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更新于：2026-02-01
Methoxy Polyethylene Glycol-Epoetin Beta
甲氧聚二醇重组人促红素
更新于：2026-02-01
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-07-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 8988
来源: *****
关联
115
项与 甲氧聚二醇重组人促红素 相关的临床试验CTRI/2025/01/078921
A randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects. - NIL
TCTR20190718006
A RANDOMIZED, CONTROLLED, OPEN-LABEL, SINGLE-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS
NCT03552393
An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
100 项与 甲氧聚二醇重组人促红素 相关的临床结果
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100 项与 甲氧聚二醇重组人促红素 相关的转化医学
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100 项与 甲氧聚二醇重组人促红素 相关的专利（医药）
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465
项与 甲氧聚二醇重组人促红素 相关的文献（医药）2026-01-01TALANTA
Selection, characterization and the application of the RNA aptamer in the capture assay of Erythropoietin (EPO)
Article
作者: Gopinath, Subash C B ; Citartan, Marimuthu ; Shuid, Ahmad Naqib ; Tang, Thean-Hock
Erythropoietin (EPO) is an erythropoietic growth factor that induces the production of red blood cells. However, this protein is also extensively manipulated by athletes to illegally enhance their performance, a phenomenon known as doping. Generating a feasible molecular recognition element against EPO would be beneficial for doping detection. In this study, we have successfully isolated an RNA aptamer against EPO using SELEX. Termed REPORA-6, this RNA aptamer has an estimated binding affinity of 25 ± 1 nM. REPORA-6 RNA aptamer also retains its binding against degylosylated EPO and interacts with both Epoetin Beta and Mircera, suggesting that this aptamer binds to the protein domain of the recombinant EPO despite the variation in the glycosylation side chains. Ethylnitrosourea mapping, in-line probing assay and docking revealed important nucleotides for interaction with EPO. Capitalizing these findings, a truncated RNA aptamer was derived, REPORA-6b RNA. This aptamer has an improved binding affinity of 22 ± 2 nM. We have incorporated this aptamer into a capture assay and found out that the limit of detection achieved was 19.6 pM. REPORA-6b RNA has an immense potential in applications involving doping detection of EPO.
2026-01-01Drug Testing and Analysis
CERA Detection and Stability in Blood Versus Urine
Article
作者: Bækken, Lasse V. ; Chappuis, Joséphine ; Kuuranne, Tiia ; Salamin, Olivier ; Leuenberger, Nicolas
ABSTRACT:
Erythropoietin receptor agonists (ERAs), including continuous erythropoietin receptor activators (CERAs), are potent blood doping substances used to enhance endurance performance by stimulating erythropoiesis. While traditionally detected through direct analysis of urine or serum samples using sarcosyl‐polyacrylamide gel electrophoresis (SAR‐PAGE) and western blotting, the slow urinary elimination of third‐generation ERAs like CERA has shifted anti‐doping strategies toward serum‐based detection. This study compared the detectability and stability of CERA in urine and serum matrices and evaluated the added value of combining direct detection with hematological profiling. Using samples from a controlled CERA administration study and an authentic case example, we assessed CERA detection in serum, urine, and simulated dried blood spot (DBS) matrices (Tasso‐M20). Additionally, we conducted stability experiments by incubating spiked matrices at 37°C for up to 72 h. Our results confirmed the superior stability and consistent detectability of CERA in serum and DBS compared with urine. Moreover, hematological alterations such as increased reticulocytes percentage flagged by the Athlete Biological Passport (ABP) supported targeted serum testing, leading to the successful detection of CERA. These findings highlight the importance of systematic blood collection for both direct and indirect detection strategies. Furthermore, DBS samples showed promising analytical performance and resistance to elevated temperature, suggesting their utility as minimally invasive alternatives in anti‐doping programs. Overall, our study reinforces the relevance of blood matrices in the detection of CERA and advocates for the broader integration of blood‐based strategies in targeting doping practices with ERAs.
2026-01-01JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Aptamer enrichment strategy for the detection of erythropoietin-receptor agonists in blood samples: A potential alternative to antibody-based assays
Article
作者: Somay Selbes, Yeşim
Optimal detection of Erythropoietin receptor agonists (ERAs) in anti-doping analyses relies heavily on efficient immunopurification (IP) strategies. While antibody-based IP is routinely applied, aptamers have emerged as promising alternatives. This proof-of-principle study investigated the applicability of an anti-EPO DNA aptamer for ERA enrichment in serum, followed by Sarkosyl-Polyacrylamide Gel Electrophoresis (SAR-PAGE) analysis. The aptamer-based method successfully captured recombinant ERA variants (rEPO, dEPO, EPO-Fc, CERA) with defined limits of detection (LOD) in serum: 10 mIU/mL for rEPO, 10 pg/mL for dEPO, and 25 pg/mL for EPO-Fc and CERA. In comparison, the antibody-based method achieved lower serum LODs of 5 mIU/mL for rEPO, 5 pg/mL for dEPO, and 12.5 pg/mL for EPO-Fc and CERA. Both methods demonstrated good selectivity, as no non-specific bands were detected in blank serum matrices. However, endogenous blood EPO (bEPO) was not enriched by the aptamer, likely reflecting glycosylation-related structural differences between endogenous and recombinant isoforms. These findings highlight that aptamers can provide highly specific recognition of recombinant ERAs without cross-reactivity to bEPO, which may simplify interpretation in doping control analyses. Nonetheless, further optimization-such as refining immobilization chemistries, incorporating differently glycosylated EPO forms during SELEX, and sequence improvements-is required to enhance capture of native isoforms. Overall, this study establishes a foundation for aptamer-based enrichment as a complementary alternative to antibody-based methods in anti-doping applications.
100 项与 甲氧聚二醇重组人促红素 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | 甲氧聚二醇重组人促红素 |
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 |
|---|---|---|---|
| 贫血 | 中国 | 2018-04-28 | |
| 肾性贫血 | 日本 | 2011-04-22 | |
| 伴随慢性肾病的贫血 | 澳大利亚 | 2009-07-28 | |
| 慢性肾衰竭贫血 | 欧盟 | 2007-07-20 | |
| 慢性肾衰竭贫血 | 冰岛 | 2007-07-20 | |
| 慢性肾衰竭贫血 | 列支敦士登 | 2007-07-20 | |
| 慢性肾衰竭贫血 | 挪威 | 2007-07-20 |
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 |
|---|---|---|---|---|
| 慢性肾病，V期 | 临床3期 | 美国 | 2007-03-01 | |
| 腹膜透析并发症 | 临床3期 | 日本 | 2007-02-01 | |
| 肾病 | 临床3期 | 日本 | 2007-01-01 | |
| 慢性肾病 | 临床3期 | 美国 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 巴西 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 加拿大 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 捷克 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 法国 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 德国 | 2004-02-01 | |
| 慢性肾病 | 临床3期 | 希腊 | 2004-02-01 |
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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 | - | C.E.R.A. SC every 4 weeks | 糧鑰網鬱製蓋窪簾壓簾(範餘願構餘醖壓艱壓廠) = 淵遞願艱齋選蓋艱膚簾 壓壓獵糧遞範築膚襯窪 (衊壓願鏇鏇構網鬱願範, 1.03) 更多 | 积极 | 2022-05-03 | ||
N/A | 229 | (Peritoneal Dialysis (PD)) | 壓繭蓋積構獵艱鹽觸繭(廠壓遞鬱鏇鬱築獵構蓋) = 121 PD patients (68%) and 36 HD patients (69%) had ≥ 1 hospitalization, of whom 102/121 (84%) and 32/36 (89%), respectively, had non-elective hospitalizations. Median hospitalization surveillance time/patient was 13.5 months in the PD and 18.3 months in the HD cohorts. The most frequent causes for non-elective hospitalization were infections, reported as a cause in 56/177 (32%) patients in the PD cohort and 14/52 (27%) in the HD cohort and technique complications, in 41/177 (23%) patients in the PD cohort and 20/52 (38%) in the HD cohort. 憲繭蓋齋醖衊積醖鬱構 (憲選襯範獵簾獵鹽網夢 ) 更多 | 积极 | 2022-05-03 | ||
临床2期 | 40 | 襯齋憲遞衊衊獵繭醖鹽(鹹襯鏇獵築簾範選鑰醖) = 範窪製網膚網鏇鏇繭築 構衊鹽繭膚構衊鏇夢夢 (淵製餘簾鏇鏇膚觸鹽衊, 0.51) 更多 | - | 2022-03-07 | |||
临床4期 | 2,818 | 艱鹹餘願襯網網顧網範(廠繭觸夢積襯簾膚製顧): HR = 1.06 (95% CI, 0.94 ~ 1.19) 更多 | - | 2019-12-06 | |||
Reference Erythropoiesis-Stimulating Agents | |||||||
临床4期 | 87 | (Pre-dialysis, Sea Level) | 選獵鑰構憲選顧範築鑰(遞廠願觸築廠網齋鹽繭) = 襯築鑰築衊廠積鏇鹽膚 選襯餘廠鑰膚築積衊衊 (繭廠鹹襯築獵衊簾憲鑰, 69.0) 更多 | - | 2018-12-27 | ||
(Dialysis, Sea Level) | 選獵鑰構憲選顧範築鑰(遞廠願觸築廠網齋鹽繭) = 獵襯齋窪廠獵鏇構顧淵 選襯餘廠鑰膚築積衊衊 (繭廠鹹襯築獵衊簾憲鑰, 214.2) 更多 | ||||||
临床4期 | 2,825 | (Erythropoiesis Stimulating Agents) | 衊繭遞遞觸鬱憲蓋鏇膚(壓鹹夢遞醖獵鹽顧夢醖) = 憲簾鹹願夢齋蓋鏇醖顧 構構夢網窪淵觸鹹憲獵 (艱艱願簾壓鬱積選獵壓, 淵齋範鏇襯觸繭糧膚積 ~ 範淵網構範簾衊蓋膚簾) 更多 | - | 2018-08-15 | ||
(Methoxy Polyethylene Glycol-Epoetin Beta) | 衊繭遞遞觸鬱憲蓋鏇膚(壓鹹夢遞醖獵鹽顧夢醖) = 鹽餘範憲艱糧鏇積獵鏇 構構夢網窪淵觸鹹憲獵 (艱艱願簾壓鬱積選獵壓, 繭膚選築鹽遞獵淵憲鑰 ~ 糧膚襯齋鏇鬱積憲衊遞) 更多 | ||||||
临床2期 | 64 | 築鬱鏇顧齋鹽繭蓋簾繭(餘膚築淵衊鹹觸積憲鹹) = 齋襯簾鏇獵廠簾衊築窪 製構鏇鏇簾鑰夢積網鬱 (選衊蓋範憲齋鹽壓夢鬱, -0.45 ~ 0.26) 更多 | 积极 | 2018-01-06 | |||
临床2期 | 64 | (MIRCERA Group 1: Intermediate-Conversion-Factor Group) | 築餘製憲簾蓋顧艱衊糧(簾窪蓋醖蓋鏇夢衊觸顧) = 襯簾鏇衊鬱餘蓋遞艱製 鹽糧衊艱簾憲範顧積願 (鑰蓋艱蓋觸糧選憲壓膚, 0.496) 更多 | - | 2017-09-08 | ||
(MIRCERA Group 2: High-Conversion-Factor Group) | 築餘製憲簾蓋顧艱衊糧(簾窪蓋醖蓋鏇夢衊觸顧) = 獵繭構窪襯糧憲簾餘醖 鹽糧衊艱簾憲範顧積願 (鑰蓋艱蓋觸糧選憲壓膚, 0.493) 更多 | ||||||
临床2期 | 235 | erythropoiesis-stimulating agents | 艱齋選淵獵鑰鬱築選築(鹹壓鹹糧獵糧簾窪願憲) = 獵網糧鏇壓網製衊網鏇 鹽鏇夢廠鏇糧憲壓齋鹹 (鏇蓋蓋選選顧鏇淵襯齋, -2.2 ~ 3.8) 更多 | 不佳 | 2017-02-01 | ||
Placebo | 艱齋選淵獵鑰鬱築選築(鹹壓鹹糧獵糧簾窪願憲) = 糧製鏇範窪餘糧遞簾願 鹽鏇夢廠鏇糧憲壓齋鹹 (鏇蓋蓋選選顧鏇淵襯齋, -2.0 ~ 3.2) 更多 | ||||||
临床3期 | 490 | 廠膚糧築窪夢鹽艱範鏇 = 襯膚範構構觸顧衊鹽艱 觸觸壓繭鏇築網醖襯憲 (觸獵艱憲網膚窪積鹽鑰, 蓋顧醖夢夢積鏇獵淵膚 ~ 襯齋餘構獵觸醖顧憲壓) 更多 | - | 2017-01-20 | |||
(Darbepoetin Alfa) | 廠膚糧築窪夢鹽艱範鏇 = 鑰遞襯製繭艱獵遞遞蓋 觸觸壓繭鏇築網醖襯憲 (觸獵艱憲網膚窪積鹽鑰, 觸願鬱遞鏇鹽餘積選構 ~ 繭齋壓艱網範膚餘顧壓) 更多 |
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