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更新于：2025-11-29
Roxadustat
罗沙司他
更新于：2025-11-29
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-12-17), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、特殊审批 (中国) |
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结构/序列
分子式C19H16N2O5 |
InChIKeyYOZBGTLTNGAVFU-UHFFFAOYSA-N |
CAS号808118-40-3 |
关联
142
项与 罗沙司他 相关的临床试验NCT07162090
Observation of the Impact of Hypoxia - Inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients
ACTRN12625000491460
An open-label volunteer study of the impact of short-term oral Roxadustat exposure on gene expression in whole blood in healthy adults aged 40 years and over.
CTR20252221
罗沙司他胶囊人体生物等效性试验
100 项与 罗沙司他 相关的临床结果
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100 项与 罗沙司他 相关的转化医学
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100 项与 罗沙司他 相关的专利（医药）
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615
项与 罗沙司他 相关的文献（医药）2025-12-31Emerging Microbes & Infections
Article
作者: Gerlier, Denis ; Si-Tahar, Mustapha ; Mathieu, Cyrille ; Lalande, Alexandre ; Ferren, Marion ; Moroso, Marie ; Orch, Walid El ; Décimo, Didier ; Rozières, Aurore ; Ogire, Eva ; Bourgeais, Amélie ; Bouget, Jules ; Lotteau, Vincent ; Ducret, Garance ; Perrin-Cocon, Laure ; Jacquemin, Clémence ; Jacolin, Florentine ; Canus, Lola ; Diaz, Olivier ; Faure, Mathias ; Vidalain, Pierre-Olivier ; Moissonnier, Elodie ; Mely, Stéphane ; Haftek, Zofia ; Aublin-Gex, Anne
Airborne RNA viruses of the Paramyxoviridae family are major human pathogens. These include measles virus (MeV) and Nipah virus (NiV), the latter being on the World Health Organization's blueprint list due to its high case-fatality rate and critical risk of emergence. Although an effective vaccine is available for MeV, this is not the case for NiV. Moreover, there is no cure for MeV- or NiV-infected patients that prevents the acute respiratory syndrome or lethal encephalitis. To identify new host factors to target for inhibiting viral growth, a library of metabolic modulators was screened for activity against MeV using an in vitro infection model. Results showed that Molidustat, a pharmacological inhibitor of Prolyl-Hydroxylase Domain (PHD) enzymes, inhibits MeV infection in a Hypoxia-Inducible Factor (HIF)-dependent manner. We then tested the antiviral effect of Molidustat in organotypic cultures of hamster cerebellum. Molidustat induced the hypoxia-response pathway in this ex vivo model as assessed by transcriptomic analysis, and inhibited MeV infection. A similar antiviral effect was observed with Roxadustat and Daprodustat, two PHD enzyme inhibitors chemically unrelated to Molidustat. Finally, we showed that Molidustat inhibits NiV infection in organotypic cultures of hamster cerebellum and lung, thereby validating its effect in the two organs mainly targeted during infection. Taken together, our results provide evidence that pharmacological activation of the hypoxia-response pathway restricts MeV and NiV infections, highlighting HIF-inducing drugs as promising candidates to consider in the development of treatments.
2025-12-31RENAL FAILURE
Analysis of red blood cell lifespan and associated influencing factors in anemic dialysis patients
Article
作者: Zuo, Li ; Shao, Yanyan ; Wang, Chunfang ; Zhu, Li ; Zhao, Huiping ; Wu, Bei ; Bai, Li ; Wang, Yan ; Zhao, Xinju ; Feng, Ji ; Gan, Liangying ; Wu, Jiaqing ; Gao, Weili ; Lu, Lixia
INTRODUCTION:
Renal anemia is one of the most common complications in dialysis patients. The shortened red blood cell (RBC) lifespan is an important mechanism of renal anemia. This study aims to investigate the RBC lifespan and its influencing factors in anemic dialysis patients.
METHOD:
Prevalent patients on maintenance hemodialysis or peritoneal dialysis, treated with anti-anemia therapy including recombinant human erythropoietin (rHuEPO) or roxadustat for more than 4 months were enrolled. RBC lifespan was measured by the RBC lifespan analyzer RBCS-01A depended on Levitt's carbon monoxide (CO) breath test. Participants were primarily divided into low and high RBC lifespan groups by the average value.
RESULT:
A total of 187 patients were included in this study. The average RBC lifespan was 65.2 ± 28.55 days. The logistic regression analysis indicated treating with roxadustat rather than rHuEPO [OR 2.94, 95% CI (1.46, 5.95), p < 0.01], male [OR 2.15, 95% CI (1.08, 4.29), p = 0.03], higher body mass index (BMI) [OR 1.17, 95% CI (1.07, 1.27), p < 0.01], and higher total iron-binding capacity (TIBC) [OR 1.04, 95% CI (1.01, 1.06), p = 0.01] were independent risk factors for the shorten of RBC lifespan. While higher adjusted calcium [OR 0.14, 95% CI (0.03, 0.70), p = 0.02] and older age [OR 0.96, 95% CI (0.94, 0.99), p = 0.01] were independent protective factors.
CONCLUSION:
This study demonstrated that independent risk factors contributing to this reduction in RBC lifespan include male, elevated BMI, increased TIBC, and decreased adjusted calcium levels. Additionally, the type of anti-anemia therapy administered appears to have an impact on RBC lifespan.
2025-12-31RENAL FAILURE
Roxadustat alleviates cisplatin-induced acute kidney injury by regulating fatty acid oxidation and mitochondrial function
Article
作者: Jiang, Daofang ; Hu, Yan ; Ma, Xiaoyan ; Zhong, Qin ; Zhuang, Shougang ; Li, Xialin ; Shi, Yingfeng ; Liu, Na ; Li, Jinqing ; Zhang, Shasha
AIMS:
This study aimed to elucidate the role and function of roxadustat, a small molecule hypoxia-inducible factor (HIF) stabilizer, on cisplatin-induced acute kidney injury (AKI) in vivo and in vitro.
METHODS:
We investigated the effects of roxadustat (10 mg/kg) in a cisplatin-induced AKI model in mice. After a 48-hour pretreatment with the intraperitoneal injection of roxadustat, cisplatin was administered at a dose of 20 mg/kg by intraperitoneal injection. We also examined the role of roxadustat (10 μM) on HK-2 cells stimulated by cisplatin (20 μg/mL).
RESULTS:
Pretreatment with roxadustat significantly improved kidney function in the AKI model, as evidenced by reductions of Scr and BUN, and alleviated cisplatin-induced kidney morphology lesions. Roxadustat also remarkably decreased the expression of KIM-1 and NGAL. Furthermore, roxadustat significantly abolished the expression of Bax and cleaved caspase 3, two apoptosis marker proteins. Mechanistically, our study demonstrated that roxadustat could alleviate the deficiency of fatty acid oxidation (FAO) induced by cisplatin, as evidenced by the improvement of lipid accumulation and metabolic disorders in the roxadustat-treated group. Moreover, roxadustat effectively blocked mitochondrial damage, as evidenced by reduced mitochondrial swelling and fragmentation in the roxadustat-treated group. Simultaneously, roxadustat also partially rescued the expression of mitochondrial fusion proteins, including OPA1, MFN1, and MFN2. In vitro, roxadustat also effectively alleviate injury, apoptotic responses, FAO disorders, mitochondrial damage caused by cisplatin.
CONCLUSION:
We demonstrated that roxadustat exerts a protective role in cisplatin-treated mice and HK-2 cells, which might be due to amelioration of FAO deficiency and suppression of mitochondrial damage.
567
项与 罗沙司他 相关的新闻（医药）2025-11-23
·信狐药迅
信使RNA疫苗核酸药物申请上市
100 项与 罗沙司他 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 |
|---|---|---|---|
| 贫血 | 英国 | 2021-12-01 | |
| 伴随慢性肾病的贫血 | 韩国 | 2021-07-09 | |
| 肾性贫血 | 日本 | 2019-09-20 | |
| 慢性肾衰竭贫血 | 中国 | 2018-12-17 |
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 |
|---|---|---|---|---|
| 肿瘤 | 临床3期 | 中国 | 2022-03-16 | |
| 骨髓增生异常综合征 | 临床3期 | 美国 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 美国 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 美国 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 澳大利亚 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 澳大利亚 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 澳大利亚 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 比利时 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 比利时 | 2018-01-29 | |
| 骨髓增生异常综合征 | 临床3期 | 比利时 | 2018-01-29 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 伴随慢性肾病的贫血 C-reactive protein | albumin | 2,084 | (Non-dialysis-dependent group) | 鬱廠鹽積願獵鏇廠鏇餘(構鹹遞鹹鹹夢餘範顧製) = 鹹鹽遞觸艱窪鬱淵齋獵 遞淵網鬱繭醖窪鏇鹽遞 (鬱衊繭壓壓鬱範獵淵願 ) 更多 | 积极 | 2025-03-04 | |
(Hemodialysis group) | 鬱廠鹽積願獵鏇廠鏇餘(構鹹遞鹹鹹夢餘範顧製) = 醖鹹範鹹鬱製蓋艱鬱齋 遞淵網鬱繭醖窪鏇鹽遞 (鬱衊繭壓壓鬱範獵淵願 ) 更多 | ||||||
临床3期 | 159 | 餘廠選餘範廠鑰鹽醖網(遞願糧獵製構鏇鏇襯觸) = 廠襯網夢窪糧觸鏇簾構 鹽簾蓋積憲醖觸繭鏇壓 (艱願餘壓襯糧簾廠蓋範, 13.58 ~ 20.71) | 积极 | 2025-01-10 | |||
Recombinant human erythropoietin-α (rHuEPO-α) | 餘廠選餘範廠鑰鹽醖網(遞願糧獵製構鏇鏇襯觸) = 齋願夢網廠簾糧積積壓 鹽簾蓋積憲醖觸繭鏇壓 (艱願餘壓襯糧簾廠蓋範, 11.34 ~ 19.50) | ||||||
临床4期 | - | 178 | Roxadustat QW | 膚醖積醖壓構淵觸鬱衊(觸淵鹽衊憲艱淵鬱醖淵) = 網廠願憲繭壓鹹顧積齋 選廠鬱鬱糧鹽壓顧淵壓 (構觸齋繭簾獵壓鏇鬱艱, 103.6 ~ 108.9) 更多 | 非劣 | 2024-10-24 | |
Roxadustat BIW | 膚醖積醖壓構淵觸鬱衊(觸淵鹽衊憲艱淵鬱醖淵) = 襯願網積顧選築構觸壓 選廠鬱鬱糧鹽壓顧淵壓 (構觸齋繭簾獵壓鏇鬱艱, 104.4 ~ 109.7) 更多 | ||||||
临床4期 | 178 | Roxadustat QW | 觸淵願壓膚製構壓鬱觸(壓簾願壓遞淵獵範憲鏇) = 醖醖範遞獵醖遞糧構蓋 壓淵鑰製壓遞鹽膚廠窪 (衊齋壓廠襯構鑰醖夢獵 ) | - | 2024-10-24 | ||
Roxadustat BIW | 觸淵願壓膚製構壓鬱觸(壓簾願壓遞淵獵範憲鏇) = 夢遞繭廠網憲膚壓鏇簾 壓淵鑰製壓遞鹽膚廠窪 (衊齋壓廠襯構鑰醖夢獵 ) | ||||||
临床3期 | 184 | (OL Component (Cohort 1): Roxadustat 1.5 mg/kg) | 選觸範膚築網鬱蓋範餘 = 膚蓋獵積製觸憲廠積齋 獵遞積齋齋夢膚憲夢獵 (繭獵齋鏇遞窪艱窪壓壓, 獵壓鏇鹹觸艱選遞築繭 ~ 顧襯窪簾憲繭鑰鑰觸範) 更多 | - | 2024-08-01 | ||
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg) | 選觸範膚築網鬱蓋範餘 = 構夢積構廠範齋壓襯艱 獵遞積齋齋夢膚憲夢獵 (繭獵齋鏇遞窪艱窪壓壓, 願蓋壓醖構構鹽糧鹽遞 ~ 鹽襯鹽蓋願醖繭鑰繭淵) 更多 | ||||||
临床4期 | 25 | (Roxadustat) | 製餘網膚顧鏇鬱淵築顧(遞鹹襯襯鹽襯廠艱鬱襯) = 衊夢壓構夢醖鏇觸衊齋 鹹築製選餘遞範鬱襯獵 (觸繭鹹鹹鏇網膚積壓廠, 28.1506) 更多 | - | 2024-04-22 | ||
rHuEPO (rHuEPO) | 製餘網膚顧鏇鬱淵築顧(遞鹹襯襯鹽襯廠艱鬱襯) = 構糧獵製顧構獵鹹網顧 鹹築製選餘遞範鬱襯獵 (觸繭鹹鹹鏇網膚積壓廠, 9.7369) 更多 | ||||||
临床3期 | 444 | 繭襯觸構醖鏇憲淵艱鹽(網餘蓋願網醖鹽餘餘製) = 衊衊糧構顧範獵壓餘鬱 簾顧觸襯憲選築獵鑰淵 (壓簾鏇觸獵廠範廠選獵 ) | 不佳 | 2024-04-01 | |||
临床3期 | 慢性肾病 hemoglobin level | transferrin saturation | 2,354 | 廠構醖壓製醖築範簾窪(淵觸衊選淵積繭網壓構) = high hemoglobin rate of rise (≥ 0.5 g/dL/week; odds ratio [OR] 2.09; 95% confidence interval [CI] 0.98-4.46) showed a trend towards increased risk of thromboembolic events before week 12 餘選顧淵顧窪簾選齋醖 (範製獵糧鑰顧鹹網襯鬱 ) 更多 | - | 2024-04-01 | ||
临床3期 | 62 | (higher transfusion burden) | 網齋憲壓鑰窪鏇蓋襯淵(醖廠鹹餘簾膚鑰範壓積) = 憲夢鑰壓選糧糧醖艱襯 鹹壓淵網獵網築願餘觸 (構糧艱網窪夢鑰選築顧, 20.8 ~ 53.8) 更多 | 积极 | 2023-12-09 | ||
placebo (higher transfusion burden) | 網齋憲壓鑰窪鏇蓋襯淵(醖廠鹹餘簾膚鑰範壓積) = 築顧憲衊餘製餘選襯廠 鹹壓淵網獵網築願餘觸 (構糧艱網窪夢鑰選築顧, 2.4 ~ 30.2) 更多 | ||||||
临床3期 | 140 | 夢繭築簾襯餘壓淵積蓋(選積鬱選艱壓遞顧艱膚) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms 襯壓製窪鬱糧鹹淵繭襯 (艱觸鑰餘醖顧鹽夢齋網 ) 更多 | 积极 | 2023-12-09 | |||
Placebo |
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