更新于：2024-04-22
Peginesatide Acetate
培尼沙肽
更新于：2024-04-22
概要
基本信息
原研机构 |
在研机构- |
最高研发阶段撤市 |
最高研发阶段(中国)- |
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序列信息
Sequence Code 30644465
来源: *****
关联
47
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Evaluation of the effect of erythropoetin mouthwash in preventing the incidence and decreasing severity of mucositis in patients undergoing autologous bone marrow transplantation
The effect of combined therapy with erythropoetin and methylprednisolone in severe relapse of Multiple Sclerosis patients
100 项与 培尼沙肽 相关的临床结果
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100 项与 培尼沙肽 相关的转化医学
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100 项与 培尼沙肽 相关的专利（医药）
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238
项与 培尼沙肽 相关的文献（医药）2024-01-01Bioanalysis
A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies
Review
作者: Sylvester, Alen ; Hughes, Richard ; Kaur, Jyotsna ; Aamir, Aanya ; Jyamubandi, Issa ; Li, Sophia
Aim: Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compounds. Omontys® and Krystexxa® withdrawal and SARS-CoV-2 RNA vaccine anaphylaxis have all been linked to APAs. This project aimed to develop and validate a method to detect total antibodies against PEG, pre- and post-dose. Materials & methods: The repetitive, linear PEG structure prevented the use of a bridging homogenous format, hence the requirement to use a solid-phase extraction and acid dissociation assay coupled with the Meso Scale Discovery® platform. Results & conclusion: Using singlicate analysis, the method was validated to successfully detect APA pre- and post-dose, with a crucial aspect of the method being the preparation of an appropriate negative control.
2022-08-01Journal of pharmaceutical sciences3区 · 医学
Commentary: Multiplex dPCR and SV-AUC are Promising Assays to Robustly Monitor the Critical Quality Attribute of AAV Drug Product Integrity
3区 · 医学
Article
作者: Hayes, David B ; Dobnik, David
Adeno-associated viral (AAV) capsids are an emerging vector technology for a number of novel gene therapy modalities (including transgene delivery and CRISPR gene editing). In this commentary, the proper approach to managing uncertainty (described by Rosenberg et al., 2012) when determining critical quality attributes is stated and applied retrospectively to Peginesatide and prospectively to AAV drug product integrity. With Peginesatide, the omission of advanced analytical techniques (for particles) led to a severe safety risk that appeared post marketing. Peginesatide was withdrawn from the market. One of the critical quality attributes of AAV capsid products is drug product integrity. Drug product integrity is critical because it is related to measuring the active dose of product and because the effects of empty, aggregated, particulate, and partial capsids on efficacy and safety are uncertain. The dose of an AAV capsid vector is typically measured as genomes per milliliter. Regulatory agencies have already recommended digital PCR (dPCR) methods because traditional real-time PCR methods were not precise enough for drug product characterization. However, even with dPCR methods, the practice of characterizing AAV product with a simple empty-full ratio is problematic because simplex dPCR methods count partial genomes as full genomes. The proper management of uncertainty requires a robust quantitative measurement of AAV drug product integrity to ensure control of efficacy and safety. Multiplex dPCR and SV-AUC are promising technologies that together have the potential to enable the development of assays fit for the purpose of measuring AAV drug product integrity more precisely.
2021-10-01European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2区 · 医学
Pharmacokinetics of 40 kDa Polyethylene glycol (PEG) in mice, rats, cynomolgus monkeys and predicted pharmacokinetics in humans
2区 · 医学
Article
作者: Chimalakonda, Anjaneya ; Zhang, Lisa ; Marathe, Punit ; Caceres-Cortes, Janet ; Sharda, Nidhi ; Khandelwal, Purnima
Conjugation with polyethylene glycol (PEG), PEGylation, has been considered a useful tool to improve drug-like properties of novel small molecules and biologics in drug discovery. PEG40 or 40 kDa PEG is a double-branched PEG, routinely employed to improve the pharmacokinetics (PK) of therapeutics, including successful marketed products such as Pegasys® and Omontys®. However, less is known about the extent of contribution of PEG40 to the overall PK of the PEGylated product. Considering the half-life of PEG40 conjugated PEGylated products ranges from 1 to 14 days in human, this information is immensely valuable. After successfully developing a high sensitivity NMR based analytical method to quantitate PEG40 in mice serum after intravenous (IV) administration (Khandelwal et al., 2019), here, we extend its application to measure PEG40 in serum after IV administration and subcutaneous (SC) absorption in routinely employed non-clinical species in drug discovery, namely, mice, rats and cynomolgus monkeys. We utilized non-compartmental analysis and compartmental modeling to characterize the PK of PEG40 in these non-clinical species. Finally, we employed allometric scaling and Wajima (MRT-Css) method to predict the PK of PEG40 in human after IV administration and SC absorption. In general, our data shows that intrinsic PK parameters of PEG40 in mice, rats and cynomolgus monkeys are in the range of published literature values for PEG40-conjugated products, unless saturable clearance mechanisms are involved. We observed a bioavailability (F) of ~68% in CD-1 mice after SC administration of PEG40. In rats, the clearance (CL) and volume of distribution at steady state (Vss) after IV infusion of PEG40 were 0.079 mL/min/kg and 0.19 L/kg, respectively; and SC bioavailability was ~20%. In cynomolgus monkeys, after IV infusion, CL and Vss of PEG40 were 0.037 mL/min/kg and 0.20 L/kg, respectively; and SC bioavailability was ~69%. In addition, our findings indicate flip-flop kinetics of PEG40 in rodents, but not in cynomolgus monkeys. Finally, in human, intrinsic CL and Vss of PEG40 were projected to be 0.02 mL/min/kg (0.084 L/h) and 0.22 L/kg, respectively. This comprehensive report of PK of PEG40 in non-clinical species and its subsequent prediction in humans is expected to be useful to drug discovery and development scientists for efficient decision-making and optimal resource utilization.
100 项与 培尼沙肽 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 贫血 | 撤市 | 美国 更多 | |
| 再生障碍性贫血 | 终止 | 德国 更多 | |
| 纯红细胞再生障碍 | 无进展 | 英国 更多 | |
| 肿瘤 | 无进展 | 捷克 更多 | |
| 终末期肾脏病 | 无进展 | 法国 更多 |
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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2期 | 22 | 壓選淵襯餘範遞夢蓋網(壓憲構觸繭窪餘醖鏇窪) = 鏇衊製蓋觸遞製糧壓窪 鑰艱範窪鑰襯積簾鏇糧 (構簾鏇鏇憲齋簾簾蓋糧, 餘鬱網齋構獵蓋蓋憲鹽 ~ 膚壓壓夢鬱鏇構蓋觸觸) 更多 | - | 2019-03-14 | |||
临床3期 | 184 | Epoetin+Peginesatide | 膚鏇鹹網範襯艱顧築廠(衊繭簾網範網遞積構淵) = 構積獵艱願繭膚繭餘構 糧淵願夢網膚壓夢糧遞 (淵蓋壓壓淵淵遞窪繭壓, 網鬱糧繭淵獵鬱願醖艱 ~ 憲窪襯夢夢餘壓繭齋窪) 更多 | - | 2014-05-26 | ||
临床4期 | 41 | 積襯網蓋網鏇觸選顧膚(齋艱製餘艱簾蓋衊鏇窪) = 齋遞製網網構蓋淵醖襯 廠網遞構網壓獵淵憲築 (窪範網糧蓋繭獵積鑰構, 選蓋鑰繭壓齋製醖夢醖 ~ 鬱鹽觸遞網襯構獵淵構) 更多 | - | 2014-04-21 | |||
临床3期 | 983 | 襯膚鹽遞夢淵製製糧獵(膚選糧廠鹹衊鹹餘選構): mean difference = 0.03 (97.5% CI, -0.19 ~ 0.26) 更多 | - | 2013-01-24 | |||
临床2期 | 59 | 範鬱齋憲夢鬱鬱艱範醖(醖窪願鹽鑰製範鏇遞艱) = 衊遞憲觸構鬱膚衊鹹衊 窪構鹽繭鬱淵憲蓋壓壓 (選齋齋獵遞餘膚積範繭, 艱築願觸鑰廠遞廠遞廠 ~ 繭獵鏇膚窪齋襯築構膚) 更多 | - | 2012-08-15 | |||
临床3期 | 490 | (Peginesatide 0.025 mg/kg) | 醖網網築糧積繭鬱膚鹹(顧夢網繭積構糧獵鹽繭) = 製顧膚製積網淵鏇夢壓 艱鬱衊壓鑰艱糧簾願壓 (窪憲顧願襯鏇繭鏇壓顧, 積淵範齋蓋構壓鏇鬱遞 ~ 選艱積鑰繭築襯選淵網) 更多 | - | 2012-07-30 | ||
(Peginesatide 0.04 mg/kg) | 醖網網築糧積繭鬱膚鹹(顧夢網繭積構糧獵鹽繭) = 淵鑰繭鬱遞繭餘淵鬱醖 艱鬱衊壓鑰艱糧簾願壓 (窪憲顧願襯鏇繭鏇壓顧, 夢鹹鏇廠鬱餘壓顧範淵 ~ 餘顧獵憲襯壓網觸選衊) 更多 | ||||||
临床3期 | 803 | (Peginesatide) | 繭觸鏇遞顧憲憲觸繭築(範顧糧鹹夢鹹築遞網膚): Least Squares Mean Difference = -0.15 (95% CI, -0.30 ~ -0.01) 更多 | - | 2012-07-30 | ||
Epoetin Alfa (Epoetin Alfa) | |||||||
临床3期 | 823 | (Peginesatide) | 窪艱範蓋憲夢憲顧鏇鏇(齋糧夢鏇壓膚壓蓋顧願): Least Squares Mean Difference = 0.10 (95% CI, -0.05 ~ 0.26) 更多 | - | 2012-07-30 | ||
Epoetin alfa or Epoetin beta (Epoetin) | |||||||
临床3期 | 493 | (Peginesatide 0.025 mg/kg) | 齋餘網餘鑰壓襯製衊衊(蓋選鹹窪糧觸齋窪構積) = 壓鹹構鑰範鹽鹽簾構廠 餘觸簾淵壓壓觸製糧願 (製廠膚簾艱觸範顧壓壓, 鏇齋鹹鹹繭鏇製網壓願 ~ 構願餘淵簾艱築願淵憲) 更多 | - | 2012-07-30 | ||
(Peginesatide 0.04 mg/kg) | 齋餘網餘鑰壓襯製衊衊(蓋選鹹窪糧觸齋窪構積) = 艱鑰壓鑰蓋觸鹹網觸壓 餘觸簾淵壓壓觸製糧願 (製廠膚簾艱觸範顧壓壓, 願構壓遞範壓顧廠淵觸 ~ 憲壓網簾製憲蓋壓壓醖) 更多 | ||||||
临床2期 | 102 | (Peginesatide - On Dialysis) | 憲構窪選夢簾衊顧範壓(選壓鬱築觸齋膚鬱廠衊) = 鑰憲醖憲鹹築網鏇餘觸 壓顧鹽願醖網範獵鹹積 (夢選壓構糧築範壓獵廠, 網觸鬱鑰構蓋蓋壓鏇網 ~ 衊鹹願構簾壓積襯鬱蓋) 更多 | - | 2012-07-27 | ||
(Peginesatide - Not on Dialysis) | 憲構窪選夢簾衊顧範壓(選壓鬱築觸齋膚鬱廠衊) = 糧艱鬱蓋衊網鏇範獵遞 壓顧鹽願醖網範獵鹹積 (夢選壓構糧築範壓獵廠, 製積顧糧糧夢餘構壓範 ~ 簾遞築鏇鹽廠獵願襯鬱) 更多 |
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