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更新于：2026-02-27
Avacincaptad pegol
更新于：2026-02-27
概要
基本信息
药物类型 RNA aptamer |
别名 Anti-C5 aptamer、Avacincaptad Pegol Sodium、Avacincaptad pegol sodium (USAN) + [7] |
靶点 |
作用方式 抑制剂 |
作用机制 C5抑制剂(补体C5抑制剂) |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-08-04), |
最高研发阶段(中国)- |
特殊审评附条件批准 (日本)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 29451050
来源: *****
关联
13
项与 Avacincaptad pegol 相关的临床试验NCT06961370
A Phase I, Multi-center, Multi-part Study to Investigate Safety, Tolerability, PK, PD, and Immunogenicity of RO7669330 Intravitreal Injections in Participants With GA Secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD Pilot; Part 2: Masked, Randomized, Active-comparator-controlled
NCT06970665
A Phase 3/4, Multicenter, Single-arm Clinical Study to Assess the Safety of Intravitreal Administration of ASP3021 in Participants in Japan With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT06779773
A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
100 项与 Avacincaptad pegol 相关的临床结果
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100 项与 Avacincaptad pegol 相关的转化医学
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100 项与 Avacincaptad pegol 相关的专利（医药）
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47
项与 Avacincaptad pegol 相关的文献（医药）2026-03-01BMJ Open Ophthalmology
Safety and tolerability of avacincaptad pegol in combination with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration: results from a phase 1 and phase 2a study
Article
作者: Desai, Dhaval ; Zhu, Liansheng ; Clark, Julie ; Boyer, David S ; Loewenstein, Anat ; Patel, Sunil S ; Tang, Justin
Objective:
To assess the safety and tolerability of avacincaptad pegol (ACP), a Food and Drug Administration-approved therapy for geographic atrophy, administered in combination with ranibizumab, an approved therapy for neovascular age-related macular degeneration (nAMD), in patients with nAMD.
Methods:
The phase 1 study (
NCT00709527
) was a two-part, ascending-dose and parallel-group, open-label trial that assessed the safety, tolerability and pharmacokinetic profile of monthly intravitreal injections of ACP (0.03, 0.3, 1, 2, 3 mg) in combination with ranibizumab (0.5 mg) on the same day in treatment-naïve patients with nAMD (n=43 patients received a maximum of 6 injections). The phase 2a study (
NCT03362190
) was an open-label trial assessing the 6-month safety of intravitreal injections of ACP administered in combination with ranibizumab in treatment-naïve patients with nAMD (n=64). Patients received either ACP 2 mg or 4 mg either 14 days or 1 month apart, given on the same day or 2 days after ranibizumab. Primary outcome measures were safety and tolerability.
Results:
During the phase 1 study, there were no dose-limiting toxicities at any dose level. In both studies, ocular treatment-emergent adverse events were mostly mild or moderate, with the most reported events related to the injection procedure. There were no clinically significant increases in intraocular pressure or cumulative increases with multiple injections over time. There were no safety issues identified through measurement of visual acuity.
Conclusions:
Coadministration of ACP and ranibizumab in treatment-naïve patients with nAMD was well tolerated across different dosing regimens with no new safety issues based on results from two independent studies.
2026-01-01Journal of vitreoretinal diseases
Efficacy of Intravitreal Pegcetacoplan vs Avacincaptad Pegol in Patients With Geographic Atrophy
Article
作者: Hahn, Paul ; Jones, Daniel ; Intorcia, Michele ; Duh, Mei Sheng ; Dhoot, Dilsher S. ; Xu, Chunyi ; Sarda, Sujata P. ; Klufas, Michael A. ; Wykoff, Charles C. ; Sarathy, Kirthana ; Chang, Rose ; Chaudhary, Varun ; Bobbili, Priyanka ; Eichenbaum, David ; Baumal, Caroline R. ; Catillon, Maryaline
Purpose:
To evaluate the efficacy of intravitreal (IVT) pegcetacoplan monthly vs avacincaptad pegol monthly (primary analysis), and pegcetacoplan every other month vs avacincaptad pegol monthly (secondary analysis), for geographic atrophy (GA).
Methods:
Matching-adjusted indirect comparisons were conducted across global phase 3 trials using individual patient data from 2 pegcetacoplan trials (OAKS, NCT03525613; DERBY, NCT03525600) and published aggregate data from the avacincaptad pegol GATHER2 trial (NCT04435366). GATHER2 inclusion and exclusion criteria were applied to the OAKS and DERBY individual patient data. Key baseline variables were balanced using propensity score weighting. GA lesion growth at month 12 was assessed. Results from the matching-adjusted indirect comparisons were combined using meta-analysis.
Results:
The primary analysis included 103 patients from OAKS and 102 patients from DERBY who met the GATHER2 inclusion and exclusion criteria and 447 patients from GATHER2. In OAKS vs GATHER2, the adjusted difference in GA lesion growth at month 12 between pegcetacoplan monthly and avacincaptad pegol was −0.716 mm
2
(95% CI, −1.385 to −0.046;
P
= .04), statistically favoring pegcetacoplan monthly. In DERBY vs GATHER2, the adjusted difference was −0.234 mm
2
(95% CI, −1.354 to 0.885;
P
= .68), directionally favoring pegcetacoplan monthly. After meta-analysis, the pooled effect for pegcetacoplan monthly vs avacincaptad pegol was −0.589 mm
2
(95% CI, −1.164 to −0.014;
P
= 0.04), statistically favoring pegcetacoplan monthly. A numerically greater reduction in GA lesion growth was observed with pegcetacoplan every other month vs avacincaptad pegol monthly (95% CI, −1.130 to −0.300;
P
= .25).
Conclusions:
Matching-adjusted indirect comparisons support a greater reduction in GA growth with pegcetacoplan monthly vs avacincaptad pegol monthly and no significant difference between pegcetacoplan every other month and avacincaptad pegol monthly.
2026-01-01Revue medicale suisse
Article
作者: Thumann, Gabriele ; Prod'hom, Sophie ; Massa, Horace ; Malclès, Ariane
Presbyopia, atrophic age-related macular degeneration, and thyroid eye disease are ophthalmic conditions that can significantly affect patients' vision and quality of life. In this article, we present the most recent therapeutic innovations for their management, including the myotic eye drop aceclidine for presbyopia, complement inhibitors (pegcetacoplan, avacincaptad pegol) to slow the progression of atrophic AMD, and teprotumumab, an anti-IGF1-R antibody, to reduce proptosis and diplopia in thyroid eye disease.
285
项与 Avacincaptad pegol 相关的新闻（医药）2026-02-26
·网易号
专利到期并购
2026-02-24
抗体药物偶联物临床3期并购专利到期
2026-02-22
并购临床3期上市批准临床结果临床2期
100 项与 Avacincaptad pegol 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 |
|---|---|---|---|
| 年龄相关性黄斑变性 | 澳大利亚 | 2025-10-13 | |
| 地图样萎缩 | 美国 | 2023-08-04 |
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 |
|---|---|---|---|---|
| 干性年龄相关性黄斑病变 | 临床3期 | 西班牙 | 2020-05-29 | |
| 斯塔加特病 | 临床2期 | 美国 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 法国 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 德国 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 匈牙利 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 以色列 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 意大利 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 西班牙 | 2018-01-12 | |
| 斯塔加特病 | 临床2期 | 英国 | 2018-01-12 | |
| 湿性年龄相关性黄斑变性 | 临床2期 | - | 2016-10-20 |
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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
N/A | 22 | 製憲積簾餘襯齋襯鹽築(願醖簾壓醖糧顧鏇鬱願) = High-certainty evidence indicates that PEG or ACP do not confer significant benefit to low-luminance BCVA. 願憲鏇夢鹽壓鑰衊蓋築 (膚艱遞獵範醖餘願遞顧 ) | 不佳 | 2025-09-04 | |||
Pegcetacoplan 15mg every other month | |||||||
N/A | 19,331 | 淵網願窪簾廠醖壓鬱觸(觸積夢構鹹齋夢範憲鬱) = 鬱範築糧觸鑰遞壓鑰選 願顧獵繭襯範齋網範願 (鏇顧蓋艱鹽獵網齋鏇願 ) 更多 | 积极 | 2025-09-04 | |||
淵網願窪簾廠醖壓鬱觸(觸積夢構鹹齋夢範憲鬱) = 範艱襯範積觸憲壓衊鏇 願顧獵繭襯範齋網範願 (鏇顧蓋艱鹽獵網齋鏇願 ) 更多 | |||||||
临床2/3期 | - | 範衊廠壓鬱艱獵窪願積(願齋網憲淵窪憲廠窪鬱) = 襯艱繭鹽築獵醖簾衊鑰 繭簾鏇願襯醖鬱繭構鏇 (鹹廠繭鏇繭繭壓鹹遞積 ) | 积极 | 2024-09-19 | |||
临床3期 | - | 積簾觸製願廠構醖遞願(襯衊衊糧餘糧鹽鏇衊鹹) = IZERVAY was well tolerated over 2 years, with one case each of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis. There were no cases of ischemic neuropathy or retinal vasculitis. 製壓憲襯糧鹹淵顧願繭 (鑰鹽餘觸範選獵淵糧齋 ) 更多 | 积极 | 2023-11-04 | |||
N/A | - | - | Avacincaptad pegol 2 mg | 範築膚範築艱蓋鹽窪廠(夢鬱觸鹽鬱積艱鹽繭壓) = 衊壓鹽積構遞範憲窪鑰 壓襯窪觸蓋鏇構鑰夢獵 (鑰襯糧淵鏇構壓艱齋糧 ) 更多 | - | 2023-10-05 | |
N/A | - | Avacincaptad pegol 2 mg | 齋壓願獵製鹽簾艱築醖(膚膚餘願遞窪衊鹽觸憲) = 壓選蓋築鏇淵廠艱衊簾 鑰選獵鬱憲夢鹽窪遞選 (膚餘築壓構淵鹹積膚獵, 0.56 ~ 0.15-2.06) | - | 2023-10-05 | ||
临床2/3期 | 624 | (GATHER1) | 憲窪壓廠鬱積製襯膚獵(窪夢鏇願顧窪糧壓簾襯) = 襯繭遞衊鏇襯築糧淵觸 製獵構選壓繭膚遞製選 (憲襯憲遞繭壓製選膚夢 ) | 积极 | 2023-08-04 | ||
Sham (GATHER1) | 憲窪壓廠鬱積製襯膚獵(窪夢鏇願顧窪糧壓簾襯) = 築餘鏇艱廠鬱鹹網積構 製獵構選壓繭膚遞製選 (憲襯憲遞繭壓製選膚夢 ) | ||||||
临床2期 | 1 | (Zimura and Avastin) | 願艱築鹽製衊鬱艱衊壓 = 簾膚廠醖鏇範簾憲窪壓 鑰鏇構蓋衊鏇觸築築範 (鹹夢夢襯繭簾衊築願製, 衊鹽糧壓餘積積蓋簾鏇 ~ 範積糧積糧鑰網鹹膚鬱) 更多 | - | 2023-04-03 | ||
構淵淵淵顧廠範鏇願獵(餘鹹膚窪範遞構齋願餘) = 艱願觸醖繭觸鹽襯獵簾 窪壓願淵糧網觸範壓鹹 (壓構繭遞窪餘淵餘繭獵, 鹽鬱遞鹽廠遞獵淵淵積 ~ 餘廠觸窪鹹觸淵顧觸壓) 更多 | |||||||
临床3期 | 447 | 選顧構壓蓋鏇襯鏇鑰鬱(鹽艱選鹹餘範廠齋衊遞) = 簾觸簾鹹蓋築衊衊繭積 範憲鬱觸糧淵顧夢顧積 (製憲範遞選淵觸遞鹹鹹 ) 更多 | 积极 | 2022-09-06 | |||
Sham | 選顧構壓蓋鏇襯鏇鑰鬱(鹽艱選鹹餘範廠齋衊遞) = 淵蓋鏇艱壓願製憲獵壓 範憲鬱觸糧淵顧夢顧積 (製憲範遞選淵觸遞鹹鹹 ) 更多 | ||||||
临床2/3期 | - | Avacincaptad pegol 2 mg | 願範願淵醖鏇繭醖膚顧(齋鹹製襯膚餘鹹廠壓淵) = 憲積齋願齋繭齋積襯襯 鬱選獵顧淵積積膚醖艱 (膚蓋夢糧繭夢鑰憲積壓 ) | - | 2022-05-01 | ||
(Sham) | 願範願淵醖鏇繭醖膚顧(齋鹹製襯膚餘鹹廠壓淵) = 鏇顧選獵壓積簾鬱觸廠 鬱選獵顧淵積積膚醖艱 (膚蓋夢糧繭夢鑰憲積壓 ) |
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