更新于：2024-12-24
Roxadustat
罗沙司他
更新于：2024-12-24
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 |
特殊审评特殊审批 (中国) |
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结构
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The Effect of Roxadustat on the Levels of Renal Oxygenation in Patients With Diabetes Nephropathy (FOXTROT)
罗沙司他片在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉生物等效性试验
健康受试者空腹和餐后状态下单次口服罗沙司他胶囊单中心的随机、开放、两制剂、两周期、两序列、双交叉设计的生物等效性试验
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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443
项与 罗沙司他 相关的文献（医药）2024-12-31Renal failure
Cardiovascular and renal safety outcomes of hypoxia-inducible factor prolyl-hydroxylase inhibitor roxadustat for anemia patients with chronic kidney disease: a systematic review and meta-analysis
Review
作者: Liu, Mengchao ; Zhao, Wenjing ; Tian, Lei ; Pang, Yanyu ; Zheng, Bingjie ; Wang, Yutong ; Zhao, Jingwen ; Wang, Mengdi
This systematic review and meta-analysis were conducted to evaluate the cardiac and kidney-related adverse effects of roxadustat for the treatment of anemia in CKD patients. 18 trials with a total of 8806 participants were identified for analysis. We employed a fixed-effects model for analysis. The pooled result revealed no significant difference in the risk of occurrence of cardiac disorders when comparing CKD patients receiving roxadustat with the placebo (RR = 1.049; CI [0.918 to 1.200]) or ESA (RR = 1.066; CI [0.919 to 1.235]), in both dialysis-dependent (DD) (RR = 1.094; CI [0.925 to 1.293]) or non-dialysis-dependent (NDD) (RR = 1.036; CI [0.916 to 1.171]) CKD patients. No significant difference was observed in the risk of kidney-related adverse events when comparing roxadustat with the placebo (RR = 1.088; CI [0.980 to 1.209]) or ESA (RR = 0.968; CI [0.831 to 1.152]), in DD (RR = 2.649; CI [0.201 to 34.981]) or NDD (RR = 1.053; CI [0.965 to 1.149]) CKD patients. A high risk of hyperkalemia was observed in the roxadustat group in DD (RR = 0.939; CI [0.898 to 0.981]). Incidence of hypertension was higher in the roxadustat for NDD patients (RR = 1.198; CI [1.042 to 1.377]), or compared to the placebo (RR = 1.374; CI [1.153 to 1.638]). In summary, the risk of cardiac or kidney-related events observed in the roxadustat was not significantly increase whether in DD or NDD patients. However, attention must be paid to the occurrence of hyperkalemia for DD patients and hypertension in NDD patients using roxadustat.
2024-12-31RENAL FAILURE
Roxadustat has risks of reversible central hypothyroidism in patients undergoing hemodialysis: a single-center retrospective cohort study
Article
作者: Otsuka, Emiko ; Funakoshi, Satoshi ; Nishino, Tomoya ; Mukae, Hiroshi ; Kitamura, Mineaki
Roxadustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor, has proven efficacy in the treatment of renal anemia; however, evidence indicates that it may cause central hypothyroidism. The prevalence and reversibility of roxadustat-induced central hypothyroidism in patients undergoing hemodialysis remain unclear. Here, we retrospectively analyzed thyroid-stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3) levels in 51 patients (mean age: 72.3 ± 10.7 years; 58.8% male) undergoing hemodialysis before, during, and after halting roxadustat treatment. TSH levels were significantly decreased from a median of 2.46 (interquartile range:1.60-4.51) mU/L before roxadustat treatment to 1.36 (0.72-2.41) mU/L during treatment (p < 0.001), and improved to 2.56 (1.78-4.63) mU/L after halting roxadustat (p < 0.001). Similarly, FT4 levels decreased from 1.11 (0.97-1.24) ng/dL before roxadustat treatment to 0.92 (0.71-1.03) ng/dL during treatment (p < 0.001) and improved to 1.05 (0.93-1.17) ng/dL after halting roxadustat (p < 0.001). FT3 levels were 2.04 (1.78-2.31) pg/mL before starting roxadustat, 1.97 (1.69-2.27) pg/mL during treatment, and 1.90 (1.63-2.18) pg/mL after halting roxadustat, with no significant difference between each group. Moreover, 2.0% of patients exhibited extremely low TSH levels (≤0.1 mU/L) and low TSH levels (>0.1 mU/L to <0.4 mU/L) before starting roxadustat and that percentage increased to 5.9% and 7.8%, respectively, during treatment. After roxadustat cessation, extremely low or low TSH levels recovered in all patients. Taken together, the results indicate that roxadustat can cause reversible central hypothyroidism in patients undergoing hemodialysis.
2024-12-31Renal failure
Influencing factors of clinical efficacy of roxadustat among hemodialysis patients
Article
作者: Di, Jia ; Hu, Nan ; Niu, Hongyan ; Li, Xiurong ; Wu, Wenhui ; Zhou, Hua ; Yang, Min
OBJECTIVE:
To explore independent influencing factors for clinical efficacy of roxadustat in hemodialysis patients.
METHODS:
Hemodialysis patients treated with roxadustat were enrolled. The plasma trough concentrations of roxadustat were measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). A multiple logistic regression model was established to determine the factors that affect clinical efficacy of roxadustat in patients undergoing hemodialysis.
RESULTS:
A total of 67 hemodialysis patients were enrolled in the study. The results showed that age, blood trough concentration of roxadustat, and baseline hemoglobin (Hb) level were independent factors of clinical efficacy of roxadustat (OR = 1.06, p = .025 for age; OR = 1.001, p = .037 for plasma concentration; and OR = 0.941, p = .003 for baseline Hb), with an AUC score of 0.859.
CONCLUSIONS:
Age, blood trough concentration of roxadustat, and baseline Hb level were independent influencing factors of the response to roxadustat in hemodialysis patients.
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 |
|---|---|---|---|---|
| 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 | |
| 骨髓增生异常综合征 | 临床3期 | 加拿大 | 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 | - | 艱顧鑰簾糧餘築鹽衊遞(衊鏇醖積遞壓範選觸構) = 鏇蓋遞簾淵糧觸繭積構 壓醖鬱構艱繭網淵廠遞 (膚蓋鏇積願積膚夢壓獵 ) | - | 2024-12-07 | |||
临床3期 | 184 | (OL Component (Cohort 1): Roxadustat 1.5 mg/kg) | 蓋鬱遞鹹餘齋糧遞衊獵(鹹憲積蓋壓醖鑰簾膚築) = 範窪簾構餘艱願窪獵鬱 繭積鹽選願簾廠選繭鬱 (醖艱築壓網廠選廠製鑰, 範構齋繭簾範鏇簾積鹽 ~ 鏇壓醖顧壓襯鹹願簾夢) 更多 | - | 2024-08-01 | ||
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg) | 蓋鬱遞鹹餘齋糧遞衊獵(鹹憲積蓋壓醖鑰簾膚築) = 製衊觸餘夢膚顧襯膚齋 繭積鹽選願簾廠選繭鬱 (醖艱築壓網廠選廠製鑰, 淵夢選廠鏇淵餘鏇夢窪 ~ 遞簾網餘願蓋遞鏇窪鑰) 更多 | ||||||
临床4期 | 25 | (Roxadustat) | 鏇製餘鑰夢蓋襯餘遞壓(顧鑰簾艱網網膚鑰齋醖) = 獵鏇淵顧窪製積簾鹹膚 鑰觸夢鹹鏇積築獵糧簾 (積襯艱鹹餘齋淵網蓋遞, 繭築糧壓憲鏇鹹餘糧醖 ~ 築選範蓋鹽憲築繭餘夢) 更多 | - | 2024-04-22 | ||
rHuEPO (rHuEPO) | 鏇製餘鑰夢蓋襯餘遞壓(顧鑰簾艱網網膚鑰齋醖) = 鑰膚範壓選襯遞窪鑰鏇 鑰觸夢鹹鏇積築獵糧簾 (積襯艱鹹餘齋淵網蓋遞, 壓鏇蓋憲積醖願蓋積構 ~ 憲窪醖顧壓觸餘簾襯鑰) 更多 | ||||||
临床3期 | 444 | 衊遞範艱廠獵鬱餘糧遞(廠衊壓築製夢構積夢艱) = 鑰鹹繭壓顧遞鏇蓋膚餘 淵觸蓋夢願衊製獵蓋範 (餘衊襯夢艱廠窪鹽艱齋 ) | 不佳 | 2024-04-01 | |||
临床3期 | 慢性肾病 hemoglobin level | transferrin saturation | 2,354 | 鑰鏇糧淵選醖構淵淵淵(鹹獵糧觸膚膚窪觸製選) = 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 膚鹽壓範壓艱築廠網鬱 (遞網網壓夢襯願餘膚簾 ) 更多 | - | 2024-04-01 | ||
临床3期 | 62 | Roxadustat (higher transfusion burden) | 鏇製艱蓋衊構夢齋窪構(醖鏇製網窪遞壓衊範餘) = 顧顧憲醖網遞鏇廠積鹹 顧製憲窪廠獵遞鏇襯齋 (齋膚壓醖簾廠簾遞憲網, 20.8 ~ 53.8) 更多 | 积极 | 2023-12-09 | ||
placebo (higher transfusion burden) | 鏇製艱蓋衊構夢齋窪構(醖鏇製網窪遞壓衊範餘) = 網餘襯襯遞廠憲範築製 顧製憲窪廠獵遞鏇襯齋 (齋膚壓醖簾廠簾遞憲網, 2.4 ~ 30.2) 更多 | ||||||
临床3期 | 140 | 獵膚網膚遞糧窪簾餘鹹(鏇獵鏇醖範鹽製選夢觸) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms 衊鏇廠衊鹽遞鏇積觸壓 (窪衊鹹簾獵鏇鹽夢廠遞 ) 更多 | 积极 | 2023-12-09 | |||
Placebo | |||||||
临床3期 | 140 | 鹽顧膚夢壓積繭醖獵繭(選膚窪夢糧衊繭構構積) = 糧壓積膚蓋構築積鏇築 醖遞繭簾觸遞憲艱製齋 (顧醖網壓遞糧壓蓋餘製, 13.58 ~ 20.71) | 非劣 | 2023-10-21 | |||
鹽顧膚夢壓積繭醖獵繭(選膚窪夢糧衊繭構構積) = 淵選憲製繭製範憲蓋獵 醖遞繭簾觸遞憲艱製齋 (顧醖網壓遞糧壓蓋餘製, 11.34 ~ 19.50) | |||||||
临床3期 | 4,072 | 積鏇網構艱鹽網製壓蓋(廠願鑰淵憲構鏇夢積顧) = The overall percentages of patients with at least one treatment-emergent adverse event were similar for patients treated with roxadustat or ESA across hsCRP quintiles. 網膚獵襯選膚艱鹹齋衊 (衊網鏇糧繭廠醖憲構鑰 ) | 积极 | 2023-06-14 | |||
N/A | 40 | 壓構夢齋夢構願襯壓壓(範蓋積構網製衊膚構鹹) = regular monitoring of thyroid function was considered essential in 'Roxadustat' users because of the presence of hypothyroidism in some cases 鏇鏇夢鬱壓醖觸齋選醖 (窪憲鏇壓淵願艱鏇淵齋 ) 更多 | 不佳 | 2023-03-01 |
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