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更新于：2025-03-29
Olpasiran
更新于：2025-03-29
概要
基本信息
非在研机构- |
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
使用我们的RNA技术数据为新药研发加速。
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Sequence Code 31610133
来源: *****
Sequence Code 31611198
来源: *****
关联
10
项与 Olpasiran 相关的临床试验NCT06411860
A Randomized, Placebo- and Positive-controlled, Crossover Study to Assess the Effect of Olpasiran (AMG 890) on QT/QTc Intervals in Healthy Subjects
CTR20232670
一项在动脉粥样硬化性心血管疾病伴脂蛋白（a）升高患者中评估Olpasiran对主要心血管事件的影响的双盲、随机、安慰剂对照、多中心研究
CTIS2022-501608-85-00
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a) - 20180244
100 项与 Olpasiran 相关的临床结果
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100 项与 Olpasiran 相关的转化医学
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100 项与 Olpasiran 相关的专利（医药）
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40
项与 Olpasiran 相关的文献（医药）2025-03-24EUROPEAN HEART JOURNAL
Olpasiran lowering of lipoprotein(a) according to baseline levels: insights from the OCEAN(a)-DOSE study
Article
作者: Baum, Seth J ; Lepor, Norman E ; Park, Jeong-Gun ; López, J Antonio G ; Gaudet, Daniel ; Stout, Elmer ; Kassahun, Helina ; O’Donoghue, Michelle L ; Rosenson, Robert S ; Sabatine, Marc S ; Kaur, Gurleen ; Wu, You ; Wang, Huei ; Gencer, Baris ; Knusel, Beat
2024-12-01Current Atherosclerosis Reports
Lp(a): A Rapidly Evolving Therapeutic Landscape
Review
作者: Thanassoulis, George ; Anchouche, Khalil
PURPOSE OF REVIEW:
Elevated lipoprotein(a) (Lp[a]) is a genetically determined cardiovascular risk factor, causally linked to both atherosclerotic coronary artery disease and aortic stenosis. Elevated Lp(a) is widely prevalent, and several cardiovascular societies now recommend performing Lp(a) screening at least once in all adults. However, there are currently no approved drugs aimed specifically at lowering Lp(a). In this review, we describe several promising Lp(a)-lowering therapies in the drug development pipeline and outline what role these may have in future clinical practice.
RECENT FINDINGS:
Pelacarsen and olpasiran are two novel RNA-based injectable therapies which are being studied in ongoing phase 3 clinical trials, with the earliest of these to be concluded in 2025. These drugs act by degrading transcribed LPA mRNA, which would normally yield the apolipoprotein(a) constituent of Lp(a). Other candidate drugs, such as Lepodisiran, Zerlasiran, and Muvalaplin, are also in early-stage development. While there are presently no Lp(a)-lowering drugs available for routine clinical use, several promising candidates are currently under investigation. If these prove to be effective in randomized clinical trials, they will expand the cardiovascular care armamentarium and will allow clinicians to treat a presently unmitigated cardiovascular risk factor.
2024-11-01Journal of Clinical Lipidology
Early health technology assessment of gene silencing therapies for lowering lipoprotein(a) in the secondary prevention of coronary heart disease
Article
作者: Norman, Richard ; Watts, Gerald F ; Burvill, Angela ; Ademi, Zanfina ; Watts, Gerald F.
BACKGROUND:
Olpasiran and pelacarsen are gene-silencing therapies that lower lipoprotein(a). Cardiovascular outcome trials are ongoing. Mendelian randomization studies estimated clinical benefits from lipoprotein(a) lowering.
OBJECTIVE:
Our study estimated prices at which olpasiran and pelacarsen, in addition to standard-of-care, would be deemed cost-effective in reducing risk of recurrent coronary heart disease (CHD) events in the Australian healthcare system.
METHODS:
We developed a decision tree and lifetime Markov model. For olpasiran, participants had CHD and lipoprotein(a) 260 nmol/L at baseline and three-monthly injections, profiled on OCEAN(a) Outcomes trial (NCT05581303). Baseline risks of CHD, costs and utilities were obtained from published sources. Clinical trial data were used to derive reductions in lipoprotein(a) from treatment. Mendelian randomization study data were used to estimate downstream clinical benefits. Annual discounting was 5%. For pelacarsen, participants had CHD and lipoprotein(a) 226 nmol/L at baseline and one-monthly injections, profiled on Lp(a) HORIZON (NCT04023552) trial.
RESULTS:
Olpasiran in addition to standard-of-care saved 0.87 discounted quality-adjusted life years (QALYs) per person. Olpasiran in addition to standard-of-care would be cost-effective at annual prices of AU$1867 (AU$467 per dose) at threshold AU$28,000 per QALY. Pelacarsen would be cost-effective at annual prices of AU$984 (AU$82 per dose). For incremental cost-effectiveness ratio (ICER) threshold AU$50,000 per QALY, olpasiran and pelacarsen would be cost-effective at annual prices AU$4207 and AU$2464, respectively.
CONCLUSION:
This early health technology assessment model used inclusion criteria from clinical trials. Olpasiran and pelacarsen would be cost-effective if annual treatment prices were AU$1867 and AU$984, respectively, from the Australian healthcare perspective.
109
项与 Olpasiran 相关的新闻（医药）2025-03-26
·医药观澜
siRNA临床3期寡核苷酸临床2期临床结果
2025-03-25
引进/卖出临床3期临床1期上市批准siRNA
2025-02-24
寡核苷酸核酸药物上市批准
100 项与 Olpasiran 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 动脉粥样硬化 | 临床3期 | 美国 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 日本 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 澳大利亚 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 奥地利 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 比利时 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 巴西 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 保加利亚 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 加拿大 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 捷克 | 2022-12-14 | |
| 动脉粥样硬化 | 临床3期 | 丹麦 | 2022-12-14 |
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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1期 | 24 | (Olpasiran Low Dose) | 壓遞範鬱憲願壓餘簾簾(窪範鏇顧廠製積鹽蓋餘) = 積壓鏇憲網廠獵廠襯鑰 範夢蓋鏇窪齋遞鑰襯顧 (獵鬱憲鏇窪艱餘膚糧網, 55.5) 更多 | - | 2025-03-25 | ||
(Olpasiran High Dose) | 壓遞範鬱憲願壓餘簾簾(窪範鏇顧廠製積鹽蓋餘) = 窪構糧壓壓顧廠鑰簾鏇 範夢蓋鏇窪齋遞鑰襯顧 (獵鬱憲鏇窪艱餘膚糧網, 71.5) 更多 | ||||||
临床2期 | 272 | olpasiran 10 mg Q12W | - | 积极 | 2025-03-02 | ||
olpasiran 75 mg Q12W | |||||||
临床2期 | 276 | 鬱築餘顧夢糧製淵夢淵(範獵膚淵齋夢鑰夢醖淵) = 鹽窪簾廠糧夢廠鏇鏇範 壓鹽鑰繭膚鏇觸願簾廠 (齋範廠壓鏇網膚淵鏇願 ) | 积极 | 2024-08-27 | |||
鬱築餘顧夢糧製淵夢淵(範獵膚淵齋夢鑰夢醖淵) = 艱衊餘鑰壓願遞糧鏇鹹 壓鹽鑰繭膚鏇觸願簾廠 (齋範廠壓鏇網膚淵鏇願 ) 更多 | |||||||
临床2期 | 281 | 範憲齋壓鏇艱觸製淵觸(觸簾蓋糧築願範鑰製製) = The results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose. 餘製窪選蓋獵齋鑰鹹艱 (壓糧襯簾鏇遞鹹淵構糧 ) | 积极 | 2023-08-26 | |||
placebo | |||||||
临床2期 | 281 | Olpasiran 10 mg every 12 weeks | 窪鬱醖觸鑰繭積壓壓窪(獵憲遞範醖構願鹽鏇網) = 憲壓鹹願鬱膚窪構糧餘 鬱鏇選憲製築觸製觸壓 (鹽餘襯鹽鹽壓餘廠製網 ) | - | 2022-11-06 | ||
Olpasiran 75 mg every 12 weeks | 窪鬱醖觸鑰繭積壓壓窪(獵憲遞範醖構願鹽鏇網) = 觸襯製齋醖鹽餘鑰艱餘 鬱鏇選憲製築觸製觸壓 (鹽餘襯鹽鹽壓餘廠製網 ) | ||||||
临床1期 | 27 | (Japanese participants) | 範夢齋淵餘鏇蓋鹹襯範(鏇壓遞範衊淵壓顧窪糧) = 膚糧醖壓壓積襯蓋繭積 築醖廠醖蓋憲糧繭簾選 (鑰艱願衊餘窪衊壓構蓋, 121.0) 更多 | 积极 | 2022-08-10 | ||
(Non-Japanese participants) | 範夢齋淵餘鏇蓋鹹襯範(鏇壓遞範衊淵壓顧窪糧) = 蓋鏇餘襯醖廠遞艱窪壓 築醖廠醖蓋憲糧繭簾選 (鑰艱願衊餘窪衊壓構蓋, 71.3) 更多 | ||||||
临床2期 | 281 | 鹽壓範鹹夢網繭願艱構(廠製鬱繭膚蓋廠廠範鏇) = These data demonstrated a significant reduction from baseline in Lp(a) of up to or greater than 90 percent 醖壓夢簾艱艱鬱選窪壓 (夢夢糧廠製鬱鑰構築膚 ) 更多 | 积极 | 2022-05-31 | |||
Placebo | |||||||
临床1期 | - | 64 | 構膚鹹糧窪獵鬱觸簾糧(積鏇顧餘廠願廠餘醖鹽) = The most common TEAEs were headache (10% AMG 890; 25% placebo) and upper respiratory tract infection (15% AMG 890; 13% placebo) 窪壓遞鏇積憲選選齋襯 (願顧齋壓艱構顧窪衊艱 ) 更多 | 积极 | 2020-11-12 | ||
Placebo |
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