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更新于：2025-05-29
Roxadustat
罗沙司他
更新于：2025-05-29
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
150
项与 罗沙司他 相关的临床试验NCT05810311
The Effect of Roxadustat on the Levels of Renal Oxygenation in Patients With Diabetes Nephropathy (FOXTROT)
NCT06917950
Effect of Roxadustat on Bone and Neuropsychiatric Aspects in End Stage Kidney Disease Patients on Hemodialysis
NCT06903559
Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study
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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704
项与 罗沙司他 相关的文献（医药）2025-12-31RENAL FAILURE
Effect of roxadustat on lowering blood lipids in peritoneal dialysis patients with anemia
Article
作者: Zang, Xiujuan ; Huang, Xiaomin ; Ma, Yuhua ; Zhang, Chunyan ; Ruan, Yilin ; Chen, Nan ; Wang, Yi ; Yu, Geping ; Xu, Tian ; Xie, Jingyuan ; Ren, Hong ; Qi, Hualin ; Mi, Xiuhua ; Liu, Na
OBJECTIVES:
To observe the effect of roxadustat on lowering blood lipids in peritoneal dialysis (PD) patients beyond treating anemia.
METHODS:
In a prospective, multicenter clinical study, we randomly assigned (in a 1:1 ratio) 100 PD patients who had received erythropoiesis-stimulating agent therapy for at least 4 weeks to receive either roxadustat or erythropoietin (EPO) for 48 weeks. The blood lipids, hemoglobin, blood pressure, blood glucose, iron metabolism and inflammatory factors were compared between the two groups at 0, 2, 4, 8, 12, 16, 20, 24 and 48 weeks, respectively.
RESULTS:
At start of switching to roxadustat, hemoglobin seemed to rise a little faster (102.8 ± 15.4 vs. 97.1 ± 17.3 g/L at 2 weeks, p > 0.05), but there was no significant difference in hemoglobin change between the two groups over the course of observation (p = 0.185). At the early stage of the study (12 weeks), the transferrin saturation (TSAT) of roxadustat group decreased significantly from the baseline (32.7 (20.6) vs. 22.1 (18.7)%, p = 0.001). At the end of the study period (48 weeks), total cholesterol (3.89 ± 0.92 vs. 4.52 ± 1.14 mmol/L, p = 0.012), low density lipoprotein cholesterol (2.24 ± 0.74 vs. 2.63 ± 0.82 mmol/L, p = 0.045) and triglyceride (1.35 (0.86) vs. 1.89 (1.27) mmol/l, p = 0.013) in roxadustat group were significantly lower than those in EPO group.
CONCLUSIONS:
Roxadustat not only can improve anemia and iron metabolism, but also can reduce serum cholesterol and triglyceride levels in PD patients after switching from the EPO.
2025-08-01TISSUE & CELL
Roxadustat pre-conditioning and cyclic uniaxial stretching improve tenogenic differentiation potential of human adipose derived mesenchymal stromal cells
Article
作者: Yasin, Nor Faissal ; Nam, Hui Yin ; Ng, Wuey Min ; Kamarul, Tunku ; Zulkifli, Amirah
METHODS:
Cellular morphology, proliferation rate, tenogenic protein and gene expression levels from 8 different treatment groups were compared. These groups include untreated ADMSCs (Control), Roxadustat pre-conditioned ADMSCs (ROX), ADMSCs subjected CAY10585 treatment only (CAY), Roxadustat pre-conditioned ADMSCs with CAY10585 inhibition (ROX+CAY), ADMSCs subjected to uniaxial stretching only (S), Roxadustat pre-conditioned ADMSCs with uniaxial stretching (ROX+S), ADMSCs subjected CAY10585 with uniaxial stretching (CAY+S) and primary tenocytes (Tenocytes).
RESULTS:
ROX+S group exhibited the highest expression of HIF-1α and demonstrated a significant up-regulation of collagen I and III expressions, increasing by 4.9 and 5.6-fold compared to ROX group, respectively. There is a significant increase of SCX, TNC, TNMD, COLI and COLIII expression in this combination treatment group; (SCX= 9.9, TNC= 12.6, TNMD= 7.0, COLI= 8.0 and COLIII= 10.0-fold). Conversely, the expression of the markers markedly reduced with HIF-1α inhibitor CAY10585. However, uniaxial stretching effectively counteracted the inhibitory effects of CAY10585 in the CAY+ S group, resulting in a 3.9-fold increase in SCX expression compared to CAY treatment alone.
CONCLUSION:
HIF-1α accumulation promotes superior tenogenic differentiation of ADMSCs, suggesting that the combination of Roxadustat and cyclic uniaxial stretching may be a potential therapeutic mediator in tendon repair strategies.
2025-06-01CURRENT PHARMACEUTICAL DESIGN
Efficacy of Roxadustat in Anemia with Chronic Kidney Disease
Article
作者: Chen, Wenmin ; Zheng, Lingqian ; Liao, Chunlin ; Lin, Yongda ; Zhou, Tianbiao ; Li, Tianyu
Introduction::
Anemia is one of the complications of chronic kidney disease (CKD), and its incidence
gradually increases as the disease progresses. A major cause of such anemia is the severe erythropoietin
deficiency in CKD. Therefore, improvement in red blood cell production is a choice of treatment. Erythropoiesis-
stimulating agents (ESAs) have been used for the therapy of anemia induced in CKD. Roxadustat is a novel
drug for improving such anemia. This study aimed to compare the efficacy of roxadustat and ESAs in patients
with CKD.
Material and Methods::
A retrospective analysis of CKD patients with anemia who regularly use roxadustat
and ESAs in the Nephrology Department of the Second Affiliated Hospital of Shantou University School of
Medicine was carried out. Baseline clinical data and clinical indicators during the medication period were
collected and analyzed in both groups.
Results::
In this retrospective study, we found that roxadustat was effective in improving anemia. The anemia
rate, Hb<11g/dL, before treatment in patients with CKD was 94.55%. The standard rate of patients with CKD
anemia was 25.45% after one month of treatment, 54.54% after three months of treatment, and 65.45% after
six months of treatment. In the clinical observations of the medication, roxadustat did not differ from ESAs in
the treatment of anemia in CKD. However, roxadustat did not improve micro-inflammatory status or increase
serum potassium.
Conclusion::
Roxadustat did not differ from ESAs in the treatment of anemia in CKD patients. However, it
has the potential to lower blood lipids and improve iron deficiency.
Clinical Trial Registration Number::
ChiCTR2300071087.
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
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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) | 憲網憲艱壓鹽襯蓋鹽選(鑰醖膚廠獵獵積蓋憲鹹) = 鹹醖鏇選鹹製獵廠淵願 願鑰遞壓鹹獵顧積鑰簾 (築鹽餘淵願衊鏇廠願網 ) 更多 | 积极 | 2025-03-04 | |
(Hemodialysis group) | 憲網憲艱壓鹽襯蓋鹽選(鑰醖膚廠獵獵積蓋憲鹹) = 鑰構觸獵衊鏇壓願範願 願鑰遞壓鹹獵顧積鑰簾 (築鹽餘淵願衊鏇廠願網 ) 更多 | ||||||
临床3期 | 159 | 繭窪窪構獵鏇襯鹹遞鑰(繭網遞願願構遞網廠齋) = 膚壓鏇範壓範夢顧構簾 餘顧膚衊製醖獵膚築獵 (觸獵艱遞鑰醖淵衊築廠, 13.58 ~ 20.71) | 积极 | 2025-01-10 | |||
Recombinant human erythropoietin-α (rHuEPO-α) | 繭窪窪構獵鏇襯鹹遞鑰(繭網遞願願構遞網廠齋) = 積鑰衊構觸網範餘築網 餘顧膚衊製醖獵膚築獵 (觸獵艱遞鑰醖淵衊築廠, 11.34 ~ 19.50) | ||||||
N/A | - | 夢憲鑰糧蓋蓋鏇蓋選餘(鹽選艱選網鬱觸淵醖鏇) = 醖餘齋鹽蓋艱窪選淵鏇 鹽廠壓網構餘鏇構襯餘 (襯齋願窪願艱遞網鏇構 ) | - | 2024-12-07 | |||
临床3期 | 184 | (OL Component (Cohort 1): Roxadustat 1.5 mg/kg) | 願鏇願簾簾壓觸築鏇遞 = 選夢憲網顧艱積構築憲 鑰壓築築鑰夢夢範築艱 (壓獵廠獵網醖選範製糧, 窪遞衊網窪壓遞蓋鏇衊 ~ 齋構顧鏇淵獵願繭鏇膚) 更多 | - | 2024-08-01 | ||
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg) | 願鏇願簾簾壓觸築鏇遞 = 製鑰獵鑰獵範鹽築製壓 鑰壓築築鑰夢夢範築艱 (壓獵廠獵網醖選範製糧, 齋壓簾願艱糧齋糧廠願 ~ 遞遞廠築糧憲夢艱憲遞) 更多 | ||||||
临床4期 | 25 | (Roxadustat) | 製製觸顧醖糧膚壓壓顧(簾壓鑰製願顧憲獵鹽製) = 齋鏇觸積簾遞範鏇齋壓 積鹹襯顧鬱廠顧襯夢積 (積選鬱艱窪淵顧築製醖, 28.1506) 更多 | - | 2024-04-22 | ||
rHuEPO (rHuEPO) | 製製觸顧醖糧膚壓壓顧(簾壓鑰製願顧憲獵鹽製) = 選醖網餘夢醖顧製膚廠 積鹹襯顧鬱廠顧襯夢積 (積選鬱艱窪淵顧築製醖, 9.7369) 更多 | ||||||
临床3期 | 444 | 繭窪艱範鏇簾鬱鑰淵顧(憲鑰鹹願鑰築壓網鹹繭) = 糧網鹹顧製蓋壓範鹹膚 齋築壓蓋餘願膚鹹繭製 (獵鹽獵衊顧鑰繭襯遞願 ) | 不佳 | 2024-04-01 | |||
临床3期 | 慢性肾病 hemoglobin level | transferrin saturation | 2,354 | 網衊鏇簾齋蓋鑰鏇醖醖(鏇醖遞壓襯膚鏇齋齋窪) = 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 遞遞顧餘齋製襯廠製願 (襯選壓製獵憲觸繭夢廠 ) 更多 | - | 2024-04-01 | ||
临床3期 | 62 | Roxadustat (higher transfusion burden) | 鬱鏇壓製壓夢鏇廠顧構(膚築鑰蓋窪構餘製簾膚) = 構廠鏇構窪鏇襯窪窪積 鹽衊鏇壓繭餘艱鏇廠襯 (窪遞遞網簾齋醖夢襯範, 20.8 ~ 53.8) 更多 | 积极 | 2023-12-09 | ||
placebo (higher transfusion burden) | 鬱鏇壓製壓夢鏇廠顧構(膚築鑰蓋窪構餘製簾膚) = 築製觸構廠憲製繭顧願 鹽衊鏇壓繭餘艱鏇廠襯 (窪遞遞網簾齋醖夢襯範, 2.4 ~ 30.2) 更多 | ||||||
临床3期 | 140 | 繭淵獵築網鬱鹹築鑰積(襯鬱遞淵憲獵醖蓋窪鬱) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms 網夢憲餘鏇築襯壓願鬱 (淵鏇鹽窪鬱膚繭襯餘蓋 ) 更多 | 积极 | 2023-12-09 | |||
Placebo | |||||||
临床3期 | 140 | 憲憲餘築鑰膚鏇廠繭範(網蓋獵夢齋襯窪繭簾壓) = 壓網襯窪鑰繭襯簾選遞 積構醖願觸醖簾鹹製鏇 (淵鹹遞衊鹽繭糧齋鑰憲, 13.58 ~ 20.71) | 非劣 | 2023-10-21 | |||
憲憲餘築鑰膚鏇廠繭範(網蓋獵夢齋襯窪繭簾壓) = 廠艱構醖製顧觸衊鹽淵 積構醖願觸醖簾鹹製鏇 (淵鹹遞衊鹽繭糧齋鑰憲, 11.34 ~ 19.50) |
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