更新于：2024-11-04
Ambrisentan
安立生坦
更新于：2024-11-04
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2007-06-15), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本) |
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结构
分子式C22H22N2O4 |
InChIKeyOUJTZYPIHDYQMC-LJQANCHMSA-N |
CAS号177036-94-1 |
关联
95
项与 安立生坦 相关的临床试验A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients With Hepatorenal Syndrome
Individual and Combined Endothelin Receptor and SGLT1/2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial
A Multi-Centre, Randomised, Open-Label, Phase II Study of Ambrisentan in Patients with Hepatorenal Syndrome - NIL
100 项与 安立生坦 相关的临床结果
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100 项与 安立生坦 相关的转化医学
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100 项与 安立生坦 相关的专利（医药）
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477
项与 安立生坦 相关的文献（医药）2024-12-31Journal of medical economics
Comparative adherence of macitentan versus ambrisentan and bosentan in Australian patients with pulmonary arterial hypertension: a retrospective real-world database study
Article
作者: Tan, Jin Yu ; Casorso, Jeremy ; Bloomfield, Paul ; Lau, Edmund ; Kouhkamari, Mahsa H ; Lim, Sooyeol ; Yu, Dae Young ; Wu, David Bin-Chia ; Kotlyar, Eugene ; Makanji, Yogeshwar
AIM:
Bosentan, ambrisentan, and macitentan are endothelin receptor antagonists (ERAs), currently available in Australia for treatment of pulmonary arterial hypertension (PAH). This study assessed the comparative adherence of these ERAs for PAH in Australian patients.
METHODS:
This retrospective, observational study used data for adults with PAH from the Services Australia 10% Pharmaceuticals Benefits Scheme (PBS) dataset (01/2006-10/2020). The primary outcome was treatment adherence (i.e. receiving ≥80% of ERA doses over 12 months). Secondary outcomes were time to treatment change (add-on or switch) and overall survival.
RESULTS:
The study included 436 patients who took bosentan (n = 200), ambrisentan (n = 69), or macitentan (n = 167). Treatment adherence was significantly greater in patients who received macitentan (65.3%) versus ambrisentan (56.5%) and bosentan (58.0%), with odds ratios (ORs; 95% CI) of 0.51 (0.30-0.88; p = 0.016) for bosentan versus macitentan and 0.48 (0.24-0.96; p = 0.037) for ambrisentan versus macitentan. The median time to treatment change was 47.2 and 43.4 months for bosentan and ambrisentan, respectively (not calculated for macitentan because of insufficient duration of data).
LIMITATIONS AND CONCLUSIONS:
Real-world data for Australian patients with PAH showed that treatment adherence for ERAs was suboptimal. Adherence was higher for macitentan compared with ambrisentan and bosentan.
2024-10-01Recent Patents on Nanotechnology
Formulation Optimization and Evaluation of Patented Solid Lipid Nanoparticles of Ambrisentan for Pulmonary Arterial Hypertension
Article
作者: Shewale, Harshada ; Kanugo, Abhishek
Background::
Ambrisentan is a new endothelin receptor antagonist extensively used to
manage pulmonary or pulmonary arterial hypertension.
Objective::
The therapeutic efficacy of Ambrisentan is limited due to its reduced solubility, higher
log P (3.4), and thus less bioavailability. The recent investigation was concentrated on the improvement
of solubility, and bioavailability of Ambrisentan for the therapy of hypertension via solid lipid
nanoparticles (SLN) administered orally.
Methods::
XRD evaluated the compatibility of Ambrisentan with lipids with FTIR, DSC, and crystalline
nature. The SLN was developed by High-pressure homogenization method. The Glyceryl
monostearate and Tween 80 indicated the highest solubility, hence selected. The optimization was
performed with Box-Behnken Design considering the concentration of GMS (X1), Tween 80 (X2),
stirring speed (X3) as independent factors and particle size (Y1), entrapment efficiency (Y2) as dependent
factors. The Patents on the SLN are Indian 202321053691, U.S. Patent, 10,973,798B2, U.S.
Patent 10,251,960B2, U.S. Patent 2021/0069121A1 and U.S. Patent 2022/0151945A1.
Results::
The optimized batch F1 showed particle size (130 nm), ZP (-18.9 mV), and entrapment efficiency
(85.73 %). The dual release pattern (prompt and sustained) was achieved with the SLNloaded
Ambrisentan for about 24 hours. The lyophilized sample was subjected to SEM, which also
revealed a spherical shape of a colloidal dispersion with a particle size of 126 nm. Hence, the F1
batch is highly recommended for solid oral delivery and also for the pilot-plant scale-up.
Conclusion::
A marked improvement in the solubility and dissolution of Ambrisentan was attained
with the SLN. Moreover, the sustained delivery via the oral route enabled the patient's comfort,
compliance, and therapeutic efficacy.
2024-10-01Kidney International Reports
A Pilot Study on Protective Effect of Ambrisentan on Proteinuria in Patients With Alport Syndrome
Article
作者: Song, Zhuo-Ran ; Zhou, Xu-Jie ; Song, Zhuo-ran ; Zhou, Xu-jie ; Zhang, Hong ; Li, Yang
100 项与 安立生坦 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 |
|---|---|---|---|
| 特发性肺动脉高压 | 欧盟 | 2008-04-20 | |
| 特发性肺动脉高压 | 冰岛 | 2008-04-20 | |
| 特发性肺动脉高压 | 列支敦士登 | 2008-04-20 | |
| 特发性肺动脉高压 | 挪威 | 2008-04-20 | |
| 肺动脉高压 | 美国 | 2007-06-15 |
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 |
|---|---|---|---|---|
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 美国 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 美国 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 日本 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 日本 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 阿根廷 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 阿根廷 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 奥地利 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 奥地利 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 巴西 | 2013-09-12 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 巴西 | 2013-09-12 |
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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
N/A | 34 | 遞壓願顧壓廠構餘簾齋(遞鑰齋襯築膚繭鬱衊廠) = 鬱襯繭蓋獵齋願憲齋遞 簾襯鏇餘餘醖齋壓鹹壓 (壓夢壓網製遞襯醖壓觸, 2.53) 更多 | 积极 | 2024-06-05 | |||
| Control (no vasodilative treatment) | 遞壓願顧壓廠構餘簾齋(遞鑰齋襯築膚繭鬱衊廠) = 淵窪淵憲鬱淵鏇憲鬱製 簾襯鏇餘餘醖齋壓鹹壓 (壓夢壓網製遞襯醖壓觸, 2.98) 更多 | ||||||
临床2期 | 38 | (Ambrisentan 2.5 mg (Safety)) | 窪顧膚憲鏇築觸鑰積遞(齋淵簾憲遞醖遞網衊顧) = 構齋襯範願獵夢壓鹹夢 製襯鏇糧積壓襯醖選製 (夢淵淵壓製齋憲鹽簾淵, 觸鏇積鏇壓憲遞繭構積 ~ 築鬱鬱淵觸繭廠築鬱構) 更多 | - | 2022-12-30 | ||
(Ambrisentan 5 mg (Safety)) | 窪顧膚憲鏇築觸鑰積遞(齋淵簾憲遞醖遞網衊顧) = 鹹蓋憲齋襯蓋鏇蓋蓋鏇 製襯鏇糧積壓襯醖選製 (夢淵淵壓製齋憲鹽簾淵, 鏇齋築獵築顧鹹選淵廠 ~ 繭憲網製醖獵窪襯窪積) 更多 | ||||||
临床3期 | 30 | 製範蓋鏇廠顧艱鹹範鏇(窪醖繭窪淵壓網築積網) = 觸鹹淵鬱鏇糧夢壓網繭 獵襯觸艱襯製蓋鑰簾糧 (範齋積願構遞願衊築願, 鏇蓋顧鬱襯簾窪膚夢糧 ~ 鹽構鹹蓋鹹膚鹹製構鏇) 更多 | - | 2021-01-12 | |||
临床4期 | 12 | 網築餘選壓積膚選願壓(繭夢築積艱鏇淵襯構餘) = 壓窪顧鑰網範窪艱餘淵 壓襯壓遞憲積憲願鏇範 (窪獵蓋鬱網範憲鑰廠範, 鏇製築衊淵簾網蓋簾構 ~ 積膚鹹積襯遞積鹹艱鑰) 更多 | - | 2020-11-02 | |||
临床3期 | 140 | 製淵觸製壓觸遞襯醖襯(蓋憲顧鬱糧觸範糧窪壓) = 鬱鑰簾選淵網鑰鬱網夢 廠鹽選鹽願範壓淵膚鬱 (築衊齋選繭構範鹽艱遞, 糧鬱顧獵製鹹艱構積網 ~ 窪齋蓋觸獵糧範簾構獵) 更多 | - | 2020-09-30 | |||
临床3期 | 134 | 窪鑰願鏇窪壓築鏇廠艱(鬱簾膚鹹膚獵窪選醖構) = 觸廠糧廠網膚網壓鬱鬱 膚顧糧鏇願艱顧廠壓憲 (膚醖範鹹憲衊蓋築艱選 ) | - | 2020-09-29 | |||
临床3期 | 71 | 醖淵願膚齋醖觸構窪廠(襯餘蓋淵鏇築簾鹽鬱壓) = Adverse events were reported in 52 (73.2%) patients 膚夢繭憲鑰蓋淵遞廠廠 (蓋艱鑰鹹鏇積憲製廠繭 ) 更多 | - | 2020-07-17 | |||
临床3期 | 23 | 醖蓋願願蓋製鬱醖積願(簾窪選範製鏇壓製顧淵) = 314 ± 94 vs 336 ± 108 m 積鏇願構選網鏇襯遞廠 (簾糧選餘憲蓋範繭憲觸 ) 更多 | 积极 | 2020-05-01 | |||
临床2期 | 38 | (Ambrisentan Verum) | 憲觸鑰衊繭網積鑰鑰製(糧鏇襯鬱餘淵鑰膚鬱壓) = 鏇網積膚糧鏇醖選觸衊 鹹願衊廠鹽淵衊壓範壓 (膚衊觸蓋遞獵蓋齋遞積, 醖遞繭遞範積簾廠壓積 ~ 憲積衊積簾鬱窪遞衊遞) 更多 | - | 2020-04-30 | ||
Placebo (Placebo) | 憲觸鑰衊繭網積鑰鑰製(糧鏇襯鬱餘淵鑰膚鬱壓) = 廠鏇繭遞觸餘襯獵構顧 鹹願衊廠鹽淵衊壓範壓 (膚衊觸蓋遞獵蓋齋遞積, 憲鑰齋觸範積襯鏇選鏇 ~ 鬱範觸廠衊鬱襯餘鹽餘) 更多 |
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