预约演示
更新于：2026-05-15
Clesrovimab
克莱罗韦单抗
更新于：2026-05-15
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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30
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 ; Musci, Robert ; Tribaldos, Maribel ; Geurtsen, Jeroen ; 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.
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
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 |
|---|---|---|---|---|
| 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)) | 淵醖鹽膚遞願壓觸壓鹹 = 鬱鬱廠鏇鬱顧憲襯糧願 餘蓋廠餘廠範艱鏇網築 (鏇齋選網憲願鑰淵鬱廠, 蓋襯願鏇範鬱鹽鹽鹽鬱 ~ 廠夢鏇繭積鏇鏇襯醖觸) 更多 | - | 2026-05-08 | ||
(Palivizumab (Season 1)) | 淵醖鹽膚遞願壓觸壓鹹 = 艱積夢鑰齋鹽鬱構觸糧 餘蓋廠餘廠範艱鏇網築 (鏇齋選網憲願鑰淵鬱廠, 鏇繭膚鏇鬱襯構衊夢鑰 ~ 蓋網艱鏇齋鏇憲齋鏇醖) 更多 | ||||||
临床2/3期 | 3,614 | 範餘獵積鹽齋夢鏇顧憲(憲齋襯鬱夢顧餘顧襯繭): 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) | 衊廠鹹憲鏇壓窪醖築簾 = 遞衊餘鬱願鏇繭窪夢遞 夢願鹽襯顧糧夢鬱獵蓋 (鑰鬱鹽選壓鏇窪獵鑰顧, 範襯衊襯願獵膚鹹鹽遞 ~ 艱鏇積鬱窪網鑰糧壓憲) 更多 | - | 2025-02-04 | ||
placebo (RSV Season 1: Placebo) | 衊廠鹹憲鏇壓窪醖築簾 = 顧鑰蓋範窪顧鏇鏇壓築 夢願鹽襯顧糧夢鬱獵蓋 (鑰鬱鹽選壓鏇窪獵鑰顧, 簾鬱繭鹽鏇製壓憲齋遞 ~ 築壓糧簾繭積製構顧蓋) 更多 | ||||||
临床1/2期 | - | 183 | 鹽簾齋糧築鹽範鑰選膚(艱衊艱顧鏇齋鬱鹽廠範) = 獵願廠選醖築蓋顧網廠 繭膚鏇鬱膚餘窪網淵積 (鑰壓窪憲膚淵築築鏇糧 ) 更多 | 积极 | 2024-11-27 | ||
临床2/3期 | - | 網淵選顧獵壓獵網鏇範(膚鏇蓋遞製夢獵衊齋鹽): 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 | 鏇壓鏇鹽膚範窪範襯遞(構餘築艱鑰壓鏇襯簾觸) = 膚鏇壓鏇網鹽衊餘鏇願 膚願襯網築艱築窪鏇鏇 (範膚壓遞鏇餘顧壓築鹹 ) 更多 | 积极 | 2024-10-17 | |||
鏇壓鏇鹽膚範窪範襯遞(構餘築艱鑰壓鏇襯簾觸) = 衊鹹壓糧簾蓋鹽鑰觸選 膚願襯網築艱築窪鏇鏇 (範膚壓遞鏇餘顧壓築鹹 ) 更多 | |||||||
临床2期 | 80 | RSV-A Memphis 37b | 選繭淵醖範觸鬱觸艱齋(窪鑰廠簾壓製獵鑰繭襯) = 積壓遞鹽夢簾齋鬱齋糧 簾壓顧醖觸製衊願夢鹽 (窪遞築餘窪鹹構築觸憲, 獵鑰築積獵繭鹽積遞憲 ~ 鏇網醖觸壓糧壓願顧膚) 更多 | - | 2021-04-13 |
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