更新于：2024-07-01

Oxytocin

缩宫素

更新于：2024-07-01

概要

概要

基本信息

简介催产素是一种以商品名OXYTOCIN®销售的OXTR激动剂，是一种因其在妇产科领域的临床疗效而受到称赞的药物。催产素由诺华公司制造，诺华是一家在药物创新方面享有盛誉的制药公司，它于1980年首次在美国获得批准。该药物主要用于产前和产后护理，因为它已被证明可以有效诱导或加强子宫收缩。它的重组激素性质使其成为全球妇产科医生的首选药物，他们为需要产前和产后护理的女性寻求可靠和值得信赖的选择。此外，已发现催产素是孕妇常用的处方药，可帮助她们分娩和分娩或控制产后出血。

药物类型

合成多肽

别名

Oxytocin (JP17/USP/INN)、Oxytocin Nasal Spray、催产素

+ [13]

靶点

OXTR

作用机制

OXTR激动剂(催产素受体激动剂)

治疗领域

泌尿生殖系统疾病其他疾病神经系统疾病+ [2]

在研适应症

宫缩乏力子宫出血流产+ [13]

非在研适应症

萎缩性阴道炎萎缩丛集性头痛+ [1]

原研机构

Par Sterile Products LLC

在研机构

Par Sterile Products LLC

Tonix Pharmaceuticals Holding Corp.Tonix Pharmaceuticals, Inc.

+ [5]

非在研机构

Dr. Reddy's Laboratories Ltd.

Peptonic Medical AB

Trigemina, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1980-11-19),

流产出血催产+ [1]

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、罕见儿科疾病 (美国)、孤儿药 (欧盟)

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结构

分子式C43H66N12O12S2

InChIKeyXNOPRXBHLZRZKH-DSZYJQQASA-N

CAS号50-56-6

序列信息

Sequence Code 124252

来源: *****

关联

802

项与缩宫素相关的临床试验

NCT04435704 / Not yet recruiting临床2期IIT

Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

The goal of this study is to validate the pharmacodynamic model for pain relief from oxytocin at a peripheral site by intravenous infusion targeted at different levels of the drug.
In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each study participant will have an intravenous(IV) catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion in varying amounts. The study team will perform some tests to evaluate how oxytocin changes perceptions on the skin. The study team will study a painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale.

开始日期2025-06-01

申办/合作机构

Wake Forest School of Medicine

NCT04433741 / Not yet recruiting临床2期IIT

Apply the Pharmacodynamic Model of Peripheral Oxytocin Action to a Multimodal Stimulus That Increases (Heat) or Decreases (Vibration) Pain Perception

This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain).
In this study healthy volunteers are recruited. Each study participant will have an IV catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion of oxytocin or placebo (inactive solution). The investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin. The investigators will study a painful perception by placing a probe on the skin and heating it to 116.6 degrees Fahrenheit for 30 seconds and a vibratory stimulus will be applied to the forearm with vibration begun at a 1 kHz frequency and decreased at a rate of 25 Hz/sec until the subject first perceives the vibration. Each study participant will score any pain that is experienced on a 0 to 10 scale and will report when the vibration is detected. Each participant will receive oxytocin and placebo in a random order and will be blinded to group they are receiving.

开始日期2025-01-01

申办/合作机构

Wake Forest School of Medicine

NCT05934812 / Not yet recruiting临床2期

A Randomized, Placebo-controlled, Double-blind, 2-period Cross-over Study in Youth With Autism Spectrum Disorders Evaluating Social and Repetitive Behaviors After Four Weeks of Twice Daily-doses of 24IU of Intranasally Administered Oxytocin

Growing evidence demonstrates the critical contribution of the neuropeptide oxytocin in the development and maintenance of autism, due to its role in social behaviour and learning processes. While some preliminary findings in oxytocin administration trials have been promising, a complete understanding of the effects of long-term oxytocin administration in autism remains elusive, as participant numbers in oxytocin administration studies in autism have been small, most studies exclusively recruit males, and reproducibility has been inconsistent.
To address this critical knowledge gap, this project will include a double-blind, placebo-controlled, randomized controlled crossover trial of a four-week intranasal oxytocin treatment (24 international units, twice-daily) in 128 male and female youth with ASD aged 12-20, with social and repetitive behaviors as primary outcome measures. The investigators predict that intranasal oxytocin treatments will increase performance on social behavior measures and reduce repetitive behaviors using caregiver-reported measures.
Along with the investigation of oxytocin's long-term effects, the investigators will also assess the impact of oxytocin administration on computer-based laboratory tasks that can precisely measure how participants process social cues and disengage with repetitive behaviours. In addition, an electrocardiogram will be collected to evaluate the impact of oxytocin administration on parasympathetic nervous system activity.

开始日期2024-09-18

申办/合作机构

Oslo universitetssykehus HF

[+1]

100 项与缩宫素相关的临床结果

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100 项与缩宫素相关的转化医学

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100 项与缩宫素相关的专利（医药）

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16,548

项与缩宫素相关的文献（医药）

2024-12-31·Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology

Statement of retraction: a prospective randomised trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix

2024-05-01·International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

Interval between balloon removal and oxytocin administration in cervical ripening with double‐balloon in singleton pregnancies: An observational study

Article

作者: Blanco-Carnero, José Eliseo ; Ruiz-Boluda, Inmaculada ; Juan-Pérez, Almudena ; Pérez-Buendía, Judit ; Nieto-Díaz, Aníbal ; Sánchez-Romero, Javier ; Motos-Garrido, Mónica

Abstract:

Objective:

To analyze the influence of the resting interval after removal of a double‐balloon for cervical ripening and oxytocin administration on the time to onset of active labor in singleton pregnancies.

Methods:

A retrospective cohort study of women who required a cervical ripening with double‐balloon was conducted between January 2019 and December 2022. We collected data for cervical ripening balloon insertion and removal, oxytocin administration, suspicious or pathological cardiotocographic trace, mode of delivery, maternal and neonatal complications, neonatal outcomes. Proportional hazards model comparing resting interval between double‐balloon cervical ripening removal and oxytocin administration.

Results:

A total of 403 singleton pregnancies were recruited and 213 pregnant women experienced a rest of 12 h between cervical balloon removal and oxytocin administration (resting group). Oxytocin was administered immediately after balloon removal in 190 women (non‐resting group). Median insertion‐to‐active labor interval and insertion‐to‐delivery interval were significantly shorter in the non‐resting group: 18.5 versus 24.0 h, HR 2.59 (CI 95%: 1.97–3.41) and 24.0 versus 29.0 h, HR 2.38 (CI 95%: 1.85–3.05) respectively. Bishop score change and mode of delivery between were similar in both groups. No differences in maternal nor neonatal complications between both groups were found.

Conclusions:

Oxytocin administration immediately after removal of a double‐balloon for cervical ripening compared with 12 h delayed interval resulted in a shortened time from insertion to active labor onset and to delivery interval without increasing maternal or neonatal adverse outcomes.

2024-04-01·Hormones and behavior

Leveraging the unique social organization of California mice to study circuit-specific effects of oxytocin on behavior

Review

作者: Trainor, Brian C ; Lake, Alyssa A

Oxytocin is a versatile neuropeptide that modulates many different forms of social behavior. Recent hypotheses pose that oxytocin enhances the salience of rewarding and aversive social experiences, and the field has been working to identify mechanisms that allow oxytocin to have diverse effects on behavior. Here we review studies conducted on the California mouse (Peromyscus californicus) that shed light on how oxytocin modulates social behavior following stressful experiences. In this species, both males and females exhibit high levels of aggression, which has facilitated the study of how social stress impacts both sexes. We review findings of short- and long-term effects of social stress on the reactivity of oxytocin neurons. We also consider the results of pharmacological studies which show that oxytocin receptors in the bed nucleus of the stria terminalis and nucleus accumbens have distinct but overlapping effects on social approach behaviors. These findings help explain how social stress can have different behavioral effects in males and females, and how oxytocin can have such divergent effects on behavior. Finally, we consider how new technological developments and innovative research programs take advantage of the unique social organization of California mice to address questions that can be difficult to study in conventional rodent model species. These new methods and questions have opened new avenues for studying the neurobiology of social behavior.

284

项与缩宫素相关的新闻（医药）

2024-06-17

·信狐药迅

仿制药申请5个品规发通知件；临床申请品种均默示许可| 新获批（6.11-6.16）

每周药品注册获批数据，分门别类呈现，一目了然。(6.11-6.16）新药上市申请药品名称企业注册分类受理号泽美洛韦玛佐瑞韦单抗注射液兴盟生物医药(苏州)有限公司1CXSS2200053国;CXSS2200053泽美洛韦玛佐瑞韦单抗注射液兴盟生物医药(苏州)有限公司1CXSS2200052国;CXSS2200052特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300053特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2300052 新药临床申请药品名称企业注册分类受理号SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400317SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400316SK-08片康臣药业(内蒙古)有限责任公司1CXHL2400315YK-051南京优科制药有限公司1CXHL2400296HSK42360片西藏海思科制药有限公司1CXHL2400306HSK42360片西藏海思科制药有限公司1CXHL2400305ASP3082注射液安斯泰来(中国)投资有限公司1CXHL2400308HY-021068片合肥医工医药股份有限公司1CXHL2400330KY386注射用浓溶液深圳开悦生命科技有限公司1CXHL2400338ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400321ASKC200搽剂江苏奥赛康药业有限公司2.2CXHL2400320布洛芬注射液山东新华制药股份有限公司3CYHL2400067布洛芬注射液山东新华制药股份有限公司3CYHL2400066注射用IAP0971盛禾(中国)生物制药有限公司1CXSL2400100注射用BGB-R046广州百济神州生物制药有限公司1CXSL2400208HY1272注射液恒翼生物医药(上海)股份有限公司1CXSL2400211 仿制药申请药品名称企业注册分类受理号帕拉米韦氯化钠注射液江苏吴中医药集团有限公司苏州制药厂3CYHS2202034国;CYHS2202034缩宫素注射液上海葆隆生物科技有限公司3CYHS2000879国;CYHS2000879尼莫地平口服溶液广东金城金素制药有限公司3CYHS2100073国;CYHS2100073艾司奥美拉唑镁肠溶胶囊浙江永太药业有限公司3CYHS2200943国;CYHS2200943艾司奥美拉唑镁肠溶胶囊浙江永太药业有限公司3CYHS2200941国;CYHS2200941氨甲环酸注射液烟台鲁银药业有限公司3CYHS2201532国;CYHS2201532氨甲环酸注射液烟台鲁银药业有限公司3CYHS2201531国;CYHS2201531己酮可可碱注射液湖南科伦制药有限公司3CYHS2201638国;CYHS2201638西洛他唑片成都倍特药业股份有限公司3CYHS2201667国;CYHS2201667己酮可可碱注射液苏州朗科生物技术股份有限公司3CYHS2201692国;CYHS2201692倍他米松磷酸钠注射液重庆华邦制药有限公司3CYHS2201703国;CYHS2201703帕拉米韦注射液福安药业集团烟台只楚药业有限公司3CYHS2201738国;CYHS2201738盐酸多巴胺注射液通合生物医药(山东)有限公司3CYHS2201817国;CYHS2201817重酒石酸间羟胺注射液海南天盛保和生物科技有限公司3CYHS2202126国;CYHS2202126盐酸多巴酚丁胺注射液北京布霖生物科技有限公司3CYHS2300097盐酸多巴酚丁胺注射液华夏生生药业(北京)有限公司3CYHS2300094盐酸肾上腺素注射液海南倍特药业有限公司3CYHS2300192法莫替丁注射液重庆药谷制药有限公司3CYHS2300234盐酸倍他司汀片森淼(山东)药业有限公司3CYHS2300349盐酸右美托咪定注射液山西远扬医药科技有限公司3CYHS2300625复方磷酸盐颗粒嘉实(湖南)医药科技有限公司3CYHS2301310中性腹膜透析液(碳酸氢盐-G4.25)芜湖道润药业有限责任公司3CYHS2201647国;CYHS2201647中性腹膜透析液(碳酸氢盐-G2.5)芜湖道润药业有限责任公司3CYHS2201646国;CYHS2201646中性腹膜透析液(碳酸氢盐-G1.5)芜湖道润药业有限责任公司3CYHS2201644国;CYHS2201644中性低钙腹膜透析液(碳酸氢盐-G2.5)芜湖道润药业有限责任公司3CYHS2201642国;CYHS2201642盐酸利多卡因局部溶液成都慧德医药科技有限公司3CYHS2301936恩曲他滨丙酚替诺福韦片石家庄龙泽制药股份有限公司4CYHS2202116国;CYHS2202116氨氯地平阿托伐他汀钙片昆山龙灯瑞迪制药有限公司4CYHS2300338低钙腹膜透析液(乳酸盐-G4.25)上海长征富民金山制药有限公司4CYHS2300883低钙腹膜透析液(乳酸盐-G2.5)上海长征富民金山制药有限公司4CYHS2300882低钙腹膜透析液(乳酸盐-G1.5)上海长征富民金山制药有限公司4CYHS2300881沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101755国;CYHS2101755沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101754国;CYHS2101754沙库巴曲缬沙坦钠片南京正大天晴制药有限公司4CYHS2101753国;CYHS2101753塞来昔布胶囊北京世桥生物制药有限公司4CYHS2200718国;CYHS2200718钆特醇注射液正大天晴药业集团股份有限公司4CYHS2200913国;CYHS2200913富马酸伏诺拉生片重庆华森制药股份有限公司4CYHS2200908国;CYHS2200908富马酸伏诺拉生片重庆华森制药股份有限公司4CYHS2200907国;CYHS2200907富马酸丙酚替诺福韦片南京海辰药业股份有限公司4CYHS2201237国;CYHS2201237地诺孕素片西安太极药业有限公司4CYHS2201323国;CYHS2201323溴芬酸钠滴眼液中山万汉制药有限公司4CYHS2201340国;CYHS2201340盐酸雷洛昔芬片重庆圣华曦药业股份有限公司4CYHS2201439国;CYHS2201439溴芬酸钠滴眼液中山万汉制药有限公司4CYHS2201616国;CYHS2201616左卡尼汀注射液华中药业股份有限公司4CYHS2201640国;CYHS2201640左卡尼汀注射液华中药业股份有限公司4CYHS2201639国;CYHS2201639缬沙坦氨氯地平片(I)长春海悦药业股份有限公司4CYHS2201717国;CYHS2201717注射用哌拉西林钠他唑巴坦钠江苏睿实生物科技有限公司4CYHS2201726国;CYHS2201726注射用哌拉西林钠他唑巴坦钠江苏睿实生物科技有限公司4CYHS2201725国;CYHS2201725盐酸乌拉地尔注射液吉林省辉南长龙生化药业股份有限公司4CYHS2201822国;CYHS2201822盐酸乌拉地尔注射液吉林省辉南长龙生化药业股份有限公司4CYHS2201821国;CYHS2201821奥拉帕利片杭州中美华东制药有限公司4CYHS2201855国;CYHS2201855奥拉帕利片杭州中美华东制药有限公司4CYHS2201854国;CYHS2201854溴莫尼定噻吗洛尔滴眼液艾尔健康眼药(辽宁)有限公司4CYHS2201864国;CYHS2201864丙酸氟替卡松雾化吸入用混悬液上海新黄河制药有限公司4CYHS2201885国;CYHS2201885枸橼酸西地那非口腔崩解片南京长澳制药有限公司4CYHS2201886国;CYHS2201886盐酸莫西沙星滴眼液海南斯达制药有限公司4CYHS2201904国;CYHS2201904伏立康唑片武汉启瑞药业有限公司4CYHS2201916国;CYHS2201916伏立康唑片武汉启瑞药业有限公司4CYHS2201915国;CYHS2201915富马酸丙酚替诺福韦片江苏科本药业有限公司4CYHS2201936国;CYHS2201936氢溴酸伏硫西汀片山东京卫制药有限公司4CYHS2202031国;CYHS2202031盐酸乌拉地尔注射液湖南科伦制药有限公司4CYHS2202064国;CYHS2202064盐酸乌拉地尔注射液湖南科伦制药有限公司4CYHS2202065国;CYHS2202065棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202111国;CYHS2202111棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202110国;CYHS2202110棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202109国;CYHS2202109棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202108国;CYHS2202108棕榈酸帕利哌酮注射液绿叶嘉奥制药石家庄有限公司4CYHS2202107国;CYHS2202107舒更葡糖钠注射液南京正大天晴制药有限公司4CYHS2202129国;CYHS2202129舒更葡糖钠注射液南京正大天晴制药有限公司4CYHS2202128国;CYHS2202128卡培他滨片江苏诚康药业有限公司4CYHS2202139国;CYHS2202139钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202160国;CYHS2202160钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202159国;CYHS2202159钆特酸葡胺注射液山东威智百科药业有限公司4CYHS2202158国;CYHS2202158注射用盐酸表柔比星浙江华海药业股份有限公司4CYHS2202149国;CYHS2202149马昔腾坦片上海旭东海普药业有限公司4CYHS2202176国;CYHS2202176碳酸镧咀嚼片江西施美药业股份有限公司4CYHS2300102左氧氟沙星滴眼液苏州弘森药业股份有限公司4CYHS2300098磷酸特地唑胺片桂林南药股份有限公司4CYHS2300180盐酸奥洛他定滴眼液国药集团三益药业(芜湖)有限公司4CYHS2300255他达拉非片新乡市常乐制药有限责任公司4CYHS2300274间苯三酚注射液湖南科伦制药有限公司4CYHS2300283富马酸比索洛尔片浙江京新药业股份有限公司4CYHS2300376富马酸比索洛尔片浙江京新药业股份有限公司4CYHS2300375沙美特罗替卡松吸入粉雾剂健康元药业集团股份有限公司4CYHS2300405注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300450注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300449注射用哌拉西林钠他唑巴坦钠成都倍特药业股份有限公司4CYHS2300448吸入用硫酸沙丁胺醇溶液浙江百代医药科技有限公司4CYHS2300508恩格列净片宁波大红鹰药业股份有限公司4CYHS2300601注射用头孢他啶阿维巴坦钠山东百诺医药股份有限公司4CYHS2300703阿卡波糖片成都恒瑞制药有限公司4CYHS2300702多巴丝肼片北京福元医药股份有限公司4CYHS2300742格列齐特缓释片浙江京新药业股份有限公司4CYHS2301097阿伐替尼片基石药业(苏州)有限公司4CYHS2301700奥美沙坦酯氨氯地平片郑州韩都药业集团有限公司4CYHS2301875氧九龙气体河北有限公司4CYHS2302089氧辉县市广福贸易有限公司4CYHS2302128氧香格里拉藏龙纯净氧气体有限公司4CYHS2302226盐酸特比萘芬乳膏齐鲁制药(海南)有限公司4CYHS2301721头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401101头孢托仑匹酯颗粒海南葫芦娃药业集团股份有限公司4CYHS2401100西甲硅油乳剂成都诺和晟鸿生物制药有限公司4CYHS2401170富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101007国;JYHS2101007富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101006国;JYHS2101006富马酸喹硫平片Dr. Reddy's Laboratories Ltd.5.2JYHS2101005国;JYHS2101005 进口申请药品名称企业注册分类受理号高血糖素鼻用粉雾剂Eli Lilly and Company5.1JXHS2200063国;JXHS2200063依伏卡塞片Kyowa Kirin Co., Ltd.5.1JXHS2200069国;JXHS2200069依伏卡塞片Kyowa Kirin Co., Ltd.5.1JXHS2200068国;JXHS2200068地舒单抗注射液Amgen Europe B.V.3.1JXSS2300031Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400070Balcinrenone达格列净胶囊AstraZeneca AB1JXHL2400069Golcadomide胶囊Celgene Corporation1JXHL2400084Golcadomide胶囊Celgene Corporation1JXHL2400083Golcadomide胶囊Celgene Corporation1JXHL2400082PF-07264660注射液Pfizer Inc.1JXSL2400066PF-07275315注射液Pfizer Inc.1JXSL2400065CID-103注射液CASI Pharmaceuticals, Inc.1JXSL2400067 中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-06-14

·BioSpace

GLP-1 Global Obesity Market to Reach $111B by 2033, Despite Headwinds: GlobalData

Pictured: Injection pens for GLP-1 medications in a box and a measuring tape/iStock, CR Despite continuing to generate blockbuster sales numbers for companies like Eli Lilly and Novo Nordisk, data analytics and consulting company GlobalData predicts the GLP-1 drug class will still face some headwinds in the obesity market. In a Thursday briefing, GlobalData revealed that GLP-1 receptor agonist sales pulled in $25 billion last year in seven major markets–the U.S., France, Spain, Germany, Italy, Japan, and the U.K.—and predicted they will reach a total of $111 billion by 2033. GlobalData’s latest estimates appeared to be a slight downward change from a May 2024 report that pegged sales reaching $125 billion in the combined type 2 diabetes and obesity markets. Other analysts have placed the market’s value much higher. Last month, Reuters reported that BMO Capital Markets estimated the obesity market to reach $150 billion by the early 2030s. Still higher, Leerink projects the weight-loss drug space will be worth around $158 billion by 2032. Costanza Alciati, a cardiovascular and metabolic disorders analyst at GlobalData, said during Thursday’s briefing that the emergence of GLP-1 biosimilars would impact branded drug sales and expand access to these medications for a larger patient population. She also anticipates that off-label use of GLP-1s will decline as awareness of the drug increases and more therapeutic options become more readily available. Despite the advances and the approval of new medicines in the obesity space, Alciati said there are unmet needs remaining in the market including the high cost of weight-loss drugs for patients in many countries, where the medications are not covered by insurance. She also contends that the efficacy and tolerability of this class of drugs could be improved. “These unmet needs in the fast-growing patient population represent a significant opportunity for new entrants in the obesity treatment market,” Alciati said. To help address these needs, companies are developing different mechanisms of action for obesity treatments to meet future demand. Alciati pointed to Regeneron’s myostatin inhibitor, which is combined with a GLP-1 receptor agonist to target the prevention of muscle wasting, and Tonix Pharmaceuticals’ intranasal oxytocin aimed at treating pediatric obesity. “In the next decade, the obesity population will continue to grow worldwide offering a significant opportunity for new entrants to try and meet patients’ demand,” Alciati said. Manufacturing challenges will also continue to plague drugmakers due to high demand for these medications. According to GlobalData, the top GLP-1 drugs are still in shortage in the U.S., Europe and Australia as demand has increased from a large worldwide patient population. “Right now, shortages are continuing. Patients are still struggling to access GLP-1 receptor agonists for obesity,” Fiona Barry, director of GlobalData’s PharmaSource, said during Thursday’s briefing. “We forecast that that demand is going to grow further... And this is happening against geopolitical and post-COVID supply chain challenges generally within the pharma industry.” However, Barry sees some hope in alleviating the problem in the manufacturing sector, as drugmakers are pouring money into boosting their capacity to make GLP-1s. This includes the $5.3 billion additional investment from Lilly in producing Mounjaro and Zepbound’s active ingredient and Novo’s $16.5 billion acquisition of three of Catalent’s production sites in the U.S. and Europe. Still, Barry noted that supply issues will remain a concern until additional manufacturing infrastructure comes online. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

并购

2024-05-25

·米内网

知名中药企业被罚！大批药品价格“跳水”，46个品种集采启动，上海医药、正大天晴1类新药亮眼

看点view本周，2024全国集采工作重点出炉，21条支持创新医药发展举措曝光，知名医院书记违纪违法被双开；药品市场迎变局，46个品种联盟集采启动，191个药品降价在即；企业大新闻，商业化CXO龙头发力中药领域，重药牵手京东加快医药流通转型升级，上海医药、正大天晴药业1类新药临床报喜......医药行业一周大事件，精彩不容错过！米内一周TOP榜米内数据第十批集采20个抗感染药备战，科伦、齐鲁发力扬子江、太极上榜止咳祛痰平喘中成药TOP20362个西药品牌火了！东阳光药勇夺销冠药企动态倍特药业拿下10个重磅品种、108个过评品种一季度净利润海思科、华北制药翻倍，23家扭亏抑酸药龙头发威，拿下15亿畅销产品审评药闻超10亿品种，苑东生物获批了亿级降脂药，鲁南贝特首家过评中药1类新药来袭！百亿市场波澜再起2024全国集采工作重点来了5月20日，国家医保局发布《关于加强区域协同做好2024年医药集中采购提质扩面的通知》，对今年的集采工作提出扩大联盟范围、加强统筹协调、聚焦重点领域、完善执行机制等四部分内容。在推进药品集采扩面上，工作重点包括：开展新批次国家组织集采；做好胰岛素和前几批集采药品协议期满接续采购；湖北牵头开展新批次全国中成药集采及期满接续采购；山东牵头开展中药饮片联采；河南牵头开展国采品种可替代药品联采；三明联盟开展肿瘤和呼吸系统等疾病用药集采等。（国家医保局）划重点：2024年年内，全国各省至少完成一批药品集采，实现国家和省级集采（含参与联盟采购）药品数累计达到500个以上，有条件的省份鼓励加大力度，全面提升省级联盟采购规模和规范性。首破4000项！临床试验总量创新高5月20日，国家药监局药品审评中心发布的《中国新药注册临床试验进展年度报告（2023年）》显示，2023年药物临床试验登记与信息公示平台登记临床试验总量首次突破4000项，1类创新药试验占新药临床试验登记总量的69.1%；儿童人群、罕见疾病患者等特定人群用药的临床试验数呈现显著增长趋势，医学影像学和放射性药物临床试验数量保持小幅增加；细胞和基因治疗产品类临床试验共81项，较2022年增长近1倍。（国家药监局）46个品种！又一大联盟集采启动5月20日，重庆市医保局发布《渝鄂桂琼黔滇青宁新新疆兵团关于部分常用药和短缺药品协议期满接续采购工作实施方案》，标志着由重庆、湖北、广西、海南、贵州、云南、青海、宁夏、新疆、新疆生产建设兵团等10个省、市及自治区组成的联盟集采（下文简称“10省联盟集采”）正式启动，46个品种拟纳入采购目录，包括间羟胺注射剂、新斯的明注射剂等20个短缺药，以及法莫替丁注射剂、玻璃酸钠注射剂等26个常用药。（重庆市医保局）延伸阅读：与此前重庆联盟集采相比，本次10省联盟集采拟中选规则简化了许多，以“带量联动、多家中选”为中心规则，区分申报企业的品种是否曾中选，企业报价符合要求，即可中选。4款1类新药获批上市5月20日、24日，国家药监局接连发布公告，4款1类创新药相继获批上市，包括海思科的苯磺酸克利加巴林胶囊（糖尿病性周围神经病理性疼痛）、上海倍而达药业的甲磺酸瑞齐替尼胶囊（非小细胞肺癌）、Entasis的注射用舒巴坦钠/注射用度洛巴坦钠组合包装（鲍曼不动杆菌-醋酸钙不动杆菌复合体感染）和康方生物的依沃西单抗注射液（非小细胞肺癌），涉及镇痛、抗感染、抗肿瘤等治疗领域。（国家药监局）豪掷8.8亿元！商业化CXO龙头发力中药领域5月20日，百洋医药发布公告称，以8.8亿元现金收购上海百洋制药股份有限公司（下称“百洋制药”）60.199%的股权，从而实现对百洋制药的控股。据悉，百洋制药是一家专注于中药现代化和缓控释制剂研发生产的医药制造企业，核心产品包括：肝病领域独家中成药品种扶正化瘀，以及以缓控释制剂技术为核心的二甲双胍、硝苯地平等高端制剂。（公司公告）米内数据：在2023年中国三大终端六大市场（统计范围详见文末），扶正化瘀合计销售规模超过6亿元，同比增长15.4%；其中在公立医疗机构终端，扶正化瘀为肝病中成药TOP2品种。21条官方举措曝光，全面支持创新医药发展5月20日，广州市医保局公布《广州医保支持创新医药发展若干措施》中提出了：加快创新医药进院使用、促进创新医药临床应用、拓展创新医药支付渠道、加强创新医药服务支持等四个方面共21条措施。其中，在采购端上，建立创新药械绿色挂网采购专区，允许国谈及集采药械之外的品种实行企业与医疗机构自主议价等；在使用端上，对国谈药等创新药费用实行单列结算或纳入按病种分值付费（DIP）予以分值加成，优化DIP特例单议机制及DIP病种目录库等。（广州市医保局）一线治疗肾癌！正大天晴1类新药临床报喜5月23日，中国生物制药公告称，下属正大天晴药业研发的1类新药贝莫苏拜单抗，联合安罗替尼用于晚期不可切除或转移性肾细胞癌（RCC）一线治疗的Ⅲ期临床主要研究终点无进展生存期达到方案预设的优效界值，公司有望于近期提交该适应症的上市申请。贝莫苏拜单抗是一款全新序列的创新PD-L1单抗，日前已获批联合盐酸安罗替尼胶囊和化疗一线治疗广泛期小细胞肺癌；盐酸安罗替尼胶囊是一款口服新型TKI抗肿瘤药，2023年在中国三大终端六大市场合计销售额超过37亿元。（米内网整理）重药牵手京东，加快医药流通数字化转型5月23日，重药控股发布公告称，与北京京东世纪贸易有限公司（简称：京东集团）签署了《战略合作框架协议》，双方以发挥各自优势领域，围绕消费品供应链、药品医疗、批发零售、仓储物流及供应链等合作内容，共同打造中国医药商业领先的“医药+物联网”新生态。（证券时报）延伸阅读：近年来，包括上海医药、九州通等大型医药流通企业都在进行数字化转型。通过业务数字化，医药流通企业在节省成本的同时，也可摆脱传统的医药分销企业角色，进一步实现降本增效。最高91%！191个品种降价在即5月20日，云南省药品集中采购平台发布《关于企业申请降价的公示》。据梳理，此次共有74家企业、191个药品提交了降价申请，基药产品占比近半。其中，盐酸托莫西汀胶囊、缩宫素注射液等品种降幅较大，均超过90%，而扬子江药业的盐酸艾司洛尔氯化钠注射液价格仅下降0.003%，为本次降幅最小的产品。（云南省药品集采平台）上海医药1类新药来袭，狙击90亿市场5月22日，CDE官网显示，上海医药的1类新药SPH7450片获批临床，拟用于抑郁症。目前，上海医药已有9款抗抑郁仿制药获批上市，包括盐酸氟西汀胶囊、盐酸文拉法辛胶囊、盐酸舍曲林胶囊、氢溴酸西酞普兰口服溶液、盐酸度洛西汀肠溶胶囊、盐酸度洛西汀肠溶片等，SPH7450片是公司创新药管线中首款抗抑郁1类创新药。米内网数据显示，2023年中国三大终端六大市场抗抑郁药合计市场规模超过90亿元。（米内网整理）生产、销售劣药！一中药企业被罚22万元5月20日，安徽省药监局公开一则行政处罚信息，芍花堂国药股份有限公司生产的豆蔻（批号2230321）不符合“桉油精【含量测定】”标准，被判定为劣药，安徽省药监局依法对其没收不合格产品及违法所得收入、罚款（合计约22万元）等行政处罚。处罚有效期截止至2024年11月20日，公示截止期至2027年5月20日。（安徽省药监局）全球制药巨头宣布3年内持续裁员5月22日，辉瑞在一份公告中宣布：将启动一项持续多年的成本削减计划，内容涵盖提升运营效率、改善工作结构、增强产品组合等方面。辉瑞指出，该计划将分多个阶段实施，其中第一阶段侧重于提升运营效率，目标是到2027年年底节省15亿美元，预计于2025年开始体现。辉瑞介绍，包括人员遣散费用在内，实施此项计划的一次性成本将高达17亿美元。（健识局）业内观点：在新冠药物需求消退以后，辉瑞的业绩面临大幅下滑的压力，公司目前正在大力削减开支。严打医药反腐！知名医院书记被双开5月21日，安徽省纪委监委公布称，蚌埠市第二人民医院原党委副书记、副院长阙胜利严重违纪违法被开除党籍、开除公职。阙胜利1969年出生，研究生学历，1991-2014年间先后于怀远县卫生学校、怀远县人民医院、蚌埠市妇幼保健院等单位工作。2015年，阙胜利开始担任蚌埠市第二人民医院党委副书记、副院长、纪委书记等职。（安徽省纪委省监委）注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

带量采购申请上市核酸药物基因疗法

100 项与缩宫素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00089	缩宫素	H01BB02	DB00107

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
宫缩乏力	澳大利亚	Viatris Pty Ltd.	1991-08-21
子宫出血	日本	ASKA Pharmaceutical Co., Ltd.	1984-07-12
流产	美国	Par Sterile Products LLC	1980-11-19
流产	美国	ENDO Medical, Inc.初创企业	1980-11-19
流产	美国	Endo Laboratories	1980-11-19
出血	美国	Endo Laboratories	1980-11-19
出血	美国	Par Sterile Products LLC	1980-11-19
出血	美国	ENDO Medical, Inc.初创企业	1980-11-19
催产	美国	Endo Laboratories	1980-11-19
催产	美国	Par Sterile Products LLC	1980-11-19
催产	美国	ENDO Medical, Inc.初创企业	1980-11-19
产后出血	美国	Par Sterile Products LLC	1980-11-19
产后出血	美国	ENDO Medical, Inc.初创企业	1980-11-19
产后出血	美国	Endo Laboratories	1980-11-19
人工流产	-	-	-

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
社交恐怖症	临床2期	美国	Tonix Pharmaceuticals, Inc.	2023-07-17
儿童肥胖	临床2期	美国	Tonix Pharmaceuticals, Inc.	2023-07-10
暴食症	临床2期	美国	The Schwartz Center for Compassionate Healthcare	2023-03-07
肥胖	临床2期	美国	The Schwartz Center for Compassionate Healthcare	2023-03-07
先兆偏头痛	临床2期	美国	Tonix Pharmaceuticals, Inc.	2022-12-06
无先兆偏头痛	临床2期	美国	Tonix Pharmaceuticals, Inc.	2022-12-06
自闭症谱系障碍	临床2期	挪威	Optinose AS	2015-04-01
萎缩	临床2期	瑞典	Peptonic Medical AB	2014-10-01
丛集性头痛	临床2期	澳大利亚	Trigemina, Inc.	2013-05-01
丛集性头痛	临床2期	智利	Trigemina, Inc.	2013-05-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03593473 (CTgov)	临床2期	产后抑郁症 \| 心理压力 \| 焦虑症	109	Intranasal Oxytocin (Intranasal Oxytocin)	鹹構壓艱糧憲鹹構鬱襯(積夢襯簾夢獵鹹簾夢夢) = 鹽糧窪遞餘廠齋壓膚壓壓鑰窪簾願構鏇網艱窪 (窪範醖糧範夢繭範糧蓋, 鏇選鹹鹹網憲憲鏇簾餘 ~ 選願齋簾艱鏇積鬱襯選) 更多	-	2024-05-24
				Placebo (Placebo)	鹹構壓艱糧憲鹹構鬱襯(積夢襯簾夢獵鹹簾夢夢) = 鑰繭鹹膚衊餘遞憲顧簾壓鑰窪簾願構鏇網艱窪 (窪範醖糧範夢繭範糧蓋, 願艱鑰襯糧淵艱壓膚鑰 ~ 積廠鹹鬱齋淵鬱憲壓鹽) 更多
NCT04028765 (POM PROM, CTgov)	临床4期	胎膜早破	108	Misoprostol (Oral Misoprostol)	鑰願築蓋顧顧選衊鬱醖(膚積築壓鏇獵積鹽獵構) = 願繭鹽廠壓製鹹觸鏇衊顧襯蓋餘簾鏇觸遞艱積 (簾淵願壓鬱窪構艱鹽構, 簾壓繭積鬱鑰獵網觸構 ~ 膚構製蓋鹹鏇鏇襯鏇餘) 更多	-	2024-04-30
				Oxytocin (Oxytocin)	鑰願築蓋顧顧選衊鬱醖(膚積築壓鏇獵積鹽獵構) = 憲壓衊夢簾鑰鬱獵簾願顧襯蓋餘簾鏇觸遞艱積 (簾淵願壓鬱窪構艱鹽構, 願淵鑰構鏇齋範觸膚鏇 ~ 構簾範鏇鬱鏇築夢壓膚) 更多
NCT02918864 (CTgov)	临床2期	自闭症谱系障碍	40	Social Cognitive Skills Training+Oxytocin (ION-ASD)	積製簾淵鹹衊簾憲鏇願(觸顧廠網簾壓獵夢鏇觸): Beta Coefficient = -0.22, P-Value = 0.037 更多	-	2024-04-05
				Facilitated Play Therapy (Facilitated Play)
NCT03043053 (CTgov)	临床2期	肥胖	61	oxytocin nasal spray (Oxytocin)	糧齋顧製齋願繭襯齋淵(齋構鹹範蓋鹹鏇製醖選) = 觸窪構鏇夢醖遞選網憲鬱鏇壓餘鏇壓醖願襯製 (廠憲範鏇壓簾夢觸範艱, 衊醖蓋鑰觸鑰醖願醖鏇 ~ 醖顧鹹糧選襯積夢艱構) 更多	-	2024-02-07
				Placebo (Placebo)	糧齋顧製齋願繭襯齋淵(齋構鹹範蓋鹹鏇製醖選) = 積築獵願糧網淵膚醖廠鬱鏇壓餘鏇壓醖願襯製 (廠憲範鏇壓簾夢觸範艱, 襯願淵襯醖鏇齋構遞繭 ~ 憲壓積壓鏇壓顧餘夢網) 更多
NCT02205034 (CTgov)	临床1/2期	普拉德-威利综合症	18	oxytocin (First Arm)	網鑰齋鏇鑰鬱醖襯餘蓋(遞膚鏇獵齋廠艱鑰餘鑰) = 醖網範選觸鏇構艱鹽襯觸鬱遞窪襯壓衊蓋鹹遞 (餘觸艱艱醖廠觸製簾襯, 簾膚襯構簾淵醖獵夢願 ~ 夢膚淵構願鏇築繭選襯) 更多	-	2023-12-04
				oxytocin (Second Arm)	網鑰齋鏇鑰鬱醖襯餘蓋(遞膚鏇獵齋廠艱鑰餘鑰) = 顧窪齋襯淵積構構襯鹽觸鬱遞窪襯壓衊蓋鹹遞 (餘觸艱艱醖廠觸製簾襯, 觸積衊遞艱鬱艱憲選顧 ~ 艱襯齋夢鑰網繭遞鹹選) 更多
NCT02564068 (CTgov)	早期临床1期	阻塞性睡眠呼吸暂停综合征	8	Oxytocin	選遞鏇壓鏇鹹獵製簾淵(糧襯網構鑰鬱積鹽築範) = 廠夢簾製襯蓋顧範鬱膚積簾艱蓋壓積廠觸鏇蓋 (餘築鏇蓋構憲遞繭夢築, 壓淵廠壓網糧鹹繭積顧 ~ 網糧艱選夢願醖遞鹹醖) 更多	-	2023-11-27
NCT02127073 (CTgov)	临床2期	非浸润性导管内癌 \| 导管癌 \| 浸润性乳腺癌	8	Intranasal Oxytocin	廠築壓蓋遞鑰壓鹽繭糧(簾醖醖齋蓋獵淵襯膚構) = 夢衊鹽鏇積願範齋壓壓艱窪築選鑰遞選壓鏇淵 (鬱鏇願繭積製選鑰築鏇, 齋鑰鑰膚衊憲鑰襯襯齋 ~ 顧獵襯醖膚遞夢窪鬱鏇) 更多	-	2023-11-09
EASD2023	N/A	2型糖尿病	25	Intranasal Oxytocin (24 IU)	夢選艱製遞淵顧夢鹹願(鑰積繭壓蓋遞願艱築醖) = 網醖齋築鬱製遞願鏇網窪獵餘鑰築鬱築淵蓋蓋 (顧選願膚願獵憲窪範鹹 ) 更多	不佳	2023-10-05
				Placebo	夢選艱製遞淵顧夢鹹願(鑰積繭壓蓋遞願艱築醖) = 鏇鑰糧鬱膚壓糧淵繭獵窪獵餘鑰築鬱築淵蓋蓋 (顧選願膚願獵憲窪範鹹 ) 更多
ESPE2023	N/A	颅咽管瘤	-	Intranasal oxytocin	糧艱齋壓醖構憲選積糧(鑰願襯糧築鏇廠糧築願) = The patient was treated with intranasal oxytocin for more than 3 years with no side-effects 膚選壓鑰壓鹹顧齋壓憲 (繭鏇壓齋鹽顧鑰構艱範 )	-	2023-09-21
				Naltrexone