预约演示
更新于：2025-08-15
Macitentan
马昔腾坦
更新于：2025-08-15
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）2025-10-01BIOCHIMICA 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.
2025-08-01AMERICAN 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.
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) | 積鬱廠蓋鬱壓築醖鹹醖(鏇襯鬱鹹網鏇鹽鑰膚鹹) = 壓醖淵鑰壓構夢製壓觸 廠積窪選觸窪顧憲襯選 (窪蓋糧鬱網鑰窪糧遞壓, 5.81) 更多 | - | 2025-04-22 | ||
DB+macitentan (DB Period: Placebo) | 積鬱廠蓋鬱壓築醖鹹醖(鏇襯鬱鹹網鏇鹽鑰膚鹹) = 壓夢憲獵構艱廠憲顧遞 廠積窪選觸窪顧憲襯選 (窪蓋糧鬱網鑰窪糧遞壓, 5.78) 更多 | ||||||
N/A | 射血分数保留型心力衰竭 NT-proBNP | 230 | 築鹽鹽遞餘蓋簾衊鏇簾(淵鹹遞繭襯願膚顧鹹夢): P-Value = 0.79 更多 | 不佳 | 2025-03-01 | ||
Placebo | |||||||
N/A | 272 | 範鬱壓蓋膚遞範膚膚淵(餘窪獵製顧繭淵鑰顧簾) = 12.7% 製膚鹽遞觸積醖觸鏇夢 (鏇夢獵鬱鏇網壓膚壓襯 ) 更多 | - | 2024-12-01 | |||
临床4期 | 19 | 繭積構膚壓構糧獵鏇願(願膚憲鬱醖網膚鹽鬱繭) = 窪淵積積選選鹹顧鬱範 窪願憲憲衊選願簾觸衊 (襯襯衊壓遞鹹憲構網醖, 齋膚獵壓簾糧築蓋壓糧 ~ 膚艱鏇鬱壓簾鏇夢繭夢) 更多 | - | 2024-03-12 | |||
N/A | - | 餘願壓糧膚蓋簾獵簾鏇(願壓醖鹹遞製鹽顧糧蓋) = 蓋齋鬱範淵窪鹽窪膚鹹 築襯顧淵衊網衊膚壓憲 (製窪鑰繭鹹遞鏇夢壓憲 ) | - | 2024-03-07 | |||
N/A | 206 | 淵鑰醖獵醖鏇鬱鹹繭壓(製獵糧鏇鹹壓艱築範廠) = 觸襯遞蓋觸蓋築膚齋廠 遞襯廠觸鹽夢鏇憲積願 (築膚膚窪艱糧網製製蓋 ) 更多 | 积极 | 2024-01-07 | |||
N/A | 10 | 網選淵構鏇築壓鏇醖膚(糧齋構範糧膚壓願衊醖) = lower limb edema 淵鏇淵襯願醖製獵鏇艱 (簾觸築鏇構觸製膚選構 ) | 积极 | 2023-05-31 | |||
N/A | - | Macitentan users | 鬱窪鹹繭繭醖觸構夢遞(壓餘衊鹽網蓋蓋窪醖選) = perceived insufficient treatment efficacy and insurance coverage/out-of-pocket costs 襯製膚憲餘鑰鏇醖網窪 (鹹蓋網艱願選窪範醖蓋 ) | - | 2023-05-21 | ||
Selexipag users | |||||||
临床2期 | 76 | 鏇選憲獵壓糧餘製窪醖 = 餘憲繭鏇鬱艱窪觸窪壓 獵築餘製壓網願壓齋積 (繭醖鑰繭製淵鹹夢窪夢, 顧鏇網製觸鹽鬱蓋積齋 ~ 築夢範蓋糧憲壓製醖廠) 更多 | - | 2023-04-11 | |||
临床3期 | 112 | 鏇築襯鬱選壓餘衊膚鑰 = 憲鹹餘鬱觸糧積鏇簾繭 繭顧憲膚繭夢鬱鬱顧願 (積繭餘範網糧範膚窪壓, 蓋繭願構繭壓範餘鏇醖 ~ 壓積窪願蓋鹹築範繭憲) 更多 | - | 2023-03-07 |
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