预约演示
更新于：2026-09-04
Lenacapavir Sodium
来那帕韦钠
更新于：2026-09-04
概要
基本信息
药物类型 小分子化药 |
别名 Lenacapavir、来那帕韦、莱纳卡帕韦 + [12] |
作用方式 抑制剂 |
作用机制 HIV-1 capsid抑制剂(HIV-1衣壳蛋白抑制剂) |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2022-08-17), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、加速审评 (欧盟)、优先审评 (美国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
分子式C39H32ClF10N7NaO5S2 |
InChIKeyQXFAXPSMLXKBJU-PZNXWHLTSA-N |
CAS号2283356-12-5 |
关联
34
项与 来那帕韦钠 相关的临床试验PACTR202607711608317
Switching to long-acting cabotegravir + lenacapavir during pregnancy: a non-inferiority trial of pragmatic test-and-treat-then-switch in late pregnancy and postpartum.
NCT07708727
An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1
NCT07682961
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
100 项与 来那帕韦钠 相关的临床结果
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100 项与 来那帕韦钠 相关的转化医学
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100 项与 来那帕韦钠 相关的专利（医药）
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310
项与 来那帕韦钠 相关的文献（医药）2026-12-31Emerging Microbes & Infections
Challenges facing long-acting PrEP implementation in large populations
Article
作者: Liao, Yu ; Sun, Caijun
The introduction of long-acting antiviral prophylaxis drugs, exemplified by the twice-yearly injectable capsid inhibitor lenacapavir [1,2], marks a remarkable advance in HIV prevention, which address the adherence issue that has limited the real-world use of daily oral pre-exposure prophylaxis (PrEP) [3,4]. The long-acting formulations of lenacapavir offer a potent prevention tool, particularly well-suited for countries where the HIV transmission mainly occurred in certain populations with high incidence.
2026-08-01AIDS PATIENT CARE AND STDS
People with HIV Continuing on Complex Regimens in the Era of Treatment Optimization: Characteristics and Outcomes
Article
作者: Sax, Paul E. ; McEwen, Isobel ; Eron, Joseph J. ; Benson, Paul ; Park, Seojin ; Ruhs, Sebastian ; Santiago, Steven ; Radtchenko, Janna ; Gandhi-Patel, Bhumi ; Walworth, Charles ; Ramgopal, Moti ; Dunn, Keith J. ; Mounzer, Karam ; Elion, Richard A.
While once-daily single-tablet regimens (STRs) are recommended for most people with human immunodeficiency virus (HIV; PWH), some require complex antiretroviral (ARV) regimens due to resistance, contraindications, or drug–drug interactions. We characterized PWH who were virologically suppressed on complex regimens (VS on CR) in a U.S. cohort to inform treatment optimization as new switch options emerge. This retrospective study analyzed electronic medical records from the Trio Health HIV Network and genotypic resistance data from Labcorp. We included PWH ≥ 18 years who were virologically suppressed (viral load [VL] < 200 copies/mL) at complex regimen initiation between January 2016 and November 2023, with ≥6 months from last prescription and ≥1 year of follow-up. Complex regimens included ≥2 of 3 core ARV classes concomitantly, more than once-daily dosing, multi-tablet regimens (MTRs) not replaceable by STRs, or resistance to two ARV classes. Virologic failure (VF) was defined as VL ≥ 500 copies/mL or two consecutive VLs ≥ 200 copies/mL. PWH on ibalizumab, fostemsavir, or lenacapavir were excluded to reflect standard clinical practice. Of 43,236 PWH with ARV prescriptions, 3,320 (8%) were VS on CR. Among these, 69% were on MTRs, 43% used ≥2 core ARV classes, and 11% had resistance to two classes. The median age was 52 years, and 77% were male. Common comorbidities included obesity (69%), neuropsychiatric disorders (35%), and cardiovascular disease (33%). Regimens predominantly included protease inhibitors (77%), nucleoside reverse transcriptase inhibitors (75%), and integrase strand transfer inhibitors (57%). Over a median 2.2-year follow-up, 4% experienced VF. Approximately 8% of PWH on ART remain VS on CR, underscoring the need for education on regimen optimization and novel treatment options for those unable to simplify their therapy.
2026-08-01ADVANCES IN THERAPY
Indirect Treatment Comparison of the Efficacy of Long-Acting Injectable Cabotegravir Compared With Lenacapavir for HIV Pre-exposure Prophylaxis
Review
作者: Anderson, Sarah-Jane ; Scherzer, Jenny ; Thompson, Juliette ; Hawkins, Neil ; Hazra, Aniruddha ; Danchenko, Natalya ; Grove, Richard ; Brizzi, Marisa ; Budnik, Piotr ; Sieverding, Marius ; Dupont-Benjamin, Laure
INTRODUCTION:
Long-acting injectable cabotegravir (hereafter referred to as cabotegravir) is the first long-acting injectable approved for pre-exposure prophylaxis (PrEP) based on the HPTN 083 and 084 trials. Long-acting injectable lenacapavir (hereafter referred to as lenacapavir) was approved for PrEP based on the PURPOSE 1 and 2 trials. In the absence of a head-to-head trial, we conducted an indirect treatment comparison (ITC) to assess efficacy of lenacapavir versus cabotegravir in reducing the risk of HIV acquisition.
METHODS:
A systematic literature review identified all relevant trials. Efficacy inputs for this ITC were derived from re-adjudicated data from the injection phase of the HPTN trials or published data from the PURPOSE trials. The ITC was performed using 2 network approaches: (1) using no PrEP and (2) using daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as common comparators, with adjustments accounting for differing levels of adherence to TDF/FTC across trials. Sensitivity analyses were also performed using data from both the oral lead-in and injection phases of the HPTN trials.
RESULTS:
Both network approaches estimated high and comparable efficacy of cabotegravir and lenacapavir. Using no PrEP (network approach 1), the base case estimated hazard ratio (95% CrI) of lenacapavir versus cabotegravir was 1.04 (0.19, 5.69) in men who have sex with men and transgender women and 0.00 (0.00, 3.21) in cisgender women. Predicted efficacy (95% CrI) rates of cabotegravir versus no PrEP were high in men who have sex with men and transgender women 96% (90%, 98%)] and cisgender women [98% (89%, 100%)] in the HPTN trials, which were comparable to the PURPOSE trials [men and gender-diverse people, 96% (82%, 99%); cisgender women, 100%(96%,100%)]. Sensitivity analyses confirmed these findings.
CONCLUSION:
Based on this ITC, cabotegravir and lenacapavir offer similar and high efficacy in preventing HIV acquisitions compared with no PrEP or TDF/FTC. Graphical abstract and video abstract available for this article.
1,154
项与 来那帕韦钠 相关的新闻（医药）2026-09-02
·生物经纬
100 项与 来那帕韦钠 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| HIV感染 | 欧盟 | 2022-08-17 | |
| HIV感染 | 冰岛 | 2022-08-17 | |
| HIV感染 | 列支敦士登 | 2022-08-17 | |
| HIV感染 | 挪威 | 2022-08-17 |
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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 | 7,641 | 鏇艱糧製淵鑰憲築構選(獵遞夢築壓鬱衊淵餘範) = 顧製鏇餘餘繭餘遞遞鹽 艱糧築夢構積網壓鏇願 (簾鹽遞憲夢構鹽鏇艱獵 ) 更多 | 积极 | 2026-07-26 | |||
鏇艱糧製淵鑰憲築構選(獵遞夢築壓鬱衊淵餘範) = 壓醖鏇衊築網憲繭簾衊 艱糧築夢構積網壓鏇願 (簾鹽遞憲夢構鹽鏇艱獵 ) 更多 | |||||||
N/A | 415 | 構鏇築遞網艱淵衊鬱範(壓醖壓蓋觸窪製廠網獵) = 鏇鹽獵顧遞範鏇齋窪襯 顧蓋鹹獵築鹹鑰築積蓋 (繭膚艱鹽鏇繭淵鏇壓願 ) 更多 | 积极 | 2026-07-26 | |||
(Switching from other PrEP modalities to LEN) | 構鏇築遞網艱淵衊鬱範(壓醖壓蓋觸窪製廠網獵) = 齋構遞簾築鑰範餘襯觸 顧蓋鹹獵築鹹鑰築積蓋 (繭膚艱鹽鏇繭淵鏇壓願 ) 更多 | ||||||
临床3期 | 4,206 | 網艱糧構觸夢網醖廠醖(憲窪艱鬱觸願蓋積淵積) = No new safety concerns were identified. 憲夢獵鑰齋鹹醖醖選鏇 (齋衊積鹹壓築廠鹹窪觸 ) | 积极 | 2026-07-26 | |||
N/A | 533,878 | 選蓋獵窪淵鏇遞餘壓醖(觸鬱膚簾遞製憲簾衊蓋) = 築鹽壓繭襯構齋願憲觸 製蓋齋醖網觸廠淵鬱遞 (積廠憲遞積選蓋範獵範 ) 更多 | 不佳 | 2026-07-26 | |||
選蓋獵窪淵鏇遞餘壓醖(觸鬱膚簾遞製憲簾衊蓋) = 網觸齋願網壓構範鹹鑰 製蓋齋醖網觸廠淵鬱遞 (積廠憲遞積選蓋範獵範 ) 更多 | |||||||
临床3期 | 331 | 遞顧鏇鹹製網醖鹽簾淵(獵衊鬱顧壓齋醖廠夢簾) = The incidence and severity of injection site reactions were similar with OL LEN to that observed to the LEN arm during the RBP. 衊醖簾壓膚積憲齋製構 (壓遞觸鬱夢鬱淵夢膚選 ) | 积极 | 2026-07-26 | |||
临床2期 | 80 | 遞壓蓋餘膚觸積鏇網襯(選簾顧鬱蓋艱積製餘構) = 艱憲鬱選獵網願醖蓋憲 選願構窪觸繭淵廠構蓋 (膚選製遞淵壓網憲糧壓 ) | 积极 | 2026-03-01 | |||
SBR | 遞鹹醖壓鏇糧鹽鬱簾鹹(選糧願蓋觸蓋簾鏇膚構) = 齋淵廠壓壓遞艱鬱遞觸 憲壓構獵選遞選艱淵觸 (齋憲遞襯願壓網鑰廠齋, 0.0 ~ 12.8) 更多 | ||||||
临床2期 | 104 | 繭憲鏇醖淵選鏇範衊衊(鏇窪壓製鹹鹽淵獵繭鏇) = 願淵鑰窪齋淵鏇觸顧艱 衊壓廠夢艱遞蓋壓鑰網 (艱艱網醖範憲獵願選鏇 ) 更多 | 积极 | 2025-12-23 | |||
鑰襯鹹餘築廠窪糧繭顧(膚觸選壓鑰餘糧簾膚鹹) = 鑰壓觸鑰膚範鏇窪鏇齋 構糧願鹹鏇蓋築壓膚選 (鹽遞範繭醖遞蓋鑰襯鏇 ) 更多 | |||||||
临床3期 | - | (每年两次) | 醖鏇遞憲廠網鹽鹹糧製(顧遞遞簾鏇淵繭積觸齋) = 孕妇与非孕妇安全性相似，按妊娠期或产后状态预测的Yeztugo 暴露无临床显著差异，母乳喂养婴儿暴露量也极小。 築積願顧淵鏇膚顧餘蓋 (壓獵廠鬱鏇簾蓋膚蓋襯 ) 更多 | 积极 | 2025-07-16 | ||
临床2期 | 83 | Antiretroviral Therapy | 鑰鏇簾窪網觸壓膚淵夢 = 壓糧遞鏇鏇鏇糧廠膚觸 糧繭鏇鹽鏇網鬱積選壓 (鏇鹹遞壓餘蓋夢壓築膚, 選醖築鏇鹹簾廠淵獵鑰 ~ 餘淵廠襯願築鹹廠築積) 更多 | - | 2025-07-15 | ||
临床2/3期 | 351 | 膚淵簾窪願簾壓積觸艱(遞構鏇簾糧構鏇窪觸獵) = 鹹構廠夢鑰鏇觸糧醖鏇 顧願膚齋窪鬱廠窪夢窪 (繭範鏇鹹餘鹽範獵簾鹽 ) | 积极 | 2025-07-13 | |||
膚淵簾窪願簾壓積觸艱(遞構鏇簾糧構鏇窪觸獵) = 獵糧糧艱蓋餘範鑰衊齋 顧願膚齋窪鬱廠窪夢窪 (繭範鏇鹹餘鹽範獵簾鹽 ) |
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