预约演示
更新于：2025-08-27
Macitentan
马昔腾坦
更新于：2025-08-27
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2013-10-18), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (澳大利亚) |
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结构/序列
分子式C19H20Br2N6O4S |
InChIKeyJGCMEBMXRHSZKX-UHFFFAOYSA-N |
CAS号441798-33-0 |
关联
91
项与 马昔腾坦 相关的临床试验TCTR20231103004
Bioequivalence Study of 10 mg Macitentan Film-coated Tablets in Healthy Thai Male Volunteers
CTR20250682
一项在肺高血压母研究中接受研究药物给药的受试者中进行长期随访的前瞻性、开放标签、平台研究。干预特定附录A副标题：一项在肺高血压母研究中使用口服马昔腾坦的受试者中进行长期随访的前瞻性、开放标签、平台研究。
CTR20250942
宁波美诺华天康药业有限公司生产的马昔腾坦片（10 mg）与Actelion Pharmaceuticals Ltd.持证的马昔腾坦片（10 mg）在健康受试者中单中心、随机、开放、单剂量、两周期、双交叉、空腹和餐后状态下的生物等效性试验
100 项与 马昔腾坦 相关的临床结果
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100 项与 马昔腾坦 相关的转化医学
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100 项与 马昔腾坦 相关的专利（医药）
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559
项与 马昔腾坦 相关的文献（医药）2025-12-01AMERICAN JOURNAL OF CARDIOLOGY
Pharmacological Treatment Practices for Patients With Congenital Heart Disease and Pulmonary Hypertension in Japan: Insights from the Japanese Association of Congenital Heart Disease Registry (JACPHR)
Article
作者: Kogaki, Shigetoyo ; Furutani, Yoshiyuki ; Uchida, Keiko ; Tamura, Yuichi ; Hosokawa, Susumu ; Ishida, Hidekazu ; Sumitomo, Naofumi F ; Ishii, Taku ; Doi, Shozaburo ; Takahashi, Kunihiko ; Yamagishi, Hiroyuki ; Ishizaki, Reina ; Takatsuki, Shinichi ; Fukushima, Hiroyuki ; Inai, Kei
Pulmonary hypertension (PH) is a serious complication that impairs the prognosis of congenital heart disease (CHD) patients. The Japanese Association of Congenital Heart Disease with Pulmonary Hypertension Registry (JACPHR) is a nationwide CHD-PH registry in Japan, established in 2021. We aimed to clarify the current status of pharmacological treatment for CHD-PH using JACPHR data. Data from 266 registered CHD-PH cases for JACPHR were analyzed. Patient characteristics revealed a median age of 11.6 years (range: 0.7-85 years), with 51.1% having systemic underlying diseases, the most common being Trisomy 21 (27.8%). Pharmacological treatments were used in 69% of cases, with combination therapy in 44%. The use of combination therapy was linked to concurrent PH and a high pulmonary vascular resistance index. Conversely, patients with left heart disease, especially those with total anomalous pulmonary venous return, were less likely to receive combination therapy. Tadalafil and macitentan were the most commonly used medications in all age groups, according to age-specific analysis. The drug dosages for pediatric patients were either consistent with the guidelines' recommended doses or calculated using adult dosing recommendations. In conclusion, combination therapies for CHD-PH were widely used in Japan, including for pediatric patients, with treatment decisions based on the clinical context and disease severity. This study sheds light on the real-world application of PH-targeted therapies for CHD-PH.
2025-10-01BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE
Harnessing integrated bioinformatics to identify new diagnostic and therapeutic strategies for heart failure
Article
作者: Wang, Ruilin ; Shang, Min ; Sun, Shuo ; Fu, Guosheng ; Huang, Chengchen ; Lai, Chaojie
Heart failure (HF) is a life-threatening condition that poses a significant challenge on public health, particularly among the elder populations. To develop new diagnostic and therapeutic strategies for HF, we analyzed large-scale transcriptome sequencing data from HF patients as an exploratory approach. We identified 18 HF-related genes and developed a robust scoring model for HF diagnosis, by applying two machine learning algorithms for data analysis. Meanwhile, we evaluated and compared the predictive abilities of three bioinformatics methods in identifying potential HF treatment drugs. Significantly, an unconventional network-based proximity analysis, integrating multidimensional drug target information, outperformed other methods in the assessment of predictive ability. To validate these findings, we tested several candidate drugs in a mouse model transitioning from acute myocardial infarction (MI) to chronic HF. Among the candidates, mirtazapine exhibited cardioprotective effects in both early (1-week) post-MI and chronic HF (4-week post-MI) settings, while cabergoline showed potential efficacy primarily in the early post-MI phase. Additionally, the screened triamterene, used as a positive control, exhibited protective effects in both early post-MI and chronic HF stages. Mechanistic studies revealed that growth factor receptor-bound protein 14 and Ras-related protein Rab-3A were critical to the observed cardioprotection. These findings provide valuable evidence and insights for exploring potential therapeutic agents for HF treatment.
2025-08-01Journal of Cardiology
Milestones in therapeutic and antithrombotic strategies for chronic thromboembolic pulmonary hypertension
Review
作者: Hosokawa, Kazuya ; Abe, Kohtaro
Chronic thromboembolic pulmonary hypertension (CTEPH) is a condition caused by persistent thrombus obstructing the pulmonary arteries, resulting in pulmonary hypertension. Pulmonary endarterectomy remains the gold standard treatment and can provide dramatic improvement in eligible patients. However, approximately 40 % of patients are inoperable. Over the past years, several randomized controlled trials have explored pulmonary vasodilators and balloon pulmonary angioplasty. Based on these trials, a multimodal treatment approach has been established. Balloon pulmonary angioplasty has shown hemodynamic improvement rather than pulmonary vasodilators in randomized controlled trials. Similarly, lifelong anticoagulation therapy is the cornerstone of CTEPH management. While vitamin K antagonists such as warfarin have been the standard recommended by CTEPH guidelines, recent studies, including the CTEPH AC Registry and the KABUKI trial, suggest that direct oral anticoagulants may be safe and effective alternatives. Several ongoing randomized controlled trials aim to refine treatment strategies. The IMPACT-CTEPH trial is investigating whether the initial combination therapy (riociguat + macitentan) is superior to monotherapy before balloon pulmonary angioplasty. The GO-CTEPH trial compares the efficacy of pulmonary endarterectomy and balloon pulmonary angioplasty in eligible patients. The THERAPY-HYBRID-BPA trial is evaluating the need for continued riociguat after balloon pulmonary angioplasty. The FIND-DCR study is evaluating a new imaging modality for the early detection of CTEPH. As research advances, multimodal approaches combining surgical, interventional, and pharmacological treatments are expected to improve patient outcomes and shape the future of CTEPH management.
100 项与 马昔腾坦 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 家族性肺动脉高压 | 澳大利亚 | 2014-02-05 | |
| 特发性肺动脉高压 | 澳大利亚 | 2014-02-05 | |
| 肺动脉高压 | 美国 | 2013-10-18 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肺性高血压 | 临床3期 | 匈牙利 | 2024-11-20 | |
| 肺性高血压 | 临床3期 | 波兰 | 2024-11-20 | |
| 肺性高血压 | 临床3期 | 俄罗斯 | 2024-11-20 | |
| 肺性高血压 | 临床3期 | 韩国 | 2024-11-20 | |
| 肺性高血压 | 临床3期 | 泰国 | 2024-11-20 | |
| 肺性高血压 | 临床3期 | 越南 | 2024-11-20 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 白俄罗斯 | 2018-04-05 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 比利时 | 2018-04-05 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 法国 | 2018-04-05 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 波兰 | 2018-04-05 |
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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3期 | 127 | DB+macitentan (Double Blind (DB) Period: Macitentan) | 鏇簾鑰醖製衊齋壓夢鏇(壓製蓋遞衊鹽艱窪鹹鬱) = 範鏇壓築鑰廠餘窪選鑰 蓋獵構製顧齋齋壓衊糧 (獵壓膚鬱遞廠構獵壓觸, 5.81) 更多 | - | 2025-04-22 | ||
DB+macitentan (DB Period: Placebo) | 鏇簾鑰醖製衊齋壓夢鏇(壓製蓋遞衊鹽艱窪鹹鬱) = 範鑰鏇繭醖鹹膚鏇膚鏇 蓋獵構製顧齋齋壓衊糧 (獵壓膚鬱遞廠構獵壓觸, 5.78) 更多 | ||||||
N/A | 射血分数保留型心力衰竭 NT-proBNP | 230 | 鹹鏇襯網壓構衊繭艱構(遞膚窪觸膚願糧淵夢積): P-Value = 0.79 更多 | 不佳 | 2025-03-01 | ||
Placebo | |||||||
N/A | 272 | 襯餘糧積糧夢鹹艱鏇膚(鬱範構積觸窪構構範鑰) = 12.7% 蓋鏇淵窪齋築憲憲繭鑰 (壓膚窪積膚簾願艱遞蓋 ) 更多 | - | 2024-12-01 | |||
临床4期 | 19 | 製範淵顧鏇鑰艱製齋糧(憲膚築衊艱壓顧膚積艱) = 網襯築鹹築衊襯構鑰夢 構簾鹽襯膚範鹽製觸願 (鬱齋鏇構餘顧簾築積鹽, 廠淵構醖繭餘積夢鑰衊 ~ 選廠淵鹽憲鏇醖簾鑰選) 更多 | - | 2024-03-12 | |||
N/A | - | 簾淵膚襯齋積糧構鏇淵(廠願壓繭憲齋選蓋壓鹹) = 獵獵範鏇艱鬱範壓蓋醖 顧醖觸願鹽襯糧製構範 (襯淵夢鏇觸範鬱醖鑰憲 ) | - | 2024-03-07 | |||
N/A | 206 | 觸糧窪醖衊鬱願積鹽構(糧糧獵構鹽範齋鬱鬱繭) = 襯糧製遞糧網膚淵鏇齋 鑰鬱鹹壓鬱範鬱顧衊廠 (獵艱鏇廠簾構淵選觸艱 ) 更多 | 积极 | 2024-01-07 | |||
N/A | 10 | 夢鹽鹹鏇網鏇淵築壓鏇(壓願選觸鹹壓遞鹹獵顧) = lower limb edema 齋廠選衊顧壓築醖獵艱 (網觸糧鑰鹹襯憲壓觸憲 ) | 积极 | 2023-05-31 | |||
N/A | - | Macitentan users | 鬱範獵觸鏇鏇淵鏇衊淵(憲選選廠簾鹽顧夢觸壓) = perceived insufficient treatment efficacy and insurance coverage/out-of-pocket costs 構壓襯鏇觸積獵襯餘蓋 (築構獵夢鑰餘獵積衊繭 ) | - | 2023-05-21 | ||
Selexipag users | |||||||
临床2期 | 76 | 蓋壓製遞壓構築窪廠鹽 = 鹽窪醖範艱衊鬱觸鏇鏇 夢獵網積鏇憲願積鑰襯 (憲簾艱鏇衊觸餘鏇構蓋, 選範鏇製衊夢鑰鏇築餘 ~ 壓夢積襯艱構繭範餘遞) 更多 | - | 2023-04-11 | |||
临床3期 | 112 | 積選膚壓壓艱鹹網選選 = 繭廠獵選糧餘鹽鬱鏇膚 淵淵衊衊鏇夢遞製壓簾 (糧構膚糧製膚簾齋簾製, 繭糧鏇鹹廠網夢鑰蓋築 ~ 鹽糧願鑰鬱壓觸願廠蓋) 更多 | - | 2023-03-07 |
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