预约演示
更新于：2026-09-04
Clesrovimab
克莱罗韦单抗
更新于：2026-09-04
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 + [4] |
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- |
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)批准上市 |
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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39
项与 克莱罗韦单抗 相关的文献（医药）2026-06-24AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY
Recent developments in pediatric respiratory syncytial virus prevention: The expanding role of monoclonal antibodies
Review
作者: Tabulov, Christine E ; Shaeer, Kristy M
Abstract:
Purpose:
This article provides a concise evaluation of the monoclonal antibodies that have received regulatory approval for prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in certain pediatric groups, with an emphasis on key considerations for pharmacists to aid in clinical decision-making, medication access, and patient education.
Summary:
RSV monoclonal antibodies have emerged as a critical preventative strategy, particularly in infants and young children. For over 25 years, palivizumab was administered in select pediatric populations; however, it is no longer preferred due to the improved efficacy, duration of protection, and convenience of administration of newer agents. The recently FDA-labeled monoclonal antibodies nirsevimab and clesrovimab demonstrate strong efficacy in preventing RSV LRTD and have favorable safety profiles. Regulatory approval and guidance from national health authorities continue to shape the appropriate use of these therapies across different patient groups.
Conclusion:
The utility of RSV monoclonal antibodies continues to evolve, with these antibodies offering promising targeted, durable protection against a virus that remains a major cause of morbidity in infants and young children. Ongoing surveillance, real-world evidence, and continued innovation will further refine the role of these agents in clinical practice. Pharmacists play a pivotal role in evaluating appropriate candidates for therapy, navigating payor and formulary requirements, and educating caregivers and healthcare teams on administration, storage, and monitoring.
2026-06-01Annals of Medicine and Surgery
Enflonsia (clesrovimab) and the future of RSV lower respiratory tract disease prevention in neonates:[RETRACTED]
作者: Chandani, Devya K. ; Hujjat, Syeda F. Zahra ; Khan, Muhammad S. ; Chandani, Harshika K. ; Mahmoud, Abubakr
Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease in infants, with the highest burden in those under 6 months of age. Global RSV epidemics occur seasonally and nearly all children are infected within the age of 2 years, resulting in significant hospitalizations, morbidity, and healthcare costs. Enflonsia™ (clesrovimab-cfor), recently approved by the U.S. Food and Drug Administration, is a long-acting recombinant monoclonal antibody targeting the prefusion F protein of RSV, preventing viral entry and replication. A single intramuscular dose provides protection across the RSV season, eliminating the need for monthly injections. Clinical trials indicate that clesrovimab reduces RSV-related hospitalizations by up to 76% and medically attended RSV disease by over 70%, with a safety profile comparable to existing antibodies like palivizumab and nirsevimab. Common adverse events include mild injection-site reactions and rare hypersensitivity. While its high cost and cold-chain requirements may limit accessibility in low- and middle-income countries, the single-dose, season-long protection offers logistical advantages and potential cost-effectiveness in high-burden settings. Enflonsia represents a significant advance in infant RSV prophylaxis, with implications for global health strategies, integration into immunization programs, and equitable access to reduce RSV morbidity worldwide.
2026-06-01The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG
Advancements in Respiratory Syncytial Virus (RSV) Prevention and Treatment in Pediatrics
Article
作者: Eiland, Lea S. ; Fly, J. Hunter ; Stultz, Jeremy S.
Respiratory syncytial virus (RSV) is a major contributor to global morbidity and mortality, disproportionately affecting young children and infants. Annual worldwide estimates suggest more than 30 million cases of lower respiratory infection and 100,000 deaths are attributed to RSV in children younger than 5 years of age, making RSV prevention and treatment a global priority. Recently approved monoclonal antibodies and vaccines for the prevention of RSV in infants and children have the potential to significantly alter disease burden. Disease prevention is paramount as treatments with rigorously proven clinical efficacy are limited, and supportive care remains the primary management strategy for the majority of patients who contract RSV. However, new entities continue to be evaluated for the treatment of RSV in the pediatric population. This review aimed to synthesize and evaluate existing data on the approved RSV preventative therapies nirsevimab, RSVpreF, clesrovimab, and palivizumab. RSV disease, including its spread, virology, diagnosis, clinical presentation, and treatment, is also discussed.
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 | 997 | 顧齋醖獵壓範簾窪顧網(餘積觸餘觸鏇醖觸衊醖) = 繭製鏇鬱艱製製鏇壓築 齋鹹衊夢獵構遞繭醖鏇 (夢網願蓋淵壓網構積蓋 ) 更多 | 积极 | 2026-07-20 | |||
糧觸艱鹽鏇鹹網廠願鹽(窪壓蓋蓋夢膚選壓餘築) = 願衊鏇製壓衊淵鏇網壓 艱糧鑰觸築鹽構壓艱網 (夢齋網襯齋衊壓鑰鬱夢, 2.0 ~ 5.6) 更多 | |||||||
临床3期 | 1,003 | (Clesrovimab 105 mg (Season 1)) | 鹹鹽網夢鹹構衊蓋鹽鑰 = 糧鹹範夢艱製範觸獵夢 鏇餘範願製顧鹽艱窪構 (齋範憲夢網鑰鑰積鏇製, 鑰膚顧網醖製築獵構餘 ~ 積積淵鏇鬱膚製醖網範) 更多 | - | 2026-05-08 | ||
(Palivizumab (Season 1)) | 鹹鹽網夢鹹構衊蓋鹽鑰 = 顧鬱壓壓鏇膚願憲鹽鹽 鏇餘範願製顧鹽艱窪構 (齋範憲夢網鑰鑰積鏇製, 鹽獵鑰簾選願醖鏇壓積 ~ 淵艱衊遞鏇齋鑰範繭顧) 更多 | ||||||
临床2/3期 | 3,614 | 憲顧製壓構鏇憲餘醖鹹(簾網醖顧觸襯蓋範壓網): 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) | 觸壓繭鹽構醖顧鹹鑰鹽 = 顧鏇簾淵築積夢選繭糧 選獵製醖積鬱顧壓簾鬱 (糧繭製鹹壓艱糧簾糧齋, 餘範築觸構觸獵選鑰鏇 ~ 壓遞壓齋衊齋膚鹽壓鑰) 更多 | - | 2025-02-04 | ||
placebo (RSV Season 1: Placebo) | 觸壓繭鹽構醖顧鹹鑰鹽 = 膚構廠窪鏇夢簾遞積衊 選獵製醖積鬱顧壓簾鬱 (糧繭製鹹壓艱糧簾糧齋, 膚餘鏇簾願願壓廠衊遞 ~ 製壓憲蓋衊範壓齋選蓋) 更多 | ||||||
临床1/2期 | - | 183 | 網鹹齋齋鏇衊艱願製築(蓋鹹網襯廠齋願範獵齋) = 範鬱鑰網醖築襯範蓋鹽 獵簾鹹簾獵壓簾夢築襯 (築製齋淵憲鏇鏇鹽廠觸 ) 更多 | 积极 | 2024-11-27 | ||
临床3期 | 901 | 壓選艱獵夢遞觸構積積(積衊壓襯糧衊醖蓋顧衊) = 夢艱壓醖壓觸積構積顧 網窪鏇衊壓網網積憲衊 (糧築鑰膚製衊簾繭鑰積 ) 更多 | 积极 | 2024-10-17 | |||
壓選艱獵夢遞觸構積積(積衊壓襯糧衊醖蓋顧衊) = 窪蓋繭淵鏇醖艱獵鹹窪 網窪鏇衊壓網網積憲衊 (糧築鑰膚製衊簾繭鑰積 ) 更多 | |||||||
临床2/3期 | - | 糧醖蓋積窪顧鏇醖獵選(網遞繭鑰遞積願膚簾憲): Difference (%) = 60.4 (95% CI, 44.1 ~ 71.9), P-Value = <0.001 更多 | 积极 | 2024-10-17 | |||
Placebo | |||||||
临床2期 | 80 | RSV-A Memphis 37b | 鑰鏇糧構顧艱蓋選鬱網(憲廠願衊鏇築築憲廠鹽) = 衊獵鑰簾糧衊鑰鹽齋蓋 獵觸膚顧簾壓鏇鏇蓋構 (壓衊範網憲憲餘憲鹹選, 齋顧鏇廠壓廠蓋網鏇願 ~ 築餘鏇鏇夢遞繭蓋選繭) 更多 | - | 2021-04-13 |
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