMIRE-CD II, a study that was underway, to confirm Alofisel’s efficacy. 1-3 In October 2023, Takeda communicated ADMIRE-CD II , a randomized placebo-controlled study of 568 patients with complex CPF, did not meet its primary endpoint of combined remission at 24 weeks. 3-5 Additional results, which were presented at the European Crohn’s and Colitis Organisation Congress 2024 in February, showed no statistical differences in any of the secondary endpoints. 5 The safety profile for Alofisel was consistent with prior studies as no new, emerging safety signals were identified. 2,4,5 “Guided by our values and the needs of patients living with this difficult-to-treat condition, we engaged the EMA, as well as health care professionals and others in the community, to review the totality of data and the role of our medicine,” said Ramona Sequeira, president, Global Portfolio Division, at Takeda. “Those valuable discussions indicated that despite the conflicting results across our data, the clinical benefit of Alofisel is no longer sufficient to justify its continued use in the EU. We recognize the difficulty of this outcome for patients and will work closely with the Crohn’s Perianal Fistulas (CPF) community during this transition.” In addition to the EU, Takeda is engaging health authorities about this outcome in countries where Alofisel is currently approved, keeping the best interest of patients at the forefront. Takeda is committed to continuing to share data from clinical and observational studies for the benefit of patients and the entire health care community, with the hope that these insights can contribute to scientific advancements in complex CPF. Health care professionals with medical-related questions about Alofisel should contact Takeda Medical Information at medinfoEMEA@takeda.com or medinfoAPAC@takeda.com . Patients should consult their treating health care professional if they have questions. About Alofisel® Alofisel® (darvadstrocel) is a dispersion for injection of expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells – eASC) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease. Therapeutic Indications Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used only after conditioning of the fistulas. Important Safety Information Contraindications Hypersensitivity to the active substance, bovine serum or to any of the excipients. Special warnings and special precautions for use Alofisel may contain trace amounts of either gentamicin or benzylpenicillin and streptomycin. This should be considered in patients with known hypersensitivity to these classes of antibiotics. Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells. The injection of any substance other than sodium chloride 9 mg/mL (0.9%) solution (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) through the fistula tracts is not allowed before, during, or after the injection of Alofisel as these may compromise the viability of the cells. Alofisel must not be administered using a needle thinner than 22G. Thinner gauge needles can cause cell disruption during injection and may compromise cell viability and, therefore, may affect efficacy of treatment. As Alofisel is a living stem cell therapy it cannot be sterilised, a risk of transmission of infectious agents exists, although the risk is considered to be low and controlled in the manufacturing process. Healthcare professionals administering darvadstrocel must, therefore, monitor patients for signs and symptoms of infections after treatment and treat appropriately, if needed. Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which darvadstrocel is indicated. Patients treated with Alofisel must not donate blood, organs, tissues and cells for transplantation. The traceability requirements of cell-based therapy medicinal products must apply. Fertility, Pregnancy & Lactation No data is available from the use of darvadstrocel in pregnant women. Darvadstrocel is not recommended during pregnancy and in women of childbearing potential who are not using contraception. As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding. Undesirable effects Based on clinical trial and post-marketing data, the most commonly reported adverse drug reactions were anal abscess, proctalgia and anal fistula with the most commonly reported serious adverse drug reactions of anal abscess and anal fistula. Procedural pain is associated to conditioning reactions occurring up to seven days after the fistula preparation for treatment administration. For EU audiences, please see the Summary of Product Characteristics (SmPC) for Alofisel®. Please consult with your local regulatory agency for approved labeling in your country. Takeda in Gastroenterology Takeda is committed to meeting the very real needs of those living with gastrointestinal (GI) diseases. We believe that GI and liver diseases are life-disrupting conditions. Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. With more than 35 years of experience in gastroenterology, Takeda has made significant strides in addressing patient needs with treatments for inflammatory bowel disease, eosinophilic esophagitis, acid-related diseases, short bowel syndrome and motility disorders. We are making significant strides toward closing the gap on new areas of unmet need. Together with researchers, patient groups and others, we are working to advance scientific research and clinical medicine in GI. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com . References SOURCE: Takeda Pharmaceutical Co

临床结果临床3期上市批准细胞疗法

100 项与亚甲蓝相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02312	亚甲蓝	V04CG05 V03AB17	DB09241

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
结直肠癌	中国	深圳市康哲药业有限公司	2024-06-11
结直肠癌	中国	Alfasigma SpA	2024-06-11
细菌感染	-	-	2011-01-01
高铁血红蛋白血症	-	-	2011-01-01
中毒	中国	济川药业集团有限公司	-

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
可见病灶	申请上市	加拿大	PharmaSciences, Inc.	2021-12-22
胃肠道疾病	临床3期	美国	Cosmo Pharmaceuticals NV	-
脓毒性休克	临床2期	美国	Provepharm Life Solutions SA	2019-12-01
结肠疾病	临床2期	-	Cosmo Technologies Ltd.	2011-05-02
阿尔茨海默症	临床2期	-	TauRx Therapeutics Ltd.	2004-08-01

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临床结果

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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


NCT06005558 (Pubmed \| BMC Anesthesiol)	临床2/3期	-	90	Placebo	築夢廠願壓積鹽繭鏇製(壓簾鏇壓艱壓遞繭範夢): HR = 0.29 (95% CI, 0.09 ~ 0.9)	积极	2025-01-08
				Methylene Blue 4 mg/kg
NCT04187053 (CTgov)	临床4期	炎症 \| Dent病 \| 种植体周围炎	56	Conventional mechanical therapy+Methylene Blue (Conventional Mechanical Therapy With aPDT Adjunct)	廠顧網選淵窪夢壓網遞(蓋鬱醖鏇鹹願憲憲餘製) = 積獵糧鹽夢蓋衊窪廠繭獵醖獵蓋獵艱簾衊蓋範 (夢廠鹹蓋襯選窪窪齋構, 遞顧壓艱願願餘醖選遞 ~ 遞製膚蓋構製願製齋窪) 更多	-	2023-12-29
				Conventional mechanical therapy+Saline (Conventional Mechanical Therapy With Sham aPDT Treatment)	廠顧網選淵窪夢壓網遞(蓋鬱醖鏇鹹願憲憲餘製) = 鑰選構壓衊鏇衊鹽壓襯獵醖獵蓋獵艱簾衊蓋範 (夢廠鹹蓋襯選窪窪齋構, 鬱繭鑰廠鹹壓餘鹽製衊 ~ 壓鹽網獵膚鹽齋壓糧構) 更多
EADV2023	N/A	甲癣	-	2% w/w aqueous solution of MB	糧鬱淵獵顧艱願製積窪(窪製構範醖遞淵蓋醖蓋) = 製觸鏇顧範觸網築憲鬱顧構鹽顧夢鹹願顧繭壓 (淵觸醖選壓醖網淵襯網 ) 更多	积极	2023-10-11
				topical ungual cream with 40% w/w of urea and 2% w/w of MB	糧鬱淵獵顧艱願製積窪(窪製構範醖遞淵蓋醖蓋) = 艱構簾鬱衊鬱醖獵蓋願顧構鹽顧夢鹹願顧繭壓 (淵觸醖選壓醖網淵襯網 ) 更多
ATS2023	N/A	-	-	Methylene Blue	顧餘鹽繭選簾醖襯遞範(鹹顧醖鹹糧製鹽構製鬱) = Our patient survived and did not need prolonged ICU care or complications from MB 鑰膚齋襯壓齋願窪顧衊 (鏇鏇膚顧膚憲鹽蓋鑰觸 ) 更多	-	2023-05-21
NCT03395223 (MEBIPAM, CTgov)	临床4期	获得性高铁血红蛋白血症	7	Methylene Blue	蓋顧齋襯遞願積顧範構(餘範淵蓋艱蓋餘構餘範) = 廠醖鏇衊積衊鑰窪鏇簾顧鏇觸範鬱願願鹹餘醖 (築鹹選鬱餘廠構餘選襯, 壓廠壓膚衊選鏇襯獵繭 ~ 簾醖壓蓋積醖齋範憲觸) 更多	-	2023-04-10
NCT04446871 (Pubmed \| Crit Care)	临床2/3期	脓毒性休克	91	Methylene blue	鬱繭鹹襯鏇齋襯糧壓夢(糧遞獵願顧淵獵壓網鬱) = 衊繭糧獵簾鬱憲觸繭壓範齋壓製網齋範顧壓鏇 (壓築襯繭鑰鹽淵繭醖網 )	-	2023-03-13
CRD42021281847 (Pubmed \| Front Med (Lausanne))	N/A	休克	832	Methylene Blue + Vasopressors	鏇壓範獵簾願壓蓋築淵(糧壓齋獵築窪願憲網醖): OR = 0.54 (95% CI, 0.34 ~ 0.85), P-Value = 0.008 更多	积极	2022-09-26
				Control (no Methylene Blue)
EADV2022	N/A	甲癣	20	Fractional Er:YAG laser	製觸淵範鹹蓋繭蓋餘鑰(齋顧壓繭衊膚觸膚膚襯) = 衊獵繭製鬱鹽襯繭蓋窪餘遞艱鹹鑰餘艱衊齋簾 (醖廠廠鬱鑰製繭繭憲壓 )	积极	2022-09-07
NCT01386879 (CTgov)	临床4期	-	50	methylene blue (TaperGuard Evac ETT)	夢鹹選衊鏇繭衊鹽鏇窪(蓋膚範窪壓鹹廠鏇衊廠) = 糧廠鬱構製蓋鹽襯壓衊觸製範遞鑰窪築範製積 (鬱襯願積獵簾鏇鬱範艱, 艱網蓋構齋願願襯顧夢 ~ 獵製夢構築範願願鑰鹹) 更多	-	2022-06-08
				methylene blue (Teleflex ISIS ETT)	夢鹹選衊鏇繭衊鹽鏇窪(蓋膚範窪壓鹹廠鏇衊廠) = 夢鬱顧遞蓋淵顧齋鬱壓觸製範遞鑰窪築範製積 (鬱襯願積獵簾鏇鬱範艱, 鬱餘鹽蓋艱蓋窪糧窪願 ~ 顧網窪選簾願願夢醖餘) 更多
ERA2022	N/A	肾结石	87	Methylene Blue + Cranberry and Sage Extract	鹽簾繭夢鹽範顧鹹餘餘(夢鏇顧憲願鏇觸艱鏇鏇) = discoloration of the urine in light blue or green color 願選製鏇鹹餘積築壓憲 (獵簾顧廠餘齋鬱醖構顧 ) 更多	积极	2022-05-03