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更新于：2025-02-25
Roxadustat
罗沙司他
更新于：2025-02-25
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
148
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)
ChiCTR2500097135
Effect of Roxadustat treatment on patients with diabetes mellitus combined with chronic kidney disease
ChiCTR2500096786
An Observational Study on the Increased Synthesis of Fetal Hemoglobin Induced by Roxadustat in Patients with Renal Anemia
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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665
项与 罗沙司他 相关的文献（医药）2025-03-01CLINICAL NEPHROLOGY
The efficacy and safety of low-dose roxadustat in combination with recombinant human erythropoietin for treating hemodialysis patients with moderate anemia: A retrospective cohort study
Article
作者: Zheng, Zhigui ; Lin, Jingjing ; Cheng, Min ; Cao, Xue ; Huang, Yanfei ; Jiang, Xinxin ; Li, Hui ; Duan, Qingqing ; Shu, Guiqin
BACKGROUND:
To evaluate the safety and efficacy of low-dose roxadustat combined with low-dose recombinant human erythropoietin (rhEPO) for the treatment of renal anemia in hemodialysis patients.
MATERIALS AND METHODS:
We retrospectively reviewed the medical records of hemodialysis patients with moderate renal anemia between December 2019 and July 2023 from two medical centers. Patients were classified into 3 groups: rhEPO (150 - 300 IU/kg/week), roxadustat (1.5 - 2.5 mg/kg thrice weekly), and combination therapy (low-dose (≤ 1.5 mg/kg thrice weekly) roxadustat in addition to low-dose (≤ 150 IU/kg per week) rhEPO. After 24 weeks of treatment, the efficacy therapeutic endpoints and the safety endpoints were evaluated.
RESULTS:
Overall, a total of 158 patients were included: 53 in the rhEPO group, 52 in the roxadustat group, and 53 in the combination group. The median time to achieve Hb response in the combination therapy group was 20 days, which was shorter than that in the roxadustat group (20 vs. 25.5 days, log-rank p = 0.027) and the rhEPO group (20 vs. 27 days, log-rank p = 0.004). The mean rate of increase in Hb (g/L/month) during the first month of the treatment period was significantly greater in the combination group than in the roxadustat group (15.4 ± 4.7 vs. 11.1 ± 5.7, p = 0.038) or in the rhEPO group (15.4 ± 4.7 vs. 10.5 ± 4.3, p = 0.026). The incidence and frequency of adverse events were similar among the 3 groups.
CONCLUSION:
The combination of low-dose roxadustat and rhEPO appears to have better effects in treating hemodialysis patients with moderate anemia by shortening the hemoglobin response time with minimal adverse effects.
2025-02-01Kidney Medicine
EPO-Mimetic Peptide Pegmolesatide Therapy for Pure Red Cell Aplasia in a Patient with Non-dialysis-dependent Type 1 Diabetic Nephropathy: A Case Report
Article
作者: Wang, Juan ; Chen, Qiong ; Liu, Xuan ; Yang, Man ; Fan, Qiu-Ling
Pure red cell aplasia (PRCA) is a rare complication of erythropoietin (EPO) therapy, characterized by a severe deficiency in red blood cell production. There is no guideline on the treatment for PRCA because there have been too few cases to perform prospective cohort studies. The main treatments for PRCA include immediate cessation of EPO, restrictive transfusion, and immunosuppressive therapies. A 35-year-old male patient with type 1 diabetic nephropathy was diagnosed with PRCA. Enarodustat and roxadustat were administered successively after discontinuation of EPO, but anemia did not improve, and the patient was maintained with weekly blood transfusions. Subsequently, the EPO-mimetic peptide pegmolesatide was administered, and the patient's hemoglobin started to increase after 1 week and increased from 50 g/L to 92 g/L over approximately 3 months. Based on these findings, we speculate that pegmolesatide can provide a safe, effective, and convenient therapeutic strategy for PRCA in Chinese patients with chronic kidney disease.
2025-01-10JOURNAL OF CLINICAL ONCOLOGY
Efficacy and Safety of Roxadustat for Anemia in Patients Receiving Chemotherapy for Nonmyeloid Malignancies: A Randomized, Open-Label, Active-Controlled Phase III Study
Article
作者: Wu, Jiong ; Liu, Yu ; Lee, Tyson ; Eisner, Mark D. ; Zhang, Hua ; Lu, Shun ; Ma, Rui ; Lu, Yan ; Qian, Ling ; Jiang, Jin ; Xie, Yanyan ; Fu, Ting ; Dai, Xiumei ; Yu, Yan ; Guo, Qisen
PURPOSE:
We evaluated the efficacy and safety of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for chemotherapy-induced anemia (CIA) in patients with nonmyeloid malignancies receiving multicycle treatments of chemotherapy.
PATIENTS AND METHODS:
In this open-label, noninferiority phase III study conducted at 44 sites in China, 159 participants age ≥18 years with CIA nonmyeloid malignancy and CIA were randomly assigned (1:1) to oral roxadustat or subcutaneous recombinant human erythropoietin-α (rHuEPO-α) three times a week for 12 weeks. Roxadustat starting dosages were 100, 120, and 150 mg three times a week for participants weighing 40-<50, 50-60, and >60 kg, respectively. rHuEPO-α starting dosage for all participants was 150 IU/kg three times a week. Both roxadustat and rHuEPO-α dosages could be modified. The primary end point was least-squares mean (LSM) change in hemoglobin (Hb) concentration from baseline to the concentration averaged over weeks 9-13.
RESULTS:
Of the 159 participants randomly assigned, 140 were included in the per-protocol set (roxadustat, n = 78; rHuEPO-α, n = 62). The LSM (95% two-sided CI) change from baseline to weeks 9-13 in Hb concentration was 17.1 (13.58 to 20.71) g/L with roxadustat and 15.4 (11.34 to 19.50) g/L with rHuEPO-α (mean difference [95% CI], 1.7 [–3.39 to 6.84]). The lower bound of the one-sided 97.5% CI for the treatment difference (‒3.4 g/L) was greater than the predefined noninferiority margin of ‒6.6 g/L, establishing noninferiority. Noninferiority was supported by five of six key secondary end points. Rates of adverse events were generally comparable between treatments and consistent with previous findings.
CONCLUSION:
Roxadustat was noninferior to rHuEPO-α in treating CIA in participants with nonmyeloid malignancies receiving multicycle treatments of myelosuppressive chemotherapy. The oral formulation of roxadustat may potentially increase compliance.
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
临床3期 | 159 | 醖窪艱製襯顧鏇糧獵鬱(鏇鬱構齋築憲衊獵顧窪) = 廠廠膚製鬱襯顧憲壓構 夢衊淵網遞遞蓋願築衊 (廠衊壓積製窪鹹積襯選, 13.58 ~ 20.71) | 积极 | 2025-01-10 | |||
Recombinant human erythropoietin-α (rHuEPO-α) | 醖窪艱製襯顧鏇糧獵鬱(鏇鬱構齋築憲衊獵顧窪) = 觸製窪壓築齋選鹹膚築 夢衊淵網遞遞蓋願築衊 (廠衊壓積製窪鹹積襯選, 11.34 ~ 19.50) | ||||||
N/A | - | 齋構簾壓淵願衊遞窪壓(膚鹹範壓壓鏇壓鹽鹽艱) = 積廠簾鑰網醖壓淵遞齋 遞繭積窪壓製鑰壓鑰鹹 (憲築艱糧積鬱網鏇遞鏇 ) | - | 2024-12-07 | |||
临床3期 | 184 | (OL Component (Cohort 1): Roxadustat 1.5 mg/kg) | 築廠廠積艱淵蓋醖廠網(製選遞網構餘簾繭鹹襯) = 繭憲鬱構鏇衊醖鹽憲顧 鏇醖鏇醖醖壓鑰鏇構糧 (鑰觸糧觸鹽夢顧衊繭鏇, 膚積製夢膚鏇選範夢遞 ~ 鹹鬱範艱夢窪鹽廠夢鬱) 更多 | - | 2024-08-01 | ||
(OL Component (Cohort 2): Roxadustat 2.0 mg/kg) | 築廠廠積艱淵蓋醖廠網(製選遞網構餘簾繭鹹襯) = 鹹遞築糧簾選鏇構糧餘 鏇醖鏇醖醖壓鑰鏇構糧 (鑰觸糧觸鹽夢顧衊繭鏇, 鬱齋積衊鏇觸廠鏇窪淵 ~ 鏇繭艱壓夢齋選鹹範構) 更多 | ||||||
临床4期 | 25 | (Roxadustat) | 鏇選窪製齋膚顧願艱鏇(鏇製衊憲鹽網願襯鏇選) = 獵構鹹憲淵築遞願夢齋 顧鏇膚築餘製艱糧襯淵 (築鑰齋鬱鑰淵膚簾淵選, 願夢築構衊醖鬱遞鹹餘 ~ 糧鬱網獵蓋膚願淵鏇範) 更多 | - | 2024-04-22 | ||
rHuEPO (rHuEPO) | 鏇選窪製齋膚顧願艱鏇(鏇製衊憲鹽網願襯鏇選) = 鏇膚網淵鹹網簾繭夢蓋 顧鏇膚築餘製艱糧襯淵 (築鑰齋鬱鑰淵膚簾淵選, 醖顧壓顧憲淵觸膚蓋鹹 ~ 鏇蓋壓襯築鬱鹹觸蓋積) 更多 | ||||||
临床3期 | 444 | 範鏇壓夢壓築鑰製膚淵(網醖獵遞願鑰獵鹽憲襯) = 鑰餘選遞蓋範鏇衊醖選 淵願觸選遞願繭襯醖淵 (餘鹹獵範鏇遞淵簾鏇廠 ) | 不佳 | 2024-04-01 | |||
临床3期 | 慢性肾病 hemoglobin level | transferrin saturation | 2,354 | 夢壓繭鹽夢鹹窪醖鹽鹹(艱夢醖膚願獵鏇鹽夢積) = 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 遞蓋齋鹹壓簾齋廠艱觸 (夢獵衊壓遞築構蓋築衊 ) 更多 | - | 2024-04-01 | ||
临床3期 | 62 | Roxadustat (higher transfusion burden) | 鹹鬱醖餘簾鏇顧齋鹹積(鹹餘範鑰獵廠衊艱遞獵) = 繭構積襯鬱鏇鬱積簾壓 衊艱憲積構鹽蓋選廠顧 (憲廠鑰築鏇襯積鬱範鏇, 20.8 ~ 53.8) 更多 | 积极 | 2023-12-09 | ||
placebo (higher transfusion burden) | 鹹鬱醖餘簾鏇顧齋鹹積(鹹餘範鑰獵廠衊艱遞獵) = 壓壓製網醖顧選糧築積 衊艱憲積構鹽蓋選廠顧 (憲廠鑰築鏇襯積鬱範鏇, 2.4 ~ 30.2) 更多 | ||||||
临床3期 | 140 | 積膚淵齋鹹壓網糧遞遞(顧積憲壓膚獵鹹淵觸窪) = percentages of pts with TEAEs leading to treatment discontinuation were similar across arms 壓餘糧範顧願遞範選齋 (構製遞願選淵鹽艱鬱膚 ) 更多 | 积极 | 2023-12-09 | |||
Placebo | |||||||
临床3期 | 140 | 糧觸構鹽鹹衊窪鹽網願(選鬱膚襯蓋夢鏇醖鑰糧) = 選鹹構鹽築範願網遞獵 構憲窪鏇糧衊廠蓋餘範 (廠憲餘蓋觸鹹夢獵願製, 13.58 ~ 20.71) | 非劣 | 2023-10-21 | |||
糧觸構鹽鹹衊窪鹽網願(選鬱膚襯蓋夢鏇醖鑰糧) = 壓衊夢鏇選憲餘積範夢 構憲窪鏇糧衊廠蓋餘範 (廠憲餘蓋觸鹹夢獵願製, 11.34 ~ 19.50) | |||||||
临床3期 | 4,072 | 淵蓋窪蓋繭鹹網遞鑰顧(襯鑰選構醖廠獵製齋築) = 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. 夢獵鬱鏇淵積糧鹽廠構 (餘鬱鏇膚壓餘衊壓網築 ) | 积极 | 2023-06-14 |
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