盐酸芬氟拉明(Fenfluramine Hydrochloride) - 药物靶点：5-HT1D receptor x 5-HT2A receptor x 5-HT2C receptor x SERT x σ1 receptor_在研适应症：Lennox-Gastaut综合征，Dravet综合征，癫痫发作_专利_临床

概要

基本信息

药物类型

小分子化药

别名

(±)-fenfluramine、1-(m-trifluoromethyl-phenyl)-2-ethylaminopropane、Brabafen

+ [12]

靶点

5-HT1D receptor x 5-HT2A receptor x 5-HT2C receptor x SERT x σ1 receptor

作用机制

5-HT1D receptor激动剂(5-羟色胺1D受体激动剂)、5-HT2A receptor激动剂(5-羟色胺2A受体激动剂)、5-HT2C receptor激动剂(5-羟色胺2C受体激动剂)

+ [2]

治疗领域

神经系统疾病遗传病与畸形其他疾病+ [2]

在研适应症

Lennox-Gastaut综合征Dravet综合征癫痫发作+ [7]

非在研适应症-

原研机构

Zogenix, Inc.

在研机构

UCB制药公司Zogenix International Ltd.

Zogenix, Inc.

+ [4]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2020-06-25),

Dravet综合征癫痫发作

最高研发阶段(中国)-

特殊审评孤儿药 (欧盟)、快速通道 (美国)、优先审评 (美国)

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结构

分子式C12H17ClF3N

InChIKeyZXKXJHAOUFHNAS-UHFFFAOYSA-N

CAS号404-82-0

查看全部结构式(2)

关联

31

项与盐酸芬氟拉明相关的临床试验

NCT06679413 / Not yet recruiting临床1期

A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age

The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008

开始日期2024-12-06

申办/合作机构

UCB BioSciences, Inc.

NCT06598449 / Not yet recruiting临床4期IIT

Assessment of Safety of the Use of Fenfluramine in Children with Dravet Syndrome Under the Age of 24 Months

Dravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav1.1, a protein necessary for sodium channels. Children with Dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. This creates some limitations in medication choices for this patient population. Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older. Randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. Additionally, 16% of children treated with fenfluramine were seizure free. Fenfluramine is likely to be as effective in children under the age of 2 years. The current study has proposed a treatment protocol to allow access to fenfluramine for children under 24 months of age.

开始日期2024-10-01

申办/合作机构

University of Colorado Denver

[+1]

NCT06118255 / Recruiting临床3期

Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.

开始日期2024-05-21

申办/合作机构

UCB BioSciences, Inc.

100 项与盐酸芬氟拉明相关的临床结果

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100 项与盐酸芬氟拉明相关的转化医学

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100 项与盐酸芬氟拉明相关的专利（医药）

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3,266

项与盐酸芬氟拉明相关的文献（医药）

2024-12-01·CNS Drugs

Recent Advances in Pharmacologic Treatments of Drug-Resistant Epilepsy: Breakthrough in Sight

Review

作者: Friedman, Daniel ; Klein, Pavel ; Kwan, Patrick

Epilepsy affects approximately 1% of the world population. Patients have recurrent seizures, increased physical and psychiatric comorbidities, and higher mortality rate than the general population. Over the last 40 years, research has resulted in 20 new antiseizure medications (ASMs) approved between 1990 and 2018. In spite of this, up to one-third of patients (~ 1 million patients in the USA) have drug-resistant epilepsy (DRE), with little change between 1982 and 2018, a period of intense new ASM development. A minority of patients with DRE may benefit from surgical treatment, but this specialized care remains challenging to scale. Therefore, the greatest hope for breakthroughs for patients with DRE is in pharmacologic therapies. Recently, several advances promise to change the outcomes for patients with DRE. Cenobamate, a drug with dual mechanisms of modulating sodium channel currents and GABA-A receptors, achieves 90-100% seizure reduction in 25-33% of patients with focal DRE, a response not observed with other ASMs. Fenfluramine, a serotonin-acting drug, dramatically reduces the frequency of convulsive seizures in Dravet syndrome, a devastating developmental epileptic encephalopathy with severe DRE. Both drugs reduce mortality. In addition, the possibility of DRE prevention was recently raised in patients with tuberous sclerosis complex, a relatively common genetic form of epilepsy. A paradigm shift is emerging in the treatment of epilepsy. Seizure freedom has become attainable in a significant proportion of patients with focal DRE, and dramatic seizure reduction has been achieved in a developmental encephalopathy. Coupled with a rich pipeline of new compounds under clinical development, the long sought-after breakthrough in the treatment of epilepsy may finally be in sight.

2024-10-01·Epilepsia

Utilizing an acute hyperthermia‐induced seizure test and pharmacokinetic studies to establish optimal dosing regimens in a mouse model of Dravet syndrome

Article

作者: Rower, Joseph E. ; Reilly, Christopher A. ; Wilcox, Karen S. ; Johnson, Kristina ; Metcalf, Cameron S. ; Mensah, Jeffrey A. ; Freeman, Tia

AbstractObjectiveThe current standard of care for Dravet syndrome (DS) includes polytherapy after inadequate seizure control with one or more monotherapy approaches. Treatment guidelines are often based on expert opinions, and finding an optimal balance between seizure control and adverse drug effects can be challenging. This study utilizes the efficacy and pharmacokinetic assessment of a second‐line treatment regimen that combines clobazam and sodium valproate with an add‐on drug as a proof‐of‐principle approach to establish an effective therapeutic regimen in a DS mouse model.MethodsWe evaluated the efficacy of add‐on therapies stiripentol, cannabidiol, lorcaserin, or fenfluramine added to clobazam and sodium valproate against hyperthermia‐induced seizures in Scn1aA1783V/WT mice. Clobazam, N‐desmethyl clobazam (an active metabolite of clobazam), sodium valproate, stiripentol, and cannabidiol concentrations were quantified in plasma and brain using liquid chromatography–tandem mass spectrometry for the combinations deemed effective against hyperthermia‐induced seizures. The concentration data were used to calculate pharmacokinetic parameters via noncompartmental analysis in Phoenix WinNonLin.ResultsHigher doses of stiripentol or cannabidiol, in combination with clobazam and sodium valproate, were effective against hyperthermia‐induced seizures in Scn1aA1783V/WT mice. In Scn1aWT/WT mice, brain clobazam and N‐desmethyl clobazam concentrations were higher in the triple‐drug combinations than in the clobazam monotherapy. Stiripentol and cannabidiol brain concentrations were greater in the triple‐drug therapy than when given alone.SignificanceA polypharmacy strategy may be a practical preclinical approach to identifying efficacious compounds for DS. The drug–drug interactions between compounds used in this study may explain the potentiated efficacy of some polytherapies.

2024-10-01·Epilepsia Open

Fenfluramine treatment in pediatric patients with Dravet syndrome reduces seizure burden and overall healthcare costs: A retrospective and observational real‐world study

Article

作者: Rubboli, Guido ; Olofsson, Kern ; Møller, Rikke S. ; Johannessen Landmark, Cecilie ; Nikanorova, Marina ; Gjerulfsen, Cathrine E.

AbstractObjectivesDravet syndrome is a developmental and epileptic encephalopathy characterized by early onset epilepsy with multiple seizure types often intractable to treatment. Randomized clinical trials have demonstrated how treatment with fenfluramine significantly reduces seizure frequency in patients with Dravet syndrome. The study aims to (1) describe the efficacy and tolerability of fenfluramine in a Danish cohort of patients with Dravet syndrome; and (2) evaluate whether treatment with fenfluramine reduces epilepsy‐related hospital contacts administrated by pediatricians or epilepsy‐trained nurses.MethodsA retrospective registry‐based cohort study at the Danish Epilepsy Centre, Filadelfia, Dianalund, Denmark, enrolled 30 pediatric patients with Dravet syndrome treated with fenfluramine between 2017 and 2023.ResultsThirty patients with Dravet syndrome (aged 3–21 years, 12 females) with a verified pathogenic SCN1A variant were included. They were treated with fenfluramine at a mean duration of 29 months with a mean maintenance dose of 0.5 mg/kg/day. The number of patient‐years on treatment was 75 years. At last follow‐up, 6 patients had discontinued treatment due to lack of efficacy or adverse effects. In the remaining 24 patients, generalized tonic–clonic seizures were reduced by ≥30% in 83%, by ≥50% in 67%, and by 100% in 25%. Additionally, 71% of the patients were reduced in concomitant anti‐seizure medication, and 75% experienced a reduction (mean reduction at 52%, range 11%–94%) in epilepsy‐related hospital contacts from baseline to the end of the treatment period.SignificanceTreatment with fenfluramine effectively reduced seizure frequency and concomitant antiseizure medication in patients with Dravet syndrome. Furthermore, a decrease in epilepsy‐related contacts by 80% was observed over 6 years of treatment, which may indicate cost‐effective benefits.Plain Language SummaryPatients with Dravet syndrome suffer from severe epileptic seizures that are difficult to treat with medication. Earlier, treatment with fenfluramine (an anti‐seizure medication) has been documented to decrease the total number of seizures in patients with Dravet syndrome. This publication summarizes the experiences with fenfluramine in children with Dravet syndrome at the Danish Epilepsy Centre, Filadelfia, Dianalund, Denmark. Our publication also illustrates that treatment with fenfluramine may reduce the patients' number of yearly contacts with doctors and nurses specialized in epilepsy treatment, which may indicate cost‐effectiveness.

62

项与盐酸芬氟拉明相关的新闻（医药）

2024-11-18

·药时代

一款减肥药撤市之后

正文共：2386字 1图预计阅读时间：5分钟由于患者招募困难，卫材终止了一项三期临床试验。美东时间2024年11月17日，知名行业媒体《Endpoints News》发文称，卫材终止了旗下Lorcaserin（氯卡色林）用于辅助治疗Dravet综合征的三期MOMENTUM 1研究（NCT04572243）。根据美国临床试验数据库（ClinicalTrials.gov）查询，目前MOMENTUM 1研究已处于终止状态，并提示该状态并非由于任何安全性或有效性原因导致。关于Dravet综合征 Dravet综合征（Dravet syndrome ，DS），为婴儿期起病的难治性癫痫综合征，由法国医生Charlotte Dravet在1978年首次报道，既往又称婴儿严重肌阵挛癫痫。 DS是一种罕见的癫痫性脑病，根据国外文献报道DS患病率为1/40000~1/20000（也有文献报道为发病率为1/15700~1/40900）占3岁以内婴幼儿癫痫的8%。2018年，该疾病被列入国家第一批罕见病目录（编号：105号）。 DS发病主要由遗传因素决定，其主要致病基因为钠离子通道α1亚单位基因SCN1A突变，此外如SCN1B、GABRG2等基因也可能与Dravet综合征有关。目前，DS暂无治愈方法，治疗主要是对症支持治疗，旨在减少癫痫发作的频率和强度。常用药物包括丙戊酸、司替戊醇、芬氟拉明、药用级大麻二酚、托吡酯等。其中，芬氟拉明作为一种5-HT2C受体激动剂，最早（1973年）被批准用于减肥，1997年因严重心脏毒性而停用。后来其较低剂量被重新启用，治疗一些癫痫性脑病：2020 年，美国和欧盟先后批准芬氟拉明作为DS治疗的添加药物。相同命运的氯卡色林此次，卫材终止的氯卡色林与芬氟拉明同为5-羟色胺（5-HT，又称血清素）受体激动剂。其研发历程也颇为相似。氯卡色林原研为Arena，2012年获FDA批准上市用于减肥治疗，商品名Belviq。后因市场表现一般，Arena于2017年将其权益卖给了卫材。值得一提的是，基于芬氟拉明的前车之鉴。FDA在批准Belviq时要求生产商开展一项随机、双盲、安慰剂对照的上市后研究，以评估氯卡色林的心血管风险。这项研究有12000例参与者，为期5年，于2018年6月结束。因此，氯卡色林是完成FDA要求的长期心脏安全研究的第一种新型减肥药物。只不过，FDA在对其安全性数据进行审查时发现，服用氯卡色林的患者被确诊为癌症的人数更多（462， 7.7% vs 423, 7.1%）。 2020年1月，FDA要求Belviq，Belviq XR从美国市场撤市。这对卫材而言，称得上无妄之灾。尽管癌症风险增高的原因还不明确，FDA也无法断定氯卡色林就是直接的致癌原因，但撤市已成定局。后者激流勇进，前者寸步难行芬氟拉明在肥胖症失利之后，在癫痫性脑病中“复活”。那么氯卡色林，理应也可走通这条路径。 2020年，卫材在与FDA协商后启动了氯卡色林治疗DS的三期MOMENTUM 1研究。当时目标是在美国招募58名受试者，如今4年过去，卫材还在招募在面临招募困境。根据《Endpoints News》报道，卫材一位的发言人通过电子邮件表示，“随着其他经FDA批准的疗法可用于治疗这一复杂的疾病（DS），招募患者进行试验性治疗变得极其困难。” 目前，针对DS的治疗涌现了各种新型治疗方式，包括但不限于：Stoke的反义寡核苷酸（ASO），STK-001；Longboard的5-HT2C受体超激动剂Bexicaserin；Encoded的AAV9介导的候选基因调控疗法，ETX101。其中，Bexicaserin已进入临床三期阶段。它虽然与氯卡色林、芬氟拉明同为5-HT2C受体激动剂，但却显示出对5-HT2C受体的选择性增加。具体而言，5-HT2受体次家族有A、B、C三种亚型，研究发现，中枢5-羟色胺主要通过作用于脑内5-羟色胺2C受体（5-HT2C）起到调节食欲的作用，这也是其减重的原因。而5-HT2A与5-HT2B激动，可能导致致幻活性与心脏毒性相关不良反应。芬氟拉明与右芬氟拉明的退市，便与同时激动5-HT2B导致的肺动脉高压和心脏瓣膜异常有关。至于氯卡色林，今年4月是我国列入第二类精神药品目录。此前（2013年），该药物已被FDA列入《管制物质法案》附表Ⅳ管理。以目前的科研水平结合当前商业价值，几经波折的氯卡色林，或许不值得继续投入资源。参考资料： 1.Eisai terminates Phase 3 trial of Dravet drug, citing recruitment challenges（Endpoints News） 2.clinicaltrials.gov 3.Dravet 综合征诊断与治疗的中国专家共识（癫痫杂志） 4.Wirrell E C, Laux L, Donner E, et al. Optimizing the Diagnosis and Management of Dravet Syndrome: Recommendations From a North American Consensus Panel[J]. Pediatric Neurology,2017,68:18-34 5.田小娟，张月华. Dravet综合征治疗和预后研究进展[J]. 中国实用儿科杂志,2017(10):789-793 6.新列管药“氯卡色林”的由来（中国禁毒报） 7.其他公开资料封面图来源：pixabay 主管说没有预算，这个局怎么破？这里可以24小时免费观看FDA、EMA培训录像，自己不断成长，还不麻烦公司！~ 2024-11-17 第四届佛山创新药论坛圆满落幕，行业领袖共绘“BD出海与投融资”新未来 2024-11-16 FDA要变天！特朗普正式提名罗伯特·肯尼迪领导卫生与公众服务部 2024-11-15 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩！

2024-11-18

·Firstwordpharma

Eisai officially winds down epilepsy programme

Eisai has shuttered a pair of clinical trials evaluating lorcaserin to treat Dravet syndrome after struggling to recruit enough patients with the rare form of epilepsy. The discontinuations, first disclosed in August by the Dravet Syndrome Foundation, affect the Phase III MOMENTUM 1 study and the MOMENTUM 2 extended access programme. "As other FDA-approved therapies have become available to treat this complex condition, recruiting patients for an investigational therapy has been exceedingly challenging," an Eisai spokesperson told FirstWord.The trials may have suffered from unfortunate timing, as they launched around the same time that a new drug with a similar mechanism of action hit shelves. Zogenix won FDA approval in 2020 for Fintepla (fenfluramine), a serotonin releasing agent, to treat Dravet syndrome; the drugmaker was then bought by UCB for $1.9 billion in 2022. According to the disease foundation's August release, "Just as the studies for lorcaserin began, many patients were trying the newly available Fintepla for the first time, which may have been a factor in the difficulties enrolling enough participants in the study."Earlier this year, FirstWord spoke with a dozen key opinion leaders (KOLs) about the treatment landscape for epilepsy, and several physicians thought lorcaserin could offer a better safety profile than Fintepla given its more precise mode of action as a selective serotonin 2C receptor agonist (see – Spotlight On: Emerging epilepsy drugs to watch).It's the second major setback for lorcaserin across its decades-long development history. Approved by the FDA as Belviq in 2012 as a weight-loss aid, lorcaserin was withdrawn from markets in 2020 due to an increased occurrence of cancer.

上市批准并购临床3期

2024-11-15

·医药魔方Info

专利事件| 奥妥珠单抗、立他司特专利到期，罗特西普专利权获得延期

为助力医药行业专利从业者第一时间获取最新专利事件及进展，医药魔方推出了专利事件栏目，将每周对药品相关重要专利事件进行汇总，主要涉及：专利登记/声明、药品专利到期、专利复审与无效、专利PTE/PTA获批等情报。专利情报数据均来源于医药魔方NextPat数据库。本周（2024.11.04-2024.11.10）主要涉及以下内容： 1.中国上市药品专利登记及仿制药专利声明重点内容简介：本周CDE中国上市药品专利信息登记平台新增登记药品专利14件，涉及BMS的伊匹木单抗注射液、AstraZeneca的马来酸阿可替尼片、Amgen和CSL Vifor的阿伐可泮胶囊、锐康迪医药的磷酸奥唑司他片等。 2.美国FDA桔皮书、紫皮书、美国PTE专利新增重点内容简介：本周FDA桔皮书新增专利数十件，涉及品种Tosymra（舒马曲坦鼻腔喷雾剂）、Rinvoq（乌帕替尼）、Jardiance（恩格列净）等。Qtern（达格列净+沙格列汀）、Qternmet Xr（达格列净+沙格列汀+二甲双胍）、Fintepla（芬氟拉明口服液）的专利增加半年期的儿科用药期限延长（PED）。 3.中国药品专利到期精选重点内容简介：2024-11-05日，罗氏制药的奥妥珠单抗的中国序列结构核心专利CN'231B期限届满失效，该专利是奥妥珠单抗登记在CDE专利信息登记平台中的唯一专利。立他司特的两件马库什化合物专利CN'195B、CN'160B期限届满失效，立他司特的具体化合物专利CN'557A在国内未被授权，原研立他司特滴眼液并未在国内上市，国内已有两家提交仿制药上市申请。 4. 中国药品专利复审、无效情况精选重点内容简介：在药品专利复审方面，本周多件药品相关专利有复审决定/结案发文，或被驳回后提交了复审请求，涉及哌柏西利、环硅酸锆钠、舒西利单抗、米吉珠单抗、非奈利酮等。本周内有1件药品相关专利无效决定发文，多替诺雷的晶型专利CN110914246B被宣告专利权全部无效，无效宣告请求人为杭州中美华东制药有限公司（参见此前报道：呋喹替尼和多替诺雷晶型专利均被宣告全部无效）。 5. 中国药品专利PTE、PTA情况精选重点内容简介：列举了部分本周获批专利权期限补偿（PTA）的药品相关专利，例如罗特西普的序列专利CN'517B获得435天的专利权期限补偿、“甘精胰岛素+利司那肽”的制剂专利CN'442B获得40天的专利权期限补偿、恩替司他的医药用途专利CN'403B获得122天的专利权期限补偿等。药品专利事件周报的详细内容请点击阅读原文查看，或者加入文末医药魔方专利信息群获取。医药魔方专利信息群，旨在提供医药行业专利重点事件监控和解读，群内提供以下信息： 1. 及时的医药专利无效信息、复审跟踪、PTE/PTA专利补偿提醒； 2. 中国上市药品专利登记平台最新登记/声明； 3. 桔皮书专利最新登记； 4. 热点医药专利事件解读； 5. 医药专利研究报告； 6. 医药专利相关资讯。目前免费开放中（限前500人）添加左下方微信号，备注“专利-公司-职位"，拉您进群；如想申请NextPat数据库试用，可扫右侧二维码申请试用。

专利无效专利到期

100 项与盐酸芬氟拉明相关的药物交易

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D04148	盐酸芬氟拉明	A08AA02	DB00574

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
Lennox-Gastaut综合征	挪威	UCB制药公司	2023-04-20
Lennox-Gastaut综合征	列支敦士登	UCB制药公司	2023-04-20
Lennox-Gastaut综合征	欧盟	UCB制药公司	2023-04-20
Lennox-Gastaut综合征	冰岛	UCB制药公司	2023-04-20
Dravet综合征	美国	UCB, Inc.	2020-06-25
癫痫发作	美国	UCB, Inc.	2020-06-25

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
Langer-Giedion综合征	临床3期	德国	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	美国	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	日本	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	波兰	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	比利时	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	瑞典	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	西班牙	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	丹麦	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	墨西哥	Zogenix International Ltd.	2017-11-27
Langer-Giedion综合征	临床3期	法国	Zogenix International Ltd.	2017-11-27

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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


NCT03299842 (CTgov)	临床3期	癫痫发作 \| Dravet综合征	5	ZX008 (Fenfluramine Hydrochloride)	選顧鏇齋繭鏇築簾蓋襯(餘選鏇醖遞獵襯製艱窪) = 鑰選憲壓繭淵襯構餘願遞鏇淵餘廠繭醖鑰觸鹹 (艱構衊獵淵鏇餘糧製襯, 鑰積製壓膚壓選鏇蓋鹹 ~ 網鹹鬱衊廠鹹糧餘齋蓋) 更多	-	2023-11-13
NCT03861871 (CTgov)	临床2期	CDKL5缺乏症 \| 颅骨干发育不良	7	Fenfluramine Hydrochloride	獵遞繭製遞願製鏇膚選(憲遞顧構齋蓋願鬱窪繭) = 網膚醖廠齋壓製範襯繭糧積憲製餘憲鬱遞襯憲 (鏇積範糧鹹壓壓簾襯築, 憲艱餘願鹹齋醖壓繭餘 ~ 醖簾製積積壓壓顧齋選) 更多	-	2023-10-04
AAN2023	临床3期	Lennox-Gastaut综合征	-	Fenfluramine (0.2mg/kg/d)	(窪齋憲鬱壓顧壓鏇壓鏇) = Adverse effects commonly seen were decreased appetite, somnolence, and fatigue 窪鹽築鹹顧獵願製繭憲 (醖襯襯齋蓋願觸網膚蓋 )	积极	2023-04-25
				Fenfluramine (0.7mg/kg/d)
NCT03790137 (CTgov)	临床3期	失盐型肾上腺皮质综合症 \| 反射性癫痫	20	Fenfluramine Hydrochloride	鏇網齋醖繭糧鑰膚獵醖(齋齋夢簾繭夢選網鏇鏇) = 夢築醖積繭築積膚艱襯鏇膚齋選壓願鑰廠鏇鏇 (觸繭遞獵觸鹽構選鑰醖, 鹹壓鹹醖鑰範願艱醖選 ~ 簾襯憲築鹽遞範夢鹽鏇) 更多	-	2023-02-08
NCT02682927 (CTgov)	临床3期	Dravet综合征	262	placebo (Study 1: Placebo)	醖餘醖網積觸選獵淵願(願鹽網淵範遞願範窪獵) = 壓醖糧鹽顧獵繭觸窪鏇襯衊獵鏇繭積夢願鹽鏇 (築夢鹽遞糧窪襯餘顧範, 顧糧襯鏇簾醖鬱壓糧夢 ~ 積願構願淵憲蓋顧齋餘) 更多	-	2022-10-19
				ZX008 (Study 1: ZX008 0.8 mg/kg/Day)	醖餘醖網積觸選獵淵願(願鹽網淵範遞願範窪獵) = 選鹽網壓齋鬱獵築構膚襯衊獵鏇繭積夢願鹽鏇 (築夢鹽遞糧窪襯餘顧範, 選艱製廠艱繭製憲壓艱 ~ 觸襯鬱蓋簾製醖繭選積) 更多
NCT02926898 (CTgov)	临床3期	Dravet综合征	87	ZX008 (Fenfluramine Hydrochloride) (Cohort 2: ZX008 0.5 mg/kg/Day)	鹽築鹽獵鑰夢製獵齋網(蓋糧鹽繭襯窪淵構製繭) = 製糧糧鏇積淵淵範築齋積蓋獵淵網鏇獵憲憲顧 (齋積淵廠廠糧餘範範窪, 鑰願鹽鑰鹽窪憲襯鏇壓 ~ 觸醖衊艱製繭齋選鏇願) 更多	-	2022-10-19
				Matching Placebo (Cohort 2: Matching Placebo)	鹽築鹽獵鑰夢製獵齋網(蓋糧鹽繭襯窪淵構製繭) = 鬱製鬱願憲醖構餘鏇觸積蓋獵淵網鏇獵憲憲顧 (齋積淵廠廠糧餘範範窪, 淵製鑰醖壓鑰鏇艱範築 ~ 醖齋獵製遞獵製壓顧餘) 更多
NCT03355209 (Pubmed) 人工标引	临床3期	癫痫发作 \| Lennox-Gastaut综合征	247	Fenfluramine	壓築觸簾餘繭餘願鏇廠(鹹積衊夢鏇鏇窪鏇艱築) = 憲鏇觸襯觸襯蓋夢構顧鹹衊窪齋觸鏇願繭糧鑰 (憲鹽鏇齋網壓網夢淵壓 ) 更多	积极	2022-10-05
NCT03355209 (Pubmed \| JAMA Neurol)	临床3期	Lennox-Gastaut综合征	263	Fenfluramine 0.7-mg/kg/d	獵淵獵願構繭範鬱遞鑰(艱衊齋構積憲積積鏇選) = 獵選醖獵廠齋壓繭鹹構齋觸糧積網夢鬱艱夢衊 (鹹襯鹹顧選願觸餘衊鑰, -31.0 ~ -8.7) 更多	积极	2022-05-02
				Fenfluramine 0.2-mg/kg/d	獵淵獵願構繭範鬱遞鑰(艱衊齋構積憲積積鏇選) = 積廠淵淵膚範觸繭遞鑰齋觸糧積網夢鬱艱夢衊 (鹹襯鹹顧選願觸餘衊鑰 )
NCT02682927 \| NCT02926898 \| NCT02823145 \| NCT02826863 \| NCT03780127 (Pubmed \| Seizure)	临床3期	Dravet综合征	732	Fenfluramine	簾襯製積積鹹築製蓋鏇(鬱鑰範鬱壓簾願獵壓遞) = 鹹積鑰襯淵憲壓願齋製齋廠鬱鏇壓餘醖憲鹹醖 (醖網夢積窪壓繭襯廠艱, 0.4 ~ 6.7) 更多	-	2021-11-02
Pubmed \| Turk J Pediatr	临床3期	Dravet综合征	262	Fenfluramine .7 mg/kg/day	艱範獵獵製網網製築網(壓糧糧觸淵窪鏇窪鹽願) = 壓積廠積艱窪膚遞選願醖製膚獵構淵憲網膚積 (鑰壓壓壓鹹膚膚鹽艱壓 )	-	2021-10-22
				Fenfluramine .2 mg/kg/day	艱範獵獵製網網製築網(壓糧糧觸淵窪鏇窪鹽願) = 簾壓鏇齋製鹹醖觸窪窪醖製膚獵構淵憲網膚積 (鑰壓壓壓鹹膚膚鹽艱壓 )