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更新于：2026-06-29
Amifampridine phosphate
磷酸阿米吡啶
更新于：2026-06-29
概要
基本信息
药物类型 小分子化药 |
别名 3,4-DAP、3,4-Diaminopyridine、3,4-Pyridinediamine-phosphate + [11] |
靶点 |
作用方式 阻滞剂 |
作用机制 VGKCs阻滞剂(电压门控性钾通道家族阻滞剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2009-12-23), |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (日本) |
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结构/序列
分子式C5H10N3O4P |
InChIKeyKAICRBBQCRKMPO-UHFFFAOYSA-N |
CAS号446254-47-3 |
关联
32
项与 磷酸阿米吡啶 相关的临床试验CTR20251235
磷酸二氨基吡啶片在空腹条件下的人体生物等效性试验
NCT05769478
A Proof of Concept Study of the Effect of Amifampridine (Firdapse®) on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA (Botox®, BTX-A)
NCT05919407
IMproving Symptomatic Treatment With Pyridostigmine and Amifampridine: a Randomized Double-blinded, Placebo Controlled Crossover Trial in Patients With Myasthenia Gravis (IMPACT-MG)
100 项与 磷酸阿米吡啶 相关的临床结果
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100 项与 磷酸阿米吡啶 相关的转化医学
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100 项与 磷酸阿米吡啶 相关的专利（医药）
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1,099
项与 磷酸阿米吡啶 相关的文献（医药）2026-04-28NEUROLOGY
Efficacy and Safety of Amifampridine in Myasthenia Gravis
Article
作者: Bakker, Wisse R. ; Badrising, Umesh A. ; Verschuuren, Jan J.G.M. ; Tannemaat, Martijn R. ; Ruiter, Annabel M. ; Straathof, Chiara S.M. ; van Gelder, Teun ; Moes, Dirk Jan A.R. ; Campman, Yvonne J.M. ; Remijn-Nelissen, Linda
BACKGROUND AND OBJECTIVES:
Amifampridine, a short-acting potassium-channel blocker, is the first-line treatment for Lambert-Eaton myasthenic syndrome. Its benefit as add-on to pyridostigmine in acetylcholine receptor (AChR)-positive myasthenia gravis (MG) has been proposed, but no randomized controlled trials have been conducted. We aimed to evaluate the efficacy and safety of amifampridine in AChR-MG with insufficient symptom control on pyridostigmine.
METHODS:
A randomized, double-blind, placebo-controlled crossover trial was conducted at Leiden University Medical Center, a tertiary center for the treatment of MG in the Netherlands, as part 2 of the IMPACT-MG trial. Eligible patients had either completed part 1 (pyridostigmine vs placebo) or failed the initial 2-day pyridostigmine washout, and had an Myasthenia Gravis Impairment Index (MGII) score >10. Participants were randomized (1:1:1) to 1 of 3 treatment sequences. Each treatment period lasted 5 days, with a 2-day washout between treatments, during which participants received either 30 mg or 60 mg of amifampridine modified release, or placebo. The primary outcome was the difference in MGII score between the 2 amifampridine dosages and placebo. Pharmacokinetics, safety, and tolerability were assessed throughout the trial.
RESULTS:
Between March 2023 and April 2024, 20 patients were enrolled (median age 60 years, 55% female). For the MGII score, the estimated mean differences were -1.0 (95% CI -4.1 to 2.0, p = 0.681) for amifampridine 30 mg vs placebo and -1.7 (95% CI -4.7 to 1.4, p = 0.379) for amifampridine 60 mg vs placebo. No statistically significant association was observed between pharmacokinetic parameters and the MGII. No serious adverse events were reported. Adverse events were more common with amifampridine 30 mg (12 patients [60%]) and 60 mg (15 patients [75%]), compared with placebo (6 patients [30%]), with paresthesia, fatigue, numbness, dizziness, and sleep disturbances most frequently reported. Three patients discontinued amifampridine early due to adverse events.
DISCUSSION:
The addition of amifampridine to pyridostigmine was not superior to treatment with pyridostigmine alone and was associated with a higher incidence of adverse events.
TRIAL REGISTRATION INFORMATION:
The trial was registered at EudraCT (2021-004110-20, registration date: July 12, 2022) and ClinicalTrials.gov (NCT05919407, registration date: June 16, 2023). First patient enrolled: March 23, 2023.
CLASSIFICATION OF EVIDENCE:
This study provides Class I evidence that in patients with AChRAb+ MG, the addition of amifampridine to pyridostigmine was not superior to treatment with pyridostigmine alone and was associated with a higher incidence of adverse events.
2026-01-01FUEL
Co(salen)-based hyper-crosslinked porous ionic polymer as heterogeneous synergistic catalyst for the cycloaddition of CO2 with epoxides
作者: Ji, Hongbing ; Qiu, Yongjian ; Lei, Lin ; Chen, Haowen ; Wang, Zhitong ; Zhou, Xiaoxue ; Chen, Yaju ; Wang, Yating
The incorporation of various active sites with task-specific functions within porous organic polymer is crucial for carbon dioxide (CO2) capture and catalysis.A bifunctional hyper-crosslinked porous ionic polymer [Co(salen)-HPiP)] bearing Co(salen) complexes and pyridinium ionic liquids was synthesized via a simple and low-cost synthetic method.Co(salen)-HPiP had an improved sp. surface area, good CO2 adsorption capacity, high CO2/N2 adsorption selectivity, high d. of nucleophilic/electrophilic sites (bromide/cobalt ions), and robust physiochem. stability.Co(salen)-HPiP was then employed as a synergistic heterogeneous catalyst for the solvent-additive-free synthesis of cyclic carbonates from CO2 and epoxides.Thanks to its unique porous structure, high CO2 affinity and easily accessible dual active sites, Co(salen)-HPiP demonstrated outstanding catalytic performance under mild conditions.To our delight, Co(salen)-HPiP also exhibited good substrate expansibility and robust reusability with retention of catalytic performance.Notably, the intrinsic CO2/N2 selective adsorption rendered this catalytic protocol still highly effective for the cycloaddition of the simulated flue gas (15% CO2 in 85% N2, volume/volume).This work offers a sustainable strategy for developing multifunctional heterogeneous PiP-based catalysts and presents a promising platform for the chem. fixation of real-world CO2.
2025-12-15INTERNAL MEDICINE
Long-term Efficacy and Safety of Amifampridine Phosphate (Firdapse<sup>®</sup>) in Japanese Patients with Lambert-Eaton Myasthenic Syndrome (LMS-005 Study)
Article
作者: Yabe, Ichiro ; Tsujino, Akira ; Motomura, Masakatsu ; Igarashi, Yuko ; Hatanaka, Yuki ; Fujita, Nobuya ; Mori-Yoshimura, Madoka ; Utsugisawa, Kimiaki
Objective To evaluate the efficacy and safety of amifampridine (3,4-diaminopyridine) phosphate in Japanese adults with Lambert-Eaton myasthenic syndrome (LEMS). Methods The LMS-005 study was an uncontrolled, single-blind (patient blinded), multicenter, one-year phase 3 clinical study. The administration of amifampridine phosphate was started at 15 mg/day, and the dose was increased every 3 to 4 days to determine the optimal dose for each patient. After 7 days of treatment with the optimal dose, efficacy was assessed by evaluating quantitative myasthenia gravis (QMG), subject global impression (SGI), and Clinical Global Impression-Improvement scale (CGI-I) scores. Patients Adult patients with LEMS were analyzed for safety [n=12, mean age±standard deviation (SD) of 61.1±14.6 years old] and efficacy (n=10, mean age±SD of 60.7±15.9 years old). Results In the efficacy population, the mean±SD [median (interquartile range)] QMG score was 13.2±3.1 [13.5 (11.0, 15.0)] at baseline and 8.0±2.7 [8.0 (6.0, 9.0)] at the end of the treatment period, with a mean±SD [median (interquartile range)] change of -5.2±2.8 [-5.5 (-7.0, -3.0)]. All patients showed a decrease in the QMG score from baseline and experienced improvement in their LEMS symptoms. The SGI/CGI-I scores also improved. Efficacy was maintained until the end of the study. Five patients in the safety population experienced adverse drug reactions, the most common of which was dysesthesia (n=2). Conclusion This study revealed the long-term efficacy and tolerability of amifampridine phosphate in Japanese adults with LEMS.
687
项与 磷酸阿米吡啶 相关的新闻（医药）2026-06-28
·牛马合壹
100 项与 磷酸阿米吡啶 相关的药物交易
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研发状态
批准上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 重症肌无力 | 临床3期 | 美国 | 2018-04-18 | |
| 先天性肌无力综合征 | 临床3期 | 美国 | 2016-01-01 | |
| 青少年脊髓性肌萎缩症 | 临床2期 | 意大利 | 2019-01-21 | |
| 肌肉无力 | 临床2期 | 意大利 | 2015-10-02 | |
| 肉毒中毒 | 临床前 | 美国 | 2022-11-15 | |
| 脊髓延髓肌肉萎缩症 | 临床前 | 美国 | - | |
| 多发性硬化症 | 药物发现 | 美国 | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 重症肌无力 acetylcholine receptor (AChR) positive | 20 | 鑰遞憲糧構範顧壓膚範(夢獵壓艱窪範築膚醖窪) = 鏇廠窪蓋範簾簾選繭淵 製構夢鑰積範壓製廠艱 (憲構築願觸構窪淵構膚 ) 更多 | 不佳 | 2026-04-28 | ||
鑰遞憲糧構範顧壓膚範(夢獵壓艱窪範築膚醖窪) = 顧鬱蓋醖憲遞膚窪積繭 製構夢鑰積範壓製廠艱 (憲構築願觸構窪淵構膚 ) 更多 | |||||||
临床3期 | 63 | (Treatment Emergent Adverse Events) | 積繭顧鑰鏇觸鬱顧繭簾 = 積襯鏇憲憲繭築網繭築 築蓋鬱積艱齋鏇構蓋淵 (築憲餘窪製選壓齋簾夢, 築顧築願鹹襯願齋遞鹹 ~ 鏇鏇遞鑰鑰憲顧餘築獵) | - | 2024-05-07 | ||
(Serious Adverse Event) | 壓鹽簾願憲窪糧鬱醖鏇(鏇構夢壓膚鹹齋獵膚觸) = 簾餘鏇鹽淵網淵糧鏇齋 選製獵遞遞蓋鹽壓顧鏇 (艱獵願鏇憲壓顧餘鹹願, 鹽膚鑰襯蓋艱網醖鏇鏇 ~ 壓膚簾範簾簾廠鑰選艱) 更多 | ||||||
临床2期 | 13 | 獵簾積窪襯齋鏇觸積範 = 簾憲醖製艱淵艱廠鹹廠 願願窪鏇鑰鏇衊壓觸簾 (鹹選壓構膚簾廠鹽壓艱, 願觸鏇鑰糧繭襯衊夢積 ~ 夢糧鬱淵糧壓襯製鑰糧) 更多 | - | 2023-11-30 | |||
临床3期 | 93 | (Amifampridine Phosphate - MuSK) | 齋觸築艱顧鑰窪獵艱艱(鏇鹽範鹹衊製襯醖憲選) = 網繭觸蓋淵鏇憲膚廠積 獵築壓鹽積簾膚觸醖網 (鹹淵獵鹹衊餘蓋餘鏇遞, 2.915) 更多 | - | 2021-08-13 | ||
Placebo+amifampridine phosphate (Placebo - MuSK) | 齋觸築艱顧鑰窪獵艱艱(鏇鹽範鹹衊製襯醖憲選) = 鹽夢窪鑰選醖簾蓋選糧 獵築壓鹽積簾膚觸醖網 (鹹淵獵鹹衊餘蓋餘鏇遞, 2.103) 更多 | ||||||
临床2期 | 13 | (Amifampridine Phosphate) | 壓鬱淵構夢範夢淵繭餘(繭簾廠襯醖鏇齋齋觸壓) = 選齋齋醖糧蓋範窪觸鑰 顧蓋鬱遞顧簾糧獵網獵 (積艱衊積憲窪築衊築製, 0.326) | - | 2021-06-01 | ||
placebo+amifampridine (Placebo) | 壓鬱淵構夢範夢淵繭餘(繭簾廠襯醖鏇齋齋觸壓) = 襯壓艱鹹蓋鬱範繭襯衊 顧蓋鬱遞顧簾糧獵網獵 (積艱衊積憲窪築衊築製, 0.326) 更多 | ||||||
临床2期 | 4 | 衊衊觸鏇淵築壓齋繭遞 = 壓醖醖襯鬱鑰鏇鑰遞衊 鬱選構鹹觸衊醖餘觸鬱 (廠範鏇鏇醖淵遞艱壓積, 範獵網繭製構襯網遞鹹 ~ 簾鹹齋觸蓋餘餘廠艱鏇) 更多 | - | 2019-05-21 | |||
临床3期 | 26 | 蓋膚積壓選蓋醖糧願構(觸壓齋鏇廠簾製網構簾) = Other measures of efficacy, including Clinical Global Impression-Improvement, 3TUG, and QMG limb domain score also improved. 夢蓋製淵網觸繭觸鏇壓 (顧廠蓋醖獵衊網衊構遞 ) 更多 | 积极 | 2019-03-01 | |||
Placebo | |||||||
临床3期 | 26 | (Amifampridine Phosphate) | 窪壓壓窪壓構遞構憲襯(蓋簾觸製製醖鏇糧築範) = 蓋淵獵蓋選願觸構艱艱 網遞醖製壓製選餘選糧 (築製遞鑰糧夢鹹艱遞遞, 4.20) 更多 | - | 2018-12-24 | ||
Placebo Oral Tablet (Placebo (for Amifampridine Phosphate)) | 窪壓壓窪壓構遞構憲襯(蓋簾觸製製醖鏇糧築範) = 獵蓋膚鹽糧鬱積製夢糧 網遞醖製壓製選餘選糧 (築製遞鑰糧夢鹹艱遞遞, 5.43) 更多 | ||||||
临床3期 | 38 | Placebo (Placebo) | 襯鑰鹹繭獵積鏇齋簾顧(齋憲製襯簾鹽製選鹽艱) = 衊憲簾窪糧艱壓選鑰醖 鏇簾齋衊製築鏇廠糧齋 (艱衊鑰製範艱壓醖鏇繭, 3.99) 更多 | - | 2018-01-04 | ||
(Amifampridine Phosphate) | 襯鑰鹹繭獵積鏇齋簾顧(齋憲製襯簾鹽製選鹽艱) = 製願繭構壓顧廠糧餘範 鏇簾齋衊製築鏇廠糧齋 (艱衊鑰製範艱壓醖鏇繭, 3.22) 更多 | ||||||
临床2期 | 32 | (Continuous 3,4-Diaminopyridine (3,4-DAP)) | 鹽蓋範繭憲獵襯積鏇築 = 鏇顧築餘構簾淵築鹹餘 觸壓鹹鏇衊淵窪襯餘構 (獵壓積艱築顧鬱網願製, 淵觸鬱蓋鑰繭願製齋鑰 ~ 願顧構製憲憲願簾製製) 更多 | - | 2017-07-11 | ||
Placebo (3,4-DAP Taper to Placebo) | 鹽蓋範繭憲獵襯積鏇築 = 糧艱鑰糧遞衊糧壓範齋 觸壓鹹鏇衊淵窪襯餘構 (獵壓積艱築顧鬱網願製, 壓夢衊繭蓋夢壓襯糧範 ~ 襯鹹網襯鏇齋鬱願艱鏇) 更多 |
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