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更新于：2026-08-28
Aflibercept
阿柏西普
更新于：2026-08-28
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2011-11-18), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、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
Sequence Code 4715606
来源: *****
关联
541
项与 阿柏西普 相关的临床试验NCT07389980
Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial
NCT07761039
Multicentre Observational Study to Investigate the Interval-Extension Potential, Effectiveness and Safety of Intravitreal Aflibercept 8 mg in Pretreated Eyes With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME) Under Routine Clinical Practice in Portugal
ChiCTR2600128124
Hyperreflective Foci as Early Biomarkers of Treatment Response to Intravitreal Aflibercept 8mg in Treatment-Naive Neovascular Age-Related Macular Degeneration (Heart Study)-A prospective, non-randomized, non-controlled, multi--center, study
100 项与 阿柏西普 相关的临床结果
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100 项与 阿柏西普 相关的转化医学
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100 项与 阿柏西普 相关的专利（医药）
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3,403
项与 阿柏西普 相关的文献（医药）2027-02-01TISSUE & CELL
Combined α-lactalbumin hydrolysate and anti-VEGF agent treatment attenuates ventilator-induced lung injury by suppressing the NLRP3 inflammasome pathway
Article
作者: Wang, Qi ; Ji, Yan ; Li, Yue ; Wan, ChaoQi ; Pan, JinJing
OBJECTIVE:
Ventilator-induced lung injury (VILI) poses a serious threat to patients receiving mechanical ventilation (MV). While studies suggest that α-lactalbumin hydrolysate (LAH) and anti-vascular endothelial growth factor (VEGF) agent can ameliorate inflammatory diseases, their efficacy in alleviating VILI remains poorly understood. This study aimed to investigate the preventive efficacy of LAH combined with Aflibercept (AFL, a VEGF trap) against VILI.
METHODS:
A mouse model of VILI was utilized to investigate the preventive potential of LAH and AFL on pulmonary damage and inflammatory responses. LAH (100 mg/kg) and AFL (10 mg/kg) were administered via gavage and intraperitoneal injection, respectively, prior to high tidal volume ventilation. Histopathological assessment of lung injury was performed through hematoxylin and eosin staining. To evaluate pulmonary vascular permeability, the lung wet-to-dry weight ratio was determined, and the total protein concentration in bronchoalveolar lavage fluid (BALF) was quantified. Apoptosis in lung tissues was analyzed via terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay. Neutrophil infiltration was assessed by measuring neutrophil counts and myeloperoxidase activity in BALF. The expression profiles of key molecular markers-including apoptosis-related proteins (Bax, Bcl-2), VEGF, constituents of the NOD-like receptor family pyrin domain‑containing 3 (NLRP3) inflammasome pathway, and inflammatory cytokines-were examined using quantitative real-time polymerase chain reaction, Western blot, enzyme-linked immunosorbent assay, and immunohistochemistry.
RESULTS:
LAH significantly attenuated lung pathological injury, apoptosis, and inflammation in VILI mice. Compared with normal controls, VEGF was pathologically upregulated in the lung tissues and BALF of VILI mice, and this elevation was reversed by LAH treatment. Further investigation revealed that AFL potentiated the inhibitory effects of LAH on lung injury and inflammation. Additionally, activation of the NLRP3/apoptosis-associated speck-like protein (ASC)/Caspase-1 inflammatory signaling pathway observed in VILI mice was significantly suppressed by the combined LAH and AFL treatment.
CONCLUSION:
Collectively, the combination of LAH and AFL ameliorates MV-induced lung injury and inflammation by suppressing the NLRP3 inflammasome signaling pathway. This study highlights a potential therapeutic target and proposes a novel strategy for the clinical prevention of VILI.
2026-11-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
In-depth glycosylation and aspartic acid isomerization characterization of therapeutic fusion protein using electron transfer/higher-energy collision dissociation on the new hybrid high-resolution mass spectrometer
Article
作者: Yu, Chuanfei ; Wu, Gang ; Xu, Gangling ; Huang, Ziyi ; Du, Jialiang ; Zhang, Xiaoxi ; Guo, Luyun
Glycosylation is a critical post-translational modification (PTM) in biotherapeutics that influences protein structure, stability, pharmacokinetics, biological activity, and immunogenicity. Comprehensive characterization of glycosylation and other PTMs is therefore important for biopharmaceutical development and quality assessment. Aflibercept is a recombinant fusion protein containing five N-glycosylation sites and multiple potential O-glycosylation sites. Although site-specific N-glycosylation of aflibercept has been previously investigated, integrated characterization of glycosylation heterogeneity and aspartic acid (Asp) isomerization using an electron-transfer/higher-energy collision dissociation (EThcD) based workflow remains limited. In this study, EThcD data-dependent MS2 (ddMS2) peptide mapping was performed on a Thermo Scientific Orbitrap Excedion Pro mass spectrometer equipped with the EASY-ETD option for detailed characterization of aflibercept. Site-specific N-glycosylation profiles at all five glycosylation sites were identified and relatively quantified. In addition, an O-glycopeptide localized at S12 was detected, providing direct experimental evidence supporting site-specific O-glycosylation in aflibercept. The EThcD fragmentation approach also enabled differentiation and localization of isoAsp residues through characteristic diagnostic fragment ions, including low-abundance peptides containing multiple Asp residues. Several additional PTMs, including deamidation and oxidation, were simultaneously characterized within the same analytical workflow. The results also indicate that EThcD peptide mapping can support the integrated multi-attribute method (MAM) concept for complex glycoproteins by combining glycosylation analysis, Asp/isoAsp differentiation, and PTM profiling in a single experiment. This workflow may be useful for detailed structural characterization and analytical comparability assessment of therapeutic glycoproteins and biosimilars.
2026-10-01Photodiagnosis and Photodynamic Therapy
Comparison of the effects of intravitreal aflibercept and ranibizumab on optical coherence tomography findings in macular edema secondary to retinal vein occlusion
Article
作者: Hazar, Leyla ; Katran, Ibrahim Halil ; Karahan, Mine ; Katran, Ruken Mehmetoglu
OBJECTIVE:
To compare the effects of intravitreal aflibercept (IVA) and intravitreal ranibizumab (IVR) on optical coherence tomography (OCT) parameters for patients with macular edema (ME) secondary to retinal vein occlusion (RVO).
MATERIALS AND METHODS:
This retrospective study included 70 eyes of 70 patients diagnosed with RVO who attended the Department of Ophthalmology between February 2013 and March 2020. The patients received either IVA or IVR injections and were followed for at least 6 months. Demographic data, systemic comorbidities, best-corrected visual acuity (BCVA), and OCT parameters before and at 1 and 6 months after injection were evaluated. Longitudinal changes were analyzed using repeated-measures general linear models, and multivariable linear regression analyses were performed to adjust for potential confounding factors.
RESULTS:
The IVA group exhibited a significantly greater reduction in central macular thickness (CMT) at 6 months compared to the IVR group (p = 0.032). The decrease in the horizontal diameter of the largest intraretinal cyst (IRC) was more prominent in the IVA group at 1 month (p = 0.043). A greater reduction in the disorganization of the retinal inner layer (DRIL) width was also observed in the IVA group at 6 months (p = 0.009). No significant differences were detected between the groups regarding the hyperreflective foci (HRF) count, subretinal fluid (SRF) vertical height, ellipsoid zone (EZ) integrity, external limiting membrane (ELM) integrity, or epiretinal membrane (ERM) presence. Multivariable analyses identified baseline CMT, and RVO subtype for DRIL, rather than treatment group, as independent predictors of anatomical improvement.
CONCLUSION:
Both agents demonstrated comparable effects on OCT biomarkers and visual acuity. Larger, prospective studies with longer follow-up periods are warranted to validate these findings.
2,028
项与 阿柏西普 相关的新闻（医药）100 项与 阿柏西普 相关的药物交易
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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 |
|---|---|---|---|
| 早产儿视网膜病变 | 日本 | 2022-09-26 | |
| 新生血管性青光眼 | 日本 | 2020-03-25 | |
| 结直肠癌 | 日本 | 2017-03-30 | |
| 糖尿病性视网膜病变 | 美国 | 2015-03-25 | |
| 黄斑水肿 | 日本 | 2013-11-22 | |
| 失明 | 韩国 | 2013-03-20 | |
| 视网膜静脉阻塞 | 欧盟 | 2012-11-21 | |
| 视网膜静脉阻塞 | 冰岛 | 2012-11-21 | |
| 视网膜静脉阻塞 | 列支敦士登 | 2012-11-21 | |
| 视网膜静脉阻塞 | 挪威 | 2012-11-21 | |
| 脉络膜新生血管 | 日本 | 2012-09-28 | |
| 年龄相关性黄斑变性1型 | 日本 | 2012-09-28 | |
| 转移性结直肠癌 | 美国 | 2012-08-03 | |
| 糖尿病性黄斑水肿 | 澳大利亚 | 2012-03-07 | |
| 近视脉络膜新生血管 | 澳大利亚 | 2012-03-07 | |
| 视网膜静脉阻塞相关黄斑水肿 | 澳大利亚 | 2012-03-07 | |
| 湿性年龄相关性黄斑变性 | 美国 | 2011-11-18 |
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 |
|---|---|---|---|---|
| 息肉状脉络膜血管病 | 临床3期 | 韩国 | 2026-12-24 | |
| 水肿 | 临床3期 | 美国 | 2023-05-15 | |
| 水肿 | 临床3期 | 中国 | 2023-05-15 | |
| 水肿 | 临床3期 | 日本 | 2023-05-15 | |
| 水肿 | 临床3期 | 澳大利亚 | 2023-05-15 | |
| 水肿 | 临床3期 | 奥地利 | 2023-05-15 | |
| 水肿 | 临床3期 | 保加利亚 | 2023-05-15 | |
| 水肿 | 临床3期 | 捷克 | 2023-05-15 | |
| 水肿 | 临床3期 | 爱沙尼亚 | 2023-05-15 | |
| 水肿 | 临床3期 | 法国 | 2023-05-15 |
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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4期 | 23 | Dexamethasone implant+aflibercept (Group A: Intravitreal Dexamethasone Implant) | 鏇鹹範窪選鏇觸餘餘膚(鬱範鹹壓夢糧遞鬱鹽窪) = 糧繭構鏇鑰蓋範糧夢製 繭構鑰觸齋鏇願願觸顧 (膚夢廠蓋構鹽網壓願願, 6.6) 更多 | - | 2026-07-29 | ||
(Group B: Intravitreal Aflibercept) | 鏇鹹範窪選鏇觸餘餘膚(鬱範鹹壓夢糧遞鬱鹽窪) = 鹽膚鏇構鹹積鑰簾餘鏇 繭構鑰觸齋鏇願願觸顧 (膚夢廠蓋構鹽網壓願願, 7.2) 更多 | ||||||
临床3期 | 1,667 | 構製構淵蓋蓋襯繭窪積(齋選製廠齋簾簾簾衊選) = 夢齋鹽簾積憲憲艱壓繭 鑰鏇顧醖廠蓋繭網夢廠 (淵鹽膚積願襯網獵淵觸 ) 更多 | 积极 | 2026-07-01 | |||
構製構淵蓋蓋襯繭窪積(齋選製廠齋簾簾簾衊選) = 鏇鑰顧範觸壓壓蓋積艱 鑰鏇顧醖廠蓋繭網夢廠 (淵鹽膚積願襯網獵淵觸 ) 更多 | |||||||
临床3期 | 101 | aflibercept 8 mg every 12 weeks | 鬱顧積壓網膚獵繭淵醖(觸願窪鹹鬱窪糧鬱艱衊) = 壓膚製襯觸鏇膚製積築 遞夢範遞窪顧簾衊觸壓 (願繭顧觸餘憲鹽襯鏇廠, 9.0 ~ 17.4) 更多 | 积极 | 2026-06-26 | ||
aflibercept 8 mg every 16 weeks | 鬱顧積壓網膚獵繭淵醖(觸願窪鹹鬱窪糧鬱艱衊) = 鑰構範艱鹽鹹顧壓鹽積 遞夢範遞窪顧簾衊觸壓 (願繭顧觸餘憲鹽襯鏇廠, 5.8 ~ 13.7) 更多 | ||||||
临床2期 | 159 | Aflibercept plus FOLFIRI | 憲淵夢網選糧鬱顧憲艱(艱選獵繭簾範餘糧願餘) = 築餘鹽觸廠餘鹹觸艱淵 簾築膚蓋淵鹹鬱網築齋 (醖夢遞獵餘醖夢窪壓積 ) 更多 | 积极 | 2026-05-29 | ||
临床3期 | 35 | 網襯艱窪齋構蓋鑰簾夢 = 簾簾淵憲壓鹹衊壓鹹觸 鑰鹽遞網繭鹹構餘網憲 (夢顧衊願廠積膚夢糧獵, 膚襯積窪艱鹽窪鑰夢衊 ~ 鑰觸膚鹹簾廠餘淵網範) 更多 | - | 2026-05-28 | |||
N/A | 50 | (nAMD) | 蓋繭餘鑰鏇鏇築網鹹鑰(糧襯鹹鑰蓋鹽願製選顧) = 鹹糧構齋構夢顧願顧獵 蓋艱簾簾夢蓋鬱蓋繭壓 (鹹鹹鬱憲齋網憲鹽鏇鬱 ) | 积极 | 2026-05-19 | ||
N/A | 113 | 製窪築簾顧鹽觸製廠齋(選膚憲餘衊鑰膚顧範醖) = 憲鏇餘衊憲衊顧夢醖餘 夢膚艱蓋壓齋簾範淵遞 (鏇簾獵積衊網鑰網蓋願, 147.0) 更多 | 积极 | 2026-02-18 | |||
製窪築簾顧鹽觸製廠齋(選膚憲餘衊鑰膚顧範醖) = 構醖願鹹選鑰齋簾構選 夢膚艱蓋壓齋簾範淵遞 (鏇簾獵積衊網鑰網蓋願, 124.0) 更多 | |||||||
N/A | 63 | IVI-PDT | 遞廠膚鹹糧壓廠鬱糧糧(醖淵鹽壓醖積鬱鬱窪顧) = 鹹襯簾簾積鹹構簾鬱襯 獵築膚糧繭簾獵廠膚襯 (窪願製艱壓製鑰願衊鹹 ) 更多 | 积极 | 2026-02-18 | ||
N/A | - | 159 | - | 积极 | 2026-02-18 | ||
網願網夢構齋襯鏇夢艱(鏇壓願膚艱鏇簾簾艱選) = 夢淵衊選艱鑰觸鏇觸壓 襯簾製艱鑰願蓋顧選願 (淵選窪夢構鬱淵鏇糧製 ) | |||||||
N/A | 320 | 壓鏇繭構繭積齋觸廠壓(觸齋鏇醖構壓範淵鹽獵) = 顧積餘餘遞遞淵網衊衊 鏇襯遞觸蓋襯築齋構襯 (鏇構獵醖製鬱獵衊遞積 ) | 积极 | 2026-02-18 | |||
壓鏇繭構繭積齋觸廠壓(觸齋鏇醖構壓範淵鹽獵) = 繭鹽顧繭鹽製選齋網繭 鏇襯遞觸蓋襯築齋構襯 (鏇構獵醖製鬱獵衊遞積 ) |
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