采用单中心、随机、开放、四周期完全重复交叉、单剂量给药设计，比较空腹和餐后给药条件下，四川科瑞德制药股份有限公司生产的雷美替胺片（规格：8 mg）与武田薬品工業株式会社持证生产的雷美替胺片（规格：8 mg，商品名：Rozerem®）在中国健康成年受试者中吸收程度和吸收速度的差异，评价空腹和餐后状态下口服两种制剂的生物等效性，并评价四川科瑞德制药股份有限公司生产的雷美替胺片（规格：8 mg）的安全性。

开始日期2024-08-12

申办/合作机构

四川科瑞德制药股份有限公司

NCT06512363

/ Not yet recruiting临床3期

A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Ramelteon in Chinese Patients With Chronic Insomnia

The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia.
Efficacy will be evaluated on objective and subjective sleep parameters.

开始日期2024-08-01

申办/合作机构

南京正大天晴制药有限公司

CTR20242252

/ CompletedN/A

雷美替胺片人体生物等效性试验

以南京正大天晴制药有限公司研制的雷美替胺片（规格：8 mg）为受试制剂（T），武田药品工业株式会社生产的雷美替胺片（商品名：Rozerem®，规格：8 mg）为参比制剂（R），研究受试制剂和参比制剂在空腹/餐后状态下单剂量给药时的药代动力学参数，进行人体生物等效性评价。评估南京正大天晴制药有限公司研制的雷美替胺片的安全性。

开始日期2024-07-01

申办/合作机构

南京正大天晴制药有限公司

100 项与雷美替胺相关的临床结果

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100 项与雷美替胺相关的转化医学

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100 项与雷美替胺相关的专利（医药）

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687

项与雷美替胺相关的文献（医药）

2025-07-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Relaxing effect of ramelteon on the uterus of non-pregnant and pregnant rats: Importance of melatonin receptors and BKCa

Article

作者: Ducza, Eszter ; Szűcs, Kálmán F ; Barna, Tamara ; Bagyánszki, Mária ; Alasaad, Kármen Mirella ; Schaffer, Annamária ; Bódi, Nikolett ; Gáspár, Róbert

AIMS:

Our objective was to measure the effect and mechanism of action of the melatonin agonist ramelteon in rat uteri from non-pregnant and pregnant rats in vitro.

MAIN METHODS:

KCl-induced contractions of non-pregnant and pregnant uterine rings samples (whole or endometrium-denuded) were investigated in an organ bath in the presence of ramelteon alone or with melatonin (MT) receptor antagonist luzindole or with the high-conductance calcium-dependent potassium channel (BK_Ca) blocker paxilline. The changes in melatonin receptor expressions were followed by RT-PCR, Western blot, and fluorescent immunohistochemistry.

KEY FINDINGS:

Ramelteon inhibited uterine contractions, with the degree of inhibition being greater towards the end of pregnancy. Both MT₁ and MT₂ receptors were identified in all uteri (except gestational day 5); they do not participate in the relaxing effect of ramelteon in non-pregnant and 5-day pregnant samples. The activation of BK_Ca appears to be a constitutive component of the uterorelaxant action of ramelteon throughout the gestational period. Endometrial melatonin receptors have a significant impact in mediating relaxation in mid- and late pregnancy.

SIGNIFICANCE:

Ramelteon has a relaxing effect on mid- and late-pregnant uteri through at least a dual mechanism of action. The alteration of melatonin receptors during the gestational period raises the possibility that melatonin receptors might be potential drug targets for the treatment of premature labour.

2025-06-01·JOURNAL OF PHARMACOLOGICAL SCIENCES

Ramelteon coordinates theta and gamma oscillations in the hippocampus for novel object recognition memory in mice

Article

作者: Suzuki, Haruka ; Izumo, Kano ; Matsumoto, Nobuyoshi ; Ikegaya, Yuji ; Iijima, Sena ; Takeda, Kinjiro ; Nagahiro, Takeshi ; Watanabe, Kisa

Object recognition memory is an animal's ability to discriminate between novel and familiar items and is supported by neural activities in not only the perirhinal cortex but also the hippocampus and prefrontal cortex. Since we previously demonstrated that ramelteon enhanced object recognition memory in mice, we sought neural correlates of the memory improvement. We recorded neural activity in the hippocampus and prefrontal cortex of mice while they performed a novel object recognition task. We found that theta oscillations in the hippocampus were enhanced when ramelteon-treated mice explored both novel and familiar objects. Moreover, we showed high coherence in phases at low gamma frequencies between the hippocampus and prefrontal cortex. We assume that theta enhancement is indicative of increased cholinergic activity by melatonin receptor activation. High coherence of low gamma oscillations between the hippocampal and prefrontal network in ramelteon-treated mice sampling novel objects suggests better cognitive operations for discrimination between novelty and familiarity. The current study sheds light upon physiological consequences of melatonin receptor activation, further contributing improved cognitive functions.

2025-05-15·Psychiatria Danubina

Evaluating machine learning algorithms for prediction of treatment response for sleep disturbances in patients with schizophrenia: A post-hoc analysis from a randomized controlled trial

Article

作者: Mishra, Archana ; Jena, Monalisa ; Srinivasan, Anand ; Maiti, Rituparna

BACKGROUND:

A post-hoc analysis was planned to create and compare machine learning algorithms to predict treatment responses to sleep disturbances in patients with schizophrenia.

SUBJECTS AND METHODS:

This post-hoc analysis was done on a randomized controlled trial (NCT03075657), studying the effect of add-on ramelteon on sleep and circadian rhythm disturbances in 120 patients with schizophrenia. We created models using random forest, k-nearest neighbors, extreme gradient boosting machine, R part Classification and regression trees and logistic regression algorithms. R language with mlbench, caret, MASS, rPART packages were used. Box plot and dot plot were plotted to visualize comparisons among the models.

RESULTS:

The logistic regression algorithm was found to be the best-fit model with a specificity of 0.93 and sensitivity of 0.45, and ROC 0.78. Predominant symptom domain (positive or negative), urinary melatonin and global PSQI score at baseline were the most important variables when plotted in terms of mean decrease accuracy. These variables contributed significantly to the final model in the logistic regression algorithm, and the accuracy of this algorithm was found to be 90% for prediction.

CONCLUSIONS:

Machine learning models are an emerging trend in clinical research and should be translated into clinical practice. The logistic regression model predicted responders with 90% accuracy.

项与雷美替胺相关的新闻（医药）

2025-06-15

·信狐药迅

佛山瑞迪奥-创新放射性核素偶联药物-锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液提交上市申请|新受理（6.9-6.15）

本周药品注册受理数据，分门别类呈现，一目了然。(6.9-6.15）新药上市申请药品名称企业注册分类受理号锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液佛山瑞迪奥医药有限公司1CXHS2500065注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽佛山瑞迪奥医药有限公司1CXHS2500064盐酸匹米替尼胶囊默克雪兰诺(北京)医药经营有限公司1CXHS2500063兰索拉唑碳酸氢钠干混悬剂南京海纳制药有限公司2.2CXHS2500067盐酸普萘洛尔滴剂海南诺恩生物科技有限公司2.2CXHS2500066新药临床申请药品名称企业注册分类受理号HP-001胶囊上海超阳药业有限公司1CXHL2500580HP-001胶囊上海超阳药业有限公司1CXHL2500579HP-001胶囊上海超阳药业有限公司1CXHL2500578注射用FZ-P001钠上海复旦张江生物医药股份有限公司1CXHL2500576RSS0393软膏瑞石生物医药有限公司1CXHL2500564RSS0393软膏瑞石生物医药有限公司1CXHL2500563RSS0393软膏瑞石生物医药有限公司1CXHL2500562D-2570片益方生物科技(上海)股份有限公司1CXHL2500560HRS-4729注射液福建盛迪医药有限公司1CXHL2500559HRS-4729注射液福建盛迪医药有限公司1CXHL2500558LY104注射液青岛海洋生物医药研究院1CXHL2500557LY104注射液青岛海洋生物医药研究院1CXHL2500556INT-210胶囊宜坤行健生物医药(上海)有限公司1CXHL2500554INT-210胶囊宜坤行健生物医药(上海)有限公司1CXHL2500553YKYY029注射液北京悦康科创医药科技股份有限公司1CXHL2500569HRS-7172片江苏恒瑞医药股份有限公司1CXHL2500568HRS-7172片江苏恒瑞医药股份有限公司1CXHL2500567HRS-7172片江苏恒瑞医药股份有限公司1CXHL2500566HRS-6093片江苏恒瑞医药股份有限公司1CXHL2500550HRS-6093片江苏恒瑞医药股份有限公司1CXHL2500549QLH12016胶囊齐鲁制药有限公司1CXHL2500548QLH12016胶囊齐鲁制药有限公司1CXHL2500547JSS-222江西施美药业股份有限公司2.2CXHL2500575司美格鲁肽注射液福建基诺厚普生物科技有限公司2.2CXHL2500574司美格鲁肽注射液福建基诺厚普生物科技有限公司2.2CXHL2500573司美格鲁肽注射液福建基诺厚普生物科技有限公司2.2CXHL2500572司美格鲁肽注射液福建基诺厚普生物科技有限公司2.2CXHL2500571司美格鲁肽注射液福建基诺厚普生物科技有限公司2.2CXHL2500570注射用BJ009(皮下注射)上海宝济药业股份有限公司2.2CXHL2500565SPIEC肠溶微片吉林天衡药业有限公司2.2CXHL2500551JMX-2005注射液无锡济煜山禾药业股份有限公司2.2;2.4CXHL2500561沙库巴曲阿利沙坦氨氯地平片深圳信立泰药业股份有限公司2.3CXHL2500555盐酸吉卡昔替尼片苏州泽璟生物制药股份有限公司2.4CXHL2500577盐酸吉卡昔替尼片苏州泽璟生物制药股份有限公司2.4CXHL2500552JT118注射液上海君拓生物医药科技有限公司1.1CXSL2500478NT-INF-001制剂嘉译生物医药(杭州)有限公司1.2CXSL2500468IBI343信达生物制药(苏州)有限公司1CXSL2500487注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2500486洛奈利单抗注射液山东新时代药业有限公司1CXSL2500485AK131注射液中山康方生物医药有限公司1CXSL2500484CVL006 注射液甫康(上海)健康科技有限责任公司1CXSL2500477注射用SHR-A2009苏州盛迪亚生物医药有限公司1CXSL2500476GKL-006Allo注射液北京基因启明生物科技有限公司1CXSL2500475注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2500473注射用SLN12140领诺(上海)医药科技有限公司1CXSL2500472注射用ZGGS18苏州泽璟生物制药股份有限公司1CXSL2500471RGL-305注射液上海瑞宏迪医药有限公司1CXSL2500479注射用HDM2012杭州中美华东制药有限公司1CXSL2500483AK109注射液康融东方(广东)医药有限公司1CXSL2500482AK117注射液中山康方生物医药有限公司1CXSL2500481AK117注射液中山康方生物医药有限公司1CXSL2500480CM536注射液康诺亚生物医药科技(成都)有限公司1CXSL2500474GR1802注射液重庆智翔金泰生物制药股份有限公司1CXSL2500469GR1802注射液重庆智翔金泰生物制药股份有限公司1CXSL2500470注射用QLS31905齐鲁制药有限公司1CXSL2500466脐带血巨核细胞注射液苏州血霁生物科技有限公司1CXSL2500465人羊膜间充质干细胞注射液源品细胞生物科技集团有限公司1CXSL2500464QL2107注射液齐鲁制药有限公司2.2CXSL2500467仿制药申请药品名称企业注册分类受理号醋酸锌颗粒仁合益康集团有限公司3CYHS2502120醋酸锌颗粒仁合益康集团有限公司3CYHS2502119酮咯酸氨丁三醇片南京海融制药有限公司3CYHS2502133盐酸溴己新口服溶液岳阳新华达制药有限公司3CYHS2502131乙酰半胱氨酸口服液合肥国药诺和药业有限公司3CYHS2502130乙酰半胱氨酸口服液合肥国药诺和药业有限公司3CYHS2502129氯化钙注射液成都青山利康药业股份有限公司3CYHS2502125腺苷钴胺胶囊江苏诚康药业有限公司3CYHS2502123注射用盐酸兰地洛尔海南合瑞制药股份有限公司3CYHS2502080托吡酯口服溶液山东鲁抗医药集团赛特有限责任公司3CYHS2502105中性低钙腹膜透析液(碳酸氢盐-G4.25%)石家庄四药有限公司3CYHS2502102注射用氢化可的松琥珀酸钠江西人可医药科技有限公司3CYHS2502100注射用氢化可的松琥珀酸钠江西人可医药科技有限公司3CYHS2502099酮洛芬贴剂湖南九典制药股份有限公司3CYHS2502085多索茶碱口服溶液山东百诺医药股份有限公司3CYHS2502115帕拉米韦注射液山东方明药业集团股份有限公司3CYHS2502112多索茶碱糖浆浙江赛默制药有限公司3CYHS2502110酮咯酸氨丁三醇注射液国药集团国瑞药业有限公司3CYHS2502108马来酸噻吗洛尔滴眼液广东南国药业有限公司3CYHS2502062比拉斯汀口服溶液南京黄龙生物科技有限公司3CYHS2502060中性腹膜透析液(碳酸氢盐-G4.25%)成都青山利康药业股份有限公司3CYHS2502052中性低钙腹膜透析液(碳酸氢盐-G4.25%)成都青山利康药业股份有限公司3CYHS2502055头孢羟氨苄干混悬剂广东万泰科创药业有限公司3CYHS2502047头孢羟氨苄干混悬剂广东万泰科创药业有限公司3CYHS2502046乙酰半胱氨酸注射液山东如至生物医药科技有限公司3CYHS2502043乙酰半胱氨酸注射液山东如至生物医药科技有限公司3CYHS2502042布洛芬去氧肾上腺素片康芝药业股份有限公司3CYHS2502033洛索洛芬钠口服溶液海南斯达制药有限公司3CYHS2502032吡格列酮二甲双胍片石家庄市华新药业有限责任公司3CYHS2502028甲磺酸雷沙吉兰片浙江九洲生物医药有限公司4CYHS2502141拉西地平片浙江贝得药业有限公司4CYHS2502140拉西地平片浙江贝得药业有限公司4CYHS2502139非诺贝特胶囊广州市陌希生物技术有限公司4CYHS2502138贝前列素钠缓释片北京泰德制药股份有限公司4CYHS2502137西达本胺片南京正大天晴制药有限公司4CYHS2502136沙库巴曲缬沙坦钠片沈阳奥吉娜药业有限公司4CYHS2502135沙库巴曲缬沙坦钠片沈阳奥吉娜药业有限公司4CYHS2502134乌帕替尼缓释片北京北陆药业股份有限公司4CYHS2502132盐酸奥布卡因滴眼液立生医药(苏州)有限公司4CYHS2502128盐酸阿罗洛尔片湖南尚众合生物医药有限公司4CYHS2502127培唑帕尼片仁合熙德隆药业有限公司4CYHS2502126克立硼罗软膏重庆华邦制药有限公司4CYHS2502124氧氟沙星滴耳液海南斯达制药有限公司4CYHS2502122环孢素滴眼液(III)苏州合美嘉制药有限公司4CYHS2502121注射用头孢他啶阿维巴坦钠山东鲁抗三叶制药有限公司4CYHS2502079小儿法罗培南钠颗粒烟台巨先药业有限公司4CYHS2502078利奈唑胺干混悬剂石药集团中诺药业(石家庄)有限公司4CYHS2502077丁二磺酸腺苷蛋氨酸肠溶片浙江皓格药业有限公司4CYHS2502076布瑞哌唑片湖南省湘中制药有限公司4CYHS2502075双氯芬酸钠双释放肠溶胶囊上海惠永制药有限公司4CYHS2502074乙酰半胱氨酸注射液陕西丽彩药业有限公司4CYHS2502073美沙拉秦灌肠液重庆健能医药开发有限公司4CYHS2502072枸橼酸西地那非片山西汾河制药有限公司4CYHS2502071枸橼酸西地那非片山西汾河制药有限公司4CYHS2502070乙酰半胱氨酸注射液海南皇隆制药股份有限公司4CYHS2502069阿昔莫司胶囊广东健信制药股份有限公司4CYHS2502104二十碳五烯酸乙酯软胶囊沐邦(北京)医药科技有限公司4CYHS2502103注射用硫酸艾沙康唑牡丹江友搏药业有限责任公司4CYHS2502101乙酰半胱氨酸注射液海南金瑞宝医药科技有限公司4CYHS2502098孟鲁司特钠颗粒山东达因海洋生物制药股份有限公司4CYHS2502097艾普拉唑肠溶片山东朗诺制药有限公司4CYHS2502096双醋瑞因胶囊杭州朱养心药业有限公司4CYHS2502095苯磺酸左氨氯地平片宁波大红鹰药业股份有限公司4CYHS2502094苯磺酸左氨氯地平片宁波大红鹰药业股份有限公司4CYHS2502093乙酰半胱氨酸注射液德全药品(江苏)股份有限公司4CYHS2502092四烯甲萘醌软胶囊昆明邦宇制药有限公司4CYHS2502091卡左双多巴缓释片山东新时代药业有限公司4CYHS2502090卡左双多巴缓释片山东新时代药业有限公司4CYHS2502089醋酸奥曲肽注射液江苏恒新药业有限公司4CYHS2502088醋酸奥曲肽注射液江苏恒新药业有限公司4CYHS2502087铝碳酸镁咀嚼片河南中杰药业有限公司4CYHS2502086苯磺酸左氨氯地平片北京双鹭药业股份有限公司4CYHS2502084苯磺酸左氨氯地平片北京双鹭药业股份有限公司4CYHS2502083乙酰半胱氨酸注射液远大医药(中国)有限公司4CYHS2502082乙酰半胱氨酸注射液成都倍特药业股份有限公司4CYHS2502081布洛芬混悬液中山可可康制药有限公司4CYHS2502106乙酰半胱氨酸注射液浙江百代医药科技有限公司4CYHS2502118乙酰半胱氨酸注射液石家庄四药有限公司4CYHS2502117乳果糖口服溶液大连百畅药物研发有限公司4CYHS2502116乳果糖口服溶液大连百畅药物研发有限公司4CYHS2502114阿戈美拉汀片北京星昊医药股份有限公司4CYHS2502113乌帕替尼缓释片山东诺禾康药业有限公司4CYHS2502111乙酰半胱氨酸注射液湖南华纳大药厂股份有限公司4CYHS2502109乙酰半胱氨酸注射液南京正大天晴制药有限公司4CYHS2502107注射用氟氧头孢钠山东鲁抗三叶制药有限公司4CYHS2502068注射用氟氧头孢钠山东鲁抗三叶制药有限公司4CYHS2502067罗沙司他胶囊山西同达药业有限公司4CYHS2502066罗沙司他胶囊山西同达药业有限公司4CYHS2502065氯吡格雷阿司匹林片江苏万高药业股份有限公司4CYHS2502064阿达帕林凝胶苏州第四制药厂有限公司4CYHS2502063左卡尼汀口服溶液黑龙江中桂制药有限公司4CYHS2502061布瑞哌唑片上海复旦复华药业有限公司4CYHS2502059布瑞哌唑片上海复旦复华药业有限公司4CYHS2502058布瑞哌唑片上海复旦复华药业有限公司4CYHS2502057乙酰半胱氨酸注射液仁合益康集团有限公司4CYHS2502056乙酰半胱氨酸注射液河北龙海药业有限公司4CYHS2502054乙酰半胱氨酸注射液海南斯达制药有限公司4CYHS2502053乙酰半胱氨酸注射液上海凯宝新谊(新乡)药业有限公司4CYHS2502051沙库巴曲缬沙坦钠片石家庄四药有限公司4CYHS2502050乙酰半胱氨酸注射液合肥国药诺和药业有限公司4CYHS2502049复方托吡卡胺滴眼液浙江莎普爱思药业股份有限公司4CYHS2502045碳酸氢钠血滤置换液山东齐都药业有限公司4CYHS2502044蒙脱石混悬液广东江正药业有限公司4CYHS2502041二十碳五烯酸乙酯软胶囊北京康立生医药技术开发有限公司4CYHS2502040硫酸氨基葡萄糖胶囊珠海同源药业有限公司4CYHS250203910%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)注射液辽宁海思科制药有限公司4CYHS2502038硫酸镁钠钾口服用浓溶液西洲医药科技(浙江)有限公司4CYHS2502037多种微量元素注射液(III)成都欣捷高新技术开发股份有限公司4CYHS2502036多种微量元素注射液(III)成都欣捷高新技术开发股份有限公司4CYHS2502035卡左双多巴缓释片重庆赛维药业有限公司4CYHS2502031乙酰半胱氨酸注射液江西科睿药业有限公司4CYHS2502048蛋白琥珀酸铁口服溶液河南泰丰生物科技有限公司4CYHS2502030盐酸乙哌立松片湖南千金协力药业有限公司4CYHS2502029注射用甲苯磺酸奥马环素齐鲁制药有限公司4CYHS2502034贝伐珠单抗眼内注射溶液兆科(广州)眼科药物有限公司3.2CXSS2500064阿达木单抗注射液四川泸州步长生物制药有限公司3.3CXSS2500061甘精胰岛素利司那肽注射液(II)赛诺菲(北京)制药有限公司3.4CXSS2500063甘精胰岛素利司那肽注射液(I)赛诺菲(北京)制药有限公司3.4CXSS2500062贝美前列素涂剂浙江孚诺医药股份有限公司3CYHL2500113雷美替胺片朗天药业(湖北)有限公司3CYHL2500112甲苯磺酸卢美哌隆胶囊荣昌制药(淄博)有限公司3CYHL2500111洛索洛芬钠凝胶贵州联盛药业有限公司3CYHL2500110洛索洛芬钠凝胶贵州联盛药业有限公司3CYHL2500109环孢素滴眼液(II)鲁南贝特制药有限公司3CYHL2500108进口申请药品名称企业注册分类受理号丝右哌甲酯右哌甲酯复方胶囊Commave Therapeutics SA5.1JXHS2500067丝右哌甲酯右哌甲酯复方胶囊Commave Therapeutics SA5.1JXHS2500066丝右哌甲酯右哌甲酯复方胶囊Commave Therapeutics SA5.1JXHS2500065帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500093帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500092帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500091帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500090帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500089帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500088帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500087帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500086帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500085帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500084帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500083帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500082帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500081帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500080帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500079帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500078帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500077帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500076帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500075帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500074帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500095帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500094AZD6793AstraZeneca AB1JXHL2500142AZD6793AstraZeneca AB1JXHL2500141AZD6793AstraZeneca AB1JXHL2500140Baxdrostat片AstraZeneca AB1JXHL2500138Baxdrostat片AstraZeneca AB1JXHL2500137ARV-471(PF-07850327)片Pfizer Inc.1JXHL2500136BMS-986504片Bristol-Myers Squibb Company1JXHL2500139PF-07248144片Pfizer Inc.1JXHL2500135PF-07248144片Pfizer Inc.1JXHL2500134PF-07248144片Pfizer Inc.1JXHL2500133BI 690517片Boehringer Ingelheim International GmbH1JXHL2500132Muvalaplin片Eli Lilly and Company1JXHL2500131甲苯磺酸利特昔替尼胶囊Pfizer Inc.2.4JXHL2500144甲苯磺酸利特昔替尼胶囊Pfizer Inc.2.4JXHL2500143注射用MK-2400Merck Sharp & Dohme LLC1JXSL2500089注射用MK-5909Merck Sharp & Dohme LLC1JXSL2500088注射用MK-1022Merck Sharp & Dohme LLC1JXSL2500086Dostarlimab注射液GlaxoSmithKline (Ireland) Limited3.1JXSL2500087中药相关申请药品名称企业注册分类受理号郁枢达片国药集团同济堂(贵州)制药有限公司1.1CXZS2500025独一味胶囊天地恒一制药股份有限公司4CYZS2500007正柴胡饮颗粒陕西天地人和药业有限公司4CYZS2500006妇科止血消痛颗粒广东方盛融科药业有限公司1.1CXZL2500039金振口服液江苏康缘药业股份有限公司2.3CXZL2500038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。

申请上市放射疗法

2025-06-03

·enveric.com

Enveric Biosciences Announces Issuance of U.S. Patent Covering a Novel Family of Molecules Including Melatonin Receptor-Targeting Compounds

CAMBRIDGE, Mass. – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced the issuance of a new U.S. patent (USPTO Number 12,187,679). The patent strengthens Enveric’s intellectual property portfolio and covers a structurally diverse class of novel molecules with potential therapeutic applications in the treatment of sleep and central nervous system (CNS) disorders. The newly granted patent, titled, “Hydroxylated Psilocybin Derivatives and Methods of Using,” expands Enveric’s proprietary drug discovery platform and includes a unique subset of compounds that demonstrate selective binding to the melatonin MT1 receptor-an established, therapeutic target known to regulate circadian rhythm and sleep-wake cycles. These molecules were identified through Enveric’s structure-activity screening efforts. Melatonin signaling is a clinically validated pathway in the treatment of sleep and mood disorders. Several approved therapies leverage this mechanism of action, including ramelteon (Rozerem®), a selective MT1/MT2 agonist approved by the FDA for insomnia, and agomelatine (Valdoxan®), an MT1/MT2 agonist and 5-HT C antagonist approved in Europe for major depressive disorder (MDD). These drugs provide market validation for targeting melatonergic pathways. Among the diverse molecules covered by the patent, select compounds exhibit potential to act as MT1-selective agonists, positioning them as promising candidates for the development of innovative sleep therapeutics. Some of these compounds also display more complex pharmacological profiles, engaging both melatonin and other CNS-relevant receptor systems. This receptor diversity may enable differentiated therapeutic approaches across a range of psychiatric and neurological indications. The Company believes this new patent enhances the strength of its drug discovery platform and supports continued expansion of its CNS-focused strategy targeting high-value therapeutic markets. Dr. Joseph Tucker, CEO of Enveric Biosciences, commented “This newly issued patent adds to the growing body of intellectual property that underpins our pipeline of next-generation neuroplastogenic therapeutics. The inclusion of selective melatonin receptor-binding compounds broadens our ability to target sleep disorders, a prevalent category representing a multi-billion-dollar annual market. This intellectual property milestone strengthens our strategic position to advance differentiated candidates in areas where current treatment options remain limited or suboptimal.” About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com. Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250603483507/en/ Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 dirish@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 cmcdonald@tiberend.com

上市批准

2025-05-27

·赛柏蓝

失眠新药！中国获批上市

作者 | 陈芋责编 | 遥望新机制失眠治疗药物中国获批上市，每月费用约500元，国内治疗格局或迎拐点。 01精准干预、非成瘾国内失眠治疗格局分水岭？5月27日，卫材正式对外宣布其原研的双食欲素受体拮抗剂——莱博雷生（商品名：达卫可/Dayvigo）获国家药监局批准上市，用于治疗成人失眠障碍。这是国内首次引入该机制的失眠治疗药物，不仅给国内3亿失眠患者提供了新选项，还可能引导中国失眠治疗市场向“精准干预+非成瘾”方向发展。此前，国内临床常用的安眠药主要包括四类——苯二氮卓类镇静催眠药：艾司唑仑（舒乐安定）、劳拉西泮、阿普唑仑等；非苯二氮卓类镇静催眠药：唑吡坦（思诺思）、右佐匹克隆等；褪黑激素受体激动剂：雷美替胺、阿戈美拉汀等；抗抑郁/精神病药：如多塞平、米氮平、曲唑酮等。上述药物对治疗失眠有效，但不足也非常明显。例如，苯二氮卓类药物存在耐药性，长期使用可能需加大剂量才能维持疗效，同时其存在一定依赖性，突然停药可能出现失眠症状加重、戒断反应等，此外还有过度镇静风险，出现白天头晕、困倦、记忆障碍等。使用非苯二氮卓药物可能出现梦游、幻觉等复杂睡眠行为，如半梦半醒间走路、进食、驾驶等，期间易发生跌倒事故等，此类药物突然停用后也可能出现反弹性失眠。褪黑激素受体激动剂对解决入睡困难有效，但是对增加睡眠总时长效果不佳，不适用于睡眠维持困难患者；抗抑郁、抗精神病类药物则主要用于存在对应疾病且伴随睡眠障碍的患者。不同于镇静类药物，作为双重食欲素受体拮抗剂的莱博雷生通过靶向调控睡眠-觉醒系统，不直接抑制中枢神经系统，在有效治疗失眠的基础上，可减少传统安眠药的部分副作用。食欲素是一种在下丘脑外侧区域产生的促进觉醒的神经肽，如果夜间分泌过多，将无法从觉醒系统切换至睡眠系统，导致失眠。莱博雷生通过阻断食欲素与食欲素1和2受体结合，抑制食欲素的促清醒作用，从而诱导生理性睡眠。数据显示，在超过12个月的治疗中，受试者使用莱博雷生常见的不良反应大多数为轻度、中度，包括白天嗜睡（10%）、头痛（6%）、异常梦境（2%）等，未观察到认知和精神运动障碍、复杂睡眠行为等不良反应。戒断反应方面，受试者在服用莱博雷生12个月后突然停药并进行为期2周的研究结束随访，期间莱博雷生的睡眠结果改善得以维持。不过，需要注意的是，食欲素受体拮抗剂的不良反应只是相对传统安眠药而言较少、较轻，其长期用药的安全数据仍较为缺乏，FDA仍要求相关药品说明书保留次日残留效应、滥用可能性等安全风险的警告标签。02国内3亿患者新市场待开发2019年12月，莱博雷生获得FDA批准用于治疗成年患者失眠，之后相继在日本、加拿大、澳大利亚等十余个国家地区上市。在中国，莱博雷生2021年率先于香港和台湾地区获批上市。之后，得益于“港澳药械通”政策，2023年4月，莱博雷生被纳入第四批急需进口目录，广东省“港澳药械通”指定医疗机构也可开具处方，5mg*28片规格价格约498元一盒。卫材年报显示，莱博雷生2024财年的全球销售额达到538亿日元（折合人民币约26.9亿元），同比增长约28.7%，其中日本本土销售额占比超过82%。随着在中国的商业化进程推进，其销售额有望进一步增长。截自卫材2024财年（2024.4-2025.3）年报据世界卫生组织报告，全球10%～49%的人患有不同程度失眠，其中，中国成年人的比例高达38.2%。国家卫健委数据显示，中国失眠人群约1.4亿至2.8亿人。中国社会科学院发布的《中国睡眠研究报告2022》显示，2021年我国民众每天平均睡眠时长约7.06小时，较2012年的8.5小时减少1.5小时。失眠与减重相似，兼具医疗和消费属性，但不同于大热的GLP-1赛道，目前国内布局失眠治疗创新药的企业不算太多。2022年11月，先声药业与Idorsia订立独家许可协议，获得双食欲素受体拮抗剂达利雷生（商品名：QUVIVIQ）在中国大陆及港澳地区开发及商业化独家权利。2024年5月，先声宣布盐酸达利雷生片用于治疗中国失眠患者的III期临床试验已达到主要研究终点。扬子江的YZJ-1139同样是双食欲素受体拮抗剂，此前公布的Ⅱ期临床研究显示，该药物可安全有效地改善失眠患者睡眠效率，具有量效关系，且未出现明显的中枢神经系统副作用；东阳光药的HEC-83518也已进入临床阶段。尽管潜在市场庞大，但国内失眠患者就诊率不足30%，实际药物治疗率更低，医生用药观念保守、患者对不良反应顾虑重、医保可及性不足等都是入局的医药企业未来需推动解决的问题。END内容沟通：郑瑶（13810174402）

100 项与雷美替胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02689	雷美替胺	N05CH02	DB00980

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
入睡和睡眠障碍	美国	Takeda Pharmaceuticals U.S.A., Inc.	2005-07-22

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
重度抑郁症	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2011-12-01
重度抑郁症	临床3期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2011-12-01
重度抑郁症	临床3期	智利	Takeda Pharmaceutical Co., Ltd.	2011-12-01
重度抑郁症	临床3期	哥伦比亚	Takeda Pharmaceutical Co., Ltd.	2011-12-01
重度抑郁症	临床3期	墨西哥	Takeda Pharmaceutical Co., Ltd.	2011-12-01
哮喘	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2008-03-01
躁郁症1型	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2007-12-01
阻塞性睡眠呼吸暂停综合征	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2006-07-01
先兆偏头痛	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2008-04-01
无先兆偏头痛	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2008-04-01

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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


ATS2022	N/A	谵妄	-	Ramelteon 8mg	壓繭簾製衊壓膚衊顧願(淵糧願鏇簾網顧蓋積範) = 蓋觸鏇築壓鬱蓋鏇遞製蓋淵餘選醖網鏇鑰鏇淵 (夢糧獵製築淵窪齋鏇糧, 7.2) 更多	-	2022-05-15
				Placebo	壓繭簾製衊壓膚衊顧願(淵糧願鏇簾網顧蓋積範) = 鑰積蓋鹹繭範繭鏇醖鹽蓋淵餘選醖網鏇鑰鏇淵 (夢糧獵製築淵窪齋鏇糧, 8.1) 更多
NCT03091738 (CTgov)	临床4期	入睡和睡眠障碍 \| 纤维化	10	Ramelteon Pill	膚餘窪願獵膚積窪鑰膚(鏇鑰積廠範製遞選襯築) = 廠積築夢繭夢淵鏇願構選遞網觸壓膚餘觸獵壓 (衊選憲範蓋蓋願製衊壓, 2.97) 更多	-	2021-03-29
NCT02324153 (RECOVER, CTgov)	临床2期	麻醉 \| 苏醒期谵妄 \| 认知障碍	80	Microcrystalline Cellulose+Ramelteon+Riboflavin 100 mg (Treatment)	網夢築鹽獵齋膚窪選鏇 = 鑰簾蓋願鏇獵廠壓齋簾夢淵積願獵艱願襯願廠 (壓糧壓餘衊獵夢構積齋, 觸鹹顧糧糧鬱醖夢糧蓋 ~ 願鏇廠鹽獵鹽製鹹積鬱) 更多	-	2020-06-30
				Microcrystalline Cellulose+Riboflavin 100 mg (Placebo)	網夢築鹽獵齋膚窪選鏇 = 鏇獵觸齋鹽網顧憲齋蓋夢淵積願獵艱願襯願廠 (壓糧壓餘衊獵夢構積齋, 鏇餘糧艱觸鏇繭積膚遞 ~ 糧鑰觸齋艱衊觸鏇蓋繭) 更多
NCT02324153 (RECOVER, Pubmed \| Am J Geriatr Psychiatry)	临床2期	苏醒期谵妄	80	Ramelteon (8 mg)	夢構繭網積選壓膚鹹網(繭蓋選觸艱構範夢簾簾) = 鏇衊齋選網鬱獵顧構醖觸鏇網鹽積鹽齋鏇鑰構 (獵鑰鏇糧積觸顧艱醖簾 )	不佳	2020-05-16
				Placebo	夢構繭網積選壓膚鹹網(繭蓋選觸艱構範夢簾簾) = 鏇範製齋鏇淵壓繭鑰淵觸鏇網鹽積鹽齋鏇鑰構 (獵鑰鏇糧積觸顧艱醖簾 )
NCT02691013 (Pubmed \| Crit Care Med)	N/A	-	-	Ramelteon 8mg	製築獵壓製淵觸鏇窪獵(鹽範鹹糧遞糧膚衊遞顧) = 淵鹽繭鹽築壓艱襯觸製簾鏇鏇膚窪壓壓繭衊選 (窪夢網廠淵簾夢壓蓋鏇 ) 更多	不佳	2019-12-01
				Placebo	製築獵壓製淵觸鏇窪獵(鹽範鹹糧遞糧膚衊遞顧) = 廠範膚範廠窪顧鏇選夢簾鏇鏇膚窪壓壓繭衊選 (窪夢網廠淵簾夢壓蓋鏇 ) 更多
NCT02560324 (RAP, CTgov)	临床2期	烟草依赖	140	Ramelteon (Ramelteon)	餘蓋獵淵獵窪壓獵鬱鬱(網壓願鏇構鏇鹽襯鹽積) = 廠窪積觸鑰積壓醖築壓願範簾淵衊壓窪遞築鹽 (鹹遞夢餘糧獵憲窪鑰觸, 1.6) 更多	-	2019-11-04
				Placebo (Placebo)	餘蓋獵淵獵窪壓獵鬱鬱(網壓願鏇構鏇鹽襯鹽積) = 糧鹽鑰觸窪簾築憲願鹽願範簾淵衊壓窪遞築鹽 (鹹遞夢餘糧獵憲窪鑰觸, 1.6) 更多
NCT02691013 (CTgov)	N/A	肺栓塞 \| 谵妄 \| 睡眠剥夺	120	Placebo (Placebo)	獵遞範鑰鑰襯遞鹹選淵(顧構鏇鹹網獵願獵夢窪) = 鏇構築淵鏇鑰繭願繭鹹網膚艱積衊夢鹹繭衊鹽 (襯壓艱繭鏇淵製憲夢製, 衊膚顧襯範網鬱齋遞鹽 ~ 艱範鹽製鏇選範醖選餘) 更多	-	2019-09-20
				Ramelteon (Ramelteon)	獵遞範鑰鑰襯遞鹹選淵(顧構鏇鹹網獵願獵夢窪) = 顧憲淵鹹鏇艱遞鏇觸膚網膚艱積衊夢鹹繭衊鹽 (襯壓艱繭鏇淵製憲夢製, 糧窪憲糧餘壓積鑰壓構 ~ 醖蓋構鹽鬱衊獵觸簾鑰) 更多
NCT02669082 (CTgov)	临床4期	入睡和睡眠障碍 \| 重度抑郁症	26	Ramelteon	選餘築鬱艱構廠廠憲鹽(簾餘襯餘範範選齋膚醖) = 艱製網鹹夢廠鬱簾窪夢鏇築壓製遞衊憲顧窪憲 (鏇齋糧糧膚淵鏇壓膚艱, 32.498) 更多	-	2019-07-22
NCT01048242 (CTgov)	临床3期	入睡和睡眠障碍 \| 阻塞性睡眠呼吸暂停综合征	27	rozerem (Ramelteon)	膚積壓襯齋蓋觸鑰範範(衊壓觸築窪鹹淵鏇選構) = 鏇廠鑰壓壓網鏇膚範淵憲鹽鑰憲觸壓蓋憲蓋膚 (築壓繭選廠衊築繭簾膚, 10.3) 更多	-	2017-05-03
				Placebo (Sugar Pill)	膚積壓襯齋蓋觸鑰範範(衊壓觸築窪鹹淵鏇選構) = 構糧獵膚遞簾廠積餘夢憲鹽鑰憲觸壓蓋憲蓋膚 (築壓繭選廠衊築繭簾膚, 30.7) 更多
NCT01467700 (CTgov)	临床3期	抑郁症 \| 躁郁症1型 \| 重度抑郁症	490	Placebo (Placebo)	窪鏇醖構遞壓鏇簾餘築(膚憲範淵蓋網廠窪齋鹽) = 艱積鬱淵獵窪積構獵範淵積鹽積淵願鏇膚鬱壓 (製鑰齋顧膚製糧廠夢衊, 0.94) 更多	-	2016-05-16
				Ramelteon SL (Ramelteon SL 0.1 mg)	窪鏇醖構遞壓鏇簾餘築(膚憲範淵蓋網廠窪齋鹽) = 餘膚製醖遞繭糧簾衊鏇淵積鹽積淵願鏇膚鬱壓 (製鑰齋顧膚製糧廠夢衊, 0.89) 更多