预约演示
更新于：2026-06-06
Clesrovimab
克莱罗韦单抗
更新于：2026-06-06
概要
基本信息
药物类型 单克隆抗体 |
别名 Anti RSV F antibody、Clesrovimab-cfor、MK 1654 + [2] |
作用方式 抑制剂 |
作用机制 呼吸道合胞病毒F蛋白抑制剂 |
在研适应症 |
非在研适应症- |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2025-06-09), |
最高研发阶段(中国)临床2/3期 |
特殊审评优先审评 (中国) |
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结构/序列
Sequence Code 31104505H
来源: *****
Sequence Code 31104507L
来源: *****
关联
5
项与 克莱罗韦单抗 相关的临床试验NCT04938830
A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
CTR20211903
一项在中国健康受试者中评价MK-1654安全性和耐受性的开放性、单剂临床研究
NCT04767373
A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
100 项与 克莱罗韦单抗 相关的临床结果
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100 项与 克莱罗韦单抗 相关的转化医学
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100 项与 克莱罗韦单抗 相关的专利（医药）
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31
项与 克莱罗韦单抗 相关的文献（医药）2026-04-01CLINICAL PHARMACOLOGY & THERAPEUTICS
Population Pharmacokinetics of Clesrovimab in Preterm and Full‐Term Infants
Article
作者: Railkar, Radha A. ; Hellmann, Farina ; Parmar, Keyur ; Cheung, S. Y. Amy ; Plock, Nele ; Maas, Brian M. ; Hu, Ziheng ; Gheyas, Ferdous ; Zang, Xiaowei
Clesrovimab is a half‐life extended monoclonal antibody targeting the respiratory syncytial virus fusion protein. Three studies (phase Ib/IIa [MK‐1654‐002], phase IIb/III [CLEVER], and phase III [SMART]) were conducted to evaluate the efficacy, safety, and pharmacokinetics (PK) of clesrovimab in infants. The objectives of this analysis were to develop an infant population PK model for clesrovimab and to evaluate the influence of intrinsic and extrinsic factors on clesrovimab PK in infants. A total of 5850 samples from 2942 participants were included in the population PK analysis. A two‐compartment model with first‐order absorption and elimination well described clesrovimab PK in infants. The estimated half‐life for clesrovimab was 44.0 days. Clearance, absorption rate constant, and central volume of distribution had low inter‐individual variability. Body weight was included as a covariate on all clearance and volume parameters, with estimated allometric scaling exponents centered on a body weight of 5 kg. A maturation function further described the change in clearance with increasing infant age. In addition to body weight and maturation function, the final model contained an effect of race on clearance. Although body weight, age, and race were identified as statistically significant covariates, the magnitude of the effect of these covariates on clesrovimab exposures was small (< 30%). The results of the population PK modeling support intramuscular administration of clesrovimab for the prevention of respiratory syncytial virus (RSV) disease in all infants, including healthy infants and infants at increased risk for severe RSV disease.
2026-04-01JOURNAL OF PHARMACY TECHNOLOGY
Clesrovimab for the Prevention of Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants
Review
作者: Jackson, Christopher ; Phillips, Jordan ; Phillips, Bradley
Objective:
To assess the clinical utility of clesrovimab-cfor (Enflonsia
®
), a newly Food and Drug Administration (FDA)-approved monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infections in infants.
Data Sources:
A literature search was conducted using the key words clesrovimab, RSV, pediatric, infant, and nirsevimab. Data were also extracted from Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), FDA prescribing information, and manufacturer data were reviewed.
Study Selection and Data Extraction:
English-language studies assessing the pharmacokinetics, pharmacodynamics, efficacy, and safety of clesrovimab were included. Key clinical trials (CLEVER and SMART) and cost-effectiveness models were reviewed.
Data Synthesis:
Clesrovimab binds to a conserved site on the RSV F protein, targeting both pre- and postfusion forms. In the CLEVER trial, it reduced RSV-associated medical visits by 60.4% and hospitalizations by 84.2%. The SMART trial showed comparable efficacy and safety to palivizumab. Adverse events were mild and injection-site related. No cross-resistance was observed with variants resistant to other monoclonal antibodies. Pharmacokinetics support single-dose administration with a half-life of 44 days.
Conclusion:
Clesrovimab offers simplified dosing, favorable safety, and potential cost savings compared with palivizumab and nirsevimab. While nirsevimab has a longer half-life, clesrovimab’s unique binding site and room-temperature stability offer practical advantages. Lack of head-to-head comparisons and limited second-season data warrant further study. Clesrovimab is a promising addition to RSV prevention strategies, offering effective, safe, and accessible immunization for infants. Ongoing research will clarify its role in high-risk populations and broader clinical use.
2026-04-01Infectious Diseases and Therapy
Cost-Effectiveness of Nirsevimab and Clesrovimab in Preventing Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants in the United States: A Modeling Study
Article
作者: Hodges, Erin N ; Chit, Ayman ; Gabriel, Veronica ; Soudani, Samira ; Krilov, Leonard R ; Geurtsen, Jeroen ; Musci, Robert ; Tribaldos, Maribel ; Yarnoff, Benjamin ; Neary, Maureen P ; Beuvelet, Matthieu
INTRODUCTION:
Respiratory syncytial virus (RSV) is the leading cause of infant hospitalizations in the United States, with a significant seasonal impact on healthcare resources. Long-acting monoclonal antibodies (mAbs), nirsevimab and clesrovimab, provide protection against RSV-related lower respiratory tract disease (LRTD); however, no head-to-head comparisons are available to inform clinical decision-making.
METHODS:
We developed a cost-effectiveness analysis framework to perform an indirect comparison of nirsevimab and clesrovimab for RSV prevention, consistent with CDC guidance for pre-season catch-up and in-season immunization for infants born outside and during the RSV season, respectively. Pharmacokinetic data were used to model the duration of cumulative efficacy over time. A 150-day duration was evaluated for nirsevimab, while three scenarios were assessed for clesrovimab (100-, 120-, and 150-day durations). A cost-utility analysis evaluated health outcomes, healthcare resource use, and associated costs.
RESULTS:
The modeled prediction suggests nirsevimab demonstrated greater clinical benefit and more favorable economic outcomes compared to clesrovimab across all protection duration scenarios. Nirsevimab use consistently resulted in reduced cases of RSV medically attended (MA)-LRTDs and therefore direct and indirect costs associated with RSV management. From a cost-effectiveness perspective, nirsevimab was dominant (i.e., more effective and less costly) compared to clesrovimab in all analyzed scenarios. Additional scenario analyses leveraging trial data differentiated by infant gestational age for both nirsevimab and clesrovimab and alternative RSV seasonality demonstrated that model conclusions remain stable. These analyses confirmed the robustness of our findings, with nirsevimab consistently offering greater value.
CONCLUSIONS:
Our findings predict that nirsevimab is economically dominant over clesrovimab while providing greater clinical protection against RSV-related disease in these scenarios. These results are robust to sensitivity analyses with nirsevimab consistently estimated as reducing healthcare resource utilization and total costs compared to clesrovimab across assumptions related to clesrovimab duration of cumulative efficacy as well as variation in key model parameters.
239
项与 克莱罗韦单抗 相关的新闻（医药）2026-06-03
2026-05-31
微生物疗法临床结果临床1期
100 项与 克莱罗韦单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12153 | - | - | - |
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 |
|---|---|---|---|
| 下呼吸道感染 | 加拿大 | 2026-02-05 | |
| 呼吸道合胞体病毒感染 | 美国 | 2025-06-09 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 呼吸道感染 | 临床2期 | 美国 | 2018-09-20 | |
| 呼吸道感染 | 临床2期 | 智利 | 2018-09-20 | |
| 呼吸道感染 | 临床2期 | 哥伦比亚 | 2018-09-20 | |
| 呼吸道感染 | 临床2期 | 南非 | 2018-09-20 | |
| 呼吸道感染 | 临床2期 | 韩国 | 2018-09-20 | |
| 呼吸道感染 | 临床2期 | 西班牙 | 2018-09-20 |
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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 | 1,003 | (Clesrovimab 105 mg (Season 1)) | 糧窪餘築遞窪襯範觸壓 = 壓獵鏇廠餘獵壓餘選鏇 築壓衊餘遞窪襯鏇廠憲 (糧糧簾顧鏇餘觸衊壓簾, 齋艱壓鬱構憲顧鏇鹽觸 ~ 簾繭醖鑰憲繭衊窪廠衊) 更多 | - | 2026-05-08 | ||
(Palivizumab (Season 1)) | 糧窪餘築遞窪襯範觸壓 = 簾築膚餘齋夢網鹽蓋觸 築壓衊餘遞窪襯鏇廠憲 (糧糧簾顧鏇餘觸衊壓簾, 憲鏇獵選壓範願齋窪餘 ~ 願淵鬱鏇鏇構製窪獵窪) 更多 | ||||||
临床2/3期 | 3,614 | 築淵範鹹願膚獵膚獵鏇(廠顧蓋獵觸簾壓淵淵鏇): efficacy = 60.4 (95.0% CI, 44.1 ~ 71.9), P-Value = <0.001 更多 | 积极 | 2025-10-02 | |||
Placebo | |||||||
临床2/3期 | 3,632 | (RSV Season 1: Clesrovimab 105 mg) | 構鹹遞膚膚艱鹽夢糧繭 = 艱襯艱鹽壓遞夢網構衊 鏇膚築糧餘構鬱鹽範窪 (憲壓築鏇製構繭襯積築, 顧範醖簾顧壓醖鬱艱鏇 ~ 憲顧網製願衊構醖鏇餘) 更多 | - | 2025-02-04 | ||
placebo (RSV Season 1: Placebo) | 構鹹遞膚膚艱鹽夢糧繭 = 鹽蓋夢構鑰齋鑰網範範 鏇膚築糧餘構鬱鹽範窪 (憲壓築鏇製構繭襯積築, 艱鑰襯蓋鬱範齋繭顧遞 ~ 膚鹹淵繭遞積範壓範壓) 更多 | ||||||
临床1/2期 | - | 183 | 艱糧顧鏇獵窪簾夢構鏇(蓋糧齋糧憲蓋艱簾網願) = 鹹壓願醖窪壓鹹鑰獵顧 顧鹽窪願齋淵醖觸艱築 (簾構齋餘遞選艱窪獵遞 ) 更多 | 积极 | 2024-11-27 | ||
临床2/3期 | - | 顧醖鏇簾襯廠窪鹽餘繭(淵齋鏇淵壓網鹽鬱衊繭): Difference (%) = 60.4 (95% CI, 44.1 ~ 71.9), P-Value = <0.001 更多 | 积极 | 2024-10-17 | |||
Placebo | |||||||
临床3期 | 901 | 範艱選廠構鬱壓艱範選(範壓遞憲醖夢餘艱壓遞) = 積製壓鬱膚糧餘獵襯衊 鏇窪築鏇憲獵鹽簾醖顧 (願選窪鬱範鏇鑰蓋憲積 ) 更多 | 积极 | 2024-10-17 | |||
範艱選廠構鬱壓艱範選(範壓遞憲醖夢餘艱壓遞) = 觸醖選淵獵壓鏇築鏇糧 鏇窪築鏇憲獵鹽簾醖顧 (願選窪鬱範鏇鑰蓋憲積 ) 更多 | |||||||
临床2期 | 80 | RSV-A Memphis 37b | 製築蓋餘鏇艱襯衊顧遞(廠鏇顧鬱繭齋醖簾願淵) = 壓簾簾鏇鑰範蓋繭構窪 壓齋觸獵築鬱製願鏇醖 (網願膚製齋憲積襯衊衊, 願醖鹹顧鹽製遞範膚餘 ~ 窪製廠構簾廠齋範醖鬱) 更多 | - | 2021-04-13 |
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