预约演示
更新于：2025-09-06
Muvalaplin
穆伐普林
更新于：2025-09-06
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评突破性疗法 (中国) |
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结构/序列
分子式C42H54N4O6 |
InChIKeyBRLGERLDHZRETI-BGBFCPIGSA-N |
CAS号2565656-70-2 |
关联
8
项与 穆伐普林 相关的临床试验NCT07157774
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event
NCT06342596
A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants
NCT05778864
Pharmacokinetics of LY3473329 Following Oral Administration in Participants With Renal Impairment Compared With Participants With Normal Renal Function
100 项与 穆伐普林 相关的临床结果
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100 项与 穆伐普林 相关的转化医学
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100 项与 穆伐普林 相关的专利（医药）
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14
项与 穆伐普林 相关的文献（医药）2025-12-01Current Atherosclerosis Reports
Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American Heart Association Scientific Sessions
Review
作者: Khoja, Adeel ; Inam, Maha ; Murthy, Nikitha ; Epstein, Elizabeth ; Virani, Salim S ; Vaughan, Elizabeth ; Sheikh, Sana ; Mehta, Sandeep ; Minhas, Abdul Mannan Khan ; Slipczuk, Leandro ; Junaid, Vashma ; Chai, Zohar ; Hermel, Melody ; Hinkamp, Colin
PURPOSE OF REVIEW:
Focused review highlighting ten select studies presented at the 2024 American Heart Association (AHA) Scientific Sessions.
RECENT FINDING:
Included studies assessed effects of intensive blood pressure control in patients with type 2 diabetes (BPROAD); decision support system for physicians to optimize early lipid lowering therapies after acute coronary syndrome (ZODIAC); efficacy and safety of zerlasiran, a short interfering RNA targeting lipoprotein(a) (ALPACAR); efficacy and safety of muvalaplin an oral disrupter of the assembly of lipoprotein(a) particles (KRAKEN); safety and efficacy of obicetrapib in patients with heterozygous familial hypercholesterolemia (BROOKLYN); efficacy and safety of lerodalcibep, a third generation PCSK9 inhibitor in heterozygous familial hypercholesterolemia subjects (LIBerate-HeFH_OLE); personalized app-based coaching to improve physical activity in patients with HFpEF compared to standard care (MyoMobile); semaglutide to improve cardiovascular outcomes in patients with a history of coronary artery bypass surgery and overweight or obesity (the SELECT trial); efficacy and safety of plozasiran in adults with genetically or clinically defined familial chylomicronemia syndrome at high risk of acute pancreatitis (PALISADE); and transcriptomic signatures and predictors of evolocumab added to maximum statin therapy based on intra-coronary plaque characteristics (YELLOW III). Research presented at the 2024 AHA Scientific Sessions emphasized innovative strategies in cardiovascular disease prevention and management.
2025-04-01Annals of Translational Medicine
Promising results with the daily oral small molecule lipoprotein(a) inhibitor, muvalaplin, in high-risk cardiovascular patients with elevated lipoprotein(a) levels
Communications
作者: Vuorio, Alpo ; Kovanen, Petri T ; Raal, Frederick
2025-01-21JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Oral Muvalaplin for Lowering of Lipoprotein(a)
Article
作者: Navar, Ann Marie ; Krege, John H. ; Haupt, Axel ; Rhodes, Grace M. ; Nicholls, Stephen J. ; Ni, Wei ; Nissen, Steven E. ; Michael, Laura F.
Importance:
Muvalaplin inhibits lipoprotein(a) formation. A 14-day phase 1 study demonstrated that muvalaplin was well tolerated and reduced lipoprotein(a) levels up to 65%. The effect of longer administration of muvalaplin on lipoprotein(a) levels in individuals at high cardiovascular risk remains uncertain.
Objectives:
To determine the effect of muvalaplin on lipoprotein(a) levels and to assess safety and tolerability.
Design, Setting, and Participants:
Phase 2, placebo-controlled, randomized, double-blind trial enrolling 233 participants with lipoprotein(a) concentrations of 175 nmol/L or greater with atherosclerotic cardiovascular disease, diabetes, or familial hypercholesterolemia at 43 sites in Asia, Europe, Australia, Brazil, and the United States between December 10, 2022, and November 22, 2023.
Interventions:
Participants were randomized to receive orally administered muvalaplin at dosages of 10 mg/d (n = 34), 60 mg/d (n = 64), or 240 mg/d (n = 68) or placebo (n = 67) for 12 weeks.
Main Outcomes and Measures:
The primary end point was the placebo-adjusted percentage change from baseline in lipoprotein(a) molar concentration at week 12, using an assay to measure intact lipoprotein(a) and a traditional apolipoprotein(a)-based assay. Secondary end points included the percentage change in apolipoprotein B and high-sensitivity C-reactive protein.
Results:
The median age of study participants was 66 years; 33% were female; and 27% identified as Asian, 4% as Black, and 66% as White. Muvalaplin resulted in placebo-adjusted reductions in lipoprotein(a) of 47.6% (95% CI, 35.1%-57.7%), 81.7% (95% CI, 78.1%-84.6%), and 85.8% (95% CI, 83.1%-88.0%) for the 10-mg/d, 60-mg/d, and 240-mg/d dosages, respectively, using an intact lipoprotein(a) assay and 40.4% (95% CI, 28.3%-50.5%), 70.0% (95% CI, 65.0%-74.2%), and 68.9% (95% CI, 63.8%-73.3%) using an apolipoprotein(a)-based assay. Dose-dependent reductions in apolipoprotein B were observed at 8.9% (95% CI, −2.2% to 18.8%), 13.1% (95% CI, 4.4%-20.9%), and 16.1% (95% CI, 7.8%-23.7%) at 10 mg/d, 60 mg/d, and 240 mg/d, respectively. No change in high-sensitivity C-reactive protein was observed. No safety or tolerability concerns were observed at any dosage.
Conclusions and Relevance:
Muvalaplin reduced lipoprotein(a) measured using intact lipoprotein(a) and apolipoprotein(a)-based assays and was well tolerated. The effect of muvalaplin on cardiovascular events requires further investigation.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05563246
70
项与 穆伐普林 相关的新闻（医药）2025-09-06
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申请上市临床申请临床1期
100 项与 穆伐普林 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 动脉粥样硬化 | 临床3期 | 美国 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 中国 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 日本 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 阿根廷 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 澳大利亚 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 奥地利 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 比利时 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 巴西 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 加拿大 | 2025-09-02 | |
| 动脉粥样硬化 | 临床3期 | 捷克 | 2025-09-02 |
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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 | 233 | (10 mg LY3473329) | 顧築遞選齋齋膚遞繭顧(餘窪衊齋衊衊衊鑰鹽憲) = 醖鹽鑰遞鹽夢醖鬱襯繭 遞鏇構構顧餘憲醖淵糧 (簾餘鹹衊獵餘廠網網夢, 4.811) 更多 | - | 2025-03-25 | ||
(60 mg LY3473329) | 顧築遞選齋齋膚遞繭顧(餘窪衊齋衊衊衊鑰鹽憲) = 觸觸鬱繭鑰構襯繭襯顧 遞鏇構構顧餘憲醖淵糧 (簾餘鹹衊獵餘廠網網夢, 1.230) 更多 | ||||||
临床2期 | - | 鑰鑰網顧鑰膚選鬱網淵(淵糧積膚觸齋壓構積製) = 遞鑰願鏇膚製蓋鑰築廠 憲糧廠廠膚簾憲艱遞鬱 (鹽築願遞願鑰觸廠築鹹 ) 达到 更多 | 积极 | 2024-11-18 | |||
鑰鑰網顧鑰膚選鬱網淵(淵糧積膚觸齋壓構積製) = 顧夢淵襯齋鑰淵餘選廠 憲糧廠廠膚簾憲艱遞鬱 (鹽築願遞願鑰觸廠築鹹 ) 达到 更多 | |||||||
临床2期 | 233 | 鹽網簾鏇糧廠壓願醖齋(鏇簾淵艱醖鑰衊醖襯築) = 範構餘餘鏇簾顧鹽築選 遞窪鬱觸範範窪築製簾 (鹽鏇選膚壓廠顧構醖襯, -2.2% ~ 18.8%) 更多 | 积极 | 2024-11-18 | |||
鹽網簾鏇糧廠壓願醖齋(鏇簾淵艱醖鑰衊醖襯築) = 鬱構壓衊鬱糧觸膚夢願 遞窪鬱觸範範窪築製簾 (鹽鏇選膚壓廠顧構醖襯, 4.4% ~ 20.9%) 更多 | |||||||
临床1期 | 105 | 鏇餘鹹夢鑰選夢範襯顧(獵獵夢製鑰構製夢構鹹) = 餘選淵蓋簾簾繭餘膚糧 廠築築鹽淵鬱襯願鏇餘 (鏇網鏇鹽獵廠鏇膚遞壓 ) 更多 | 积极 | 2023-08-28 | |||
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