A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects

A single and multiple-dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.

开始日期2024-11-24

申办/合作机构

Ensysce Biosciences, Inc.

[+1]

NCT06676085

/ RecruitingN/AIIT

A Novel Strategy Combined Regional Anticoagulation in Membrane Oxygenator and Low-intensity of Systemic Anticoagulation Applied in Management of Extracorporeal Membrane Oxygenation

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

开始日期2024-11-01

申办/合作机构

北京朝阳医院

ChiCTR2400083973

/ Suspended临床1期IIT

Regional citrate anticoagulation versus nafamostat mesylate for continuous renal replacement therapy in patients at high risk of bleeding: a prospective randomized study

开始日期2024-05-13

申办/合作机构-

100 项与甲磺酸萘莫司他相关的临床结果

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100 项与甲磺酸萘莫司他相关的转化医学

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100 项与甲磺酸萘莫司他相关的专利（医药）

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1,276

项与甲磺酸萘莫司他相关的文献（医药）

2025-03-24·Journal of biomolecular structure & dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

作者: Abdalla, Mohnad ; Mitra, Debanjan ; Afreen, Shagufta ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.Communicated by Ramaswamy H. Sarma.

2025-02-01·ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS

The identification of insect specific iAANAT inhibitors

Article

作者: Sabbagh, Christian ; Henry, Gabrielle ; Radulovic, Peter W ; Merkler, David J ; Suarez, Gabriela ; Hawley, Aidan J ; Holets, Tyler ; Scearbo, Matthew ; Bhandari, Suzeeta ; Borisova, Natalia

An important aspect of food security is the development of innovative insecticides, particularly ones that specifically target insect pests and exhibit minimal toxicity to mammals. The insect arylalkylamine N-acyltransferases (iAANATs) could serve as targets for novel insecticides that satisfy these criteria. There exists a wealth of structural and biochemical information for the iAANATs and iAANAT knockdown experiments show that these enzymes are critical to insect health. Herein, we have expressed, purified, and characterized two new iAANATs, one from Apis mellifera (honey bee, AmNAT1) and another from Diaphorina citri (Asian citrus psyllid, DcNAT). We discovered that diminazene, a compound used to treat livestock for trypanosomiasis and babesiosis, inhibits AmNAT1, DcNAT, and D. melanogaster DmAgmNAT with modest affinity, K_i values ranging from 0.8 μM to 200 μM. We found a series of guanidines, amidines, and a hydroxamate, structurally related to diminazene, also inhibit the iAANATs, including camostat, gabexate, nafamostate, and panobinostat. Significantly, we found DmAgmNAT is far more susceptible to inhibition by four of these five of these compounds. In particular, camostat, nafamostat, and gabexate inhibit DmAgmNAT with K_i values of 0.2-30 μM, but no inhibition of AmNAT1 and DcNAT was observed at 500 μM for any of the three. These results show that a species-specific inhibitor targeted against an iAANAT is a real possibility. Also, we report that adipoyl-CoA is a substrate for AmNAT1 and DcNAT and that succinoyl-CoA is a substrate for DcNAT. These results contribute to a growing body of data suggesting that N-dicarboxyacyl-amines are metabolites in insects and other organisms.

2025-01-31·JOURNAL OF VIROLOGY

The respective roles of TMPRSS2 and cathepsins for SARS-CoV-2 infection in human respiratory organoids

Article

作者: Katoh, Hiroshi ; Takeda, Makoto ; Ryo, Akihide ; Kakizaki, Masatoshi ; Nagata, Noriyo ; Kitai, Yuki ; Shirato, Kazuya ; Takayama, Kazuo ; Hashimoto, Rina ; Okura, Takashi ; Akahori, Yukiko ; Yamamoto, Takuya

ABSTRACT:

A critical aspect of the mechanism of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is the protease-mediated activation of the viral spike (S) protein. The type II transmembrane serine protease TMPRSS2 is crucial for SARS-CoV-2 infection in lung epithelial Calu-3 cells and murine airways. However, the importance of TMPRSS2 needs to be re-examined because the ability to utilize TMPRSS2 is significantly reduced in the Omicron variants that spread globally. For this purpose, replication profiles of SARS-CoV-2 were analyzed in human respiratory organoids. All tested viruses, including Omicron variants, replicated efficiently in these organoids. Notably, all SARS-CoV-2 strains retained replication ability in TMPRSS2-gene knockout (KO) respiratory organoids, suggesting that TMPRSS2 is not essential for SARS-CoV-2 infection in human respiratory tissues. However, TMPRSS2-gene knockout significantly reduces the inhibitory effect of nafamostat, indicating the advantage of TMPRSS2-utilizing ability for the SARS-CoV-2 infection in these organoids. Interestingly, Omicron variants regained the TMPRSS2-utilizing ability in recent subvariants. The basal infectivity would be supported mainly by cathepsins because the cathepsin inhibitor, EST, showed a significant inhibitory effect on infection with any SARS-CoV-2 strains, mainly when used with nafamostat. A supplementary contribution of other serine proteases was also suggested because the infection of the Delta variant was still inhibited partially by nafamostat in TMPRSS2 KO organoids. Thus, various proteases, including TMPRSS2, other serine proteases, and cathepsins, co-operatively contribute to SARS-CoV-2 infection significantly in the respiratory organoids. Thus, SARS-CoV-2 infection in the human respiratory tissues would be more complex than observed in cell lines or mice.

IMPORTANCE:

We explored how the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus infects human respiratory organoids, which are a cultured cell model made to mimic the physiological conditions of the human airways. We focused on understanding the role of different proteases of host cells in activating the virus spike proteins. Specifically, we looked at TMPRSS2, a transmembrane serine protease, and cathepsin L, a lysosomal enzyme, which helps the virus enter cells by cutting the viral spike protein. We discovered that while TMPRSS2 is crucial for the virus in certain cells and animal models, other proteases, including cathepsins and various serine proteases, also play significant roles in the SARS-CoV-2 infection of human respiratory organoids. We suggest that SARS-CoV-2 uses a more complex mechanism involving multiple proteases to infect human airways, differing from what we see in conventional cell lines or animal models. This complexity might help explain how different variants can spread and infect people effectively.

项与甲磺酸萘莫司他相关的新闻（医药）

2025-02-12

·信狐药迅

银诺医药1类新药依苏帕格鲁肽α获批上市用于治疗2型糖尿病获批上市| 新获批(1.20-2.9）

每周药品注册获批数据，分门别类呈现，一目了然。(1.20-2.9）新药上市申请药品名称企业注册分类受理号ASK120067片江苏奥赛康药业有限公司1CXHS2101052国;CXHS2101052IMP4297胶囊上海君派英实药业有限公司1CXHS2300074IMP4297胶囊上海君派英实药业有限公司1CXHS2300073左乙拉西坦缓释颗粒上海安必生制药技术有限公司2.2CXHS2300026巯嘌呤微片华润双鹤药业股份有限公司2.2CXHS2300091赛立奇单抗注射液重庆智翔金泰生物制药股份有限公司1CXSS2400001塔戈利单抗注射液四川科伦博泰生物医药股份有限公司1CXSS2400049苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300085苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300084苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300083苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300082苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300081苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300080苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300079苏帕鲁肽注射液上海银诺医药技术有限公司1CXSS2300078司普奇拜单抗注射液成都康诺行生物医药科技有限公司1CXSS2400045 新药临床申请药品名称企业注册分类受理号JKN2306片健康元药业集团股份有限公司1CXHL2401175JKN2306片健康元药业集团股份有限公司1CXHL2401174CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2401193CYH001肠溶胶囊北京承颐医药科技有限公司1CXHL2401192NTQ5082胶囊南京正大天晴制药有限公司1CXHL2401199NTQ5082胶囊南京正大天晴制药有限公司1CXHL2401198SAR444656赛诺菲(中国)投资有限公司1CXHL2401212SAR444656赛诺菲(中国)投资有限公司1CXHL2401211ICP-248片北京诺诚健华医药科技有限公司1CXHL2401218QBT-006颗粒山东青佰欣达医药科技有限公司1CXHL2401214QBT-006颗粒山东青佰欣达医药科技有限公司1CXHL2401213UBT251注射液联邦生物科技(珠海横琴)有限公司1CXHL2401227BG-60366片百济神州(苏州)生物科技有限公司1CXHL2401234BG-60366片百济神州(苏州)生物科技有限公司1CXHL2401233BG-60366片百济神州(苏州)生物科技有限公司1CXHL2401231HWH340片湖北生物医药产业技术研究院有限公司1CXHL2401241HWH340片湖北生物医药产业技术研究院有限公司1CXHL2401240ADC308片嘉兴安帝康生物科技有限公司1CXHL2401239HSK44459片海思科医药集团股份有限公司1CXHL2401244HSK44459片海思科医药集团股份有限公司1CXHL2401243BL0175注射液上海弼领生物技术有限公司1CXHL2401248TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2401180TM471-1胶囊知微生物医药(新乡)有限公司1CXHL2401179注射用培泰菁绿南京诺源医疗器械有限公司1CXHL240118718F-NYM005注射液无锡诺宇医药科技有限公司1CXHL2401197NEP018片深圳海王医药科技研究院有限公司1CXHL2401235NBB-002中硼(厦门)生物医药有限公司1CXHL2401242SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401249SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401250SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401251SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401257SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401256SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401255BPI-452080片贝达药业股份有限公司1CXHL2401265BPI-452080片贝达药业股份有限公司1CXHL2401264BPI-452080片贝达药业股份有限公司1CXHL2401263HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401183HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401182HSK39004吸入粉雾剂西藏海思科制药有限公司1CXHL2401181注射用ZHB601江苏众红生物工程创药研究院有限公司1CXHL2401252注射用咔喏霉素牡丹江友搏药业有限责任公司1CXHL2401258TY-2699a胶囊浙江同源康医药股份有限公司1CXHL2401272TY-2699a胶囊浙江同源康医药股份有限公司1CXHL2401271HT-101注射液苏州星曜坤泽生物制药有限公司1CXHL2401270XH-S004片浙江星浩澎博医药有限公司1CXHL2401279XH-S004片浙江星浩澎博医药有限公司1CXHL2401278HPB-143片杭州多域生物技术有限公司1CXHL2401282HPB-143片杭州多域生物技术有限公司1CXHL2401281TYK-00540片浙江同源康医药股份有限公司1CXHL2401284TYK-00540片浙江同源康医药股份有限公司1CXHL2401283INV-6452片广东省创新药转化医学研究院有限公司1CXHL2401293INV-6452片广东省创新药转化医学研究院有限公司1CXHL2401292Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401304Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401303Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401302Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401301HS-10502片江苏豪森药业集团有限公司1CXHL2401300HS-10502片江苏豪森药业集团有限公司1CXHL2401299AL2846胶囊正大天晴药业集团股份有限公司1CXHL2401309QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401276QB0208-1胶囊北京清博汇能医药科技有限公司1CXHL2401275AY-1001安域生物科技(杭州)有限公司2.1CXHL2401289AY-1001安域生物科技(杭州)有限公司2.1CXHL2401288HXHTT024湖南慧泽生物医药科技有限公司2.2CXHL2401203司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2401232司美格鲁肽注射液海南中和药业股份有限公司2.2CXHL2401230注射用BSY001北京北生研医药科技有限公司2.2CXHL2401422注射用硼[10B]法仑海南普利制药股份有限公司2.2CXHL2401266ZL2301广东众丽医药科技有限公司2.2CXHL2401260ZL2301广东众丽医药科技有限公司2.2CXHL2401259ZL2301广东众丽医药科技有限公司2.2CXHL2401280利拉鲁肽注射液浙江和泽医药科技股份有限公司2.2CXHL2401290葡萄糖缓释颗粒北京科信必成医药科技发展有限公司2.2;2.4CXHL2401236注射用紫杉醇聚合物胶束山东华铂凯盛生物科技有限公司2.2;2.4CXHL2401237胶原酶软膏远大生命科学(鞍山)有限公司2.4CXHL2401189注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2401253格索雷塞片上海正大天晴医药科技开发有限公司2.4CXHL2401254西达本胺片深圳微芯生物科技股份有限公司2.4CXHL2401285泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHL2401298泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHL2401297SYS6017(带状疱疹mRNA疫苗)石药集团巨石生物制药有限公司1.2CXSL2400778二价肠道病毒灭活疫苗(Vero细胞)北京民海生物科技有限公司1.4CXSL2400762四价肠道病毒灭活疫苗(Vero细胞)北京民海生物科技有限公司1.4CXSL2400761注射用聚乙二醇化促血小板生成肽重庆派金生物科技有限公司1CXSL2400770AK129注射液康方汇科(上海)生物有限公司1CXSL2400776注射用SKB445四川科伦博泰生物医药股份有限公司1CXSL2400780IBI3010信达生物制药(苏州)有限公司1CXSL2400758注射用SIBP-A19上海生物制品研究所有限责任公司1CXSL2400757注射用AMT-754普众发现医药科技(上海)有限公司1CXSL2400760重组人源化抗表皮生长因子受体单抗注射液上海津曼特生物科技有限公司1CXSL2400769HX044注射液翰思艾泰生物医药科技(武汉)股份有限公司1CXSL2400783注射用BGB-A3055广州百济神州生物制药有限公司1CXSL2400785HB0017注射液华博生物医药技术(上海)有限公司1CXSL2400749TAEST16001注射液香雪生命科学技术(广东)有限公司1CXSL2400766GenSci120注射液长春金赛药业有限责任公司1CXSL2400764HBM9378(SKB378)注射液和铂医药(上海)有限责任公司1CXSL2400771GC310腺相关病毒注射液北京锦篮基因科技有限公司1CXSL2400774GC310腺相关病毒注射液北京锦篮基因科技有限公司1CXSL2400775ICG318 CAR-T细胞注射液松鹤免疫生物医疗(深圳)有限公司1CXSL2400773GLS-W1100胶囊杭州远大生物制药有限公司1CXSL2400784AA001单抗北京智源鸿晟生物医药有限公司1CXSL2400788HT-102注射液苏州星曜坤泽生物制药有限公司1CXSL2400790BA1106注射液山东博安生物技术股份有限公司1CXSL2400796AWT020注射用无菌粉末上海君实生物医药科技股份有限公司1CXSL2400793注射用BL-M07D1成都百利多特生物药业有限责任公司1CXSL2400792SCT650C 注射液神州细胞工程有限公司1CXSL2400801CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400804GenSci120注射液长春金赛药业有限责任公司1CXSL2400803CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400802ESG206注射液上海诗健生物科技有限公司1CXSL2400807KYS202002A注射液江苏康缘药业股份有限公司1CXSL2400808注射用YL201苏州宜联生物医药有限公司1CXSL2400828恩朗苏拜单抗注射液石药集团巨石生物制药有限公司2.2CXSL2400782A140注射液四川科伦博泰生物医药股份有限公司2.2CXSL2400786LY01015注射液山东博安生物技术股份有限公司2.2CXSL2400794LY01015注射液山东博安生物技术股份有限公司2.2CXSL2400795夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2400806夫那奇珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2400805注射用BAT1006百奥泰生物制药股份有限公司2.4CXSL2400798 仿制药申请药品名称企业注册分类受理号醋氯芬酸片江苏吉贝尔药业股份有限公司3CYHS2300707头孢丙烯干混悬剂国药集团致君(深圳)制药有限公司3CYHS2300773左氧氟沙星口服溶液安徽四环科宝制药有限公司3CYHS2301258氨氯地平贝那普利胶囊浙江高跖医药科技股份有限公司3CYHS2301300注射用比阿培南安徽省先锋制药有限公司3CYHS2301365米力农注射液浙江亚瑟医药有限公司3CYHS2301494米力农注射液浙江亚瑟医药有限公司3CYHS2301493尼麦角林片北京九能天远科技有限公司3CYHS2301585尼麦角林片海南斯达制药有限公司3CYHS2301664复合磷酸氢钾注射液石家庄四药有限公司3CYHS2301676依帕司他片江苏东科康德药业有限公司3CYHS2301765头孢羟氨苄片海南广升誉制药有限公司3CYHS2301830头孢羟氨苄片海南广升誉制药有限公司3CYHS2301829磷酸奥司他韦干混悬剂福建省宝诺医药研发有限公司3CYHS2301932磷酸奥司他韦颗粒成都第一制药有限公司3CYHS2301973奥沙西泮片湖南洞庭药业股份有限公司3CYHS2302048美索巴莫注射液华润双鹤利民药业(济南)有限公司3CYHS2302187磷酸奥司他韦干混悬剂广东红珊瑚药业有限公司3CYHS2302274葡萄糖酸钙注射液浙江沣华医药科技有限公司3CYHS2302296法莫替丁注射液云南药科院生物医药股份有限公司3CYHS2302358重酒石酸间羟胺注射液锦州奥鸿药业有限责任公司3CYHS2302395注射用盐酸罗沙替丁醋酸酯广东众生药业股份有限公司3CYHS2302623法莫替丁注射液成都归合科技有限公司3CYHS2302636普瑞巴林口崩片江西施美药业股份有限公司3CYHS2301762普瑞巴林口崩片江西施美药业股份有限公司3CYHS2301761复方氨基酸(16AA)/葡萄糖(12.6)电解质注射液福建盛迪医药有限公司3CYHS2301098氨溴特罗口服溶液山东京卫制药有限公司3CYHS2301056盐酸利多卡因注射液江苏长江药业有限公司3CYHS2302033盐酸多巴胺注射液山西惠达林曦医药科技有限公司3CYHS2301746生理氯化钠溶液北京柏雅联合药物研究所有限公司3CYHS2302042米诺地尔搽剂四川科伦药业股份有限公司3CYHS2300598米诺地尔搽剂四川科伦药业股份有限公司3CYHS2300597富马酸福莫特罗吸入溶液立生医药(苏州)有限公司3CYHS2202102国;CYHS2202102甲氨蝶呤片国药一心制药有限公司3CYHS2301363无水乙醇注射液北京同济达药业有限公司3CYHS2301982酮咯酸氨丁三醇注射液四川新斯顿制药股份有限公司3CYHS2201428奥美拉唑碳酸氢钠干混悬剂(I)山东益康药业股份有限公司3CYHS2300355马来酸曲美布汀片山西振东安欣生物制药有限公司3CYHS2300384阿立哌唑口腔崩解片北京星昊医药股份有限公司3CYHS2300395阿立哌唑口腔崩解片北京星昊医药股份有限公司3CYHS2300394西他沙星细粒济川药业集团有限公司3CYHS2300503布洛芬注射液西安汉丰药业有限责任公司3CYHS2300749盐酸去氧肾上腺素注射液海南普利制药股份有限公司3CYHS2300995盐酸去氧肾上腺素注射液海南普利制药股份有限公司3CYHS2300994咪达唑仑口服溶液福安药业集团湖北人民制药有限公司3CYHS2301040咪达唑仑口服溶液福安药业集团湖北人民制药有限公司3CYHS2301039普瑞巴林口服溶液温岭市创新生物医药科技股份有限公司3CYHS2301083复方醋酸钠林格注射液赤峰源生药业有限公司3CYHS2301149复方醋酸钠林格注射液赤峰源生药业有限公司3CYHS2301148普瑞巴林口服溶液哈尔滨市康隆药业有限责任公司3CYHS2301427琥珀酸去甲文拉法辛缓释片宜昌人福药业有限责任公司3CYHS2301475琥珀酸去甲文拉法辛缓释片宜昌人福药业有限责任公司3CYHS2301474琥珀酸去甲文拉法辛缓释片宜昌人福药业有限责任公司3CYHS2301473布美他尼注射液成都苑东生物制药股份有限公司3CYHS2301586钠钾镁钙注射用浓溶液仁合益康汇泽药业河北有限公司3CYHS2301702尼莫地平口服溶液南京泽恒医药技术开发有限公司3CYHS2301838氯化钾口服溶液哈尔滨誉衡制药有限公司3CYHS2301861氯化钾口服溶液哈尔滨誉衡制药有限公司3CYHS2301860盐酸右美托咪定注射液江西赣南海欣药业股份有限公司3CYHS2301902盐酸右美托咪定注射液江西赣南海欣药业股份有限公司3CYHS2301901硫酸沙丁胺醇注射液浙江恒研医药科技有限公司3CYHS2302013硫酸沙丁胺醇注射液四川国瑞药业有限责任公司3CYHS2302079复方电解质醋酸钠葡萄糖注射液南京赛瑞谱顿制药有限公司3CYHS2302151复方电解质醋酸钠葡萄糖注射液南京赛瑞谱顿制药有限公司3CYHS2302150左乙拉西坦氯化钠注射液贵州阜康仁制药有限公司3CYHS2302205间苯三酚口崩片浙江沣华医药科技有限公司3CYHS2302302注射用阿莫西林钠四川制药制剂有限公司3CYHS2302414注射用阿莫西林钠四川制药制剂有限公司3CYHS2302413注射用阿莫西林钠四川制药制剂有限公司3CYHS2302412二羟丙茶碱注射液西藏诺泽生物医药有限公司3CYHS2302503吸入用盐酸丙卡特罗溶液浙江恒研医药科技有限公司3CYHS2302956吸入用盐酸丙卡特罗溶液浙江恒研医药科技有限公司3CYHS2302955巴氯芬口服溶液成都倍特得诺药业有限公司3CYHS2400124富马酸福莫特罗吸入溶液江苏长泰药业股份有限公司3CYHS2300852注射用尼可地尔康普药业股份有限公司3CYHS2302713注射用尼可地尔康普药业股份有限公司3CYHS2302711琥珀酸普芦卡必利片山东新时代药业有限公司4CYHS2300935曲氟尿苷替匹嘧啶片江苏奥赛康药业有限公司4CYHS2301190曲氟尿苷替匹嘧啶片江苏奥赛康药业有限公司4CYHS2301189甲磺酸艾立布林注射液江西青峰药业有限公司4CYHS2301225注射用艾司奥美拉唑钠海南葫芦娃药业集团股份有限公司4CYHS2302081注射用艾司奥美拉唑钠海南葫芦娃药业集团股份有限公司4CYHS2302080普瑞巴林胶囊浙江昂利康制药股份有限公司4CYHS2302143普瑞巴林胶囊浙江昂利康制药股份有限公司4CYHS2302142地夸磷索钠滴眼液山东绅联药业股份有限公司4CYHS2302284他克莫司软膏江西施美药业股份有限公司4CYHS2302322他克莫司软膏江西施美药业股份有限公司4CYHS2302321盐酸莫西沙星片山西德元堂药业有限公司4CYHS2302348氢溴酸伏硫西汀片石家庄龙泽制药股份有限公司4CYHS2302356依托考昔片通化东宝药业股份有限公司4CYHS2302354依托考昔片通化东宝药业股份有限公司4CYHS2302353依托考昔片通化东宝药业股份有限公司4CYHS2302352瑞巴派特片辰欣药业股份有限公司4CYHS2302392瑞格列奈片通化万通药业股份有限公司4CYHS2302442溴芬酸钠滴眼液浙江莎普爱思药业股份有限公司4CYHS2302454溴芬酸钠滴眼液浙江莎普爱思药业股份有限公司4CYHS2302453氢溴酸伏硫西汀片江苏恩华药业股份有限公司4CYHS2302448脂肪乳注射液(C14-24)合肥源丰顺医药科技有限公司4CYHS2302465脂肪乳注射液(C14-24)合肥源丰顺医药科技有限公司4CYHS2302464亚叶酸钙注射液四川汇宇制药股份有限公司4CYHS2302488氢溴酸伏硫西汀片中山万汉制药有限公司4CYHS2302486氢溴酸伏硫西汀片中山万汉制药有限公司4CYHS2302485聚甲酚磺醛溶液湖南明瑞制药股份有限公司4CYHS2302549地夸磷索钠滴眼液桂林华诺威基因药业股份有限公司4CYHS2302545普瑞巴林胶囊大桐制药(中国)有限责任公司4CYHS2302612普瑞巴林胶囊大桐制药(中国)有限责任公司4CYHS2302611注射用头孢他啶阿维巴坦钠正大天晴药业集团股份有限公司4CYHS2302631布洛芬缓释胶囊湖北亨迪药业股份有限公司4CYHS2302627注射用维库溴铵成都苑东生物制药股份有限公司4CYHS2302672马来酸非尼拉敏盐酸萘甲唑啉滴眼液广州大光制药有限公司4CYHS2302719西格列汀二甲双胍片(II)浙江永太药业有限公司4CYHS2302714西格列汀二甲双胍片(I)浙江永太药业有限公司4CYHS2302712妥布霉素滴眼液浙江视方极医药科技有限公司4CYHS2302705氢溴酸伏硫西汀片石家庄四药有限公司4CYHS2302754阿仑膦酸钠片浙江恒研医药科技有限公司4CYHS2302750依折麦布片山东鲁抗医药股份有限公司4CYHS2302775地夸磷索钠滴眼液湖南华纳大药厂股份有限公司4CYHS2302765地夸磷索钠滴眼液湖南华纳大药厂股份有限公司4CYHS2302764他氟前列素滴眼液沈阳兴齐眼药股份有限公司4CYHS2302829复方α-酮酸片温州海鹤药业有限公司4CYHS2303205羟苯磺酸钙胶囊广东华南药业集团有限公司4CYHS2303351地夸磷索钠滴眼液南京华兴医药科技有限公司4CYHS2303457氧河南众益气体有限公司4CYHS2401016乳果糖口服溶液安徽新世纪药业有限公司4CYHS2302658乳果糖口服溶液福元药业有限公司4CYHS2303541达格列净二甲双胍缓释片(III)北京福元医药股份有限公司4CYHS2302742达格列净二甲双胍缓释片(I)北京福元医药股份有限公司4CYHS2302741氧(液态)首钢股份公司迁安钢铁公司4CYHS2401002头孢地尼颗粒国药集团致君(深圳)制药有限公司4CYHS2300795洛索洛芬钠凝胶贴膏乐明药业(苏州)有限公司4CYHS2301270熊去氧胆酸胶囊常州制药厂有限公司4CYHS2301769瑞戈非尼片石药集团欧意药业有限公司4CYHS2302121注射用硼替佐米山西普德药业有限公司4CYHS2302212玻璃酸钠滴眼液龙吉川(宁夏)医药科技发展有限公司4CYHS2302374利丙双卡因乳膏四川科伦药业股份有限公司4CYHS2302432恩格列净片山东新华制药股份有限公司4CYHS2302760米拉贝隆缓释片乐泰药业有限公司4CYHS2302823他克莫司缓释胶囊湖南科伦制药有限公司4CYHS2303199他克莫司缓释胶囊湖南科伦制药有限公司4CYHS2303198奥美沙坦酯氨氯地平片北京百奥药业有限责任公司4CYHS2300179富马酸福莫特罗吸入溶液天津金耀药业有限公司4CYHS2302420硫酸氨基葡萄糖胶囊北京朗迪制药有限公司4CYHS2302662阿帕他胺片四川科伦药业股份有限公司4CYHS2303016多种油脂肪乳注射液(C6-24)成都国为生物医药有限公司4CYHS2301836培哚普利氨氯地平片(I)杭州和泽坤元药业有限公司4CYHS2404330孟鲁司特钠颗粒广州博济生物医药科技园有限公司4CYHS2400823艾考糊精腹膜透析液青岛瑞奈医疗科技有限公司4CYHS2401682吸入用布地奈德混悬液宁波美舒医药科技有限公司4CYHS2302707蛋白琥珀酸铁口服溶液北京民康百草医药科技有限公司4CYHS2201491氟维司群注射液南京健友生化制药股份有限公司4CYHS2201613复方电解质注射液杭州民生药业股份有限公司4CYHS2201884利丙双卡因乳膏德全药品(江苏)股份有限公司4CYHS2300115复方托吡卡胺滴眼液湖北远大天天明制药有限公司4CYHS2300392利丙双卡因乳膏苏州二叶制药有限公司4CYHS2300566聚乙二醇钠钾散浙江国镜药业有限公司4CYHS2300922盐酸环喷托酯滴眼液山东绅联药业股份有限公司4CYHS2301333替米沙坦氨氯地平片北京百奥药业有限责任公司4CYHS2301330盐酸乌拉地尔注射液山东泰盛药物研究有限公司4CYHS2301468非诺贝特酸胆碱缓释胶囊福建省宝诺医药研发有限公司4CYHS2301502非诺贝特酸胆碱缓释胶囊福建省宝诺医药研发有限公司4CYHS2301501洛索洛芬钠凝胶贴膏北京泰德制药股份有限公司4CYHS2301716恩格列净片甘李药业山东有限公司4CYHS2301895注射用硼替佐米吉斯美(武汉)制药有限公司4CYHS2301908他克莫司缓释胶囊辰欣药业股份有限公司4CYHS2301980他克莫司缓释胶囊辰欣药业股份有限公司4CYHS2301979妥洛特罗贴剂北京泰德制药股份有限公司4CYHS2301978西甲硅油乳剂北京北陆药业股份有限公司4CYHS2302027复方电解质注射液(II)温岭市创新生物医药科技股份有限公司4CYHS2302045复方电解质注射液(II)温岭市创新生物医药科技股份有限公司4CYHS2302044马来酸阿伐曲泊帕片山东凤凰制药股份有限公司4CYHS2302165氟比洛芬凝胶贴膏武汉法玛星制药有限公司4CYHS2302265头孢地尼颗粒广州江正医药科技有限公司4CYHS2302270甲氨蝶呤注射液湖南慧泽生物医药科技有限公司4CYHS2302316盐酸二甲双胍片赤峰维康生化制药有限公司4CYHS2302314聚乙二醇钠钾散圣嘉(滨海)生物医药科技有限公司4CYHS2302335盐酸阿莫罗芬搽剂武汉诺安药业有限公司4CYHS2302347注射用替加环素浙江亚太药业股份有限公司4CYHS2302384利托那韦片齐鲁制药(海南)有限公司4CYHS2302393孟鲁司特钠咀嚼片海南锦瑞制药有限公司4CYHS2302439多索茶碱注射液山东益健药业有限公司4CYHS2302524环孢素软胶囊齐鲁制药有限公司4CYHS2302506注射用培美曲塞二钠四川百利药业有限责任公司4CYHS2302563注射用亚胺培南西司他丁钠/氯化钠注射液湖南科伦制药有限公司4CYHS2302635米拉贝隆缓释片南京美瑞制药有限公司4CYHS2302679达格列净片河北智恒医药科技股份有限公司4CYHS2302695四烯甲萘醌软胶囊河南泰丰生物科技有限公司4CYHS2302690注射用醋酸卡泊芬净广州瑞尔医药科技有限公司4CYHS2302702枸橼酸伊沙佐米胶囊齐鲁制药有限公司4CYHS2302789枸橼酸伊沙佐米胶囊齐鲁制药有限公司4CYHS2302788枸橼酸伊沙佐米胶囊齐鲁制药有限公司4CYHS2302787盐酸乌拉地尔注射液杭州民生药业股份有限公司4CYHS2302820盐酸乌拉地尔注射液杭州民生药业股份有限公司4CYHS2302819依西美坦片重庆圣华曦药业股份有限公司4CYHS2302937环孢素软胶囊齐鲁制药有限公司4CYHS2302962利格列汀片山东朗诺制药有限公司4CYHS2303095替米沙坦氨氯地平片(II)山西德元堂药业有限公司4CYHS2303152甘油磷酸钠注射液华夏生生药业(北京)有限公司4CYHS2303336甘油磷酸钠注射液北京布霖生物科技有限公司4CYHS2303341注射用盐酸吉西他滨四川百利药业有限责任公司4CYHS2303364恩格列净片湖南汉森制药股份有限公司4CYHS2303427富马酸二甲酯肠溶胶囊宜昌人福药业有限责任公司4CYHS2303483酒石酸溴莫尼定滴眼液乐信乐美(海南)生物科技有限公司4CYHS2303524达格列净片江苏德源药业股份有限公司4CYHS2303509达格列净片江苏德源药业股份有限公司4CYHS2303508富马酸卢帕他定片山东华铂凯盛生物科技有限公司4CYHS2400932依折麦布阿托伐他汀钙片(II)江西施美药业股份有限公司4CYHS2302561奥美沙坦酯片浙江华海药业股份有限公司4CYHS2302996奥美沙坦酯片浙江华海药业股份有限公司4CYHS2302995罗沙司他胶囊江苏万邦生化医药集团有限责任公司4CYHS2301374罗沙司他胶囊江苏万邦生化医药集团有限责任公司4CYHS2301373依折麦布阿托伐他汀钙片(I)江西施美药业股份有限公司4CYHS2302562奥美沙坦酯氨氯地平片江苏联环药业股份有限公司4CYHS2303069西妥昔单抗注射液四川科伦博泰生物医药股份有限公司3.3CXSS2300075聚乙二醇化重组人粒细胞刺激因子注射液杭州九源基因工程股份有限公司3.4CXSS2300032 进口申请药品名称企业注册分类受理号八氟丙烷脂质微球注射液LANTHEUS MI CANADA INC5.1JXHS2400011艾沙妥昔单抗注射液Sanofi Winthrop Industrie2.2JXSS2400044艾沙妥昔单抗注射液Sanofi Winthrop Industrie2.2JXSS2400043地氯雷他定片Mylan Laboratories Limited5.2JYHS2300021特立氟胺片INTAS PHARMACEUTICALS LTD.5.2JYHS2300033瑞戈非尼片Dr. Reddy′s Laboratories Ltd.5.2JYHS2300051他达拉非片Hetero Labs Limited5.2JYHS2300069他达拉非片Hetero Labs Limited5.2JYHS2300068他达拉非片Hetero Labs Limited5.2JYHS2300067Baxdrostat片AstraZeneca AB1JXHL2400264Baxdrostat片AstraZeneca AB1JXHL2400263INCB057643片Incyte Corporation1JXHL2400269INCB057643片Incyte Corporation1JXHL2400268PF-07220060Pfizer Inc.1JXHL2400299PF-07220060Pfizer Inc.1JXHL2400298PF-07220060Pfizer Inc.1JXHL2400297Adagrasib 片Mirati Therapeutics, Inc.2.4JXHL2400270DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400278DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400277DS-3201b片Daiichi Sankyo, Inc.2.4JXHL2400276PF-07868489Pfizer Inc.1JXSL2400216注射用MK-2400Merck Sharp & Dohme LLC1JXSL2400222输注用无菌冻干粉Telisotuzumab VedotinAbbVie Inc.1JXSL2400226DS-1062aDaiichi Sankyo, Inc.1JXSL2400231PIT565Novartis Pharma AG1JXSL2400232VAY736注射液Novartis Pharma AG1JXSL2400223MK-7240注射液Merck Sharp & Dohme LLC1JXSL2400225Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400228帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2400221注射用戈沙妥珠单抗Gilead Sciences, Inc.2.2JXSL2400229Eflapegrastim注射液Hanmi Pharm. Co., Ltd.3.1JXSL2400230注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214坎地沙坦酯氢氯噻嗪片江西施美药业股份有限公司3CYHL2400220坎地沙坦酯氢氯噻嗪片江西施美药业股份有限公司3CYHL2400219达普司他片上海博志研新药物研究有限公司3CYHL2400222伏环孢素软胶囊杭州中美华东制药有限公司3CYHL2400223他替瑞林片江苏杜瑞制药有限公司3CYHL2400221复方硫酸钠片山东诚创蓝海医药科技有限公司3CYHL2400216复方硫酸钠片保定天浩制药有限公司3CYHL2400215盐酸环苯扎林缓释胶囊鲁南贝特制药有限公司3CYHL2400218盐酸环苯扎林缓释胶囊鲁南贝特制药有限公司3CYHL2400217格隆溴铵新斯的明注射液南京正科医药股份有限公司3CYHL2400227右美沙芬安非他酮缓释片四川科伦药业股份有限公司3CYHL2400228盐酸利多卡因局部溶液呋欧医药科技(湖州)有限公司3CYHL2400231盐酸利多卡因局部溶液呋欧医药科技(湖州)有限公司3CYHL2400230吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHL2400234布瑞哌唑片宜昌人福药业有限责任公司3CYHL2400226布瑞哌唑片宜昌人福药业有限责任公司3CYHL2400225布瑞哌唑片宜昌人福药业有限责任公司3CYHL2400224冻干人用狂犬病疫苗(人二倍体细胞)艾美荣誉(宁波)生物制药有限公司3.3CXSL2400789人纤维蛋白原郑州莱士血液制品有限公司3.4CXSL2400800人纤维蛋白原郑州莱士血液制品有限公司3.4CXSL2400799 中药相关申请药品名称企业注册分类受理号辛芪通鼻片北京以岭药业有限公司1.1CXZS2300024一贯煎颗粒上海凯宝药业股份有限公司3.1CXZS2400014苓桂术甘颗粒上海凯宝药业股份有限公司3.1CXZS2400013HC009合剂北京厚成医药科技有限公司1.1CXZL2400074苓仙颗粒苏州玉森新药开发有限公司1.1CXZL2400077柴芩宁神颗粒山西省中医药研究院(山西省中医院)1.1CXZL2400078 注：橙色字体部分结论为不批准或收到通知件；

上市批准申请上市

2025-01-22

·ir.ensysce.com

Ensysce Biosciences Announces Positive Interim Data for Breakthrough Therapy PF614-MPAR

~ Positive Phase 1b Data Confirms Overdose Protection for Highest Dosage Form of PF614-MPAR ~ SAN DIEGO, CA / ACCESS Newswire / January 22, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced interim data from its second clinical trial to evaluate PF614-MPAR for overdose protection. Clinical study PF614-MPAR-102, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 Capsule is Co‑Administered with Nafamostat as a Combination of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,' was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination. In 2024, PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), and had its development bolstered by a $14 million multi-year award from the National Institute on Drug Abuse (NIDA) to continue studying the PF614-MPAR overdose protection observed in an initial clinical study, PF614-MPAR-101. The PF614-MPAR-102 study showed that a 100 mg dosage form of PF614-MPAR provides overdose protection when a greater-than-prescribed dose is consumed at one time. Subjects were studied as their own control and received three doses of the overdose-protected PF614-MPAR versus PF614. The subjects receiving the MPAR product had a significantly lower (p=0.0019) total maximum blood concentration of oxycodone (Cmax) compared to PF614 alone, an indication of overdose protection. As designed, subjects who received a single 100 mg dose of PF614 or PF614 MPAR showed no difference in Cmax values (p=0.523). Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR. The trial will now continue to enroll the final cohorts of Part 1 of the study and then move to Part 2, which is designed to examine potential food effects. Part 3 will then evaluate repeat dosing of PF614 vs. PF614-MPAR over 4.5 days. The aggregation of interim data allows the Company to focus on perfecting a final drug product to move to commercialization. Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "Clinical data from our initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA's Breakthrough Therapy designation, a first for an opioid drug product. This second study builds on the initial data and further demonstrates that MPAR is a vital tool to limit unwanted overdoses from prescription medications. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is being realized." Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "We are delighted with the positive early interim data which confirms that MPAR provides overdose protection in the planned dosage range for our PF614-MPAR drug product. We will continue to quickly execute the final stages of this study using the Translational Pharmaceutics® platform of Quotient Sciences in advance of our work with our new commercial manufacturing partner to prepare this very unique product for the market. We look forward to completing this highly important three-part trial and generating additional evidence to conduct productive discussions with the FDA on the path to registration for the first overdose-protected opioid." About Ensysce Biosciences Ensysce Biosciences is a clinical stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com. Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196 Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811 ENSC@mzgroup.us SOURCE: Ensysce Biosciences, Inc. Released January 22, 2025

临床结果临床1期突破性疗法

2025-01-14

·ir.talphera.com

Talphera Announces Agreement with the FDA for Prior Approval Supplement Review to Reduce the Number of Patients in the NEPHRO CRRT Study

Submission of a Prior Approval Supplement for a reduction in the number of patients in the NEPHRO CRRT study is expected within the coming week The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study SAN MATEO, Calif., Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), the agency has agreed to review a Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study. A PAS is reviewed by the FDA within 30 days, and its approval by the agency is required before formally amending the study protocol. During this same meeting, the agency agreed to two other changes to broaden the clinical study inclusion criteria which would allow the Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours as well as heparin-tolerant patients at certain institutions. These changes are being made through a five-day protocol amendment notice to the FDA with no additional FDA review required. "We continue to evaluate and focus on opportunities to support completion of the NEPHRO CRRT study by the end of the year. In addition to new clinical sites, our continuous improvement efforts in study execution were strengthened following our positive face-to-face meeting with the FDA where the agency agreed we should submit a PAS to reduce the number of patients in the NEPHRO CRRT study. We plan to submit the PAS in the coming week which requires a review period of up to 30 days," stated Shakil Aslam, MD, Talphera's Chief Medical Officer. "Our breakthrough designation status and close collaboration with the FDA continue to support our confidence in the importance of nafamostat as an alternative anticoagulant for patients on CRRT," continued Dr. Aslam. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com. About Niyad and nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™ is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking statements This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation that the NEPHRO study enrollment rates will accelerate due to the protocol changes, and will support the study completion by the end of 2025, and that the PAS will be submitted in the coming week. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-agreement-with-the-fda-for-prior-approval-supplement-review-to-reduce-the-number-of-patients-in-the-nephro-crrt-study-302349947.html SOURCE Talphera, Inc. Investor Contacts: Talphera, Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com; LifeSci Advisors, Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com; Chris Calabrese, 917-680-5608, ccalabrese@lifesciadvisors.com

临床3期

100 项与甲磺酸萘莫司他相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	甲磺酸萘莫司他	B02AB	DB12598

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适应症	国家/地区	公司	日期
弥散性血管内凝血	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1989-03-31
出血	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1989-03-31
胰腺炎	日本	Nichi-Iko Pharmaceutical Co., Ltd.	1989-03-31

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适应症	最高研发状态	国家/地区	公司	日期
慢性胰腺炎	临床1期	中国	兰州京陇医药科技有限公司	2016-09-14
创伤性胰腺炎	临床1期	中国	兰州京陇医药科技有限公司	2016-09-14
新型冠状病毒感染	临床前	美国	Talphera, Inc.	2024-12-01
急性呼吸窘迫综合征	临床前	美国	Talphera, Inc.	2024-12-01

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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


Pubmed \| J Biol Chem 人工标引	临床2期	胰腺癌	47	nafamostat mesilate+Gemcitabine+Tegafur+Gimeracil+Oteracil	繭獵簾襯鑰齋艱膚構鹽(顧膚網積齋鬱糧鹽網衊) = 艱廠醖遞鑰簾壓鹽鹽襯簾製憲觸壓構艱鏇壓簾 (窪襯遞願壓齋鏇積鏇觸, 8.4 ~ 12.0) 更多	积极	2022-05-11
NCT04623021 (Pubmed)	临床2期	新型冠状病毒感染	104	Nafamostat plus standard-of-care (SOC)	築構壓觸壓觸艱醖壓顧(鑰積廠觸鏇膚鹽齋構壓) = 壓淵鏇淵夢餘廠淵願醖積範顧簾製齋蓋選糧製 (淵鑰鬱遞廠齋餘鏇淵齋 )	-	2021-11-01
				Standard-of-care (SOC) alone	築構壓觸壓觸艱醖壓顧(鑰積廠觸鏇膚鹽齋構壓) = 獵醖壓繭積鹹鏇衊餘製積範顧簾製齋蓋選糧製 (淵鑰鬱遞廠齋餘鏇淵齋 )
ASN2021	N/A	-	-	Nafamostat Mesylate	構鹹醖餘淵糧糧艱膚鹽(齋鬱餘壓構鑰蓋構夢襯) = 夢獵構襯鏇廠範糧壓獵膚鹽鏇製鑰憲齋築蓋積 (窪齋鹹鬱積鏇網窪獵鹹, [22 ~ 68])	积极	2021-10-27
				Regional Citrate Anticoagulation	構鹹醖餘淵糧糧艱膚鹽(齋鬱餘壓構鑰蓋構夢襯) = 齋夢淵顧壓衊壓獵範醖膚鹽鏇製鑰憲齋築蓋積 (窪齋鹹鬱積鏇網窪獵鹹, [16 ~ 67])
ASN2020	N/A	-	-	Nafamostat Mesylate	醖廠夢齋膚獵網廠選觸(繭艱鏇願廠觸製鹹繭壓) = 網憲艱簾繭獵襯淵範餘艱淵獵鏇範遞簾遞積獵 (選積遞餘鑰顧顧糧鑰鏇 )	积极	2020-10-19
				Regional Citrate Anticoagulation	醖廠夢齋膚獵網廠選觸(繭艱鏇願廠觸製鹹繭壓) = 衊鹽壓製醖夢選繭齋醖艱淵獵鏇範遞簾遞積獵 (選積遞餘鑰顧顧糧鑰鏇 )
UEGW2016	N/A	-	-	Nafamostat mesilate (FUT)	鹽膚遞願簾選夢積襯積(構憲鹽齋構膚窪廠鑰艱) = 醖積艱積遞範繭鑰艱餘鏇蓋憲遞鑰築壓憲廠壓 (夢糧鹽廠餘鬱廠鏇窪蓋 )	-	2016-10-01
				Low-molecular-weight heparin (LMWH)	鹽膚遞願簾選夢積襯積(構憲鹽齋構膚窪廠鑰艱) = 醖鏇鹽願醖夢選蓋繭網鏇蓋憲遞鑰築壓憲廠壓 (夢糧鹽廠餘鬱廠鏇窪蓋 )
SP234 (ERA2015)	N/A	危重病	115	Nafamostat mesilate	選夢廠艱憲構鹽齋鑰願(鹹衊觸築鏇壓選積獵鬱) = 齋艱夢廠鹹獵獵醖夢淵窪獵簾糧糧齋範淵製醖 (蓋選膚構醖壓醖鏇鹹衊 ) 更多	积极	2015-05-21
				Unfractinated heparin (UFH)	選夢廠艱憲構鹽齋鑰願(鹹衊觸築鏇壓選積獵鬱) = 蓋積齋願窪蓋製製製壓窪獵簾糧糧齋範淵製醖 (蓋選膚構醖壓醖鏇鹹衊 ) 更多
NCT04352400 (Pubmed \| Pancreas)	临床2/3期	ERCP术后胰腺炎	2,956	Nafamostat	繭築襯範糧齋簾簾艱壓(夢鏇糧積憲網廠餘齋鹽) = 淵淵願構鹹齋鏇膚鑰積願遞遞鑰繭觸範簾淵壓 (糧鏇衊顧觸顧鬱鹽簾夢, 0.34 ~ 0.63)	积极	2015-05-01
				Nonnafamostat	-
ASN2014	N/A	-	115	Nafamostat Mesilate	膚窪願構顧獵夢簾鑰淵(艱顧蓋願窪遞膚鏇齋選) = 壓艱鑰齋網憲觸衊選鹽願襯選構鹹襯鏇願鬱糧 (鏇襯積觸廠繭築憲鹹範 ) 更多	积极	2014-11-11
				Unfractionated Heparin	膚窪願構顧獵夢簾鑰淵(艱顧蓋願窪遞膚鏇齋選) = 觸獵築繭艱範衊鏇夢簾願襯選構鹹襯鏇願鬱糧 (鏇襯積觸廠繭築憲鹹範 ) 更多
ASCO2010	临床2期	胰腺癌	30	Gemcitabine + Nafamostat Mesilate	衊鏇鏇構餘夢願膚鹽範(繭選衊憲築獵蓋齋壓鹽) = 艱膚願憲積艱廠鑰顧鹽選願繭膚鹹窪餘獵簾繭 (築製廠淵壓築鏇範獵壓 )	-	2010-05-20
NCT01001403 (CTgov)	临床4期	失盐型肾上腺皮质综合症 \| Prieto X连锁智力低下综合征	62	Nafamostat (Nafamostat)	襯蓋鹽築襯選鹽淵遞築(糧窪遞構廠鬱蓋蓋憲鏇) = 構廠鑰壓鑰鏇積淵遞築齋製獵顧觸積鹹餘選獵 (構鬱範糧網鹽範製遞選, 選糧觸醖範齋積簾繭鏇 ~ 艱願構膚襯鬱壓餘繭鹽) 更多	-	2010-05-03
				Normal Saline (Control)	襯蓋鹽築襯選鹽淵遞築(糧窪遞構廠鬱蓋蓋憲鏇) = 壓壓網積蓋鹽築鹽鏇鹹齋製獵顧觸積鹹餘選獵 (構鬱範糧網鹽範製遞選, 構觸糧襯積築簾壓衊構 ~ 廠壓淵遞膚顧壓簾鹹淵) 更多