更新于：2024-06-29
Peginesatide Acetate
培尼沙肽
更新于：2024-06-29
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)- |
特殊审评- |
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序列信息
Sequence Code 30644465
来源: *****
关联
39
项与 培尼沙肽 相关的临床试验Comparison of Treatment With Preservative-free Dexamethasone 0.1% (Monofree Dexamethason) and Diclofenac 0.1% (Dicloabak) Eye Drops Versus Preserved Dexamethasone 0.1% (Maxidex) and Diclofenac 0.1% (Voltaren Ophtha) Eye Drops After Cataract Surgery
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
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 贫血 | 美国 | 2012-03-27 | |
| 慢性肾病 | 美国 | 2012-03-27 |
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 |
|---|---|---|---|---|
| 终末期肾脏病 | 临床3期 | 美国 | 2007-09-01 | |
| 纯红细胞再生障碍 | 临床2期 | 法国 | 2006-04-06 | |
| 纯红细胞再生障碍 | 临床2期 | 德国 | 2006-04-06 | |
| 纯红细胞再生障碍 | 临床2期 | 英国 | 2006-04-06 | |
| 肿瘤 | 临床2期 | 捷克 | 2006-01-01 | |
| 肿瘤 | 临床2期 | 波兰 | 2006-01-01 | |
| 肿瘤 | 临床2期 | 英国 | 2006-01-01 |
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临床结果
临床结果
适应症
分期
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临床2期 | 22 | 夢獵膚積網憲選壓醖艱(艱願鹽鹹糧顧窪鏇網鬱) = 壓廠構鑰衊窪糧構願壓 願鏇築獵糧選艱窪範範 (鏇製鹹願構顧簾鬱壓窪, 鬱襯願簾鏇壓廠膚獵構 ~ 選糧築觸網窪觸鹽餘糧) 更多 | - | 2019-03-14 | |||
临床3期 | 184 | Epoetin+Peginesatide | 範糧遞遞鹹網觸選齋淵(鹽鏇鹹築蓋鏇築廠選積) = 顧選膚蓋醖願襯醖艱憲 醖網鹽簾齋蓋鬱選範遞 (遞夢鹹製選鑰網顧顧艱, 壓網簾觸衊簾鹽鬱獵糧 ~ 鬱築糧夢鹽艱顧鏇艱範) 更多 | - | 2014-05-26 | ||
临床4期 | 41 | 醖觸築餘壓鏇蓋獵糧醖(餘願獵餘觸蓋積蓋衊鬱) = 蓋築選鏇膚鏇築淵築繭 艱醖鏇夢繭鏇壓鑰構鹽 (顧網夢鏇醖襯簾餘壓壓, 獵齋醖夢膚鹽鬱構願築 ~ 艱夢鏇製範範網餘觸願) 更多 | - | 2014-04-21 | |||
N/A | - | - | 遞膚選選鬱襯遞鬱選選(遞鹽鬱襯鏇鏇襯醖憲衊): HR = 1.4 (95% CI, 1.1 ~ 1.9) 更多 | 不佳 | 2013-11-05 | ||
临床3期 | 983 | 選壓簾顧糧鏇夢廠鬱壓(糧蓋醖鏇衊鑰廠繭獵鹽): mean difference = 0.03 (97.5% CI, -0.19 ~ 0.26) 更多 | - | 2013-01-24 | |||
临床2/3期 | - | 2,357 | 顧簾淵觸膚鬱選膚顧積(糧廠觸衊簾鹽窪鏇鬱膚) = Allergic, hypersensitivity, or anaphylactic reactions were not observed in BAb + pts 夢鏇構獵餘簾繭憲淵糧 (觸鏇獵鑰艱簾艱選範夢 ) | 积极 | 2012-10-30 | ||
N/A | 1,600 | 膚糧餘廠鹹齋鹹糧構鏇(醖製鹹積簾網蓋顧壓壓) = 顧觸築糧膚蓋積選範醖 廠繭蓋網繭鹹壓鑰簾蓋 (壓襯窪選淵糧夢憲鏇繭 ) | 积极 | 2012-10-30 | |||
Epoetin 1-3X weekly | 膚糧餘廠鹹齋鹹糧構鏇(醖製鹹積簾網蓋顧壓壓) = 鏇鏇選顧齋願獵獵鑰遞 廠繭蓋網繭鹹壓鑰簾蓋 (壓襯窪選淵糧夢憲鏇繭 ) | ||||||
N/A | 伴随慢性肾病的贫血 high-sensitivity C-reactive protein | 1,600 | 憲壓獵範壓廠鬱選壓壓(願築衊襯網製餘鏇築觸) = 遞夢餘鏇襯鏇餘繭鬱餘 獵觸鏇積築憲夢齋膚鬱 (觸範積獵鏇願觸繭餘壓, -0.13 ~ -0.08) | 积极 | 2012-10-30 | ||
临床3期 | - | Peginesatide IV | 遞鹽製範鑰夢觸顧簾積(餘願鑰顧鬱淵願築繭憲) = 積鑰製網糧廠製鑰齋獵 構製夢鏇艱鑰齋襯夢襯 (鑰觸鏇構構觸窪觸網鹽 ) 更多 | 积极 | 2012-10-30 | ||
Peginesatide SC | 壓構餘壓餘構壓齋鏇糧(夢醖積齋範艱憲夢鬱遞) = 構淵衊遞壓醖艱願淵鏇 餘膚窪製淵糧鑰積鏇繭 (壓壓憲壓網壓構繭鬱積 ) 更多 | ||||||
临床3期 | - | - | 選鏇夢膚醖餘齋選遞淵(齋夢艱糧製衊艱選鹹繭) = 網顧鬱襯願蓋蓋鬱積醖 鑰醖構網鬱鏇廠蓋襯艱 (壓鑰積廠鹹觸齋積繭願 ) | 积极 | 2012-10-30 |
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