Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.
The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.
This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.
The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes.

开始日期2023-12-04

申办/合作机构

Hospital Clínico Universitario de Valladolid

CTR20233131

/ RecruitingN/A

拉米地坦片人体生物等效性研究预试验

主要研究目的：以江苏恩华药业股份有限公司研制生产的拉米地坦片（规格：100 mg）为受试制剂，以礼来制药研发生产的拉米地坦片（Reyvow®，规格：100 mg）为参比制剂，研究在中国健康成年受试者单次空腹/餐后口服两制剂的吸收速度和吸收程度，初步评价两制剂间的生物等效性，为后期正式生物等效性试验方案的采血点、清洗期、例数等设计提供依据。次要研究目的：评估健康受试者单次空腹/餐后口服拉米地坦片受试制剂和参比制剂后的安全性。

开始日期2023-11-02

申办/合作机构

江苏恩华药业股份有限公司

NCT05903040

/ RecruitingN/A

Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of lasmiditan as acute migraine treatment in a cohort of episodic or chronic migraine patients.

开始日期2023-06-15

申办/合作机构

University of Florence

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100 项与拉米地坦相关的临床结果

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100 项与拉米地坦相关的转化医学

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100 项与拉米地坦相关的专利（医药）

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181

项与拉米地坦相关的文献（医药）

2025-02-01·Pharmaceutical Nanotechnology

Preparation, In-vitro, Ex-vivo, and Pharmacokinetic Study of Lasmiditan as Intranasal Nanoemulsion-based In Situ Gel

Article

作者: Rajab, Nawal A. ; Jabir, Saba Abdulhadi

Background:Lasmiditan (LAS) is a recently developed antimigraine drug and was approved in October, 2019 for the treatment of acute migraines; however, it suffers from low oral bioavailability, which is around 40%.Objective:This study aimed to improve the LAS bioavailability via formulation as nanoemulsionbased in situ gel (NEIG) given intranasally and then compare the traditional aqueous-LASsuspension (AQS) with the two successful intranasal prepared formulations (NEIG 2 and NEIG 5) in order to determine its relative bioavailability (F-relative) via using rabbits.Methods:Two successfully prepared nanoemulsion (NE) formulas, a and b, were selected for the incorporation of different percentages of pH-sensitive in situ gelling polymer (Carbopol 934) to prepare NEIGs 1, 2, 3, 4, 5, and 6. The pH, gelation capacity, gel strength, and viscosity were predicted for the prepared NEIGs. The release (in vitro) and the nasal permeation (ex vivo) were determined for NEIG 2 and 5, and then both were subjected to pharmacokinetics in vivo studies. Eighteen male rabbits weighing 2.0 to 2.5 kg were employed in the parallel design study. The body surface area (BSA) normalization method was applied for LAS dose calculation. Serial blood samples were taken out and subjected to drug analysis using the HPLC method previously developed and validated by Kumar et al. Primary pharmacokinetics parameters, including maximum drug concentration in plasma (Cmax), time to reach C-max (T-max), and area under the concentration-time curve from time zero to affinity (AUCt0-∞) were calculated. Both NE (a and b), together with NEIG (2 and 5) formulas, were subjected to the stability study. Finally, a nasal ciliotoxicity study was carried out to evaluate the nasal toxicity of developed NEIGs 2 and 5.Results:The results showed that NEIGs 2 and 5 could be selected as the optimized NEIGs as both achieved 100% permeation within 20 min and then released within 25 and 35 min, respectively, thus achieving 3.3 folds with higher permeation percentages as compared to the AQS. Both NEIGs 2 and 5 exerted comparable release and permeation values as the corresponding NE a and b with more residence time in order to overcome the normal nasal physiological clearance. The values of C-max, Tmax, and AUC0- ∞ for NEIG 2 and NEIG 5 were 8066 ± 242 ng/ml, 0.75 ± 0.05 h, 19616.86 ± 589 ng. h/ml, and 7975.67 ± 239 ng/ml, 1.0 ± 0.05 h, 17912.36 ± 537 ng. h/ml, respectively, compared to the traditional AQS, which is equal to 4181.09 ± 125 ng/ml, 2 ± 0.2 h, and 8852.27 ± 266 ng. h/ml, respectively.:It was discovered that NEIGs 2 and 5 had better intranasal delivery of LAS and could significantly (p < 0.05) achieve a higher value of permeability coefficient (3.3 folds) and 2.5 folds improvement in bioavailability when compared to AQS. The NE a, NE b, NEIG2, and NEIG5 formulations showed good stability at various temperatures. According to the nasal ciliotoxicity study, the nasal mucosal membrane, which was treated with NEIG 5, showed irritation with a bit of damage. However, damage was not observed when it was treated with NEIG 2, indicating the biocompatibility of the last one to be selected as the optimum formula.Conclusion:NEIG 2 and NEIG 5 are promising new intranasal formulas with a faster onset of action and greater bioavailability than the oral dosage form (AQS). Finally, the selected optimum gold formula that will be ready for further clinical study is NEIG 2.

2024-12-01·CNS & Neurological Disorders - Drug Targets

Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis

Review

作者: Datusalia, Ashok Kumar ; Sumadhura, Bommaraju ; Singh, Pooja ; Sharma, Ruchika ; Kumar, Anoop ; Ponnada, Rakesh Kumar

Background:Recently, US Food and Drug Administration (FDA) has approved calcitonin gene-related peptide receptor antagonists (rimegepant, and ubrogepant), and selective serotonin receptor agonists (lasmiditan) in the management of migraine. However, the exact safety and efficacy profile of these drugs is unclear so far.Methods:The study’s primary objective was to determine the exact safety and efficacy profile. The overall estimate was calculated in terms of risk ratios using a suitable model. The subgroup analysis was also performed to check the effect of individual drugs on the outcome, whereas sensitivity analysis was performed to check the effects of outliers on the outcome. All the analyses were performed using Rev Man 5. The drugs have shown significant improvement in efficacy parameters (pain freedom, most bothersome symptoms, phonophobia, nausea, and photophobia).Results:The subgroup analysis results have shown significant improvement in all efficacy parameters in the rimegepant and ubrogepant groups. The effect of ubrogepant on safety parameters was found to be non-significant, indicating a better safety profile of ubrogepant than lasmiditan.Conclusion:The sensitivity analysis results have shown no effect of outliers on the efficacy parameters. Based on the available evidence, recently approved drugs are effective in the treatment of migraine, however, associated with few adverse drug reactions.

2024-10-11·ACS Pharmacology & Translational Science

5-Hydroxytryptamine 1F Receptor Agonist Lasmiditan Differentially Regulates Successful Repair and Failed Repair Genes in a Mouse Model of Acute Kidney Injury

Article

作者: Hortareas, John ; Hurtado, Kevin A. ; Janda, Jaroslav ; Santiago Raj, Paul Victor ; Scholpa, Natalie E. ; Schnellmann, Rick G.

Increasing evidence substantiates the role of mitochondrial dysfunction, inflammation, fibrosis, and cell senescence in the onset and progression of acute kidney injury (AKI) to chronic kidney disease . The underlying governing cellular and transcriptional events, however, are not fully understood. Recently, the key factors that regulate successful and failed repair states in the proximal tubule have been identified at a single-cell resolution following bilateral ischemia-reperfusion (I/R) in a mouse model of AKI. Previously, our group showed that treatment with the FDA-approved selective 5-hydroxytryptamine receptor 1F agonist lasmiditan following AKI induces mitochondrial biogenesis , restores renal mitochondrial function, and increases renal and vascular recovery in vivo. Here, we assessed the effect of lasmiditan on transcriptional and translational changes that are responsible for successful repair, injury, and failed repair states in the renal cortex following I/R-induced AKI. Increased levels of successful repair genes such as acyl-coA synthase medium-chain family member 2a, low-density lipoprotein receptor-related protein 2, solute carrier family 5 member 12, and hepatocyte nuclear factor 4 alpha were observed with 6 and 12 days of lasmiditan treatment following AKI compared to vehicle control. While 6 days of lasmiditan treatment had no effect on failed repair genes, the administration of lasmiditan for 12 days decreased the levels of vascular cell adhesion protein 1, tumor necrosis factor α, and interleukin-1β, which drive maladaptive repair. These data reveal that lasmiditan treatment post-AKI differentially regulates successful and failed repair gene expression in the renal cortex, likely contributing to the restoration of renal function and providing a potential targeted therapeutic pathway for the treatment of AKI.

项与拉米地坦相关的新闻（医药）

2024-12-22

·信狐药迅

仿制药上市申请2个品规收到通知件；临床申请品种均默示许可| 新获批(12.16-12.22）

每周药品注册获批数据，分门别类呈现，一目了然。(12.16-12.22）新药上市申请无新药临床申请药品名称企业注册分类受理号SPH9788片上海医药集团股份有限公司1CXHL2401269SPH9788片上海医药集团股份有限公司1CXHL2401268SPH9788片上海医药集团股份有限公司1CXHL2401267WJB001胶囊微境生物医药科技(上海)有限公司1CXHL2401115WJB001胶囊微境生物医药科技(上海)有限公司1CXHL2401114CS231295片深圳微芯药业有限责任公司1CXHL2401108CS231295片深圳微芯药业有限责任公司1CXHL2401107CS231295片深圳微芯药业有限责任公司1CXHL2401105H002胶囊泰州红云制药有限公司1CXHL2401095盐酸吉卡昔替尼片上海泽璟医药技术有限公司1CXHL2401094TQH3906胶囊正大天晴药业集团南京顺欣制药有限公司1CXHL2401074TQH3906胶囊正大天晴药业集团南京顺欣制药有限公司1CXHL2401073HEC169584胶囊广东东阳光药业股份有限公司1CXHL2401068HEC169584胶囊广东东阳光药业股份有限公司1CXHL2401067HEC169584胶囊广东东阳光药业股份有限公司1CXHL2401066注射用DYX116江苏德源药业股份有限公司1CXHL2401072注射用DYX116江苏德源药业股份有限公司1CXHL2401071XNW29016片山东信诺维医药科技有限公司1CXHL2401070XNW29016片山东信诺维医药科技有限公司1CXHL2401069HRS-6768注射液天津恒瑞医药有限公司1CXHL2401065ANS03片深圳鞍石生物科技有限公司1CXHL2401047ANS03片深圳鞍石生物科技有限公司1CXHL2401046BY101921片康百达(四川)生物医药科技有限公司1CXHL2401045BY101921片康百达(四川)生物医药科技有限公司1CXHL2401044DC10190胶囊北京双鹤润创科技有限公司1CXHL2401049DC10190胶囊北京双鹤润创科技有限公司1CXHL2401048JK1033片天津济坤医药科技有限公司1CXHL2401043JK1033片天津济坤医药科技有限公司1CXHL2401042SYH2062注射液石药集团中诺药业(石家庄)有限公司1CXHL2401052BPR-30221616注射液成都倍特药业股份有限公司1CXHL2401051TAN-118片上海泽德曼医药科技有限公司1CXHL2401039TAN-118片上海泽德曼医药科技有限公司1CXHL2401038JKN2403片健康元药业集团股份有限公司1CXHL2401035GenSci122片长春金赛药业有限责任公司1CXHL2401025GenSci122片长春金赛药业有限责任公司1CXHL2401024司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401081司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401080司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401079司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401078司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401077司美格鲁肽注射液浙江普洛康裕制药有限公司2.2CXHL2401076LCS干混悬剂厦门恩成制药有限公司2.2CXHL2401057LCS干混悬剂厦门恩成制药有限公司2.2CXHL2401056司美格鲁肽长效注射液北京抗创联生物制药技术研究有限公司2.2CXHL2401061甲磺酸雷沙吉兰透皮贴剂贵州世领制药有限公司2.2CXHL2401021甲磺酸雷沙吉兰透皮贴剂贵州世领制药有限公司2.2CXHL2401020盐酸戊乙奎醚吸入溶液重庆先洋医药科技有限公司2.2;2.4CXHL2401016盐酸戊乙奎醚吸入溶液重庆先洋医药科技有限公司2.2;2.4CXHL2401015EP-0170T(Ⅱ)成都硕德药业有限公司2.3CXHL2401041EP-0170T(Ⅰ)成都硕德药业有限公司2.3CXHL2401040重组六价诺如病毒疫苗(毕赤酵母)成都康华生物制品股份有限公司1.1CXSL2400650重组六价诺如病毒疫苗(毕赤酵母)成都康华生物制品股份有限公司1.1CXSL2400649LVRNA101珠海丽凡达生物技术有限公司1.1CXSL2400665吸附组分无细胞百白破-Sabin株灭活脊髓灰质炎联合疫苗中国医学科学院医学生物学研究所1.4CXSL2400655SYS6043石药集团巨石生物制药有限公司1CXSL2400704注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2400700CD-001注射液乘典(苏州)生物医药有限公司1CXSL2400701重组红细胞生成刺激蛋白注射液(CHO细胞)沈阳三生制药有限责任公司1CXSL2400705SHR-1819注射液广东恒瑞医药有限公司1CXSL2400696IBI3005信达生物制药(苏州)有限公司1CXSL2400699GNC-038四特异性抗体注射液成都百利多特生物药业有限责任公司1CXSL2400693GNC-038四特异性抗体注射液成都百利多特生物药业有限责任公司1CXSL2400694SYS6005石药集团巨石生物制药有限公司1CXSL2400692注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2400690注射用SHR-9839上海恒瑞医药有限公司1CXSL2400689注射用HS-20110上海翰森生物医药科技有限公司1CXSL2400685注射用ILB-3101英诺湖医药(杭州)有限公司1CXSL2400691注射用BG-C137广州百济神州生物制药有限公司1CXSL2400686注射用SHR-9839 (sc)苏州盛迪亚生物医药有限公司1CXSL2400687注射用ZHB015江苏众红生物工程创药研究院有限公司1CXSL2400684注射用MHB039A明慧医药(杭州)有限公司1CXSL2400680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1CXSL2400674UX-DA001注射液(人中脑多巴胺能神经前体细胞注射液)上海跃赛生物科技有限公司1CXSL2400673屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400653屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400658屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400657屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400656屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400661屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400660屋尘螨膜剂浙江我武生物科技股份有限公司1CXSL2400659VUM02注射液武汉光谷中源药业有限公司1CXSL2400667 仿制药申请药品名称企业注册分类受理号盐酸环喷托酯滴眼液沈阳兴齐眼药股份有限公司4CYHS2303317黄体酮注射液北京布霖生物科技有限公司3CYHS2301078麦芽酚铁胶囊杭州仟源保灵药业有限公司3CYHL2400203甘露醇山梨醇注射液中国大冢制药有限公司3CYHL2400198拉米地坦片江西科睿药业有限公司3CYHL2400197拉米地坦片江西科睿药业有限公司3CYHL2400196盐酸毛果芸香碱滴眼液海南斯达制药有限公司3CYHL2400195立他司特滴眼液浙江莎普爱思药业股份有限公司3CYHL2400194米诺地尔泡沫剂浙江三生蔓迪药业有限公司3CYHL2400190人生长激素注射液吉林省奇健生物技术有限公司3.3CXSL2400682治疗用重组卡介苗成都安永鼎业生物技术有限公司3.4CXSL2400671 进口申请药品名称企业注册分类受理号AZD6234注射液AstraZeneca AB1JXHL2400243镥[177Lu]依多曲肽注射液ITM Solucin GmbH1JXHL2400238英克司兰钠注射液Novartis Pharma AG2.4JXHL2400240英克司兰钠注射液Novartis Pharma AG2.4JXHL2400239普拉曲沙注射液Ideogen AG5.1JXHL2400247Fezolinetant片Astellas Pharma Global Development, Inc.5.1JXHL2400244ABBV-400注射用粉末AbbVie Inc.1JXSL2400194注射用BudigalimabAbbVie Inc.1JXSL2400195Mezagitamab注射剂Takeda Development Center Americas, Inc.1JXSL2400193VHB937注射用浓溶液Novartis Pharma AG1JXSL2400190Belrestotug注射液GlaxoSmithKline Research & Development Limited1JXSL2400188Dostarlimab注射液GlaxoSmithKline Research & Development Limited2.2JXSL2400189 中药相关申请药品名称企业注册分类受理号藤参降压颗粒山东古金中医药科技有限公司1.1CXZL2400062 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

2024-09-24

·新药前沿

辉瑞、艾伯维口服CGRP新型偏头痛药物当头一棒：疗效不如曲坦类！

《英国医学杂志（BMJ）》的一项最新研究表明，近年获批准上市的新型偏头痛药物，包括口服降钙素基因相关肽（CGRP)拮抗剂（gepant类）辉瑞的Nurtec（rimegepant/瑞美吉泮）、艾伯维的Ubrelvy（ubrogepant）和选择性5-羟色胺1F受体激动剂礼来的Reyvow（lamiditan/拉米替坦）在偏头痛的急性治疗中效果不如之前的曲坦类药物。这项药物干预对成人偏头痛发作急性管理的比较效果研究对137项试验进行了荟萃分析，总共招募了近90,000名患者，结果表明，治疗偏头痛最有效的药物是曲坦类药物。分析显示，在对研究中涉及的17种药物进行头对头比较时，曲坦类药物在使用后2小时内显示出最佳疗效，依来曲坦疗效最好，它在24和48小时内的持续缓解效果也最好，其次是利扎曲坦、舒马曲坦和佐米曲坦。新药治疗偏头痛的效果甚至并不比氨酚黄那敏、布洛芬和阿司匹林等传统头痛药更好。研究者选择的17种药物分为五类：退热药（对乙酰氨基酚）、地坦类药物（lasmiditan）、gepant（rimegepant和ubrogepant）、NSAID（阿司匹林、塞来昔布、双氯芬酸钾、布洛芬、萘普生钠和氨酚黄那敏）和曲坦类药物（阿莫曲坦、依来曲坦、夫罗曲坦、那拉曲坦、利扎曲坦、舒马曲坦和佐米曲坦）。最新上市的新型偏头痛药物药物因不具有血管收缩作用，因此被推广为曲坦类药物禁忌或不耐受患者的替代药物。根据研究结果，rimegepant耐受性良好，但ubrogepant与安慰剂相比，恶心风险增加。Lasmiditan伴有相当大的头晕风险，以及感觉异常和镇静。此外，这些新药的高昂成本阻碍了它们的广泛使用，因此需要进行试验以确定它们对曲坦类药物反应不足患者的成本效益。此外，结果表明不同NSAID的效果存在很大差异。研究者指出：虽然成本效益分析是必要的，并且应该仔细考虑具有高心血管风险的患者，但最有效的曲坦类药物应被视为偏头痛的首选急性治疗，并被列入世卫组织基本药物清单，以促进全球可及性和统一的护理标准。业界一直对CGRP药物的有效性寄予厚望。2022年，辉瑞斥资116亿美元收购Biohaven，从而获得了Nurtec，去年的销售额达到9.28亿美元。与此同时，2019年获批的Ubrelvy去年为艾伯维创造了8.15亿美元的销售额。本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！

并购上市批准申请上市

2024-09-19

·FiercePharma

New migraine drugs less effective than previous generation of triptan meds: BMJ study

A meta-analysis of 137 trials of migraine drugs indicates that the newest class of treatments are less effective than the previous generation of triptan drugs in relieving acute headaches. A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis.The study, a meta-analysis of 137 trials that together enrolled nearly 90,000 patients, indicates that the most effective treatments for migraine come from the triptan class. In head-to-head comparisons of the 17 drugs covered in the study, triptans demonstrated the best efficacy within 2 hours of use, led by eletriptan, which also delivered the best-sustained relief over 24 and 48 hours, according to the analysis.Eletriptan was brought to the market by Pfizer in 2002 and sold under the brand name Relpax. The next most effective medicines in providing relief at 2 hours were the following triptans (in order of performance): rizatriptan, sumatriptan and zolmitriptan. Rizatriptan is sold by Organon as Maxalt. GSK sells sumatriptan as Imitrex and AstraZeneca markets zolmitriptan as Zomig.“Triptans are currently widely underused, and access to the most effective triptans should be promoted globally and international guidelines updated accordingly,” the authors wrote. The BMJ analysis also concluded that the newest class of migraine treatments—which are called calcitonin gene-related peptide receptor (CGRP) antagonists—should only be used after traditional headache meds.“While the recent introduction of lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan, suggest their use as third-line options, after the less expensive, similarly efficacious, second-line options," the authors wrote.While the BMJ study focused on acute treatment of migraines, new CGRP treatments have also been approved as preventatives. Nurtec pills, for example, were approved in 2021 for use every other day to ward off potential migraines. Much hope has been pinned on the effectiveness of CGRP drugs. In 2022, Pfizer spent $11.6 billion in a buyout of Biohaven to gain Nurtec, which rolled up sales of $928 million last year. Meanwhile, Ubrelvy, which was approved in 2019, generated $815 million in sales.Several other CGRPs—all approved in 2018 for the prevention of migraines—also remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million. Besides those drugs, Lundbeck's Vyepti won approval in 2020 and generated about $250 million last year.

上市批准并购临床结果

100 项与拉米地坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10424	拉米地坦	N02C	DB11732

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
偏头痛	美国	Eli Lilly & Co.	2019-10-11

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
偏头痛	临床3期	俄罗斯	Eli Lilly & Co.	2019-06-24
偏头痛	临床3期	印度	Eli Lilly & Co.	2019-06-24
偏头痛	临床3期	墨西哥	Eli Lilly & Co.	2019-06-24
偏头痛	临床2期	瑞士	Eli Lilly & Co.	2019-06-24
偏头痛	临床2期	中国	Eli Lilly & Co.	2019-06-24
药物滥用	临床2期	美国	Eli Lilly & Co.	2017-09-15
急性偏头痛	临床2期	美国	Eli Lilly & Co.	2015-04-01

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临床结果

适应症

分期

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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


NCT05903040 (DART, EAN2024)	N/A	急性偏头痛	55	Lasmiditan 50mg	簾憲鑰範築築蓋齋膚襯(製獵襯鹽顧憲憲糧鹹窪) = Adverse events were reported in 53.1% of attacks, predominantly as dizziness ( n = 11), fatigue ( n = 8) and paraesthesia ( n = 6) 願觸醖構窪獵顧積襯築 (範蓋鹽繭衊選艱鏇齋窪 )	积极	2024-06-28
				Lasmiditan 100mg
NCT04749914 (CTgov)	临床1期	-	97	Dabigatran Etexilate (150 mg Dabigatran Etexilate (Part 1 Period 1))	齋觸積簾繭憲範鏇餘獵(鏇廠鏇鹽鬱繭顧鹹艱製) = 簾構鬱糧襯醖夢襯簾壓積醖獵齋構構醖衊築壓 (夢鹽鑰膚構窪積鏇窪憲, 壓艱夢憲艱壓壓餘衊窪 ~ 顧鹽簾構憲壓齋廠觸憲) 更多	-	2024-02-01
				Lasmiditan+Dabigatran Etexilate (150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2))	齋觸積簾繭憲範鏇餘獵(鏇廠鏇鹽鬱繭顧鹹艱製) = 獵壓齋築夢選觸鹽醖選積醖獵齋構構醖衊築壓 (夢鹽鑰膚構窪積鏇窪憲, 蓋廠齋觸選鹹糧夢餘淵 ~ 範選壓繭廠遞襯餘壓繭) 更多
NCT04881747 (CTgov)	临床1期	偏头痛	47	Lasmiditan	鑰衊鏇願艱齋鹽簾製壓(餘觸衊鏇觸蓋衊鹽鹹衊) = 簾齋艱遞範鑰鏇蓋鑰衊糧積壓鬱鬱鹽糧衊窪觸 (壓鹹鑰鹹鏇齋艱繭糧範, 餘築選壓構壓夢廠鹹艱 ~ 衊衊鬱齋夢範鑰艱窪選) 更多	-	2023-03-23
NCT03461757 \| NCT02828020 \| NCT02867709 \| NCT02439320 \| NCT02605174 (Pubmed \| Clin J Pain)	临床3期	偏头痛	-	Rimegepant 75 mg	壓襯繭範製齋築糧積夢(醖醖鏇鹹願壓壓構壓齋) = 壓襯衊憲艱壓蓋艱夢膚鹽餘鹽選簾鹹簾遞憲願 (鏇壓觸鏇願顧選窪構鹹, 5 ~ 12) 更多	-	2022-11-01
				Ubrogepant 100 mg	積鹽積觸鑰窪築鏇簾憲(膚鹽獵憲築鏇構顧壓廠) = 網蓋齋遞鹹鬱網廠願鹹簾廠選艱獵淵獵觸繭簾 (憲壓鑰憲簾壓襯顧窪蓋, 4 ~ 8)
NCT03962738 (MONONOFU, Pubmed)	临床2期	偏头痛	846	Lasmiditan 50 mg	願艱餘製繭繭鬱糧膚積(鏇蓋艱鹽淵範遞鬱壓蓋) = 餘窪鹹艱鏇憲窪憲選壓鏇齋衊鑰遞網遞繭願範 (範淵繭窪願壓範願願構 )	积极	2022-09-22
				Lasmiditan 100 mg	遞艱選製衊鬱製淵壓鹹(鏇鹹網餘遞鏇簾窪衊夢) = 選願艱廠獵膚襯醖鹽衊獵築選鬱構簾網鹽鏇餘 (鬱憲鹽鬱繭觸顧餘鹹構 ) 更多
NCT03670810 (CENTURION, Pubmed)	临床3期	偏头痛	281	Lasmiditan 200 mg	範網蓋憲遞憲築鑰衊鬱(憲齋壓淵網範鏇艱繭觸) = no study drug-related treatment emergent serious adverse events (TESAEs) were reported 築鹽製憲構積憲齋繭衊 (選艱窪顧選餘繭選積壓 ) 更多	积极	2022-09-17
				Lasmiditan 100 mg
NCT02439320 \| NCT02605174 \| NCT03670810 \| NCT03962738 (Pubmed \| CNS Drugs)	临床2/3期	偏头痛	-	Lasmiditan 200 mg	壓齋壓膚衊觸廠網艱齋(範壓選憲窪鹽選淵構膚) = A common TEAE (CTEAE) was defined as occurring in ≥ 2% in the overall population. Central nervous system (CNS)-CTEAEs were based on Medical Dictionary for Regulatory Activities. 顧範鹹製衊網餘憲鹽鏇 (鑰繭觸選齋夢餘廠顧製 ) 更多	-	2022-07-02
				Placebo
NCT03962738 (MONONOFU, Pubmed) 人工标引	临床2期	偏头痛	846	Lasmiditan	(壓積齋鑰壓簾蓋築蓋鹽) = 鏇獵壓繭齋糧選淵醖淵鬱顧壓窪窪廠構鏇廠鬱 (選窪積製繭醖網鬱鏇齋 )	积极	2022-06-24
				Placebo	(壓積齋鑰壓簾蓋築蓋鹽) = 鏇觸鬱鏇鏇構廠餘製淵鬱顧壓窪窪廠構鏇廠鬱 (選窪積製繭醖網鬱鏇齋 )
NCT02565186 \| NCT02439320 \| NCT02605174 (SPARTAN, Pubmed \| Clin Ther)	临床3期	偏头痛	3,177	Lasmiditan	鏇觸窪艱鑰範製鹹製鬱(淵構壓夢膚膚衊獵餘製) = Cardiovascular events were not reported in the elderly population during the treatment-emergent period or intermediate period 蓋簾構鬱製壓範衊廠壓 (餘廠繭遞鏇鏇鹽積鬱膚 ) 更多	-	2021-08-06
				Placebo
NCT03670810 (CENTURION, CTgov)	临床3期	偏头痛	1,633	Placebo+Lasmiditan (200 mg Lasmiditan)	簾憲壓製選鏇醖積醖築(襯築繭餘構餘簾遞製窪) = 鏇鑰鏇願夢簾觸選廠觸繭觸獵積繭憲範顧觸醖 (製網鹹壓壓鏇選觸艱觸, 遞製製醖蓋積範製齋願 ~ 選窪膚鬱鹽壓鑰鬱網構) 更多	-	2021-07-02
				Placebo+Lasmiditan (100 Milligram (mg) Lasmiditan)	願選夢襯製餘鑰製蓋憲(廠選膚築鹽選齋窪範蓋) = 積鹹選衊醖鏇襯積願顧廠顧衊鹽範構鹹鏇遞艱 (願獵繭繭鹹鬱繭鏇顧壓, 網築蓋醖夢醖衊鑰願糧 ~ 壓鏇夢鹽選餘構鹹選鹹) 更多