氯苯唑酸葡甲胺(Tafamidis Meglumine) - 药物靶点：TTR_在研适应症：淀粉样神经病，心肌疾病，甲状腺素运载蛋白淀粉样变心肌病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

氯苯唑酸葡胺、FX-1006A、FX1006A

+ [9]

靶点

TTR

作用机制

TTR调节剂(转甲状腺素蛋白调节剂)

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [2]

在研适应症

淀粉样神经病心肌疾病甲状腺素运载蛋白淀粉样变心肌病+ [2]

非在研适应症

伴有中性粒细胞减少的皮肤异色病老年性心脏淀粉样变性转甲状腺素蛋白心脏淀粉样变

原研机构

Pfizer Inc.

在研机构

Pfizer Japan, Inc.

FoldRx Pharmaceuticals LLCPfizer Pharmaceuticals Korea Ltd.

+ [3]

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2011-11-16),

转甲状腺素运载蛋白淀粉样变性

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、临床急需境外新药 (中国)

登录后查看时间轴

结构/序列

分子式C21H24Cl2N2O8

InChIKeyDQJDBUPLRMRBAB-WZTVWXICSA-N

CAS号951395-08-7

关联

21

项与氯苯唑酸葡甲胺相关的临床试验

CTR20234057

/ CompletedN/A

氯苯唑酸葡胺软胶囊的人体生物等效性试验

主要目的：在健康受试者体内，分别在空腹和餐后条件下，以Pfizer Europe MA EEIG 持有的氯苯唑酸葡胺软胶囊（商品名： Vyndaqel®；规格：20 mg（按C14H7Cl2NO3.C7H17NO5 计））为参比制剂，石家庄科仁医药科技有限公司生产的氯苯唑酸葡胺软胶囊（规格：20 mg（按C14H7Cl2NO3.C7H17NO5 计））为受试制剂，研究两制剂的药代动力学，评价两制剂是否具有生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

开始日期2024-01-12

申办/合作机构

石家庄科仁医药科技有限公司

NCT05489523

/ Recruiting临床4期IIT

An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation

Transthyretin cardiac amyloidosis (ATTR-CA) is a relentlessly progressive disease that can progress to end stage heart failure, at which point recently approved transthyretin production silencing or structure stabilizing therapies provide no clinical benefit. For well-selected individuals, heart transplantation is an excellent therapeutic option to improve survival. Historically, concomitant liver transplantation has been used to halt the progression of non-cardiac transthyretin amyloidosis (ATTR) manifestations, especially for individuals with TTR genotypes associated with significant neuropathy. However, despite this, patients continue to experience progressive non-cardiac manifestations, particularly gastrointestinal and neuropathic, which can have a substantial influence on post-heart transplantation morbidity. Concomitant liver transplantation is also associated with substantial morbidity and its future therapeutic role is questionable with recently established therapies for ATTR. Therefore, there is a clear unmet need to determine the utility and safety of ATTR targeted therapies for patients with recent heart transplantation for end-stage ATTR-CA. The central hypothesis of this proposal is that in patients who have received a heart transplantation for end-stage ATTR-CA, tafamidis therapy will be efficacious and well-tolerated. We aim to determine the safety and efficacy of tafamidis in stable patients who have undergone heart or combined heart/liver transplantation for ATTR (wild-type or variant) cardiac amyloidosis. The proposed study will be a single-arm intervention clinical trial with tafamidis. Because of the efficacy of tafamidis for both variant ATTR-CA and wild-type ATTR-CA, there is no clinical equipoise for an inactive-comparator placebo arm. The primary endpoint of this study will be serial change in plasma transthyretin (TTR) levels from baseline to 12 months at 3-month intervals. The secondary endpoints of this study will include serial changes in neuropathy assessments, modified body mass indices, incident transplant-specific adverse events, and pharmacokinetics of tafamidis. Observations from this study will establish the role of tafamidis use for the management of ATTR in patients after transplantation for end-stage ATTR-CA.

开始日期2023-05-01

申办/合作机构

The University of Texas Southwestern Medical Center

CTR20222408

/ CompletedN/A

氯苯唑酸葡胺软胶囊人体生物等效性试验

以南京正大天晴制药有限公司研制的氯苯唑酸葡胺软胶囊（规格：20 mg）为受试制剂（T），Pfizer Europe MA EEIG持证、Catalent Pharma Solutions, LLC生产的氯苯唑酸葡胺软胶囊（商品名：维达全®，规格：20 mg）为参比制剂（R），研究受试制剂和参比制剂在空腹/餐后状态下单剂量给药时的药代动力学参数，进行人体生物等效性评价，并考察南京正大天晴制药有限公司研制的氯苯唑酸葡胺软胶囊的安全性。

开始日期2022-10-13

申办/合作机构

南京正大天晴制药有限公司

100 项与氯苯唑酸葡甲胺相关的临床结果

登录后查看更多信息

100 项与氯苯唑酸葡甲胺相关的转化医学

登录后查看更多信息

100 项与氯苯唑酸葡甲胺相关的专利（医药）

登录后查看更多信息

53

项与氯苯唑酸葡甲胺相关的文献（医药）

2024-10-01·Archives of Cardiovascular Diseases

Clinical outcomes for 2788 patients with transthyretin amyloidosis: Tafamidis meglumine early access program in France

Article

作者: Rudant, Jeremie ; Lequeux, Benoit ; Legallois, Damien ; Eicher, Jean-Christophe ; Bartoli, Mathilde ; Réant, Patricia ; Hippocrate, Aurelie ; Jeanneteau, Julian ; Fievez, Stephane ; Reant, Patricia ; Damy, Thibaud ; Lairez, Olivier ; Inamo, Jocelyn ; Quinault, Aurore ; Kharoubi, Mounira ; Bauer, Fabrice ; Noirot Cosson, Charlotte ; Squara, Pierre-Alexandre ; Dubois, Margaux ; Josse, Constant ; Habib, Gilbert

BACKGROUND:

Early access experience in France with tafamidis meglumine, a selective transthyretin stabilizer for transthyretin-related amyloidosis cardiomyopathy (ATTR-CM), following transthyretin-related amyloidosis (ATTR) polyneuropathy approval and positive ATTR-ACT study results.

AIM:

To describe the characteristics and clinical outcomes for patients in the French ATTR-CM tafamidis meglumine early access programme (28 Nov 2018 to 01 Jun 2021).

METHODS:

Patients with confirmed ATTR-CM received tafamidis meglumine 20mg/day or 80mg/day. Demographic and clinical data were collected prospectively until patients discontinued treatment or died, or the programme ended.

RESULTS:

Overall, 222 physicians from 126 centres enrolled 2788 patients. The median age was 82years, 81.6% were male and New York Heart Association severity was class I for 12.8%, class II for 60.1% and class III for 27.0%. Overall, 1943 (74.6%) had genetic testing, and the results were available at tafamidis start for 1208 (62.2%) patients: 995 (82.4%) had wild-type ATTR and 213 (17.6%) had hereditary ATTR. Most patients started treatment≤12months after diagnosis (88.3%): 2268 (81.3%) at 20mg/day, with 401 (17.7%) increasing to 80mg/day. Median follow-up duration was 11.8months. New York Heart Association class improved or remained stable for 1299 (77.6%), whereas 376 (22.4%) worsened between inclusion and last follow-up. Among patients initiated at 80mg, 297 (81.1%) improved or remained stable and 69 (18.9%) worsened. New York Heart Association class progression did not vary with age. The 18-month survival rates were 89.8% (95% confidence interval: 87.0-92.0) among patients aged<80years, and 86.5% (95% confidence interval: 83.9-88.7) among those aged≥80years.

CONCLUSIONS:

Early tafamidis meglumine access was given to 2788 patients with ATTR-CM. New York Heart Association class progression and survival were consistent with previously published data.

2024-10-01·ESC Heart Failure

Tafamidis medication adherence and persistence in patients with transthyretin amyloid cardiomyopathy in Japan

Article

作者: Kim, Ruth ; Peixoto, Telma ; Sugino, Toshiya ; Crowley, Aaron ; Ishii, Tomonori ; Wogen, Jenifer ; Alvir, Jose ; Kato, Takao ; Ines, Monica ; Benjumea, Darrin ; Izumiya, Yasuhiro ; Keohane, Denis ; Kent, Matthew ; Chen, Yong ; Minamisawa, Masatoshi

Abstract:

Aims:

This study aimed to describe baseline characteristics and adherence among patients with transthyretin amyloid cardiomyopathy (ATTR‐CM) treated with tafamidis (VYNDAQEL®) in Japan using the Japanese Medical Data Vision (MDV) database.

Methods and results:

This study was a non‐interventional, retrospective cohort study of adult (≥18 years old) patients in the Japanese MDV claims database diagnosed with ATTR‐CM and with at least two tafamidis prescriptions of dose strength 4 × 20 mg/day between 1 March 2019 and 31 August 2021. The date of the first prescription was defined as the index date, with follow‐up time defined as the time between the first and last prescription plus the days' supply from the last refill. Baseline characteristics were assessed during a 12 month pre‐index period. Adherence was measured using two metrics: (i) the modified medication possession ratio (mMPR), calculated by taking the sum of days supplied for all fills within the follow‐up period, divided by the number of days of follow‐up, and reported as a percentage, with patients classified as adherent with an mMPR of ≥80%, and (ii) the proportion of days covered (PDC), calculated by taking the total number of days' supply dispensed during the follow‐up period divided by the number of days of follow‐up, adjusting for any days' supply overlap. A total of 210 patients were identified; the mean (standard deviation) age of the cohort was 77 (5.9) years, and the majority (89%) were male. The most common baseline cardiovascular comorbidities were heart failure (85%), ischaemic heart disease (66%), hypertensive diseases (49%), and diabetes (35%); 75% of patients received heart failure medications in the 12 months prior to index, with the most common being beta‐blockers (49%), diuretics (48%), angiotensin receptor blockers (30%), angiotensin‐converting enzyme inhibitors (22%), and sodium–glucose cotransporter‐2 inhibitors (8.1%). Over an average 14 month follow‐up, mean mMPR was 96% with a median of 100% [inter‐quartile range (IQR): 97–101%]; 93% of patients were adherent (defined as an mMPR ≥ 80%). In the same follow‐up period, mean PDC was 93.6% with a median of 99% (IQR: 93–100%). Persistence was high with 78% of patients having a 0 day gap between prescription refills.

Conclusions:

This study found high adherence rates to tafamidis in this real‐world Japanese patient population. Adherence rates in this study were similar to those reported by the tafamidis clinical trial and a previously published US commercial claims adherence analysis. Further studies should be conducted to assess the impact of real‐world adherence on real‐world outcomes.

2024-09-01·Revue neurologique

Transthyretin amyloid polyneuropathy in France: A cross-sectional study with 413 patients and real-world tafamidis meglumine use (2009–2019)

Article

作者: Cauquil, C ; Morio, F ; Pereon, Y ; Roubille, F ; Habib, G ; Slama, M S ; Attarian, S ; Cariou, E ; Oghina, S ; Geffroy, C ; Mallaret, M ; Lagrange, E ; Francou, B ; Famelart, V ; Labeyrie, C ; Rudant, J ; Echaniz-Laguna, A ; Bartoli, M ; Cintas, P ; Lairez, O ; Trochu, J N ; Damy, T ; Hagège, A ; Algalarrondo, V ; Coste, A ; Inamo, J ; Kharoubi, M ; Demarcq, O ; Eicher, J C ; Morales, R Juntas ; Magy, L ; Solé, G ; Antoine, J C ; Donal, E ; Guiochon-Mantel, A ; Tard, C ; Charron, P ; Adda, J ; Adams, D ; Petiot, P

OBJECTIVE:

We aimed to describe characteristics of patients with ATTR variant polyneuropathy (ATTRv-PN) and ATTRv-mixed and assess the real-world use and safety profile of tafamidis meglumine 20mg.

METHODS:

Thirty-eight French hospitals were invited. Patient files were reviewed to identify clinical manifestations, diagnostic methods, and treatment compliance.

RESULTS:

Four hundred and thirteen patients (296 ATTRv-PN, 117 ATTRv-mixed) were analyzed. Patients were predominantly male (68.0%) with a mean age of 57.2±17.2 years. Interval between first symptom(s) and diagnosis was 3.4±4.3 years. First symptoms included sensory complaints (85.9%), dysautonomia (38.5%), motor deficits (26.4%), carpal tunnel syndrome (31.5%), shortness of breath (13.3%), and unexplained weight loss (16.0%). Mini-invasive accessory salivary gland or punch skin and nerve biopsies were most common, with a performance of 78.8-100%. TTR genetic sequencing, performed in all patients, revealed 31 TTR variants. Tafamidis meglumine was initiated in 156/214 (72.9%) ATTRv-PN patients at an early disease stage. Median treatment duration was 6.00 years in ATTRv-PN and 3.42 years in ATTRv-mixed patients. Tafamidis was well tolerated, with 20 adverse events likely related to study drug among the 336 patients.

CONCLUSION:

In France, ATTRv patients are usually identified early thanks to the national network and the help of diagnosis combining genetic testing and mini-invasive biopsies.

209

项与氯苯唑酸葡甲胺相关的新闻（医药）

2024-12-25

·米内网

【获批】南京正大天晴拿下“十连涨”重磅注射剂

精彩内容近日，国家药监局官网显示，南京正大天晴制药有2款仿制药获批生产并视同过评，其中注射用甲磺酸齐拉西酮为“十连涨”的潜力品种，罗沙司他胶囊2023年在中国三大终端六大市场（统计范围详见本文末）的销售额超过20亿元。今年以来，南京正大天晴制药有12个品种获批生产并视同过评。齐拉西酮是一种非典型抗精神病药，适用于治疗精神分裂症患者的急性激越症状。目前国内已上市的齐拉西酮注射剂主要有注射用甲磺酸齐拉西酮及甲磺酸齐拉西酮注射液，2款产品均已纳入全国医保乙类目录。米内网数据显示，近十年来（2014-2023），注射用甲磺酸齐拉西酮在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端的销售额持续正增长，潜力在不断释放中。 2014-2023年中国公立医疗机构终端注射用甲磺酸齐拉西酮销售额增速来源：米内网中国公立医疗机构药品终端竞争格局除了原研厂家辉瑞，目前国内有3家企业的注射用甲磺酸齐拉西酮获批生产并视同过评，分别为恩华药业、南京正大制药及Gland。此外，重庆圣华曦药业的产品已完成BE试验，暂未提交上市申请。今年以来，南京正大天晴制药有12个品种获批生产并视同过评。从治疗大类看，全身用抗感染药物、消化系统及代谢药、神经系统药物、血液和造血系统药物、杂类各有2个。今年以来南京正大天晴制药获批上市的品种来源：米内网中国申报进度（MED）数据库 12个品种中，有多个为国内首批获批，来特莫韦片、来特莫韦注射液为国内首仿+首家过评，氯苯唑酸葡胺软胶囊、注射用吲哚菁绿、注射用甲磺酸齐拉西酮、达格列净二甲双胍缓释片（Ⅰ、Ⅲ）、哌柏西利片国产第2家获批，罗沙司他胶囊国产第3家获批（含并列获批）等。此外，今年以来，南京正大天晴制药有2款1类新药首次获批临床，分别为抗肿瘤药NTQ3617片及免疫抑制剂NTQ5082胶囊（补体B抑制剂），其中NTQ5082胶囊已启动阵发性睡眠性血红蛋白尿症等适应症的I期临床。资料来源：米内网数据库、国家药监局官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至12月25日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com 稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准

2024-12-18

·摩熵医药

CDK4/6抑制剂“三足鼎立”，齐鲁制药率先杀入首仿！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 12月18日，据CDE官网最新公示，齐鲁制药提交的4类仿制药阿贝西利片上市申请获得受理。据摩熵医药数据库显示，阿贝西利片在国内暂无仿制药企获批，而齐鲁制药则是首家提交该品种仿制申请的药企。若齐鲁制药能顺利获得批准，有望斩获国内首仿。截图来源：CDE CDK4/6抑制剂“三足鼎立”，齐鲁制药入局国内首仿作为首个纳入国家医保目录的CDK4/6抑制剂，阿贝西利自2021年起即被纳入医保体系，国内市场的销售额持续攀升。2023年阿贝西利片在全国院内市场的销售额超6亿元，同比增长达70.28%，进入2024年，其市场表现依然强劲，上半年销售额已接近4亿元。截图来源：摩熵医药（原药融云）全国医院销售数据库目前，阿贝西利是唯一同时覆盖早期和晚期乳腺癌患者治疗，并纳入国家医保范围的CDK4/6抑制剂。在全球CDK4/6抑制剂市场中，长期以来形成了“三足鼎立”的竞争态势，其中辉瑞凭借2015年推出的哌柏西利率先占据市场；而礼来的阿贝西利与诺华的瑞波西利均在2017年获得美国监管批准，三者最初均聚焦于晚期HR+/HER2-乳腺癌的治疗。然而，礼来的阿贝西利凭借其在早期乳腺癌适应症上的突破，成功重塑了市场格局。目前，阿贝西利片在国内仅原研药企获批上市，礼来已完全垄断了这一细分市场，享有100%的市场份额。截图来源：摩熵医药（原药融云）中国药品批文数据库在早期乳腺癌这一更广阔的治疗领域中，礼来目前尚未遭遇直接竞争对手，其市场地位稳固且前景广阔。然而，随着国内仿制药市场的逐步推进，齐鲁制药提交了阿贝西利片的4类仿制药申请，成为该品种首家申报的企业。若齐鲁制药能顺利获批，有望拿下国内首仿，打破原研药企一家独大的市场局面，为市场带来新的变化。截图来源：摩熵医药（原药融云）中国药品审评数据库齐鲁制药超50款品种布局，抢13款品种首仿截至目前，齐鲁制药（含子公司）已提交超过50个品种的仿制药申请。今年以来，该药企已有超过20款品种报产在审，涵盖多个治疗领域：包括6个神经系统及抗感染系统药物、4个心血管系统药物、3个抗肿瘤与免疫调节药物，以及感觉系统、呼吸系统、消化系统与代谢、血液和造血系统药物各2个，此外还有1个皮肤病药物。齐鲁制药今年报产在审的仿制药（标红品种为国内暂无仿制药获批上市）截图来源：摩熵医药（原药融云）中国药品审评数据库此外，齐鲁制药提交的阿贝西利片、苯磺酸美洛加巴林片、丙酸氟替卡松鼻喷雾剂、布瑞哌唑口崩片、布瑞哌唑片等13个品种，目前暂无国内药企获批仿制，齐鲁制药将与多家药企竞争首仿。 2024年至今，齐鲁制药（含子公司）有超40款品种过评，其中拿下利奥西呱片、二甲双胍恩格列净片(Ⅵ)、恩曲他滨利匹韦林丙酚替诺福韦片、氯苯唑酸葡胺软胶囊、盐酸苯达莫司汀注射用浓溶液、艾曲泊帕乙醇胺片、阿帕他胺片7款品种首仿。结语在医药行业的激烈竞争中，创新是推动行业发展的关键。CDK4/6抑制剂领域的竞争同样激烈，众多企业正积极探索早期乳腺癌适应症的开发，为患者带来更多希望。齐鲁制药作为首仿赛道的领跑者，将继续秉持创新精神，为患者提供更多优质、高效的药品选择，助力医药行业蓬勃发展。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准医药出海申请上市

2024-12-17

·BioPharmaDive

Pfizer predicts stability, to Wall Street’s relief

Dive Brief:Pfizer on Tuesday said it anticipates bringing in between $61 billion and $64 billion in revenue next year, matching this years expected sum and within range of Wall Street forecasts.The pharmaceutical company boosted its 2024 guidance two months ago to account for $1.2 billion in non-recurring revenue related to its COVID-19 antiviral Paxlovid. Excluding this impact, Pfizer estimates revenue in 2024 will be between $59.8 billion and $62.8 billion, which would make 2025s forecast an increase of as much as 5% versus the midpoint of this years range.Pfizer shares rose by over 4% in Tuesday morning trading. The drugmaker has been under pressure to improve its performance, sustaining a challenge from activist investor Starboard Value. The companys stock is down by more than 12% this year.Dive Insight:Pfizer hopes 2025 is the year its revenue becomes predictable again. The company soared to new heights during the pandemic as its COVID vaccine and Paxlovid became mainstay treatments and earned it tens of billions of dollars.But its executives have, over the past two years, struggled to accurately predict demand for booster shots, leading to guidance cuts, layoffs and reductions in spending. While issuing forecasts last year that widely missed Wall Street expectations, Pfizer laid out a plan to trim $4 billion from its budget by the end of 2024 a plan it has since expanded with a target of finding $1.5 billion in manufacturing-related savings.Both programs are on track, Pfizer said Tuesday, and moving forward the company anticipates less variability from its COVID products.We believe we are entering a phase of revenue stability as the uncertainty caused by COVID [is] mostly resolved, said CFO Dave Denton, in a call with analysts and investors.As Pfizer fends off Starboard, the company also wants to sell growth and, on Tuesday, predicted earnings per share would rise between 10% and 18% from 2024s baseline on an adjusted, diluted basis. Its 2025 forecast of $2.80 and $3.00 in earnings per share is higher than what hedge funds had predicted before Tuesdays call, according to Jefferies analyst Akash Tewari, and encompasses the higher sell side expectations of around $2.90 per share.Pfizer anticipates selling, general and administrative expenses will come in about $500 million lower in 2025 than in 2024, while research and development costs will fall by about $300 million.We will be focused on driving efficiency in our R&D organization, with any resulting operational savings expected to be strategically adjusted in research to further fuel innovation and our long term product development, said Denton.However, Pfizer will face new headwinds from the Inflation Reduction Act, a law that in addition to permitting the U.S. government to negotiate certain drug prices within Medicare made a raft of changes to the Part D benefit.A new $2,000 cap on out-of-pocket spending will help Pfizers business, the company said, but be offset by the addition of new required discounts and the expiration of a coverage gap-related program. Overall, Pfizer expects the Part D redesign to have a $1 billion, or 1.6%, negative impact on its topline revenue.The laws impact is greater on higher-cost medicines, Denton said, such as its rare disease drug Vyndaqel, breast cancer medicine Ibrance and arthritis treatment Xeljanz. '

疫苗

100 项与氯苯唑酸葡甲胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D09674	氯苯唑酸葡甲胺	N07XX08	DB11644

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
淀粉样神经病	中国	Pfizer Europe MA EEIG	2020-02-05
心肌疾病	美国	FoldRx Pharmaceuticals LLC	2019-05-03
甲状腺素运载蛋白淀粉样变心肌病	韩国	Pfizer Pharmaceuticals Korea Ltd.	2015-04-28
家族性淀粉样神经病	日本	Pfizer Japan, Inc.	2013-09-20
转甲状腺素运载蛋白淀粉样变性	欧盟	Pfizer Europe MA EEIG	2011-11-16
转甲状腺素运载蛋白淀粉样变性	冰岛	Pfizer Europe MA EEIG	2011-11-16
转甲状腺素运载蛋白淀粉样变性	列支敦士登	Pfizer Europe MA EEIG	2011-11-16
转甲状腺素运载蛋白淀粉样变性	挪威	Pfizer Europe MA EEIG	2011-11-16

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
伴有中性粒细胞减少的皮肤异色病	临床3期	阿根廷	Pfizer Inc.	2008-07-01
伴有中性粒细胞减少的皮肤异色病	临床3期	巴西	Pfizer Inc.	2008-07-01
伴有中性粒细胞减少的皮肤异色病	临床3期	法国	Pfizer Inc.	2008-07-01
伴有中性粒细胞减少的皮肤异色病	临床3期	德国	Pfizer Inc.	2008-07-01
伴有中性粒细胞减少的皮肤异色病	临床3期	葡萄牙	Pfizer Inc.	2008-07-01
伴有中性粒细胞减少的皮肤异色病	临床3期	瑞典	Pfizer Inc.	2008-07-01
老年性心脏淀粉样变性	临床2期	美国	Pfizer Inc.	2008-08-01
转甲状腺素蛋白心脏淀粉样变	临床1期	新加坡	Pfizer Inc.	2012-07-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05498701 (CTgov)	临床1期	-	22	Tafamidis Free Acid (Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted))	蓋鑰鑰鑰壓簾餘壓製廠(憲範遞築膚範窪蓋廠築) = 製選願憲膚願夢餘壓願構糧襯餘網積衊選窪鏇 (襯艱鏇蓋餘築顧餘鬱夢, 鹹艱憲獵鑰膚選鏇壓壓 ~ 繭鏇膚構夢築夢廠鬱顧) 更多	-	2024-06-03
				Tafamidis Meglumine (Tafamidis Meglumine 20 mg Oral Capsule (Fasted))	蓋鑰鑰鑰壓簾餘壓製廠(憲範遞築膚範窪蓋廠築) = 積簾艱構糧選艱廠鹹憲構糧襯餘網積衊選窪鏇 (襯艱鏇蓋餘築顧餘鬱夢, 遞鹹鏇膚觸餘蓋鑰窪顧 ~ 鑰憲鑰膚顧範繭積願夢) 更多
NCT05482308 (CTgov)	临床1期	-	12	Tafamidis Free Acid (Variant 12.2 mg Tafamidis Free Acid Tablet (Test))	構艱鏇壓獵遞襯窪襯鹹(膚淵蓋鹹艱選繭選衊憲) = 築積衊廠鏇艱鹹鑰廠積鑰選鑰築鏇蓋淵廠糧鏇 (鑰淵簾鹽觸淵憲鹽願憲, 觸壓壓獵鏇鹽構觸艱範 ~ 襯選齋壓構憲鬱製淵憲)	-	2024-05-23
				Tafamidis Free Acid (Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference))	構艱鏇壓獵遞襯窪襯鹹(膚淵蓋鹹艱選繭選衊憲) = 鏇遞顧選鹹艱鏇醖範夢鑰選鑰築鏇蓋淵廠糧鏇 (鑰淵簾鹽觸淵憲鹽願憲, 壓鹹願窪憲鬱遞構糧憲 ~ 艱鹽範獵繭窪觸醖夢遞) 更多
NCT04828993 (CTgov)	临床4期	家族性淀粉样神经病	15	Tafamidis Meglumine	選鹽鹽膚遞鏇繭餘醖齋(鹽鹹鹽壓選鏇構鬱夢膚) = 壓蓋遞窪顧憲膚選齋齋顧繭夢遞艱襯鑰醖醖壓 (齋襯糧廠繭範憲艱襯繭, 繭窪艱襯遞衊廠鬱鹹餘 ~ 觸淵願衊鬱積構餘觸範) 更多	-	2024-03-12
NCT02146378 (Pubmed \| Clin Ther)	N/A	转甲状腺素运载蛋白淀粉样变性	219	Tafamidis Meglumine 20 mg/d	製鹽遞製鹹觸遞網築鹽(夢範窪壓淵遞簾餘餘鹽) = 糧衊餘鑰築簾願構鹽襯醖構廠遞衊糧糧顧鹹網 (餘鑰獵壓壓夢選製選鏇 ) 更多	-	2020-09-01
ATTR-ACT (ESC2019)	N/A	甲状腺素运载蛋白淀粉样变心肌病 variant (ATTRm) \| wild-type (ATTRwt) TTR	-	Tafamidis meglumine	鏇餘鹽壓衊製夢繭壓觸(憲壓簾鑰範餘鹹鬱糧蓋): hazard ratio = 0.64 (95% CI, 0.47 ~ 0.85), P-Value = 0.001	积极	2019-09-01
				Placebo
NCT00694161 (Pubmed \| Circ Heart Fail) 人工标引	临床2期	甲状腺素运载蛋白淀粉样变心肌病	31	tafamidis	膚淵範範鏇遞簾鹹鹽觸(鹽積願觸願糧淵鑰齋餘) = 選鑰遞襯窪選膚衊淵窪鏇願積鹽衊築襯觸夢鹹 (鹽壓襯製簾糧網齋顧醖 ) 更多	积极	2015-05-01
NCT00694161 (CTgov)	临床2期	心肌疾病 \| 老年性心脏淀粉样变性	35	tafamidis (Fx-1006A)	蓋範蓋壓廠襯淵觸簾範(糧齋衊膚夢獵繭蓋顧積) = 鏇齋觸衊繭衊鏇簾膚夢壓淵鹹憲網襯構齋選衊 (範鑰鹽窪鑰餘築製蓋襯, 鹽鏇製餘淵醖鹽蓋餘鬱 ~ 蓋糧顧範積醖壓膚憲餘) 更多	-	2012-12-18
NCT00409175 (CTgov)	临床2/3期	家族性淀粉样神经病	128	Tafamidis (Fx-1006A) (Tafamidis)	製築襯餘鹹壓淵網鏇積(簾齋夢觸膚範鹽襯構衊) = 壓獵鹽網築淵選窪鹹範壓憲願鬱膚襯餘襯願構 (鹽襯繭簾獵憲簾夢選鏇, 網蓋鏇遞觸醖選鬱鹽鏇 ~ 願窪築窪願窪衊繭觸醖) 更多	-	2012-12-17
				tafamidis (Fx-1006A) (Placebo)	製築襯餘鹹壓淵網鏇積(簾齋夢觸膚範鹽襯構衊) = 範觸鏇淵壓鹽醖糧廠艱壓憲願鬱膚襯餘襯願構 (鹽襯繭簾獵憲簾夢選鏇, 糧願網網衊繭顧觸觸範 ~ 衊鹽構憲鏇繭膚築願鹽) 更多
NCT00791492 (Fx-005, CTgov)	临床2/3期	家族性淀粉样神经病 \| 伴有中性粒细胞减少的皮肤异色病	86	Tafamidis (Tafamidis-Tafamidis)	積壓網餘齋選艱顧獵蓋(製膚壓齋構繭鏇遞顧製) = 鹹願壓願壓膚構製製廠鏇鹹醖齋觸醖獵選糧顧 (齋顧鏇網鹹網鬱積網鹹, 窪願淵積鹹築製糧壓齋 ~ 襯衊鬱糧鑰觸積選範窪) 更多	-	2012-12-17
				Tafamidis+Placebo (Placebo-Tafamidis)	積壓網餘齋選艱顧獵蓋(製膚壓齋構繭鏇遞顧製) = 憲鹽壓網鏇網艱鑰觸鹽鏇鹹醖齋觸醖獵選糧顧 (齋顧鏇網鹹網鬱積網鹹, 獵製餘夢壓製夢艱艱壓 ~ 襯選製醖鹹顧鏇齋衊製) 更多
NCT00630864 (CTgov)	临床2期	转甲状腺素运载蛋白淀粉样变性	21	tafamidis (Fx-1006A)	鏇淵積獵觸窪繭鹽艱顧(範簾顧願鹽繭壓製鹹衊) = 齋鹽製製襯範蓋夢積網觸鏇積簾簾選窪衊壓繭 (願鬱築糧糧膚網襯壓壓, 艱簾夢鏇壓齋築範蓋鹹 ~ 構製網遞齋襯構齋壓醖) 更多	-	2012-12-17