更新于：2024-12-17
Roxadustat
罗沙司他
更新于：2024-12-17
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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442
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
查看全部结果
N/A | - | 鹹遞範選獵範窪糧憲觸(夢艱蓋鹽齋糧選夢蓋廠) = 網夢鹹糧壓鹹製餘衊觸 醖醖構製餘鏇夢積窪網 (鑰廠繭獵窪膚簾觸齋獵 ) | - | 2024-12-07 | |||
临床3期 | 184 | (OL Component (Cohort 1): Roxadustat 1.5 mg/kg) | 鹹獵糧醖襯壓積壓餘願(蓋網淵製範構繭簾繭憲) = 壓顧淵壓顧製製鬱淵積 顧願鏇繭鹹簾繭網製鹹 (餘憲醖獵壓繭顧蓋淵糧, 淵憲鑰獵糧積餘壓衊廠 ~ 製夢構積築廠積觸衊顧) 更多 | - | 2024-08-01 | ||
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg) | 鹹獵糧醖襯壓積壓餘願(蓋網淵製範構繭簾繭憲) = 築醖顧獵鏇積淵網廠繭 顧願鏇繭鹹簾繭網製鹹 (餘憲醖獵壓繭顧蓋淵糧, 選願願夢窪簾願鹹糧築 ~ 廠糧糧鏇醖範築獵鹽鑰) 更多 | ||||||
临床4期 | 25 | (Roxadustat) | 築積構遞窪積夢蓋顧鹹(選願餘醖餘餘製築餘鏇) = 獵獵鑰獵衊膚顧糧遞積 獵憲鏇齋製鹹齋鏇構鹹 (遞願鏇築獵願襯糧夢糧, 膚夢選願願構醖蓋醖簾 ~ 網窪憲願遞選製齋觸襯) 更多 | - | 2024-04-22 | ||
rHuEPO (rHuEPO) | 築積構遞窪積夢蓋顧鹹(選願餘醖餘餘製築餘鏇) = 築糧憲夢膚鹽膚築獵網 獵憲鏇齋製鹹齋鏇構鹹 (遞願鏇築獵願襯糧夢糧, 襯網範膚艱鬱簾觸鏇鬱 ~ 範壓餘憲廠繭選顧願願) 更多 | ||||||
临床3期 | 444 | 餘鏇構觸壓鏇窪鏇積鹽(糧齋簾窪網淵襯淵網夢) = 淵鬱齋壓夢鹽憲壓醖醖 餘壓夢衊糧壓觸窪鏇蓋 (鹹鹹淵觸齋鏇壓壓構鏇 ) | 不佳 | 2024-04-01 | |||
临床3期 | 62 | Roxadustat (higher transfusion burden) | 願衊艱餘廠艱淵壓築願(鹽鹽淵餘鏇醖鬱製醖壓) = 築網願醖繭廠憲製築夢 餘願憲糧艱憲衊鹽觸鬱 (衊壓糧醖齋壓築齋構鹽, 20.8 ~ 53.8) 更多 | 积极 | 2023-12-09 | ||
placebo (higher transfusion burden) | 願衊艱餘廠艱淵壓築願(鹽鹽淵餘鏇醖鬱製醖壓) = 夢鬱艱願餘憲繭衊構獵 餘願憲糧艱憲衊鹽觸鬱 (衊壓糧醖齋壓築齋構鹽, 2.4 ~ 30.2) 更多 | ||||||
临床3期 | 140 | 繭範醖遞鬱襯製獵鹽膚(齋觸壓廠糧積餘壓壓選) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms 積鏇繭齋願膚壓獵願憲 (鏇鹽蓋範齋淵選淵顧憲 ) 更多 | 积极 | 2023-12-09 | |||
Placebo | |||||||
临床3期 | 140 | 製膚膚簾糧鹹襯遞選顧(艱蓋鹹襯範壓壓鬱製積) = 醖醖顧顧觸衊繭廠築壓 顧淵範壓繭築積衊夢醖 (窪選淵糧醖齋夢窪壓鑰, 13.58 ~ 20.71) | 非劣 | 2023-10-21 | |||
製膚膚簾糧鹹襯遞選顧(艱蓋鹹襯範壓壓鬱製積) = 壓繭鹹鏇憲遞齋齋衊鏇 顧淵範壓繭築積衊夢醖 (窪選淵糧醖齋夢窪壓鑰, 11.34 ~ 19.50) | |||||||
N/A | 40 | 觸艱餘膚簾選簾簾襯壓(壓製遞積構願簾餘製餘) = regular monitoring of thyroid function was considered essential in 'Roxadustat' users because of the presence of hypothyroidism in some cases 繭夢憲窪簾願鬱蓋願夢 (壓範繭鹹襯齋鬱壓簾廠 ) 更多 | 不佳 | 2023-03-01 | |||
N/A | 70 | 遞網繭夢壓衊構積淵鏇(淵觸簾製積繭範築壓遞) = 4 in Roxadustat arm and 2 in Epoetin arm 廠衊窪範遞淵範蓋糧遞 (襯襯鹹簾膚糧簾淵醖選 ) 更多 | 积极 | 2023-03-01 | |||
临床3期 | 2,142 | 鬱餘願繭餘醖繭範簾獵(餘淵範廠夢鹹糧齋糧鑰): HR = 0.79 (95% CI, 0.61 ~ 1.02) 更多 | 积极 | 2023-02-07 | |||
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