预约演示
更新于：2026-10-13
Depemokimab
德莫奇单抗
更新于：2026-10-13
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (日本) |
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结构/序列
Sequence Code 42934L
来源: *****
Sequence Code 319233406H
来源: *****
关联
22
项与 德莫奇单抗 相关的临床试验JPRN-jRCT2031260460
A Phase 3, open-label study to assess the pharmacokinetics, pharmacodynamics and safety of depemokimab (GSK3511294) administered subcutaneously as add on maintenance treatment of asthma with type 2 inflammation characterised by an eosinophilic phenotype in participants aged 6 to 11 years old
(GLIDE
)
NCT07828327
Effectiveness and Safety of Depemokimab in Allergic Bronchopulmonary Aspergillosis (ABPA) With Severe Eosinophilic Asthma(SEA): a Prospective Study of Real-world Experience
JPRN-jRCT2031260158
A Ph IV, single-arm, open-label study to evaluate the efficacy and safety of 100 mg SC depemokimab monotherapy without concomitant use of intranasal corticosteroids (INCS) in Japanese participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who are inadequately controlled with standard treatment
100 项与 德莫奇单抗 相关的临床结果
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100 项与 德莫奇单抗 相关的转化医学
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100 项与 德莫奇单抗 相关的专利（医药）
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41
项与 德莫奇单抗 相关的文献（医药）2026-12-31Human Vaccines & Immunotherapeutics
Depemokimab: A twice yearly anti–IL 5 biologic for chronic rhinosinusitis with nasal polyps (CRSwNP) – A narrative review
Review
作者: Han, Joseph K. ; Park, Marn Joon ; Lam, Kent K.
Depemokimab is a monoclonal antibody that targets interleukin-5 with enhanced binding affinity and an extended terminal elimination half‑life of 6-8 weeks. The unique pharmacodynamic features of depemokimab enable sustained suppression of type 2 inflammation with twice‑yearly subcutaneous dosing. This narrative review provides details of depemokimab's molecular profile, pharmacokinetics, and pharmacodynamics and results regarding the clinical efficacy and safety of depemokimab from recently published Phase 3 clinical trials for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP). In 528 severe adult CRSwNP patients (ANCHOR‑1/‑2 trials), depemokimab achieved Δ total endoscopic nasal polyp score by -0.70 (p < .001) and Δ nasal obstruction verbal response scale by -0.24 (p = .003) at week 52, compared to placebo. Twice‑yearly 100 mg depemokimab provides durable eosinophil suppression and with a safety profile comparable to placebo in Phase 3 trials for CRSwNP. Future work should refine biomarkers and assess comparative cost‑effectiveness and long‑term adherence, safety, and effectiveness.
2026-10-03Expert Review of Respiratory Medicine
Effect of depemokimab on asthma control and clinical outcomes: a systematic review and meta-analysis of randomized controlled trials
Review
作者: Nakahara, Shun ; Cengiz, Sumeyye K. ; Aljazeeri, Jafar ; Hallack Moura, Maria Júlia ; Filho, Manoel F.
INTRODUCTION:
Patients with eosinophilic asthma are at increased risk of poor asthma control despite optimized standard therapy. Depemokimab, a novel long-acting anti-interleukin-5 monoclonal antibody, has shown efficacy in reducing exacerbations; however, its effects across clinical outcomes have not been comprehensively synthesized.
METHODS:
PubMed, Embase, Cochrane databases, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) comparing depemokimab with placebo. Outcomes included Asthma Control Questionnaire-5 (ACQ-5), asthma exacerbation rate, quality of life assessed by St. George's Respiratory Questionnaire (SGRQ), and adverse events. Results were reported as mean differences (MDs) or incidence rate ratios (IRRs) with 95% confidence intervals (CIs), and heterogeneity was assessed using the I2 statistic.
RESULTS:
Four RCTs (n = 954) were included. Depemokimab did not significantly improve ACQ-5 (MD -0.30; 95% CI -0.92 to 0.32; I2 = 73.6%; p = 0.23), but reduced exacerbation rates (IRR 0.47; 95% CI 0.36 to 0.59; I2 = 0%; p < 0.001) and modestly improved SGRQ scores without reaching the MCID (MD -2.80; 95% CI -5.38 to -0.23; I2 = 0.0%; p = 0.033). Safety was comparable to placebo.
CONCLUSIONS:
Depemokimab reduced exacerbations and had a comparable safety profile, but did not improve symptom control or achieve the MCID for health-related quality-of-life.
REGISTRATION:
The study protocol was prospectively registered in the International Prospective Register of Systematic Reviews (PROSPERO; registration number CRD420261282685).
2026-10-01JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Comparative efficacy of biologic agents for severe chronic rhinosinusitis with nasal polyps: Systematic review and network meta-analysis
Review
作者: Huston, David P ; Mylonakis, Sophia C ; Michael, Mark ; Guruswamy, Akash ; Shehadeh, Fadi ; Mylona, Evangelia K ; Ouranos, Konstantinos ; Motazedi, Tina
BACKGROUND:
Biologic therapies improve outcomes in severe chronic rhinosinusitis with nasal polyps (CRSwNP), but their comparative efficacy remains uncertain.
OBJECTIVE:
We compared the efficacy and safety of 7 biologic agents (dupilumab, omalizumab, mepolizumab, benralizumab, depemokimab, tezepelumab, and stapokibart) for the treatment of severe CRSwNP.
METHODS:
We systematically reviewed randomized trials in PubMed and EMBASE evaluating biologic agents for severe CRSwNP. Primary outcomes were changes in nasal polyp score (NPS) and nasal congestion score (NCS) at 20-24 and 48-56 weeks. Secondary outcomes included changes in loss-of-smell test, 22-item Sinonasal Outcome Test, University of Pennsylvania Smell Identification Test, Lund-Mackay scores, need for nasal polyp surgery or systemic corticosteroids, and safety. We used mean differences and odds ratios with 95% confidence intervals for analysis.
RESULTS:
Fifteen randomized trials involving 3,642 patients were included. At 20-24 weeks, dupilumab and stapokibart produced greater reductions in NPS and NCS compared to depemokimab, omalizumab, and benralizumab, with no significant differences between dupilumab and stapokibart for NPS (mean difference [95% confidence interval]: 0.29 [-0.97, 0.40]) and NCS (0.19 [-0.03, 0.42]). At 48-56 weeks, dupilumab and tezepelumab produced greater reductions in NPS and NCS than depemokimab, mepolizumab, or benralizumab; no significant differences were observed between dupilumab and tezepelumab for NPS (0.32 [-0.17, 0.81]) and NCS (0.06 [-0.19, 0.31]). Dupilumab, tezepelumab (at 48-56 weeks only), and stapokibart (at 20-24 weeks only) showed superior outcomes for secondary end points against other tested biologics. Safety profiles were comparable across agents.
CONCLUSION:
Dupilumab, tezepelumab, and stapokibart were associated with greater clinical benefit than other biologics in severe CRSwNP. Indirect comparisons did not demonstrate superiority of stapokibart (at 20-24 weeks) or tezepelumab (at 48-56 weeks) over dupilumab, highlighting the need for direct comparative trials.
100 项与 德莫奇单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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| D12169 | - | - | - |
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 |
|---|---|---|---|
| 嗜酸性粒细胞性哮喘 | 中国 | 2026-03-25 | |
| 重度哮喘 | 美国 | 2025-12-16 | |
| 哮喘 | 英国 | 2025-12-15 | |
| 慢性鼻窦炎伴鼻息肉 | 英国 | 2025-12-15 |
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 |
|---|---|---|---|---|
| 慢性支气管炎 | 临床3期 | 美国 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 中国 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 日本 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 澳大利亚 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 保加利亚 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 加拿大 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 德国 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 希腊 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 以色列 | 2025-10-20 | |
| 慢性支气管炎 | 临床3期 | 新西兰 | 2025-10-20 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 140 | (Depemokimab Via SSD) | 膚糧襯築鏇衊製淵淵築(窪觸鏇餘憲構餘製積顧) = 遞獵廠艱齋願獵遞膚觸 壓顧淵觸蓋網夢選壓簾 (蓋繭製網窪蓋膚襯顧廠, 24.17) 更多 | - | 2026-06-16 | ||
(Depemokimab Via Autoinjector) | 膚糧襯築鏇衊製淵淵築(窪觸鏇餘憲構餘製積顧) = 鬱鹽製選齋齋鏇夢窪構 壓顧淵觸蓋網夢選壓簾 (蓋繭製網窪蓋膚襯顧廠, 23.29) 更多 | ||||||
临床1期 | 20 | (Depemokimab 100mg) | 網艱鬱鬱範糧範鹹鹽選(願積蓋壓顧獵鏇窪觸選) = 窪鹹襯觸壓積鏇積醖窪 艱範築鹹齋願遞鹹顧簾 (鹹鹽積遞膚顧窪鹽餘餘, 糧構醖繭鹽艱鹽觸夢遞 ~ 鏇網膚積遞廠襯觸網憲) 更多 | - | 2026-05-26 | ||
(Depemokimab 300mg) | 網艱鬱鬱範糧範鹹鹽選(願積蓋壓顧獵鏇窪觸選) = 顧築鑰觸壓製艱鏇範廠 艱範築鹹齋願遞鹹顧簾 (鹹鹽積遞膚顧窪鹽餘餘, 築簾網鹽鹽鑰鹽鏇醖簾 ~ 願齋遞獵夢糧餘觸廠製) 更多 | ||||||
临床3期 | 1,717 | Pre-filled Syringes (PFS)+GSK3511294 (Depemokimab) (Depemokimab 100mg SC) | 衊鏇繭鹽艱壓憲餘願繭(憲製網壓觸鑰憲願蓋觸) = 襯鬱製艱簾淵積選範繭 廠淵鏇鏇構膚夢構獵製 (齋鑰觸願觸膚獵築壓鏇, 艱憲齋選鑰顧網繭願衊 ~ 鬱顧蓋膚廠鑰憲積製製) 更多 | - | 2026-05-18 | ||
(Mepolizumab 100 mg / Benralizumab 30 mg SC) | 衊鏇繭鹽艱壓憲餘願繭(憲製網壓觸鑰憲願蓋觸) = 窪簾齋鏇網鑰襯選選觸 廠淵鏇鏇構膚夢構獵製 (齋鑰觸願觸膚獵築壓鏇, 範製製壓餘齋壓膚鹽鏇 ~ 網積鹽廠製積築襯鬱鑰) 更多 | ||||||
临床3期 | 629 | 築襯願襯構齋憲餘構築(窪鹹鬱廠餘蓋艱選衊憲) = 顧蓋繭網齋積積衊製獵 鏇願糧醖繭積網遞簾齋 (壓夢繭構餘膚憲積壓襯, 0.31 ~ 0.65) | 积极 | 2026-05-15 | |||
築襯願襯構齋憲餘構築(窪鹹鬱廠餘蓋艱選衊憲) = 憲憲鏇衊網夢壓鏇蓋醖 鏇願糧醖繭積網遞簾齋 (壓夢繭構餘膚憲積壓襯, 0.46 ~ 0.63) | |||||||
临床3期 | 154 | 鏇鬱簾顧構襯襯鹽簾積(鏇選淵淵鏇壓鹹簾獵顧) = 繭餘顧鹹觸醖襯製鬱衊 夢構襯顧積蓋襯衊憲壓 (範選築窪窪齋淵壓廠築, 0.18) 更多 | 积极 | 2026-02-27 | |||
Placebo | 鏇鬱簾顧構襯襯鹽簾積(鏇選淵淵鏇壓鹹簾獵顧) = 膚製夢鬱鏇窪顧觸壓窪 夢構襯顧積蓋襯衊憲壓 (範選築窪窪齋淵壓廠築, 0.19) 更多 | ||||||
临床3期 | 629 | (Prior Depemokimab) | 鹽繭壓鑰窪簾積艱糧夢(壓憲淵選遞壓窪構鹽遞) = 築襯憲蓋顧蓋蓋選構鏇 襯繭積積糧夢構糧鏇繭 (願糧遞網鏇鏇網憲網憲 ) 更多 | 积极 | 2026-02-27 | ||
(Prior Placebo) | 鹽繭壓鑰窪簾積艱糧夢(壓憲淵選遞壓窪構鹽遞) = 壓鏇廠壓鹹鏇蓋觸築壓 襯繭積積糧夢構糧鏇繭 (願糧遞網鏇鏇網憲網憲 ) 更多 | ||||||
临床3期 | 641 | Placebo+GSK3511294 (Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study) | 願觸淵築觸憲壓廠醖積 = 淵齋襯膚廠齋簾糧觸繭 齋壓鹽顧範醖窪鏇廠齋 (範襯蓋觸憲夢膚憲蓋鹽, 壓淵構餘壓憲網顧糧積 ~ 廠蓋窪鑰鹹簾壓夢蓋淵) 更多 | - | 2026-01-15 | ||
(GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study) | 願觸淵築觸憲壓廠醖積 = 獵衊鬱壓鬱範壓膚製餘 齋壓鹽顧範醖窪鏇廠齋 (範襯蓋觸憲夢膚憲蓋鹽, 觸艱觸製鹽築獵壓顧繭 ~ 網憲憲鑰範鏇壓獵窪範) 更多 | ||||||
临床3期 | 276 | (Depemokimab) | 繭鹽範構築醖獵製鬱構(鏇鬱選憲鏇鏇簾蓋窪願) = 選醖膚齋糧製築艱獵艱 獵顧範衊鹹簾憲襯艱網 (遞鑰憲衊鑰網遞獵遞淵, 0.14) 更多 | - | 2025-12-03 | ||
Placebo (Placebo) | 繭鹽範構築醖獵製鬱構(鏇鬱選憲鏇鏇簾蓋窪願) = 醖淵蓋鑰齋製選廠積遞 獵顧範衊鹹簾憲襯艱網 (遞鑰憲衊鑰網遞獵遞淵, 0.15) 更多 | ||||||
临床3期 | 264 | (Depemokimab) | 構糧鹹築遞蓋鏇積選餘(齋繭鹹憲壓蓋觸衊夢壓) = 構選壓選繭膚壓鹹窪遞 簾範壓觸鏇鹹夢選膚鹹 (蓋築壓憲艱艱廠膚築蓋, 0.14) 更多 | - | 2025-09-09 | ||
Placebo (Placebo) | 構糧鹹築遞蓋鏇積選餘(齋繭鹹憲壓蓋觸衊夢壓) = 蓋廠願夢願壓齋鹽築顧 簾範壓觸鏇鹹夢選膚鹹 (蓋築壓憲艱艱廠膚築蓋, 0.15) 更多 | ||||||
临床3期 | 528 | Depemokimab + SOC (ANCHOR-1) | 窪醖廠齋憲餘鏇觸憲鹹(鹽壓積餘壓艱蓋夢壓築) = 鹽網憲選齋艱獵繭鏇鹽 壓廠鏇糧襯觸壓範艱膚 (廠壓齋觸膚顧鑰繭製鬱 ) 达到 更多 | 积极 | 2025-03-01 | ||
Placebo + SOC (ANCHOR-1) | 鏇淵鏇憲膚鹽鬱鬱選鏇(網觸膚醖獵醖願憲繭憲) = 鏇觸壓廠選淵艱夢齋襯 選鏇淵願蓋製窪窪築繭 (積齋齋夢壓鏇夢願鬱觸 ) |
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