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更新于：2025-04-14

Risperidone

利培酮

更新于：2025-04-14

概要

基本信息

简介利培酮（商品名为：RISPERDAL®）是一种非典型抗精神病药物。该药品由强生公司开发，于1993年12月29日获得美国食品药品监督管理局（FDA）批准。利培酮用于治疗精神分裂症，以及与双相I型障碍相关的急性躁狂或混合发作，可作为单药治疗或与锂或丙戊酸辅助治疗。此外，该药品还被批准用于治疗与自闭症谱系障碍相关的烦躁情绪。该药品通过抑制多巴胺2型（D2）和5-羟色胺2型（5HT2）受体结合起作用，这被认为是其治疗精神分裂症的疗效贡献之一。利培酮一般耐受性较好，但可能会引起体重增加、嗜睡和锥体外系症状等副作用。

药物类型

小分子化药

别名

Risperdal OD、Risperidone (JP17/USP/INN)、Risperidone for Depot Suspension

+ [43]

靶点

5-HT2A receptor x D2 receptor

作用方式

拮抗剂

作用机制

5-HT2A receptor拮抗剂(5-羟色胺2A受体拮抗剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂)

治疗领域

神经系统疾病

在研适应症

躁郁症1型自闭症躁郁症+ [3]

非在研适应症

急性精神分裂症阿尔茨海默症阿斯伯格综合症+ [24]

原研机构

Johnson & Johnson

在研机构

Teva Neuroscience, Inc.

Janssen Pharmaceuticals, Inc.

Laboratorios Farmaceúticos Rovi SA

+ [6]

非在研机构

Janssen Pharmaceutica NVJanssen-Cilag International NVJohnson & Johnson Pharmaceutical Research & Development LLC

+ [11]

最高研发阶段批准上市

首次获批日期

美国 (1993-12-29),

精神分裂症

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C23H27FN4O2

InChIKeyRAPZEAPATHNIPO-UHFFFAOYSA-N

CAS号106266-06-2

关联

505

项与利培酮相关的临床试验

NCT06878833

/ Withdrawn临床3期

A Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder

Lyndra Therapeutics, Inc., is developing a long-acting oral (LAO) treatment of risperidone (LYN-005) in a capsule dosage form (LYNX® drug delivery platform). The intent of LYN-005 is to reduce the dosing frequency of orally-administered risperidone to once weekly or less and, thereby improve treatment adherence and management of schizophrenia and schizoaffective disorder.
This study will evaluate the safety and tolerability of multiple administrations of LYN-005 at 3 dose levels.

开始日期2025-04-18

申办/合作机构

Lyndra Therapeutics, Inc.初创企业

NCT06512220

/ Not yet recruiting临床2期IIT

Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)

Limit: 5000 characters. Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.
The purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.

开始日期2025-03-01

申办/合作机构

Centre for Addiction & Mental Health

IRCT20200721048159N9

/ Suspended临床3期IIT

Evaluation of the Effects of Crocin and Risperidone Separately and Synergistically on the Improvement of Pain Syndrome and Anxiety Caused by Addiction Withdrawal

开始日期2025-01-20

申办/合作机构-

100 项与利培酮相关的临床结果

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100 项与利培酮相关的转化医学

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100 项与利培酮相关的专利（医药）

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14,151

项与利培酮相关的文献（医药）

2025-12-31·Gut Microbes

Reutericyclin, a specialized metabolite of Limosilactobacillus reuteri , mitigates risperidone-induced weight gain in mice

Article

作者: Kindel, Tammy L ; Smith, Brian C ; Grobe, Justin L ; Hadiono, Matthew A ; Kazen, Alexis B ; Keyes, Robert F ; Aboulalazm, Fatima A ; Kellogg, Stephanie L ; Lozada-Fernandez, Valery ; deLeon, Orlando ; Saravia, Fatima L ; Kirby, John R ; Müller, Susanne

The role of xenobiotic disruption of microbiota, corresponding dysbiosis, and potential links to host metabolic diseases are of critical importance. In this study, we used a widely prescribed antipsychotic drug, risperidone, known to influence weight gain in humans, to induce weight gain in C57BL/6J female mice. We hypothesized that microbes essential for maintaining gut homeostasis and energy balance would be depleted following treatment with risperidone, leading to enhanced weight gain relative to controls. Thus, we performed metagenomic analyses on stool samples to identify microbes that were excluded in risperidone-treated animals but remained present in controls. We identified multiple taxa including Limosilactobacillus reuteri as a candidate for further study. Oral supplementation with L. reuteri protected against risperidone-induced weight gain (RIWG) and was dependent on cellular production of a specialized metabolite, reutericyclin. Further, synthetic reutericyclin was sufficient to mitigate RIWG. Both synthetic reutericyclin and L. reuteri restored energy balance in the presence of risperidone to mitigate excess weight gain and induce shifts in the microbiome associated with leanness. In total, our results identify reutericyclin production by L. reuteri as a potential probiotic to restore energy balance induced by risperidone and to promote leanness.

2025-06-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Inter-individual variability in the metabolism of psychotropic drugs by the enzyme activities from the human gut microbiome

Article

作者: Lyu, Yuanfeng ; Tsang, Tsz Fung ; Zuo, Zhong ; Chan, Paul Ks ; Boon, Siaw Shi ; Chong, Ka Chun ; Wang, Xuan ; Cheng, Sau Wan ; Lai, Christopher Kc ; Yang, Xiao

The interaction between marketed drugs and the gut microbiome is increasingly being recognized, and it is now known that enzymes produced by the bacteria in the human gut can degrade psychotropic drugs. However, the degree of inter-individual variation in their metabolism remains largely unknown. Here, we present a simple model for detecting individual drug-microbiome interaction using fecalase. We incubated fecalase prepared from freshly collected stool samples from healthy volunteers (n = 18) and incubated with nine selected psychotropic medications. We proved fecalase retained enzymatic activities and showed the degree of drug degradation differed significantly for different psychotropic drugs, and there was significant inter-individual variation in the metabolism of phenytoin, amitriptyline, and chlorpromazine with the inter-individual point difference between the strongest and weakest metabolizer of 85 %, 39 %, and 30 % respectively. These findings highlight the potential of fecalase as a model for studying personalized drug metabolism and underscore the importance of considering gut microbiome variability in pharmacological research.

2025-05-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Stability of antipsychotic biomarkers for wastewater-based epidemiology

Article

作者: Heath, Ester ; Heath, David ; Boogaerts, Tim ; Laimou-Geraniou, Maria ; van Nuijs, Alexander L N ; Covaci, Adrian ; Quireyns, Maarten

Wastewater-based epidemiology (WBE) offers a promising approach by providing objective data on antipsychotic drug consumption within a population that can be used to monitor abuse, misuse, and regional prescription patterns. However, accurate estimations depend on knowing the stability of drug biomarkers. This study provides a comprehensive analysis of the stability of 11 antipsychotic biomarkers (parent drugs and their metabolites) in influent wastewater, using a series of experiments mimicking in-sewer transport (in-sewer setup and deconjugation) and in-sample stability (benchtop, frozen cartridge, long-term sample storage, and freeze-thaw). In-sample stability experiments are exposed to various conditions (i.e., filtration, acidification) commonly used for storage. The results reveal compound-specific stability profiles, with quetiapine showing notable high stability across most experiments. In contrast, N-desmethylolanzapine and dehydroaripiprazole demonstrated rapid degradation. Acidification before storage led to significant degradation of some compounds, decreasing the accuracy of WBE consumption estimates and rendering it unsuitable as a sample storage method. Overall, the study found that compound-specific degradation patterns underscore the necessity for tailored analytical approaches when using WBE to monitor antipsychotic drug use. Future research should focus on bioreactor studies mimicking in-sewer conditions and the application of correction factors to enhance the accuracy of consumption estimates, facilitating more reliable public health surveillance through WBE.

439

项与利培酮相关的新闻（医药）

2025-04-11

·生物制品圈

下一个赛道来自“精分”？强生、BMS、再鼎、绿叶竞逐

精神病领域有望迎来下一个重磅药物。4月9日晚，强生宣布已完成对Intra - cellular的收购，通过此次收购，强生不仅将卢美哌隆（lumateperone）纳入囊中，还包括具有同类最优潜力的临床阶段管线，进一步丰富了其在精神健康领域的布局。据悉，此前强生豪掷146亿美元收购中枢神经系统（CNS）治疗药物的企业Intra - cellular。这一金额超过了强生自己在2024年创下的全球医药企业收购金额记录。强生天价收购Intra-cellular，主要目标就是拿下具有两大类精神疾病适应症的卢美哌隆，其销售业绩表现强劲，从2020年的2281万美元增长至2023年的4.64亿美元，2024年预计达到6.85亿美元。本次，强生对Intra-Cellular的收购，只是CNS领域蓬勃发展的一个缩影。精神类药物市场正成为全球药企新的竞争焦点，也带起了该赛道的风口，达成的收购金额呈现上涨趋势，其中Karuna是以140亿美元被BMS收购，艾伯维以87亿美元收购Cerevel 。MNC对CNS的兴趣还在延续，2025年1月渤健宣布将总估值为4.42亿美元“抄底”Sage。不过，高价押注CNS赛道能否真正带来预期的市场回报？CNS“难啃的骨头”相较于传统优势领域（如肿瘤、免疫）竞争白热化，CNS领域仍有大量未被满足的临床需求。然而CNS的药物研发领域一直被认为是医药行业的“硬骨头”，从机制不明，到动物模型难验证、临床开发难，每一项都是CNS药物开发的拦路虎。2024年11月，艾伯维宣布其收购 Cerevel的核心药物——用于治疗精神病症状急性加重的精神分裂症新药Emraclidine的两项EMPOWER临床试验失败。同年，Neumora精神分裂症治疗药物NMRA-266因临床前数据显示该药物引发了兔子的抽搐被FDA叫停试验。NMRA-266 是 M4 毒蕈碱受体的高选择性正变构调节剂；2024年9月，Neurocrine的精神分裂症药物luvadaxistat二次临床II期失败，最终决定停止开发luvadaxistat（NBI-1065844）。而在此之前，罗氏和丹麦灵北制药都曾宣布终止相关管线。接连的试验失败凸显了CNS药物研发的高风险特性，也表明这一领域的药物以及更广泛的新神经科学项目背后机制的复杂性远超预期。收购公告中，强生强调了自身在神经科学领域近70年的经验，拥有多款商业化的神经类药物，其中抗抑郁鼻腔喷雾剂Spravato在2024年销售额突破10亿美元，研管线中还有两款III期临床产品seltorexant和aticaprant。2024年Q3更新的研发管线中，强生终止了3个CNS临床研究项目，分别是seltorexant治疗阿尔茨海默病的2期临床研究、P2X7拮抗剂治疗双相障碍的2期临床研究以及JNJ-0376治疗帕金森病的I期临床研究。可见即使手握可观盈利产品的强生，也面临CNS的研发困境。2024年，强生神经科学业务营收71.15亿美元，在创新制药业务中占比仅12.5%，远低于肿瘤业务的36.48%和免疫业务的31.30%。收购Intra-Cellular不仅能助力强生在神经领域的发展，还囊括一款50亿美元的重磅炸弹。卢美哌隆2019年首次获得FDA批准，治疗精神分裂症，2021年12月又获批了双相情感障碍适应症。在这两大适应症的支撑下，卢美哌隆已经展现出了不菲的商业化潜力。2023年，其销售额已经达到4.62亿美元，同比增长86%；2024年继续增长，前三季度销售额达到4.82亿美元，预计全年最高可达6.85亿美元。值得一提的是，卢美哌隆还将继续快速增长。就在2024年底，Intra-Cellular向FDA提交了卢美哌隆的第3项新适应症上市申请，用于重度抑郁症（MDD）的辅助治疗。MDD的潜在患者人数要远多于精分和双相。根据强生披露的数据，全球超过10亿人——即每8人中就有1人患有神经精神或神经退行性疾病。而在美国，大约240万成年人患有精神分裂症，610万成年人患有双相情感障碍，2100万成年人患有MDD。因此，强生对Caplyta寄予厚望，预计其销售峰值将达到50亿美元。研发难且热情不减根据Frost & Sullivan的预测，全球神经科学药物市场规模将从2022年的1600亿美元增长到2028年的2200亿美元。尽管开发CNS药物具有较大的难度和风险，但由于市场进入壁垒高，且空间潜力巨大，仍吸引着许多药企抢滩布局。技术进步也是推动CNS领域发展的重要因素，2024年9月，BMS宣布Karuna的核心产品KarXT获美国FDA批准上市，它是数十年来首个获批的全新机制的精神分裂症治疗药物。此次批准使BMS在神经科学和精神病学领域获得了重要的立足点。值得一提的是，再鼎医药拥有KarXT大中华区市场的权益，据再鼎医药披露的信息，中国约有80万精神分裂症患者。有望于2024年到2025年上半年获得研究的关键数据，并在中国内地提交KarXT用于精神分裂症的新药上市申请。据悉，除了治疗精神分裂症以外，KarXT目前正在进行注册临床试验，评估治疗阿尔茨海默病精神病的效果，预计2026年获得数据。此外，BMS认为KarXT在其他适应症方面也具有潜力，包括I型双相情感障碍和阿尔茨海默病躁动症。有分析师估计，BMS的KarXT已进入FDA的精神分裂症治疗程序，其销售额可能高达60亿美元。在KarXT身后，全球已进入临床Ⅲ期或注册申请阶段的抗精神分裂症药物已有9款，包括三菱制药的roluperidone、丹麦灵北制药与恩华药业的Lu AF35700、SyneuRx的苯甲酸钠、Newron的依文酰胺、勃林格殷格翰的iclepertin等。此外，国内药企绿叶制药自研的瑞可妥（Rykindo）是一种利培酮微球产品，分别于2021年、2023年在中国、美国获批上市，用于治疗精神分裂症和双相情感障碍，是首个由中国药企自主研发并在美获批的中枢神经系统新药。在CNS领域，绿叶制药还有数款已上市产品或在研管线，彰显出极为强劲的竞争力。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

并购临床2期临床3期

2025-04-07

·信狐药迅

东阳光英强布韦片掘金7.8亿市场；青峰创新流感药玛舒拉沙韦获批上市| 新获批(3.31-4.6）

每周药品注册获批数据，分门别类呈现，一目了然。(3.31-4.6）新药上市申请药品名称企业注册分类受理号SHR0302片江苏恒瑞医药股份有限公司1CXHS2300108GP681片江西青峰药业有限公司1CXHS2300106英强布韦片宜昌东阳光长江药业股份有限公司1CXHS2300069新药临床申请药品名称企业注册分类受理号INS018_055片英矽智能科技(上海)有限公司1CXHL2500120HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500111HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500110HRS-1167片江苏恒瑞医药股份有限公司1CXHL2500109BIOS-0618片杭州百诚医药科技股份有限公司1CXHL2500104BIOS-0618片杭州百诚医药科技股份有限公司1CXHL2500103TQB3912片正大天晴药业集团股份有限公司1CXHL2500108TQB3912片正大天晴药业集团股份有限公司1CXHL2500107HBW-012336胶囊成都海博为药业有限公司1CXHL2500099HRS-6719片山东盛迪医药有限公司1CXHL2500094HRS-6719片山东盛迪医药有限公司1CXHL2500092GenSci128片长春金赛药业有限责任公司1CXHL2500080IMP1707片上海瑛派药业有限公司1CXHL2500088GenSci128片长春金赛药业有限责任公司1CXHL2500081IMP1707片上海瑛派药业有限公司1CXHL2500089HS-10380片江苏豪森药业集团有限公司1CXHL2401508CMC-2310口溶膜复星医药(徐州)有限公司2.2CXHL2500113CMC-2310口溶膜复星医药(徐州)有限公司2.2CXHL2500112ASKC635干混悬剂江苏奥赛康药业有限公司2.2CXHL2500083HZ039干混悬剂浙江和泽医药科技股份有限公司2.2CXHL2500029HZ039干混悬剂浙江和泽医药科技股份有限公司2.2CXHL2500028注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500118HK241雾化吸入溶液南京华盖制药有限公司2.4CXHL2500106三价流感病毒裂解疫苗(ZFA02佐剂)安徽智飞龙科马生物制药有限公司1.3CXSL2500007PT217凡恩世制药(北京)有限公司1CXSL2500090注射用DR30206浙江道尔生物科技有限公司1CXSL2500079BNT324映恩生物制药(苏州)有限公司1CXSL2500073BNT327百欧恩泰(上海)医药有限公司1CXSL2500072注射用TQB2922正大天晴药业集团南京顺欣制药有限公司1CXSL2500062注射用7MW3711迈威(上海)生物科技股份有限公司1CXSL2500057注射用ZL-1310再鼎医药(上海)有限公司1CXSL2500052SSGJ-627注射液三生国健药业(上海)股份有限公司1CXSL2500024ZT006片北京质肽生物医药科技有限公司1CXSL2500021ZT006片北京质肽生物医药科技有限公司1CXSL2500020ZT006片北京质肽生物医药科技有限公司1CXSL2500019泰它西普注射液荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2500014DJ-01注射剂苏州德进生物制药有限公司2.4CXSL2500059仿制药申请药品名称企业注册分类受理号腺苷钴胺胶囊四川新斯顿制药股份有限公司3CYHS2302959吡拉西坦注射液石家庄凯达生物工程有限公司3CYHS2302936吡拉西坦注射液石家庄凯达生物工程有限公司3CYHS2302935吡拉西坦注射液石家庄凯达生物工程有限公司3CYHS2302934氨茶碱注射液浙江北生药业汉生制药有限公司3CYHS2302798碳酸氢钠林格注射液河北天成药业股份有限公司3CYHS2302620甲硫酸新斯的明注射液上海旭东海普药业有限公司3CYHS2302585甲硫酸新斯的明注射液上海旭东海普药业有限公司3CYHS2302584奥美拉唑碳酸氢钠胶囊(II)宁波美诺华天康药业有限公司3CYHS2302576奥美拉唑碳酸氢钠胶囊宁波美诺华天康药业有限公司3CYHS2302575盐酸多巴胺注射液遂成药业股份有限公司3CYHS2302519盐酸多巴胺注射液遂成药业股份有限公司3CYHS2302518依帕司他片河北瑞森药业有限公司3CYHS2302427布美他尼注射液四川美大康华康药业有限公司3CYHS2302402重酒石酸间羟胺注射液安徽美来药业股份有限公司3CYHS2302378脑脊髓手术用灌流液山东齐都药业有限公司3CYHS2302269氯化钾注射液南京赛瑞谱顿制药有限公司3CYHS2302235碳酸氢钠注射液石家庄四药有限公司3CYHS2302249福多司坦口服溶液江苏联环药业股份有限公司3CYHS2302224氯化钾注射液海南景泽康生物科技有限公司3CYHS2302201硫辛酸片湖南先施制药有限公司3CYHS2302036硫辛酸片湖南先施制药有限公司3CYHS2302035泊马度胺胶囊扬子江药业集团有限公司3CYHS2301871泊马度胺胶囊扬子江药业集团有限公司3CYHS2301870米诺地尔搽剂山东百诺医药股份有限公司3CYHS2301792左乙拉西坦缓释片东北制药集团沈阳第一制药有限公司3CYHS2301768己酮可可碱注射液河南朗冠药品制剂研究院有限公司3CYHS2301750盐酸艾司洛尔注射液海南倍特药业有限公司3CYHS2301678西格列汀二甲双胍缓释片齐鲁制药(海南)有限公司3CYHS2301590羧甲司坦口服溶液北京沃邦医药科技有限公司3CYHS2301440聚乙二醇3350散哈尔滨葵花药业有限公司3CYHS2301409米诺地尔搽剂北京博喆研医药科技有限公司3CYHS2301232二羟丙茶碱注射液安徽金太阳生化药业有限公司3CYHS2301131福多司坦口服溶液四川益生智同医药生物科技发展有限公司3CYHS2301118盐酸阿比多尔片石家庄四药有限公司3CYHS2201031国;CYHS2201031酒石酸溴莫尼定滴眼液石家庄格瑞药业有限公司4CYHS2400266硫酸氨基葡萄糖胶囊广州迈凯安生物医药研究院有限公司4CYHS2400149美阿沙坦钾片江苏联环药业股份有限公司4CYHS2303603美阿沙坦钾片江苏联环药业股份有限公司4CYHS2303602帕利哌酮缓释片合肥立方制药股份有限公司4CYHS2303619帕利哌酮缓释片合肥立方制药股份有限公司4CYHS2303618盐酸尼卡地平注射液石家庄四药有限公司4CYHS2303526甲钴胺片湖南千金湘江药业股份有限公司4CYHS2303515利培酮片重庆药友制药有限责任公司4CYHS2303313利培酮片重庆药友制药有限责任公司4CYHS2303312玻璃酸钠滴眼液苏州工业园区天龙制药有限公司4CYHS2303281富马酸丙酚替诺福韦片河北山姆士药业有限公司4CYHS2303238碘海醇注射液浙江兄弟药业有限公司4CYHS2303204碘海醇注射液浙江兄弟药业有限公司4CYHS2303203碘海醇注射液浙江兄弟药业有限公司4CYHS2303202盐酸决奈达隆片山东新时代药业有限公司4CYHS2303144西罗莫司凝胶福建科瑞药业有限公司4CYHS2303061艾地骨化醇软胶囊正大制药(青岛)有限公司4CYHS2303058艾地骨化醇软胶囊正大制药(青岛)有限公司4CYHS2303057维生素B12滴眼液广州仁恒医药科技股份有限公司4CYHS2302984盐酸贝尼地平片浙江高跖医药科技股份有限公司4CYHS2302979盐酸贝尼地平片浙江高跖医药科技股份有限公司4CYHS2302978盐酸普拉克索缓释片植恩生物技术股份有限公司4CYHS2302880盐酸普拉克索缓释片植恩生物技术股份有限公司4CYHS2302878非诺贝特酸胆碱缓释胶囊江苏慧聚药业股份有限公司4CYHS2302853非诺贝特酸胆碱缓释胶囊江苏慧聚药业股份有限公司4CYHS2302852奥氮平片重庆药友制药有限责任公司4CYHS2302838奥氮平片重庆药友制药有限责任公司4CYHS2302837熊去氧胆酸胶囊杭州民生药业股份有限公司4CYHS2302808布洛芬混悬滴剂哈尔滨葵花药业有限公司4CYHS2302694他达拉非片河北瑞森药业有限公司4CYHS2302219吸入用乙酰半胱氨酸溶液广州世济医药科技有限公司4CYHS2302167瑞戈非尼片北京双鹭药业股份有限公司4CYHS2301372奥利司他胶囊安徽省先锋制药有限公司4CYHS2300819奥利司他胶囊安徽省先锋制药有限公司4CYHS2300818注射用硼替佐米广东鼎信医药科技有限公司4CYHS2201206酮洛芬贴剂河北一品制药股份有限公司3CYHL2500023洛索洛芬钠凝胶贴膏云南白药集团无锡药业有限公司4CYHL2500024冻干人用狂犬病疫苗(人二倍体细胞)北京科兴中维生物技术有限公司3.3CXSL2500017静注人免疫球蛋白(10%)广东双林生物制药有限公司3.2CXSL2500022进口申请药品名称企业注册分类受理号他氟噻吗滴眼液Santen Oy5.1JXHS2300015纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400059纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400058伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400056伊匹木单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400055阿柏西普眼内注射溶液Bayer AG3.1JXSS2300092罗泽利昔珠单抗注射液UCB, Inc.3.1JXSS2300081奥瑞利珠单抗注射液Roche Pharma (Schweiz) AG3.1JXSS2300065奥瑞利珠单抗注射液Roche Pharma (Schweiz) AG3.1JXSS2300064注射用头孢唑林钠Taiwan Biotech Co., Ltd.5.2JYHS2300132注射用头孢唑林钠Taiwan Biotech Co., Ltd.5.2JYHS2300131氟维司群注射液EVER Valinject GmbH5.2JYHS2200093利鲁唑片Kenton Chemicals and Pharmaceuticals Corporation5.2JYHS2200063国;JYHS2200063TAK-279胶囊Takeda Development Center Americas, Inc.1JXHL2500005TAK-279胶囊Takeda Development Center Americas, Inc.1JXHL2500004AZD5492AstraZeneca AB1JXSL2500016AZD5492AstraZeneca AB1JXSL2500015AZD2936AstraZeneca AB1JXSL2500014HCB301注射液FBD Biologics Limited1JXSL2500010VG901注射液ViGeneron GmbH1JXSL2500003本瑞利珠单抗注射液AstraZeneca AB2.2JXSL2500019度伐利尤单抗注射液MedImmune LLC2.2JXSL2500017Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500013Ravulizumab注射液Alexion Pharmaceuticals, Inc.2.2JXSL2500012艾加莫德α注射液argenx BV3.1JXSL2500011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；

疫苗上市批准申请上市

2025-04-07

·PRNewswire

Luye Pharma Announces U.S. Launch of ERZOFRI® (paliperidone palmitate) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Schizoaffective Disorder

PRINCETON, N.J., April 6, 2025 /PRNewswire/ -- Luye Pharma Group today announced that ERZOFRI® (paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder. ERZOFRI, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8. ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. The most common side effects of ERZOFRI include injection site reactions, sleepiness or drowsiness, dizziness, feeling restless or like you need to move, and abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurrent relapses[1]. Non-adherence to medication is a major challenge in patients with such conditions. Failure of follow-up care after discharge significantly increases patients' non-adherence to prescribed medications, relapse and rehospitalization[2]. LAI antipsychotics, with a reduced dosage frequency compared to oral antipsychotics, effectively improve medication adherence and reduce the risk of healthcare providers not knowing if their patients fail to follow the prescribed dosage regimen[3]. ERZOFRI's approval by the FDA is based on the results of an open-label, randomized, multiple-dose, parallel-group study evaluating its pharmacokinetic (PK) profile and relative bioavailability at steady state versus an established paliperidone palmitate LAI drug for reference. The study demonstrated the bioequivalence of ERZOFRI to the listed drug at steady state (treatment day 8) without the need for a second initiation injection. Comparable total drug exposure and a safety profile consistent with the listed drug were established. In addition to the unique 351 mg/2.25mL initiation dose, ERZOFRI is available in single-use kits in the following strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL. "This newly approved long-acting injectable antipsychotic for the management of schizophrenia can help address treatment initiation complexities and provides an exciting alternative to help patients reach their treatment goals." said Christoph U Correll, MD, Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, New York, USA. Rongbing Yang, President of Luye Pharma Group, added: "Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder. Using LAIs is effective in increasing medication adherence. ERZOFRI, with its simplified dosage regimen eliminating the need for a second dose when initiating treatment is expected to increase treatment adherence in the initial stage. Its commercial launch in the U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S. The central nervous system is a key therapeutic area of focus for Luye Pharma, and we are committed to providing innovative therapies to combat mental disorders and expand treatment options." ERZOFRI® (paliperidone palmitate) extended-release injectable suspension INDICATIONS What is ERZOFRI® (paliperidone palmitate)? ERZOFRI is a prescription medicine given by injection by a healthcare provider and used to treat: schizophrenia in adults schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants It is not known if ERZOFRI is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR ERZOFRI (paliperidone palmitate) ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis. Do not receive ERZOFRI if you are allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI. What are the possible serious side effects of ERZOFRI? Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic Malignant Syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms: high fever stiff muscles confusion sweating changes in your breathing, pulse, heart rate, or blood pressure Problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms: passing out or feeling like you will pass out dizziness feeling as if your heart is pounding or missing beats Uncontrolled body movements (tardive dyskinesia). ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI. Problems with your metabolism such as: High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI. Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI: feel very thirsty feel very hungry feel sick to your stomach need to urinate more than usual feel weak or tired feel confused, or your breath smells fruity Increased fat levels (cholesterol and triglycerides in your blood). Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI. Weight gain. You and your healthcare provider should check your weight regularly during treatment with ERZOFRI. Decreased blood pressure (orthostatic hypotension) and fainting. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Falls. ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Low white blood cell counts. Your healthcare provider may do blood tests during treatment with ERZOFRI. Increased prolactin levels in your blood (hyperprolactinemia). ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection. Sleepiness, drowsiness feeling tired, difficulty thinking and doing normal activities. Seizures (convulsions). Difficulty swallowing that can cause food or liquid to get into your lungs. Prolonged or painful erection lasting more than 4 hours (priapism). Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours. Problems with control of your body temperature so that you feel too warm. Before taking ERZOFRI, tell your healthcare provider about all of your medical conditions including if you: have never taken paliperidone or risperidone before have had neuroleptic malignant syndrome (NMS) have or had heart problems, including heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have or had low levels of potassium or magnesium in your blood have or had uncontrolled movements of your tongue, face, mouth or jaw (tardive dyskinesia) have or had kidney or liver problems have or had high blood sugar, diabetes or have a family history of diabetes have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have Parkinson's disease or a type of dementia called Lewy Body Dementia have or had problems with dizziness or fainting or are being treated for high blood pressure have or had a low white blood cell count have or had seizures or epilepsy are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby. If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit . Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare provider know if these symptoms occur. are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine. The most common side effects of ERZOFRI include: injection site reactions sleepiness or drowsiness dizziness feeling restless or like you need to move abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at or call 1-800- FDA-1088. About Luye Pharma Group Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies. Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast-growing emerging markets. SOURCE Luye Pharma Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床结果

100 项与利培酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00426	利培酮	N05AX08	DB00734

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
自闭症	美国	Janssen Pharmaceuticals, Inc.	2006-10-06
情绪易怒	美国	Janssen Pharmaceuticals, Inc.	2006-10-06
躁郁症1型	美国	Janssen Pharmaceuticals, Inc.	2003-12-04
躁郁症	美国	Janssen Pharmaceuticals, Inc.	2002-03-03
精神分裂症	美国	Janssen Pharmaceuticals, Inc.	1993-12-29

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
急性精神分裂症	临床3期	美国	Indivior, Inc.	2014-04-01
自杀意念	临床3期	美国	Janssen Pharmaceuticals, Inc.	2004-06-01
创伤后应激障碍	临床3期	美国	Janssen Pharmaceuticals, Inc.	2004-04-01
广泛性焦虑障碍	临床3期	美国	Janssen Pharmaceuticals, Inc.	2004-02-01
恐慌	临床3期	美国	Janssen Pharmaceuticals, Inc.	2004-02-01
儿童行为障碍	临床3期	-	Janssen-Cilag Ltd.	2003-09-01
学习障碍	临床3期	-	Janssen-Cilag Ltd.	2003-09-01
难治性抑郁症	临床3期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2002-10-01
难治性抑郁症	临床3期	-	Janssen LP	2002-10-01
阿尔茨海默症	临床3期	-	Janssen Pharmaceuticals, Inc.	2002-03-01

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临床结果

适应症

分期

评价

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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


NCT04201834 (CTgov)	临床2期	亨廷顿舞蹈病	6	BioStamp nPoint device+Risperidone	衊膚繭鑰餘觸顧顧窪願(範糧鹽憲構膚鬱憲醖齋) = 觸蓋顧構廠觸蓋選醖鏇糧襯壓選遞餘膚築積製 (壓糧範鑰築淵積顧衊鹽, 糧選鏇醖窪範艱簾糧築 ~ 襯鏇築淵獵艱簾夢憲顧) 更多	-	2025-03-21
NCT04418466 (DLP-114, CTgov)	临床1/2期	精神分裂症	34	Risperidone (DLP-114 Alpha-4 (6-months))	艱壓獵醖膚製鬱衊願鏇 = 餘製繭醖壓觸衊選夢醖鹹淵鑰網鏇鹽糧蓋願壓 (製網壓鑰鹽襯願獵壓願, 憲淵遞窪衊糧壓顧鹹鹹 ~ 製蓋鑰選願鏇願憲選餘) 更多	-	2024-12-27
				Risperidone (DLP-114 Alpha-7 (12-months))	艱壓獵醖膚製鬱衊願鏇 = 夢鬱醖獵憲簾顧築簾築鹹淵鑰網鏇鹽糧蓋願壓 (製網壓鑰鹽襯願獵壓願, 構積範糧獵襯蓋獵壓餘 ~ 襯廠壓網製網遞遞製膚) 更多
NCT03323437 (CTgov)	临床4期	精神分裂症	26	Risperidone (Patient)	繭簾積範蓋鏇鹹襯遞構(襯範憲醖衊構衊蓋糧製) = 憲選淵廠餘選築構糧製遞願網觸醖網簾構鬱衊 (築積積繭選網獵蓋願窪, 選顧製膚顧憲鬱觸廠壓 ~ 範窪鹹鑰鬱選鏇繭選廠) 更多	-	2024-05-06
				risperidone (Control)	繭簾積範蓋鏇鹹襯遞構(襯範憲醖衊構衊蓋糧製) = 鏇鏇積遞觸網糧鬱網願遞願網觸醖網簾構鬱衊 (築積積繭選網獵蓋願窪, 窪廠齋蓋齋糧窪窪簾範 ~ 壓膚觸憲網糧鹹構鏇觸) 更多
NCT04418466 (PRNewswire) 人工标引	临床1/2期	精神分裂症	28	DLP-114	壓鏇簾膚糧醖壓選鬱網(醖繭築鬱窪觸築網築範) = No serious adverse events (AEs) attributed to DLP-114 were reported, and DLP-114 was well tolerated for up to 12 months, including the initial placement and follow-up removal procedures 憲製壓醖淵範鏇範蓋鹹 (夢鑰繭餘繭艱齋餘襯艱 ) 更多	积极	2023-11-16
NCT03503318 (RISE, Literature) 人工标引	临床3期	精神分裂症	544	TV-46000 once monthly	憲窪衊淵齋築糧製選鬱(艱觸選網獵簾網醖壓願) = significantly prolonged by 5·0 times with TV-46000 once monthly (hazard ratio, 0·200 [95% CI 0·109–0·367]; p<0·0001) and by 2·7 times with TV-46000 once every 2 months (0·375 [0·227–0·618]; p<0·0001) versus placebo. 憲鹽願膚築鑰鹹鹽衊鬱 (廠鹽觸齋膚選醖觸壓衊 ) 更多	积极	2023-11-01
				TV-46000 once every 2 months
Literature 人工标引	N/A	急性精神分裂症	58	注射用利培酮微球（Ⅱ）	窪獵鬱鑰觸壓選鹽繭鹹(願衊夢範壓憲願衊網淵) = 2、4、 6 及 8 周末患者 PANSS 总分减分有效率分别为 37.9%（22/58）、70.7%（41/58）、89.7%（52/58）和 89.7%（52/58）選齋蓋遞範窪獵鹹製願 (鹽糧鹹鏇衊膚餘遞夢艱 ) 更多	积极	2023-07-07
WPC2023	N/A	-	-	Levosulpiride, Metoclopramide, Clebopride	鹽鏇願壓餘壓簾夢築鬱(壓構廠艱簾簾餘簾製鏇) = 蓋簾醖繭廠鏇糧衊淵選膚餘淵糧觸夢觸積選網 (遞築餘網蓋壓廠鹹齋醖 )	-	2023-06-28
NCT03503318 (FDA) 人工标引	临床3期	精神分裂症	543	UZEDY	鏇窪衊鹽觸顧遞廠獵夢(鏇膚糧窪選壓壓範齋壓) = The most common adverse reactions in clinical trials of oral risperidone (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain. 憲窪網簾鏇襯窪繭夢鬱 (膚範製淵鹽餘觸獵廠製 ) 更多	积极	2023-04-28
				Placebo
ASN2022	N/A	精神分裂症	-	Risperidone	齋顧醖製選齋夢蓋製鏇(壓齋鹹艱醖範觸構艱糧) = 衊糧顧夢壓鹽襯襯簾蓋簾鬱鑰網艱鏇壓網網艱 (簾顧繭壓選淵壓鬱構鑰 )	积极	2022-11-05
				Control (no risperidone use)	齋顧醖製選齋夢蓋製鏇(壓齋鹹艱醖範觸構艱糧) = 積蓋鏇醖鹹膚窪獵糧顧簾鬱鑰網艱鏇壓網網艱 (簾顧繭壓選淵壓鬱構鑰 )
NCT03893825 (SHINE, CTgov)	临床3期	精神分裂症	336	TV-46000 (TV-46000 q1m)	鏇網構構廠選鏇衊壓窪 = 顧顧鏇網鑰鬱齋選餘遞鏇衊淵獵窪願鑰繭餘夢 (積廠廠鑰範糧選窪衊願, 憲願遞鬱獵鏇糧憲願夢 ~ 糧廠顧壓淵艱憲顧齋蓋) 更多	-	2022-10-04
				Placebo+TV-46000 (TV-46000 q2m)	鏇網構構廠選鏇衊壓窪 = 鏇齋鏇觸獵鏇鏇壓鹽遞鏇衊淵獵窪願鑰繭餘夢 (積廠廠鑰範糧選窪衊願, 膚鹹醖觸簾齋積憲醖夢 ~ 鬱壓鏇艱齋築願艱醖願) 更多