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更新于：2025-05-28

Topiramate

托吡酯

更新于：2025-05-28

概要

基本信息

简介托吡酯以商品名Topamax ® 销售，是一种抗惊厥药物，于1995年在英国由Janssen Services 首次推上市场。其作用机制为 GABAAR 激动剂。主要用于治疗癫痫，也被批准用于预防和治疗偏头痛。托吡酯通过稳定大脑中的电活动起作用，从而降低癫痫发作的可能性。已发现它可有效降低癫痫患者癫痫发作的频率和严重程度，以及减少偏头痛的频率。托吡酯有片剂形式，通常按照医疗保健提供者的指示每天口服一次或两次。

药物类型

小分子化药

别名

2,3:4,5-bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate、2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate、Topiramate (JAN/USP/INN)

+ [22]

靶点

AMPA receptor x CAs x GABAA receptor x VGSCs

作用方式

拮抗剂、抑制剂、激动剂、

+ [1]

作用机制

AMPA receptor拮抗剂(离子型谷氨酸受体AMPA拮抗剂)、CAs抑制剂(碳酸酐酶家族抑制剂)、GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂)

治疗领域

神经系统疾病遗传病与畸形其他疾病

在研适应症

癫痫偏头痛Lennox-Gastaut综合征+ [4]

非在研适应症

精神病性情感障碍酗酒暴食症+ [27]

原研机构

Janssen Global Services LLC

在研机构

Janssen Pharmaceuticals, Inc.Prevep, Inc.

Supernus Pharmaceuticals, Inc.

+ [6]

非在研机构

Janssen Pharmaceutica NVJanssen Research & Development LLCJohnson & Johnson Pharmaceutical Research & Development LLC

+ [3]

权益机构

Eton Pharmaceuticals, Inc.

Tulex Pharmaceuticals, Inc.

Janssen Korea Ltd.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1996-12-24),

癫痫部分性发作强直阵挛性癫痫

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C12H21NO8S

InChIKeyKJADKKWYZYXHBB-XBWDGYHZSA-N

CAS号97240-79-4

关联

327

项与托吡酯相关的临床试验

NCT05209984

/ Not yet recruiting临床3期

A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/topiramate XR in Overweight Adults with Comorbidities/obesity

A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity

开始日期2026-04-01

申办/合作机构

Eurofarma Laboratórios SA

NCT04613024

/ Withdrawn早期临床1期IIT

Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction

The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery

开始日期2025-07-01

申办/合作机构

Stanford University

NCT06972056

/ Not yet recruiting临床4期IIT

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

This goal of this study is to compare three medications used for migraine preventive treatment.
This study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others.
Research participants will:
* Be randomly assigned to one of the three medications.
* Provide information about their migraine pattern using a daily headache diary and during research visits.

开始日期2025-07-01

申办/合作机构

Mayo Clinic

[+3]

100 项与托吡酯相关的临床结果

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100 项与托吡酯相关的转化医学

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100 项与托吡酯相关的专利（医药）

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8,413

项与托吡酯相关的文献（医药）

2025-12-01·Acta Epileptologica

Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database

Article

作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan

Abstract:

Background:

Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods:

This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results:

A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.

Conclusions:

This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.

2025-09-01·Journal of Environmental Sciences

Extracting critical paths for synergistic control of carbon emissions and air pollution: Case of Henan Province

Article

作者: Chun, Tiantian ; Li, Yeke ; Zhao, Yingying ; Zhang, Ruiqin ; Wang, Shanshan ; Wang, Ningwei

Synergistic reduction of carbon emissions and air pollution is the core means to address the two major strategic tasks of fundamentally improving the ecological environment and the 'Dual-carbon target'. The issue of synergistic reduction at the provincial level needs to be addressed as a matter of urgency. Taking Henan Province, the largest economy in central China, as an example, this study uses environmentally extended input-output analysis and structural path analysis to identify the key sectors that contribute to CO₂, SO₂, and total particulate matter (TPM) emissions, and to sort out key emission pathways (e.g., Final Demand → Sector…). The results indicate that S2 (Mining of Fossil Energy), S10 (Nonmetal Mineral Products), S11 (Metal Smelting), S13 (Power and Heat) and S17 (Transportation) are mainly responsible for CO₂, SO₂, and TPM direct emissions on the production side, while S16 (Construction), S12 (Equipment) and S18 (Services) account for more than 45 % of CO₂, SO₂, and TPM embodied emissions on the consumption side. 32 shared emission pathways are extracted from the top 100 pathways for CO₂, SO₂, and TPM emissions, which account for 27 %-51 % of total emissions in Henan Province. P9 (Export → Nonmetal Mineral Products), P10 (Export → Metal Smelting) and P21 (Gross Capital Formation → Construction → Nonmetal Mineral Products) are the leading paths responsible for embodied emissions. The research results provide the foundation and guidance for well-designed mitigation policies, as well as a reference for better synergistic control in provinces facing similar situations.

2025-08-01·JOURNAL OF HAZARDOUS MATERIALS

A framework to assess pharmaceutical accumulation in crops: from wastewater irrigation to consumption

Article

作者: Trapp, Stefan ; Garduño-Jiménez, Andrea ; Nightingale, John ; Carter, Laura

The reuse of treated wastewater for irrigation can inadvertently introduce a suite of emerging contaminants such as pharmaceuticals into agri-ecosystems. However, current monitoring efforts to characterise exposure usually focus on a limited range of analytes. A modelling framework was developed that employs a sequence of pre-developed models to predict accumulative potential in a model crop, Zea mays (corn), using chemical structure and excretion rate as the only model inputs. Z. mays was selected as the model crop as it is a major food source, stands as one of the highest cultivated crops globally, and is characterised as having a medium uptake potential. The framework was used to predict uptake in Z. mays in three regions characteristic of high wastewater reuse (Australia, the US and the Middle East). Despite regional and plant specific differences, 72.7 % of the calculated concentrations were within a factor of ten of those reported in the literature. Topiramate, furosemide, and gemfibrozil were observed to accumulate to the greatest extent in Z. mays, predicted concentrations ranged between 50.27 and 418.01 ng/g (dw) for the top 10. Acids predominantly accumulated in leaves and fruit whereas a higher proportion of bases were predicted to accumulate in the roots. To the best of our knowledge 56.7 % of the 30 highest-ranked pharmaceuticals have not been previously documented in existing literature or monitoring campaigns. This presented framework demonstrates a method to assess risk posed by pharmaceutical compounds with limited experimental data.

148

项与托吡酯相关的新闻（医药）

2025-05-25

·梅斯医学

反复发呆、行为异常、记忆力减退……原来是大脑在攻击自己！

21岁的李婷，从小就被认为“性格古怪”。她安静寡言，偶尔发呆，时常说些让人听不懂的话。家人以为她只是内向，老师觉得她“情绪不稳定”，同学则悄悄疏远她。上了大学后，她变得越来越难以集中注意力，常常记不住刚听过的内容。有一天，舍友发现她独自在宿舍喃喃自语，面容呆滞，眼神游离，甚至突然抽搐倒地。她被紧急送往医院，医生初步判断为癫痫发作，但进一步的观察发现，她还出现了幻觉、行为异常和记忆力严重减退。脑电图显示颞叶区域有癫痫样放电，脑脊液检查提示轻度白细胞升高，MRI未见明显结构异常，但PET显示双侧边缘系统代谢异常。最关键的发现来自脑脊液的抗体检测：抗NMDAR抗体阳性，最终确诊为自身免疫性脑炎。“什么是自身免疫性脑炎自身免疫性脑炎属于自身免疫性疾病诱发的中枢神经系统炎性病变，该疾病患病率占脑炎所有类型的十分之一到十分之二。以抗N－甲基－D－门冬氨酸受体脑炎为最常见的类型，占自身免疫性脑炎的百分之八十。“临床表现自身免疫性脑炎（AIE）可发生于任何年龄，男女发病无明显差异。其起病方式多为急性或亚急性，部分患者病程中可出现复发。部分病例在发病前有前驱症状，例如抗NMDAR脑炎患者常在发病前出现发热、头痛等表现，或继发于单纯疱疹病毒性脑炎之后。临床表现复杂多样，最常见的是近事记忆力减退、精神行为异常、意识水平下降、癫痫发作及局灶性神经功能缺损。某些患者还可出现不自主运动，如舞蹈样动作或肌阵挛等。睡眠障碍也较常见，包括失眠、异常的睡眠行为和活动、睡眠呼吸暂停以及过度嗜睡等。自主神经功能紊乱常表现为血压波动、心动过速和呼吸功能障碍（如通气不足）。此外，一些患者还会出现胃肠道症状，如腹泻、胃轻瘫及便秘等。部分患者表现出周围神经兴奋性增高，如肌张力异常或感觉异常。“诊断根据《中国自身免疫性脑炎诊治专家共识》，自身免疫性脑炎的诊断需结合临床表现、辅助检查、抗体检测以及对其他病因的排除，诊断标准具体总结如下：自身免疫性脑炎的确诊需同时满足以下四项条件：一是临床表现方面，患者多呈急性或亚急性起病，需出现以下一种或多种神经精神症状或临床综合征，包括：边缘系统受累症状（如近事记忆减退、癫痫、精神行为异常）、脑炎综合征表现（弥漫性或多灶性脑损害）、基底核或间脑/下丘脑受累表现，或精神障碍且经精神专科评估排除非器质性疾病。二是辅助检查支持，至少需具备以下之一：脑脊液异常（如白细胞增多、淋巴细胞性炎症、寡克隆区带阳性）、神经影像学或电生理异常（如MRI边缘系统T2/FLAIR异常信号、PET代谢异常、脑电图癫痫样放电或慢波节律）或发现与自身免疫性脑炎相关的特定肿瘤（如抗NMDAR脑炎合并卵巢畸胎瘤、边缘性脑炎合并小细胞肺癌）。三是确诊实验方面，需检测到神经元表面抗原抗体阳性，其中抗NMDAR抗体以脑脊液检测阳性为主要依据。四是需合理排除其他病因，如感染、中毒、代谢性脑病、结构性病变等，排除其他可能导致类似症状的疾病。若仅满足第1、2和4条，则可诊断为可能的自身免疫性脑炎；若四条均满足，方可确诊为自身免疫性脑炎。该诊断标准强调综合评估临床症状、实验室与影像学依据，并重视排除其他病因的重要性，以提高诊断的准确性。“治疗对症治疗：癫痫发作可使用广谱抗癫痫药物，如苯二氮类、丙戊酸钠、拉莫三嗪、拉考沙胺和托吡酯，使用左乙拉西坦需警惕精神副作用。精神症状可用奥氮平、氯硝西泮、喹硫平等，注意意识和锥体外系影响。免疫治疗：应尽早启动免疫治疗。一线治疗包括糖皮质激素、静脉免疫球蛋白（IVIG）、血浆置换（PE）或免疫吸附。甲泼尼龙联合IVIG是常用方案。若10–14天后无效，可采用二线治疗，如利妥昔单抗或环磷酰胺，必要时使用托珠单抗。免疫吸附副作用小，较PE更安全。肿瘤治疗：合并肿瘤者应积极处理。抗NMDAR脑炎合并卵巢畸胎瘤者应尽早手术，恶性肿瘤需多学科治疗。预后：早期治疗、非肿瘤性AIE预后较好。部分患者需二线免疫治疗。抗NMDAR脑炎复发率约12%，抗LGI1和抗CASPR2脑炎复发率分别为31%和10%，部分患者可留有记忆障碍。参考资料：[1]中华医学会神经病学分会神经感染性疾病与脑脊液细胞学学组,王佳伟,关鸿志,赵钢.中国自身免疫性脑炎诊治专家共识(2022年版)[J].中华神经科杂志,2022,55(9):931-949[2]刘磊,谢竹霄,王佳伟.自身免疫性脑炎的分类及诊治[J].中国临床医生杂志,2021,49(6):634-639[3]黄宇.自身免疫性脑炎诊治进展[J].中文科技期刊数据库（引文版）医药卫生,2022(6):258-261来源 | 梅斯医学编辑 | wanny神经系统罕见病交流群↓点击下方“阅读原文”，下载梅斯医学APP吧！

2025-05-07

·医脉通

从用药无效到症状缓解：典型前庭性偏头痛治疗全记录

病史女，29岁；主诉：反复发作性眩晕1+年就诊：2019.7.11患者一年前情绪明显受刺激后开始出现反复发作性眩晕，每周3-4次，严重时每天发作两次。每次发作约1-5小时好转。伴随症状：恶心、呕吐（并非每次出现），头痛，无心悸出汗、无畏声畏光、无腹痛腹泻，无意识丧失。眩晕发作前后有明显走路不稳。耳部症状：左侧听力下降伴耳鸣10年，眩晕发作前偶有耳鸣加重表现，眩晕停止后耳鸣回到基线。压力和紧张可能为其诱发因素。自发病以来睡眠差，情绪自述尚可查体无自发眼震、凝视眼震、无扫视跟踪异常Romberg test（—）甩头试验（—）摇头试验：未做变位：阴性检查上下滑动阅览纯音测听：左侧感音神经性耳聋，平坦型，65db声导抗：正常温度实验：双侧外半规管超低频功能下降。右向自发眼震0.7°/svHIT：正常耳蜗电图：右侧正常，左侧未引出变位试验：（—）cVEMP/oVEMP：正常面听神经MRI：左侧内听道神经血管骑跨诊断前庭性偏头痛左侧感音神经性耳聋治疗及随访上下滑动阅览盐酸氟桂利嗪胶囊，10mg，QN甲磺酸倍他司汀片，3-3-3银杏叶，1-1-1复诊：7.18近一周有4天均有发作7.17再次发作3次，伴恶心呕吐，每次约3小时好转无其他伴随症状追问病史：发作时偶有左侧面部刺痛、麻木感、肌肉抽搐，同时伴有左侧耳鸣加重治疗方案调整盐酸氟桂利嗪胶囊，10mg，QN甲磺酸倍他司汀片，3-3-3右佐匹克隆片 0-0-0-1/2，qn随访：8.3微信吃药20天，共发作2-3次自述症状缓解60-70%治疗方案：同前随访：8.23最近10天头晕次数发作5次，发作时间约1小时自觉药物开始无效伴头痛明显，眼睛胀痛治疗方案调整：停盐酸氟桂利嗪胶囊调整为：文拉法辛缓释胶囊，75mg，Qd +甲磺酸倍他司汀片随访：9.1微信、9.12微信文拉法辛用药两周感觉用药效果不佳头晕眩晕反复发作，每周2-3次患者自行加用加巴喷丁复诊：9.19文拉法辛+加巴喷丁用药效果不佳眩晕仍然反复发作，自我感觉回到了刚开始的状态持续使用甲磺酸倍他司汀片，患者外半规管功能明显改善复查温度实验：右向自发眼震1.1°/s治疗方案：停文拉法辛、加巴喷丁调整为：托吡酯片，25mg，QN 一周后加量为25mg-0-25mg甲磺酸倍他司汀片，3-3-3，po注：原有的双侧半规管轻瘫已明显好转，但眩晕仍反复发作随访：10.4用药期间有一天发作，发作2次继续托吡酯片治疗微信随访：10.19 11.3无发作10.19开始托吡酯片减量为0-0-25mg复诊 11.5 头晕头痛无发作偶尔休息差时有眼睛干涩症状温度试验：右向自发眼震4.4°/s托吡酯片 25mg，qd微信随访：2020.1.7患者已自行断药，未再发作医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。点击“阅读原文”查看完整病例，一起参与互动，欢迎评论、点赞、收藏、转发

临床结果

2025-05-01

·PRNewswire

EPIDIOLEX Continues to Lead the Way in Cannabinoid-Based Epilepsy Treatment | DelveInsight

EPIDIOLEX has significant market potential due to the growing demand for alternative therapies and its effectiveness in treating rare seizure disorders like Lennox-Gastaut syndrome and Dravet syndrome. As awareness around the benefits of CBD in treating neurological conditions increases, EPIDIOLEX stands to benefit from expanding indications and market reach. LAS VEGAS, May 1, 2025 /PRNewswire/ -- DelveInsight's ' EPIDIOLEX Market Size, Forecast, and Market Insight Report' highlights the details around EPIDIOLEX, the first FDA-approved prescription cannabidiol (CBD) to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age or older. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of EPIDIOLEX. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Jazz Pharmaceuticals' EPIDIOLEX (cannabidiol) Overview EPIDIOLEX (formerly known as GWP42003-P and marketed as EPIDYOLEX in Europe) is the first plant-based, prescription cannabis-derived oral medication developed by GW Pharmaceuticals. It represents a new category of antiepileptic drugs with a unique mechanism of action. The active compound, cannabidiol (CBD), is a naturally occurring cannabinoid found in the Cannabis sativa L. plant. While the exact way EPIDIOLEX works to reduce seizures in humans remains unclear, it is distinct from traditional anticonvulsants. CBD does not act through CB1 receptors or by blocking voltage-gated sodium channels, which are typical pathways for other antiepileptic drugs. Instead, CBD is thought to work by influencing multiple internal pathways, potentially producing a combined anticonvulsant effect. These include enhancing neuronal inhibition (through synaptic and extrasynaptic GABA channels), affecting intracellular calcium levels (via TRPV channels, VDAC, and GPR55), and reducing inflammation, possibly via adenosine modulation. Importantly, CBD does not directly bind to or activate the CB1 or CB2 receptors at levels relevant to its seizure-reducing effects. Ongoing research is examining other possible mechanisms such as interactions with adenosine, glycine, GABAergic systems, and serotonin receptors. EPIDIOLEX has received regulatory approval in numerous countries, including the U.S. (FDA), Europe (European Commission), Great Britain (MHRA), Australia (Therapeutic Goods Administration), Switzerland (Swissmedic), Israel (Ministry of Health), and New Zealand (Medicines and Medical Devices Safety Authority). It is formulated as an oral solution containing highly purified CBD. In the U.S., it is approved to treat seizures linked to Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC) in patients aged one year and older. In the European Union, under the name Epidyolex, it is approved as an add-on treatment with clobazam for LGS and DS in patients two years and older, and for TSC-associated seizures as well. Both the FDA and EMA have granted Orphan Drug Designation (ODD) for EPIDIOLEX/EPIDYOLEX for these conditions. EPIDIOLEX/EPIDYOLEX net product sales rose by 15% to USD 972.4 million in 2024 and by 14% to USD 275.0 million in the fourth quarter of 2024, compared to the corresponding periods in 2023. Learn more about EPIDIOLEX/EPIDYOLEX projected market size for DEE @ EPIDIOLEX Market Potential Developmental and epileptic encephalopathies (DEE) encompass a group of severe neurological conditions marked by developmental delays and persistent epilepsy. These disorders typically present early in life and are linked to significant cognitive deficits. According to DelveInsight's analysis, there were approximately 287K diagnosed prevalent cases of DEE across the 7MM in 2024. This number is projected to increase due to the rise in neurological disorders, including epilepsy, as well as environmental and maternal health factors contributing to a higher DEE prevalence throughout the forecast period (2025−2034). The US FDA has approved a range of medications for conditions like LGS, Dravet Syndrome, and CDKL5 Deficiency Disorder, including various drug classes such as sodium channel modulators, GABA receptor modulators, calcium channel blockers, receptor blockers, and others. Some of the available anti-epileptic drugs (AEDs) include FINTEPLA, EPIDIOLEX, TOPAMAX, BANZEL, LAMICTAL, FELBATOL, ONFI, KLONOPIN, DIACOMIT, SABRIL, and more. In 2024, the total market size for DEE in the 7MM was around USD 2.3 billion, and this figure is expected to grow by 2034, driven by wider adoption of approved therapies due to label expansions and the introduction of emerging treatments. Discover more about the DEE market in detail @ Developmental and Epileptic Encephalopathy Market Report Emerging Competitors of EPIDIOLEX Some of the drugs in the pipeline include EPX-100 (Harmony Biosciences), Bexicaserin (Lundbeck), Zorevunersen (Stoke Therapeutics/Biogen), Relutrigine (Praxis Precision Medicines), and others. In August 2024, the FDA removed a partial clinical hold as the company advances toward a Phase III registrational study of zorevunersen (STK-001) in children and adolescents with Dravet syndrome. In July 2024, Longboard Pharmaceuticals announced that the FDA had granted Breakthrough Therapy designation for its investigational drug bexicaserin for the treatment of seizures associated with DEEs for patients 2 years of age or older. To know more about the number of competing drugs in development, visit @ EPIDIOLEX Alternatives Key Milestones of EPIDIOLEX In August 2024, Jazz Pharmaceuticals reported top-line results from a Phase 3 open-label, single-arm study conducted in Japan, assessing the safety and effectiveness of its cannabidiol oral solution (marketed globally as EPIDIOLEX/EPIDYOLEX) as an add-on therapy for seizures linked to Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC). While the trial did not achieve its primary efficacy goal—defined as a pre-specified percentage reduction in seizure frequency during the up-to-16-week treatment period compared to baseline in Japanese pediatric patients—numerical improvements were noted in both the primary and several secondary measures. The study did not identify any new safety concerns. In May 2021, Jazz Pharmaceuticals acquired EPIDIOLEX as part of the acquisition of GW Pharmaceuticals plc, or GW, which expanded its growing neuroscience business with a global, high-growth childhood-onset epilepsy franchise. In April 2021, EPIDYOLEX was approved for adjunctive therapy of seizures associated with TSC for patients 2 years of age and older in the EU. In July 2020, EPIDYOLEX was approved for the treatment of seizures associated with TSC in patients one year of age and older. FDA also approved the expansion of all existing indications, LGS and DS, to patients one year of age and older. In September 2019, the European Commission approved EPIDYOLEX for use as adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients two years of age and older. In June 2018, EPIDIOLEX was approved in the US for the treatment of seizures associated with two rare and severe forms of epilepsy, LGS and DS, in patients two years of age and older. EPIDIOLEX Launch Status EPIDIOLEX was launched on November 1, 2018, in the US market after FDA approval for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. EPIDYOLEX was launched in 2019 in Germany and the UK market for use as adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older (GW Pharmaceuticals, 2019b). In 2021, EPIDYOLEX was launched in Spain. In the first quarter of 2022, the company launched EPIDYOLEX for LGS, Dravet syndrome, and TSC in Ireland, for TSC in Scotland and Wales. In the third quarter of 2022, the company launched EPIDYOLEX for TSC in Italy and Switzerland. In the fourth quarter of 2022, the company successfully completed the pricing and reimbursement process and commercial launch of EPIDYOLEX in France. Discover how EPIDIOLEX/EPIDYOLEX is shaping the DEE treatment landscape @ EPIDIOLEX CBD EPIDIOLEX Market Dynamics EPIDIOLEX, the first FDA-approved cannabidiol (CBD)-based medication for the treatment of rare forms of epilepsy, has had a significant impact on the pharmaceutical market since its approval in 2018. The drug is primarily used to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome, two rare and severe forms of epilepsy. The market dynamic for EPIDIOLEX is shaped by several factors, including increasing awareness of its therapeutic potential, the expanding medical cannabis industry, and the growing demand for alternative treatments to traditional anti-epileptic drugs. One of the main drivers of the EPIDIOLEX market is the rising acceptance of CBD-based therapies. As medical cannabis becomes more mainstream and research into its medicinal properties continues to grow, patients and healthcare providers are increasingly turning to EPIDIOLEX as a treatment option. The growing body of clinical evidence supporting its effectiveness and safety has reinforced this trend. Additionally, as the stigma around cannabis-derived medications continues to fade, it opens up more opportunities for EPIDIOLEX in both pediatric and adult patient populations. However, the market for EPIDIOLEX is not without its challenges. High treatment costs and insurance coverage issues can limit accessibility for some patients, especially in markets outside the United States. Despite its clinical efficacy, the price point for EPIDIOLEX remains a point of contention, as it may not be affordable for all families, especially when compared to other conventional anti-epileptic drugs. Furthermore, competition from other cannabinoid-based therapies, as well as new developments in the broader epilepsy drug market, could impact the drug's market share over time. Looking ahead, the market dynamics for EPIDIOLEX will likely continue to evolve as the global regulatory landscape changes and new clinical trials further establish its benefits in other neurological conditions. With increasing research into CBD's potential applications, there may be opportunities for EPIDIOLEX to expand its indications, providing a solid foundation for its continued growth. However, market growth will also depend on the ability to address pricing concerns, improve insurance coverage, and navigate potential competitive pressures from both traditional and emerging therapies. Dive deeper to get more insight into EPIDIOLEX/EPIDYOLEX's strengths & weaknesses relative to competitors @ EPIDIOLEX Market Drug Report Table of Contents Related Reports Developmental and Epileptic Encephalopathies Market Developmental and Epileptic Encephalopathies Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DEE companies, including vid Therapeutics, Stoke Therapeutics, Biogen, Harmony Biosciences, Lundbeck (Longboard Pharmaceuticals), Praxis Precision Medicines, SK Life Science, Cerecin Neurosciences, Encoded Therapeutics, Praxis Precision Medicines, among others. Developmental and Epileptic Encephalopathies Pipeline Developmental and Epileptic Encephalopathies Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DEE companies, including Denovo Biopharma, Cantex Pharmaceuticals, CNS Pharmaceuticals, CANbridge Pharmaceuticals, Vaximm, Inovio Pharmaceuticals, Mustang Bio, Bullfrog AI Holdings, Cantex, Chimeric Therapeutics, Philogen, Boehringer Ingelheim, Photonamic GmbH, Berg Pharma, Beyond Bio, Genenta Science, Polaris Pharmaceuticals, Telix Pharmaceuticals, Shanghai Simnova Biotechnology, NEONC Technologies, among others. Dravet Syndrome Market Dravet Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Dravet syndrome companies including Biocodex, GW Pharmaceuticals, Zogenix, Ovid Therapeutics, PTC Therapeutics, among others. Lennox-Gastaut Syndrome Market Lennox-Gastaut Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Lennox-Gastaut syndrome companies, including GlaxoSmithKline, Meda Pharmaceuticals, Roche, Lundbeck, Greenwich Biosciences, Janssen Pharmaceuticals, Eisai, Zogenix, Takeda, Ovid Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 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3期并购突破性疗法孤儿药

100 项与托吡酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00537	托吡酯	N03AX11	DB00273

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
癫痫	日本	Kyowa Kirin Co., Ltd.	2007-07-31
偏头痛	美国	Janssen Pharmaceuticals, Inc.	2004-08-11
Lennox-Gastaut综合征	美国	Janssen Pharmaceuticals, Inc.	2001-08-28
癫痫部分性发作	美国	Janssen Pharmaceuticals, Inc.	1996-12-24
强直阵挛性癫痫	美国	Janssen Pharmaceuticals, Inc.	1996-12-24

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
病理性赌博症	临床3期	美国	Ortho-McNeil Pharmaceutical LLC	2005-10-01
尼古丁成瘾	临床3期	美国	Ortho-mcneil Neurologics, Inc.	2005-09-22
散发性偏瘫型偏头痛	临床3期	美国	Ortho-mcneil Neurologics, Inc.	2004-02-01
暴食症	临床3期	-	Janssen-Cilag Farmacêutica Ltda.	2003-11-01
强迫症	临床3期	美国	Ortho-McNeil Pharmaceutical LLC	2003-01-01
创伤后应激障碍	临床3期	美国	Ortho-mcneil Neurologics, Inc.	2002-09-01
神经认知障碍	临床3期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2002-01-01
特发性震颤	临床3期	-	Johnson & Johnson Pharmaceutical Research & Development LLC	2001-10-01
特发性震颤	临床3期	-	Ortho-mcneil Neurologics, Inc.	2001-10-01
震颤	临床3期	-	Ortho-mcneil Neurologics, Inc.	2001-10-01

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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


APAO2024	N/A	闭角型青光眼	4	Topiramate	簾鏇衊壓積製構憲構淵(繭衊蓋構鹹艱艱齋襯襯) = All four cases had a history of intake of topiramate within the past 2-3 weeks prescribed by their physicians for the symptom of headache 顧淵顧鬱膚積衊簾製選 (襯繭獵積齋築鹹觸蓋鬱 )	积极	2024-02-22
APAO2024	N/A	-	-	Topiramate	觸餘鑰選鏇糧築鹹觸願(憲獵製蓋顧艱選鏇齋構) = Bilateral shallow Anterior chamber (AC) 廠範蓋簾範鹹艱構遞蓋 (鹽夢鑰鏇憲繭夢窪鹹願 ) 更多	-	2024-02-22
NCT03176953 (TOP, CTgov)	临床2/3期	酒精使用障碍 \| 创伤后应激障碍	100	prolonged exposure+topiramate (Prolonged Exposure + Topiramate)	廠選糧願願簾壓憲鏇製(餘鑰餘顧壓鑰獵糧獵願) = 襯簾繭築願憲鹽製網蓋鏇憲蓋壓鏇壓醖淵範廠 (鹹觸衊夢鬱淵膚廠壓餘, 1.794) 更多	-	2023-11-18
				placebo (Prolonged Exposure + Placebo)	廠選糧願願簾壓憲鏇製(餘鑰餘顧壓鑰獵糧獵願) = 積窪窪選網艱蓋壓膚積鏇憲蓋壓鏇壓醖淵範廠 (鹹觸衊夢鬱淵膚廠壓餘, 1.794) 更多
NCT02878798 (TopCSPN, CTgov)	临床2期	代谢综合征 \| 感觉神经病	132	Placebo (Placebo)	遞鏇範範觸壓遞構鏇網(壓製鬱鹽窪積夢獵襯願) = 顧網鹹鹽觸蓋願鏇製醖廠壓繭餘淵蓋夢遞鑰艱 (艱醖積範鑰憲淵鹹積襯, 廠鬱製衊窪築顧鬱憲觸 ~ 築窪蓋鑰齋鹽獵餘窪構) 更多	-	2023-11-14
				topiramate (Topiramate)	遞鏇範範觸壓遞構鏇網(壓製鬱鹽窪積夢獵襯願) = 鬱築艱壓餘繭夢蓋築網廠壓繭餘淵蓋夢遞鑰艱 (艱醖積範鑰憲淵鹹積襯, 願選膚築齋構築選繭壓 ~ 顧觸獵窪繭範鏇糧鬱選) 更多
NCT00208130 (25(5):23m03555, Pubmed)	临床4期	创伤后应激障碍	72	Topiramate	積鹹遞顧繭糧簾鹹糧築(築鏇艱膚夢鏇膚淵選顧) = 26% vs 18% 壓鬱願鬱膚簾蓋鑰網鬱 (網選獵膚蓋襯糧製選鹹 ) 更多	积极	2023-10-19
				Placebo
IEC2023	N/A	-	-	Topiramate 200 mg/day	醖醖鬱鹹構淵製範簾艱(選鏇鏇窪糧選廠膚夢夢) = 築憲鑰廠構網製願艱齋觸繭糧鹹觸淵艱窪簾窪 (選蓋構選壓糧鹽鏇範鹽 )	-	2023-09-04
				Valproic acid	鹽簾遞壓憲選襯鬱糧廠(顧艱壓膚壓製鑰膚鹹夢) = 壓鹹獵蓋繭壓願繭鹽壓壓艱鬱衊鹽齋窪糧積齋 (遞廠築範鹹蓋顧選壓範 ) 更多
EURAP registry (IEC2023)	N/A	先天性畸形	9,840	Valproate	廠鏇憲遞艱艱鏇積憲膚(簾衊蓋餘壓齋壓艱鏇廠) = 觸製範獵網蓋夢淵憲鏇蓋鹹齋蓋蓋鑰壓憲願鏇 (窪鹹夢獵夢網膚蓋齋蓋 )	积极	2023-09-04
				Phenytoin	廠鏇憲遞艱艱鏇積憲膚(簾衊蓋餘壓齋壓艱鏇廠) = 願遞廠糧鬱壓淵顧繭遞蓋鹹齋蓋蓋鑰壓憲願鏇 (窪鹹夢獵夢網膚蓋齋蓋 )
ANA2023	N/A	癫痫发作	396	Topiramate monotherapy	淵廠簾築蓋繭範鏇築獵(艱鹽願夢壓製鹹製膚壓) = 範壓構醖壓壓壓築膚鏇膚襯簾觸淵範齋鹽簾鏇 (觸蓋製觸製鏇鹹齋鹹遞, 117.7) 更多	积极	2023-09-01
				Topiramate polypharmacy	網遞積範製窪築繭壓糧(選鹽夢憲顧壓憲顧繭選) = 廠願鹽繭觸選壓鹽窪鏇鹹網窪選簾膚選選憲簾 (觸鹹製範衊憲艱積餘簾, 1.1)
NCT04408586 (CTgov)	临床4期	肥胖	80	Online support system+Topiramate+Phentermine (Phentermine - Topiramate Extended Release Group)	壓襯簾積膚壓遞廠願衊(簾構築壓遞齋製鬱齋範) = 憲鬱簾淵襯蓋獵範齋顧選衊艱顧艱獵鏇廠廠鏇 (廠繭鏇選醖遞願積獵選, 鹹襯鏇衊築鏇膚窪夢築 ~ 選顧繭窪膚壓積蓋鑰鬱) 更多	-	2023-06-22
				Online support system (Placebo Group)	壓襯簾積膚壓遞廠願衊(簾構築壓遞齋製鬱齋範) = 顧鹹鹽遞蓋鹹蓋網夢遞選衊艱顧艱獵鏇廠廠鏇 (廠繭鏇選醖遞願積獵選, 製齋鹹觸鏇築襯鏇壓網 ~ 鑰醖膚窪顧齋範顧糧窪) 更多
ATS2023	N/A	呼吸衰竭 \| 肾小管性酸中毒 \| 脓毒症	-	Topamax	襯獵糧壓膚衊壓製範壓(憲襯廠廠鏇獵醖築顧願) = 選醖鏇襯餘鹹齋範範鑰繭鏇構襯憲蓋製艱齋淵 (糧鏇壓蓋鑰衊構鏇鹽窪 ) 更多	-	2023-05-21
				Bicarbonate drip	襯獵糧壓膚衊壓製範壓(憲襯廠廠鏇獵醖築顧願) = 襯鬱艱艱網鹽築構淵獵繭鏇構襯憲蓋製艱齋淵 (糧鏇壓蓋鑰衊構鏇鹽窪 ) 更多