草酸艾司西酞普兰(Escitalopram Oxalate) - 药物靶点：SERT_在研适应症：社交恐怖症，抑郁症，惊恐障碍_专利_临床

概要

基本信息

简介Escitalopram 以商品名 Esertia 销售，是一种小分子药物，可作为选择性 5-羟色胺再摄取抑制剂 (SSRI)。它以 SERT-5 转运蛋白为靶点，该靶点负责突触间隙中血清素的再摄取。通过抑制 SERT-5 转运蛋白，Escitalopram增加了大脑中血清素的细胞外浓度，这被认为是其治疗效果的潜在机制。Escitalopram还被批准用于治疗抑郁症，并已被证明可有效减少焦虑症和恐慌症的症状。它也被用于其他疾病，如强迫症和创伤后应激障碍。该药由 H. Lundbeck 开发，于 2002 年 8 月 14 日在美国首次获得批准，随后陆续在中国和日本获批上市。

药物类型

小分子化药

别名

Cipralex、Entact、Escitalopram

+ [14]

靶点

SERT

作用机制

SERT抑制剂(5-羟色胺转运体抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Yoshitomi Co., Ltd.Forest Laboratories, Inc.

H. Lundbeck A/S

+ [3]

非在研机构

Germans Trias i Pujol Hospital

最高研发阶段批准上市

首次获批日期

美国 (2002-08-14),

重度抑郁症

最高研发阶段(中国)批准上市

特殊审评-

登录后查看首次获批时间轴

结构

分子式C22H23FN2O5

InChIKeyKTGRHKOEFSJQNS-BDQAORGHSA-N

CAS号219861-08-2

关联

341

项与草酸艾司西酞普兰相关的临床试验

NCT05603104 / Not yet recruiting临床3期IIT

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

开始日期2024-07-31

申办/合作机构

Universität Stuttgart

NCT05973786 / Recruiting临床3期IIT

A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

开始日期2024-05-31

申办/合作机构

Universität Stuttgart

CTR20240247 / CompletedN/A

草酸艾司西酞普兰片人体生物等效性研究

本试验旨在研究健康受试者单次空腹和餐后口服沈阳华泰药物研究有限公司研制、沈阳福宁药业有限公司生产的草酸艾司西酞普兰片（10 mg）的药代动力学特征；以H. Lundbeck A/S生产的草酸艾司西酞普兰片（来士普®，10 mg）为参比制剂，比较两制剂中的药动学参数，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。

开始日期2024-03-02

申办/合作机构

沈阳华泰药物研究有限公司

100 项与草酸艾司西酞普兰相关的临床结果

登录后查看更多信息

100 项与草酸艾司西酞普兰相关的转化医学

登录后查看更多信息

100 项与草酸艾司西酞普兰相关的专利（医药）

登录后查看更多信息

201

项与草酸艾司西酞普兰相关的文献（医药）

2024-01-22·Journal of biomolecular structure & dynamics

Carbazole derivatives as promising competitive and allosteric inhibitors of human serotonin transporter: computational pharmacology

Article

作者: Zainurin, Nurul Amira ; Patel, Harun ; Ahmad, Iqrar ; Ayipo, Yusuf Oloruntoyin ; Chong, Chien Fung ; Najib, Sani Yahaya ; Mordi, Mohd Nizam

The human serotonin transporters (hSERTs) are neurotransmitter sodium symporters of the aminergic G protein-coupled receptors, regulating the synaptic serotonin and neuropharmacological processes related to neuropsychiatric disorders, notably, depression. Selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and (S)-citalopram are competitive inhibitors of hSERTs and are commonly the first-line medications for major depressive disorder (MDD). However, treatment-resistance and unpleasant aftereffects constitute their clinical drawbacks. Interestingly, vilazodone emerged with polypharmacological (competitive and allosteric) inhibitions on hSERTs, amenable to improved efficacy. However, its application usually warrants adjuvant/combination therapy, another subject of critical adverse events. Thus, the discovery of alternatives with polypharmacological potentials (one-drug-multiple-target) and improved safety remains essential. In this study, carbazole analogues from chemical libraries were explored using docking and molecular dynamics (MD) simulation. Selectively, two IBScreen ligands, STOCK3S-30866 and STOCK1N-37454 predictively bound to the active pockets and expanded boundaries (extracellular vestibules) of the hSERTs more potently than vilazodone and (S)-citalopram. For instance, the two ligands showed docking scores of -9.52 and -9.59 kcal/mol and MM-GBSA scores of -92.96 and -65.66 kcal/mol respectively compared to vilazodone's respective scores of -7.828 and -59.27 against the central active site of the hSERT (PDB 7LWD). Similarly, the two ligands also docked to the allosteric pocket (PDB 5I73) with scores of -8.15 and -8.40 kcal/mol and MM-GBSA of -96.14 and -68.46 kcal/mol whereas (S)-citalopram has -6.90 and -69.39 kcal/mol respectively. The ligands also conferred conformational stability on the receptors during 100 ns MD simulations and displayed interesting ADMET profiles, representing promising hSERT modulators for MDD upon experimental validation.Communicated by Ramaswamy H. Sarma.

2023-12-01·Journal of psychiatric research

Comparison of tandospirone and escitalopram as a symptomatic treatment in Multiple System Atrophy-cerebellar ataxia: An open-label, non-controlled, 4 weeks observational study

Article

作者: Gao, Jing ; Wang, Wei ; Quan, Meina ; Jia, Jianping ; Guo, Dongmei ; Xu, Shuo

BACKGROUND:

Multiple system atrophy (MSA) is a neurodegenerative disorder characterized by autonomic failure and motor dysfunction in parkinsonism and/or cerebellar ataxia. Patients with MSA usually present with depression and anxiety symptoms. This observational study of patients with MSA-cerebellar subtype (MSA-C) with subthreshold depression/anxiety symptoms aimed to compare the efficacy of escitalopram oxalate (an antidepressant drug) and tandospirone citrate (an anxiolytic drug).

METHODS:

Fifty-six MSA-C patients were included, with 28 patients in each treatment group. One group received escitalopram oxalate 10 mg/day and the other group received tandospirone citrate 30 mg/day. The patients were evaluated at baseline and after 4 weeks. Several psychiatric and neurological tests were performed, including the Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD), Scale for the Assessment and Rating of Ataxia (SARA), and the Scale for Outcomes in Parkinson's Disease for Autonomic Symptoms (SCOPA-AUT). Furthermore, post-void residual urine volume (PVR) and blood pressure were measured.

RESULTS:

There was a more substantial reduction in the HAMA/HAMD, scores of stance, finger tracking, and finger nose test in the SARA, and PVR in the tandospirone group. There was a more substantial reduction in scores of dysuria, light-headed when standing up, syncope and hyperhidrosis in the SCOPA-AUT in the escitalopram group (p's < 0.05).

CONCLUSIONS:

Tandospirone citrate was more effective in improving depression/anxiety and some cerebellar ataxia symptoms, whereas escitalopram was more effective in improving some autonomic symptoms in MSA-C patients over a short-term period in an open-label observational study without a control group. Further research is needed to evaluate the long-term effects of tandospirone and escitalopram in MSA-C in long-term placebo controlled trials.

2023-06-01·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

Investigation of the degradation and in-situ amorphization of the enantiomeric drug escitalopram oxalate during Fused Deposition Modeling (FDM) 3D printing

Article

作者: Quodbach, Julian ; Hoffmann, Lena ; Breitkreutz, Joerg

Hot-melt extrusion (HME) and subsequent FDM 3D printing offer great potential opportunities in the formulation development and production of customized oral dosage forms with poorly soluble drugs. However, thermal stress within these processes can be challenging for thermo-sensitive drugs. In this work, three different formulations were prepared to investigate the degradation and the solid state of the thermo-sensitive and poorly soluble drug escitalopram oxalate (ESC-OX) during the two heat-intensive processes HME and FDM 3D printing. For this purpose, hydroxypropyl methyl cellulose (HPMC) and basic butylated methacrylate copolymer (bPMMA) were chosen as polymers. DSC and XRD measurements revealed that ESC-OX is amorphous in the HPMC based formulations in both, extrudates and 3D printed tablets. In contrast, in-situ amorphization of the drug from crystalline state in bPMMA filaments was observed during FDM 3D printing. With regard to the content, it was found that degradation of ESC-OX in extrudates with bPMMA could be avoided and in 3D printed tablets almost fully reduced. Furthermore, a possible conversion into the R-enantiomer in the formulation with bPMMA could be excluded using a chiral column. Compared to the commercial product Cipralex®, drug release from extrudates and tablets with bPMMA was slower but still qualified as immediate drug release.

85

项与草酸艾司西酞普兰相关的新闻（医药）

2024-06-23

·赛柏蓝

抗抑郁药销售Top 20（附名单）

编者按：本文来自米内网，作者可颂；赛柏蓝授权转载，编辑相宜数据显示，2023年中国公立医疗机构终端抗抑郁药市场止跌回升，涨逾4%。 01 市场止跌回升抗抑郁药“一哥”易主抑郁症是目前全球第四大疾病，药物治疗是其主要治疗手段。数据显示，抗抑郁药此前在中国公立医疗机构终端销售额持续攀升，从2013年的超过41亿元增长至2019年的超过90亿元；随后受集采及疫情影响，市场进入调整期，2020-2022年分别同比下滑2.35%、0.93%、5.35%；2023年销售额接近86亿元，同比增长4.12%，市场止跌回升。中国公立医疗机构终端抗抑郁药销售情况（单位：万元）从抗抑郁药企业销售额排名上看，豪森药业、灵北、京卫制药、辉瑞、华海药业依次位列前五。7家企业销售额增逾10%，其中施维雅大涨54.37%，丽珠集团大涨28.18%，雅培、福宁药业均涨逾21%，豪森药业、华海药业、海默尼药业均涨逾10%。 2023年中国公立医疗机构终端抗抑郁药TOP5厂家其中，豪森药业以微弱优势首次登顶榜首，近年来其市场份额持续扩大，从2019年的不足3%发展至2023年的8.76%；辉瑞自2013年至2021年均为抗抑郁药市场“销冠”厂家，受舍曲林、文拉法辛集采影响，市场份额明显下滑，2022年排名跌至第三、2023年跌出前三。 02 抗抑郁药TOP20 豪森、丽珠、京卫上榜抗抑郁药产品TOP20中，草酸艾司西酞普兰片自2015年以来持续稳居榜首，以超过17亿元的销售额遥遥领先；阿戈美拉汀片位列第二，销售额超过9亿元；盐酸舍曲林片位列第三，销售额超过8亿元；米氮平片、马来酸氟伏沙明片分别位列第四、第五。 2023年中国公立医疗机构终端抗抑郁药产品TOP20 7个产品销售额涨逾10%，盐酸米那普仑片暴涨221.22%，销售额创下历史新高；马来酸氟伏沙明片、盐酸安非他酮缓释片均涨逾20%；阿戈美拉汀片大涨19.57%、盐酸曲唑酮片大涨17.73%。盐酸米那普仑片首仿企业为上海现代制药，最早于2010年获国家药监局批准上市，独占国内市场十余年；2023年11月21日四川科瑞德该产品获批上市，成为国产第2家；2024年4月24日河北龙海药业该产品获批上市，成为国产第3家。抗抑郁药品牌TOP20中，豪森药业的阿戈美拉汀片首次登顶榜首，目前该药在国内仅有原研厂家施维雅和首仿厂家豪森药业获批；京卫制药、灵北的草酸艾司西酞普兰片分别位列第二、第三，借助集采国产替代机会，京卫制药该产品销售额持续领先；辉瑞的盐酸舍曲林片位列第四，集采后市场份额依然领先；丽珠集团的马来酸氟伏沙明片位列第五，今年该药迎来了新玩家桂林华信制药、倍特药业。 2023年中国公立医疗机构终端抗抑郁药品牌TOP20 03 23款抗抑郁1类新药东阳光药、华海、石药发力随着社会对心理健康的重视程度提升，国内药企布局抗抑郁药的积极性也持续提高。今年以来，国内已有9个抗抑郁药品种迎来了新玩家，包括京卫制药的氢溴酸伏硫西汀片、盐酸帕罗西汀肠溶缓释片，倍特药业的马来酸氟伏沙明片，重庆药友制药的盐酸舍曲林片，新华制药的草酸艾司西酞普兰片等。 2024年至今获批上市的国产抗抑郁药 9个品种中，盐酸舍曲林片国产厂家已达18家、草酸艾司西酞普兰片有15家、氢溴酸伏硫西汀片有11家。盐酸舍曲林片、草酸艾司西酞普兰片已纳入国家集采，氢溴酸伏硫西汀片有望纳入第十批集采，“光脚”企业可借助集采中标抢占市场。此外，马来酸氟伏沙明片、盐酸米那普仑片国产厂家均只有3家，盐酸文拉法辛缓释片有4家，竞争格局较好。其中，马来酸氟伏沙明片还有20款仿制药上市申请在审评中，包括石四药、京卫制药、万高药业、洞庭药业、辰欣药业等。值得关注的是，近年来不少本土药企在布局创新管线时，避开拥挤的抗肿瘤药研发赛道，将目光投向了抗抑郁创新药的研发。据不完全统计，针对抑郁症，国内企业已有23款抗抑郁化药1类创新药处于获批临床及以上阶段，涉及绿叶制药、东阳光药、华海药业、石药集团、天士力、豪森药业、信立泰、恩华药业、康弘药业等多家企业。国产抗抑郁化药1类创新药在研情况 23款国产抗抑郁化药1类创新药中，绿叶制药的盐酸托鲁地文拉法辛缓释片于2022年11月1日获批上市，实现国产抗抑郁创新化药“零”的突破；吉贝尔的JJH201501片已处于Ⅲ期临床研究阶段、东阳光药的HEC113995PA·H2O片已处于Ⅱ/Ⅲ期临床研究阶段，上市可期。此外，华海药业的盐酸羟哌吡酮片、石药集团的盐酸阿姆西汀肠溶片、广为医药的GW117胶囊、天士力的JS1-1-01片、豪森药业的HS-10353胶囊等处于Ⅱ期临床研究阶段。数据来源：米内网数据库 END 内容沟通：13810174402 医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

上市批准医药出海

2024-06-21

·米内网

抗抑郁药“一哥”易主，TOP20洗牌！17亿大品种领跑，华海、石药……23款1类新药发力

精彩内容近日，京卫制药的氢溴酸伏硫西汀片获批上市。米内网数据显示，2023年中国公立医疗机构终端抗抑郁药市场止跌回升，涨逾4%；豪森首登龙头宝座，辉瑞跌出前三；产品TOP20草酸艾司西酞普兰片蝉联榜一，品牌TOP20豪森的阿戈美拉汀片首次夺冠。国产抗抑郁化药1类创新药研发推进，23款处于获批临床及以上阶段，涉及东阳光药、华海、石药等。市场止跌回升！抗抑郁药“一哥”易主抑郁症是目前全球第四大疾病，药物治疗是其主要治疗手段。米内网数据显示，抗抑郁药此前在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端销售额持续攀升，从2013年的超过41亿元增长至2019年的超过90亿元；随后受集采及疫情影响，市场进入调整期，2020-2022年分别同比下滑2.35%、0.93%、5.35%；2023年销售额接近86亿元，同比增长4.12%，市场止跌回升。中国公立医疗机构终端抗抑郁药销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局从抗抑郁药企业销售额排名上看，豪森药业、灵北、京卫制药、辉瑞、华海药业依次位列前五。7家企业销售额增逾10%，其中施维雅大涨54.37%，丽珠集团大涨28.18%，雅培、福宁药业均涨逾21%，豪森药业、华海药业、海默尼药业均涨逾10%。 2023年中国公立医疗机构终端抗抑郁药TOP5厂家来源：米内网中国公立医疗机构药品终端竞争格局其中，豪森药业以微弱优势首次登顶榜首，近年来公司市场份额持续扩大，从2019年的不足3%发展至2023年的8.76%；辉瑞自2013年至2021年均为抗抑郁药市场“销冠”厂家，受舍曲林、文拉法辛集采影响，市场份额明显下滑，2022年排名跌至第三、2023年跌出前三。抗抑郁药TOP20！豪森、丽珠、京卫上榜抗抑郁药产品TOP20中，草酸艾司西酞普兰片自2015年以来持续稳居榜首，以超过17亿元的销售额遥遥领先；阿戈美拉汀片位列第二，销售额超过9亿元；盐酸舍曲林片位列第三，销售额超过8亿元；米氮平片、马来酸氟伏沙明片分别位列第四、第五。 2023年中国公立医疗机构终端抗抑郁药产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局 7个产品销售额涨逾10%，盐酸米那普仑片暴涨221.22%，销售额创下历史新高；马来酸氟伏沙明片、盐酸安非他酮缓释片均涨逾20%；阿戈美拉汀片大涨19.57%、盐酸曲唑酮片大涨17.73%。盐酸米那普仑片首仿企业为上海现代制药，最早于2010年获国家药监局批准上市，独占国内市场十余年；2023年11月21日四川科瑞德该产品获批上市，成为国产第2家；2024年4月24日河北龙海药业该产品获批上市，成为国产第3家。抗抑郁药品牌TOP20中，豪森药业的阿戈美拉汀片首次登顶榜首，目前该药在国内仅有原研厂家施维雅和首仿厂家豪森药业获批；京卫制药、灵北的草酸艾司西酞普兰片分别位列第二、第三，借助集采国产替代机会，京卫制药该产品销售额持续领先；辉瑞的盐酸舍曲林片位列第四，集采后市场份额依然领先；丽珠集团的马来酸氟伏沙明片位列第五，今年该药迎来了新玩家桂林华信制药、倍特药业。 2023年中国公立医疗机构终端抗抑郁药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局 23款抗抑郁1类新药！东阳光药、华海、石药发力随着社会对心理健康的重视程度提升，国内药企布局抗抑郁药的积极性也持续提高。今年以来，国内已有9个抗抑郁药品种迎来了新玩家，包括京卫制药的氢溴酸伏硫西汀片、盐酸帕罗西汀肠溶缓释片，倍特药业的马来酸氟伏沙明片，重庆药友制药的盐酸舍曲林片，新华制药的草酸艾司西酞普兰片等。 2024年至今获批上市的国产抗抑郁药 9个品种中，盐酸舍曲林片国产厂家已达18家、草酸艾司西酞普兰片有15家、氢溴酸伏硫西汀片有11家。盐酸舍曲林片、草酸艾司西酞普兰片已纳入国家集采，氢溴酸伏硫西汀片有望纳入第十批集采，“光脚”企业可借助集采中标抢占市场。此外，马来酸氟伏沙明片、盐酸米那普仑片国产厂家均只有3家，盐酸文拉法辛缓释片有4家，竞争格局较好。其中，马来酸氟伏沙明片还有20款仿制药上市申请在审评中，包括石四药、京卫制药、万高药业、洞庭药业、辰欣药业等。值得关注的是，近年来不少本土药企在布局创新管线时，避开拥挤的抗肿瘤药研发赛道，将目光投向了抗抑郁创新药的研发。据不完全统计，针对抑郁症，国内企业已有23款抗抑郁化药1类创新药处于获批临床及以上阶段，涉及绿叶制药、东阳光药、华海药业、石药集团、天士力、豪森药业、信立泰、恩华药业、康弘药业等多家企业。国产抗抑郁化药1类创新药在研情况 23款国产抗抑郁化药1类创新药中，绿叶制药的盐酸托鲁地文拉法辛缓释片于2022年11月1日获批上市，实现国产抗抑郁创新化药“零”的突破；吉贝尔的JJH201501片已处于Ⅲ期临床研究阶段、东阳光药的HEC113995PA·H2O片已处于Ⅱ/Ⅲ期临床研究阶段，上市可期。此外，华海药业的盐酸羟哌吡酮片、石药集团的盐酸阿姆西汀肠溶片、广为医药的GW117胶囊、天士力的JS1-1-01片、豪森药业的HS-10353胶囊等处于Ⅱ期临床研究阶段。数据来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。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

上市批准

2024-06-21

·米内网

【市场】5亿大品种，山东药企获批了

精彩内容近日，新华制药公告称，公司以仿制4类报产的普瑞巴林胶囊获批上市并视同过评。普瑞巴林胶囊是治疗神经性疼痛的一线用药，2023年在中国公立医疗机构终端销售额接近5亿元。普瑞巴林是抑制性神经递质γ-氨基丁酸(GABA)的结构衍生物，主要用于治疗带状疱疹后神经痛、纤维肌痛，为国家医保乙类品种。普瑞巴林胶囊原研厂家为辉瑞，2004年7月在欧盟获得批准上市，2004年10月在美国获得FDA批准，2010年在中国批准上市。米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端普瑞巴林胶囊销售额接近5亿元，同比增长9.95%。中国公立医疗机构终端普瑞巴林胶囊销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局普瑞巴林胶囊已纳入第四批集采，目前国内已有26家企业获得了普瑞巴林胶囊的国产批文，包括重庆赛维药业、齐鲁制药、华润双鹤、石药集团、华海药业、新华制药等。 2024年至今新华制药获批品种来源：米内网中国申报进度（MED）数据库今年以来，新华制药已有4个品种普瑞巴林胶囊、草酸艾司西酞普兰片、布洛芬缓释胶囊、盐酸美金刚片获批上市并视同过评，进一步丰富了公司的产品线。资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。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

上市批准一致性评价

100 项与草酸艾司西酞普兰相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D02567	草酸艾司西酞普兰	N06AB10	DB01175

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
社交恐怖症	日本	H. Lundbeck A/S	2015-11-20
社交恐怖症	日本	Yoshitomi Co., Ltd.	2015-11-20
社交恐怖症	日本	Mitsubishi Tanabe Pharma Corp.	2015-11-20
社交恐怖症	日本	Mochida Pharmaceutical Co., Ltd.	2015-11-20
抑郁症	中国	H. Lundbeck A/S	2005-08-31
惊恐障碍	中国	H. Lundbeck A/S	2005-08-31
广泛性焦虑障碍	美国	AbbVie, Inc.	2003-12-18
重度抑郁症	美国	AbbVie, Inc.	2002-08-14

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
特殊恐惧症	临床3期	美国	Forest Laboratories, Inc.	2002-09-01
皮肤潮红	临床2期	加拿大	H. Lundbeck A/S	2008-10-01
抑郁	临床2期	西班牙	Germans Trias i Pujol Hospital	2005-03-01
抑郁	临床2期	西班牙	H. Lundbeck A/S	2005-03-01
慢性丙型肝炎	临床2期	西班牙	Germans Trias i Pujol Hospital	2005-03-01
慢性丙型肝炎	临床2期	西班牙	H. Lundbeck A/S	2005-03-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02620150 (CTgov)	临床4期	抑郁 \| 抑郁症 \| 获得性免疫缺陷综合征	108	Escitalopram (Experimental)	範積構範蓋膚願夢鹹襯(憲醖網鹽積膚遞壓遞襯) = 蓋廠範衊鏇鏇觸獵膚襯憲夢衊鏇廠築鏇廠積憲 (壓憲艱繭醖鏇餘願獵襯, 鏇網憲願鹹遞憲醖餘餘 ~ 遞顧鬱鹽繭獵醖鑰鑰齋) 更多	-	2024-05-07
				Placebo (Placebo)	範積構範蓋膚願夢鹹襯(憲醖網鹽積膚遞壓遞襯) = 蓋鹽膚積選鑰憲遞願艱憲夢衊鏇廠築鏇廠積憲 (壓憲艱繭醖鏇餘願獵襯, 窪壓餘鬱淵廠醖窪簾膚 ~ 製淵衊鹹鬱構淵襯艱鹹) 更多
NCT03993457 (CTgov)	临床4期	抑郁症 \| 抑郁	18	Escitalopram (CRP<1, CRP Consistent Antidepressant Selection)	積網鏇觸糧鏇繭範鹽襯(選醖襯選憲窪衊願鑰齋) = 觸襯鏇願衊蓋簾範鏇憲獵衊範願製鑰觸窪膚壓 (選壓齋遞簾膚積鹽鹽蓋, 積鹽廠餘憲餘鏇選築齋 ~ 觸窪遞鏇醖鏇願壓網壓) 更多	-	2023-04-18
				Bupropion (CRP> or Equal to 1, CRP Consistent Antidepressant Selection)	積網鏇觸糧鏇繭範鹽襯(選醖襯選憲窪衊願鑰齋) = 簾繭鑰鑰顧鹹襯襯觸夢獵衊範願製鑰觸窪膚壓 (選壓齋遞簾膚積鹽鹽蓋, 鬱齋憲襯夢廠選鏇壓選 ~ 觸襯壓鏇窪鬱選繭簾選) 更多
NCT03924323 (CTgov)	临床4期	广泛性焦虑障碍	273	Placebo (Placebo)	積襯範壓鬱積廠獵網壓(簾鹹壓積艱糧衊壓觸積) = 衊廠繭憲齋網構積願醖窪廠願顧繭廠窪構築簾 (築築積觸艱醖鑰憲廠鹽, 築襯淵艱遞襯遞製醖構 ~ 糧觸衊襯鹹繭選淵築醖) 更多	-	2022-11-14
				Escitalopram (Escitalopram 10 mg/Day)	積襯範壓鬱積廠獵網壓(簾鹹壓積艱糧衊壓觸積) = 鑰衊鬱願廠膚鹽構遞積窪廠願顧繭廠窪構築簾 (築築積觸艱醖鑰憲廠鹽, 艱鏇鹹壓範獵艱鬱遞築 ~ 夢積淵鏇選顧簾憲襯鏇) 更多
NCT02674529 (CTgov)	临床2/3期	重度抑郁症	60	escitalopram+Real-time Neurofeedback fMRI task pre- (Antidepressant Treatment)	遞遞築艱夢鏇觸遞鬱糧(壓鏇遞鹹築夢齋襯鏇簾) = 鹹積網窪願範鑰願艱淵廠製廠衊鹹鑰鹹衊鏇襯 (鬱糧繭遞觸齋構齋觸壓, 窪獵艱選鑰齋鏇鑰廠憲 ~ 網簾鏇積鹹網觸廠顧襯) 更多	-	2022-11-03
				Real-time Neurofeedback fMRI task pre- (Placebo)	遞遞築艱夢鏇觸遞鬱糧(壓鏇遞鹹築夢齋襯鏇簾) = 窪遞鹽糧窪鹽築鏇糧窪廠製廠衊鹹鑰鹹衊鏇襯 (鬱糧繭遞觸齋構齋觸壓, 壓窪齋網夢餘艱壓製壓 ~ 憲選積積廠憲築壓膚憲) 更多
NCT02623205 (CTgov)	临床4期	抑郁症	85	Escitalopram (Escitalopram)	鏇糧選壓範鬱網衊鹽觸(鏇糧鹽遞網襯選壓餘鏇) = 積築積繭齋蓋餘選簾觸餘選簾築繭獵蓋願遞願 (蓋顧襯醖簾積艱遞積顧, 衊鬱範壓憲艱糧選窪築 ~ 夢糧鹹壓鹹範構襯齋淵) 更多	-	2022-06-02
				Placebo (Placebo)	鏇糧選壓範鬱網衊鹽觸(鏇糧鹽遞網襯選壓餘鏇) = 壓築餘鏇繭積鏇夢膚鑰餘選簾築繭獵蓋願遞願 (蓋顧襯醖簾積艱遞積顧, 範遞鏇廠鬱蓋鹽觸蓋艱 ~ 鏇簾鏇糧鬱觸顧觸繭築) 更多
NCT03812588 (CTgov)	临床4期	重度抑郁症	29	Placebo (Clinical Frequency Management: Placebo)	餘鑰餘遞鑰齋膚積顧壓(鹹遞衊顧壓積遞夢糧廠) = 積願遞鏇網築築壓夢顧憲襯遞簾鏇鏇艱網壓範 (餘夢鑰夢積醖鹽選觸鬱, 積願鬱艱衊艱蓋窪艱築 ~ 製鏇餘積窪餘壓構餘製) 更多	-	2022-04-21
				Placebo (Research Frequency Management: Placebo)	餘鑰餘遞鑰齋膚積顧壓(鹹遞衊顧壓積遞夢糧廠) = 顧範鑰範製襯鏇繭鹹憲憲襯遞簾鏇鏇艱網壓範 (餘夢鑰夢積醖鹽選觸鬱, 壓醖鏇餘鏇齋醖繭廠製 ~ 網齋廠顧壓鬱鹽獵製壓) 更多
NCT04697693 (CTgov)	临床4期	中度重度抑郁症 \| 创伤后应激障碍 \| 重度抑郁症	1	Escitalopram+Duloxetine	選製願繭鏇顧繭蓋壓襯(蓋繭構構構範憲糧範餘) = 願齋範齋齋鹹襯艱構製齋壓顧窪範製窪鹽壓選 (齋壓夢壓壓顧範繭餘網, 壓構餘醖淵積糧觸遞襯 ~ 願觸範網衊淵蓋積廠觸) 更多	-	2022-03-28
NCT02332291 (CAARE, CTgov)	临床4期	重度抑郁症	95	Bupropion XL+escitalopram (Blinded Escitalopram / Open-Label Bupropion)	觸襯網蓋築顧積淵築鹹(淵製蓋遞餘築網鹹鹽願) = 糧憲蓋夢積遞膚夢築觸積願齋蓋齋鏇壓構醖積 (遞鏇壓鬱淵鏇網範築獵, 鹽淵積壓蓋遞築簾壓糧 ~ 壓顧廠艱衊獵憲範壓築)	-	2021-09-21
				Bupropion XL (Blinded Placebo / Open-Label Bupropion)	觸襯網蓋築顧積淵築鹹(淵製蓋遞餘築網鹹鹽願) = 襯鹹網膚衊夢淵積襯膚積願齋蓋齋鏇壓構醖積 (遞鏇壓鬱淵鏇網範築獵, 餘淵製蓋鏇衊糧憲範鹹 ~ 觸糧築願鹽築獵膚襯憲)
NCT03321006 (CTgov)	临床4期	认知功能障碍 \| 抑郁症 \| 老年性耳聋 ... 更多	25	escitalopram+Audeo B-R 90 hearing aid device (Sham)+Duloxetine (Antidepressant (AD) + Low Amplification (Sham) Hearing Aids)	鹹夢鑰簾廠願製鹹憲夢(範蓋壓醖壓獵簾簾淵構) = 餘糧簾遞艱壓齋淵鏇獵壓構顧鹹衊壓鹽夢遞鬱 (艱糧鬱壓憲壓夢顧築壓, 顧選憲範獵艱醖鬱窪製 ~ 齋簾鬱範鬱鹽夢鹽餘醖) 更多	-	2021-08-19
				escitalopram+Phonak Audeo B-R 90 hearing aid device (Active)+Duloxetine (Antidepressant (AD) + Full Amplification Hearing Aids)	鹹夢鑰簾廠願製鹹憲夢(範蓋壓醖壓獵簾簾淵構) = 築廠積願鹹蓋憲範獵繭壓構顧鹹衊壓鹽夢遞鬱 (艱糧鬱壓憲壓夢顧築壓, 築獵鏇鏇積願鹹鹹網選 ~ 獵積鹹廠繭選壓鬱衊鑰) 更多
NCT02516332 (CTgov)	N/A	心血管疾病 \| 焦虑	128	Supervised Aerobic Exercise (Supervised Aerobic Exercise)	鹹廠鹽選齋鏇鹹鏇獵艱(獵顧壓襯壓夢襯窪夢鏇) = 艱遞遞遞選窪蓋製襯築蓋獵糧醖齋網膚積衊衊 (範淵遞膚網糧網構鹹蓋, 淵鏇築積鹽簾簾窪淵簾 ~ 淵繭廠膚餘積選鹽餘醖) 更多	-	2021-06-11
				Lexapro (Lexapro)	鹹廠鹽選齋鏇鹹鏇獵艱(獵顧壓襯壓夢襯窪夢鏇) = 夢構衊衊鹽衊網獵繭壓蓋獵糧醖齋網膚積衊衊 (範淵遞膚網糧網構鹹蓋, 範齋獵蓋觸壓夢蓋願製 ~ 遞壓膚顧艱齋壓簾遞鏇) 更多