更新于：2024-06-21
Tigulixostat
替古索司他
更新于：2024-06-21
概要
基本信息
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评- |
关联
14
项与 替古索司他 相关的临床试验Tigulixostat 片（IBI128）在中国健康受试者中随机、开放、单次给药的药代动力学研究
A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects
A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of Tigulixostat on the Pharmacokinetics of a Single Oral Dose of Theophylline
100 项与 替古索司他 相关的临床结果
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100 项与 替古索司他 相关的转化医学
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100 项与 替古索司他 相关的专利（医药）
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6
项与 替古索司他 相关的文献（医药）2024-01-01International journal of rheumatic diseases
Comment on serum urate‐lowering efficacy and safety of Tigulixostat in gout patients with hyperuricemia: A randomized, double‐blind, placebo‐controlled, dose‐finding trial
Letter
作者: Chen, Ai-Lin ; Chang, Hui Wen ; Wei, James Cheng-Chung ; Hsu, Tai-Ming
2023-07-01Arthritis & rheumatology (Hoboken, N.J.)
Serum Urate–Lowering Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia: A Randomized, Double‐Blind , Placebo‐Controlled , Dose‐Finding Trial
Article
作者: Shin, Seonghye ; Saag, Kenneth G. ; Lee, Jisoo ; Min, Jiyoung ; Terkeltaub, Robert
Objective:
To evaluate the safety and efficacy of the nonpurine xanthine oxidase inhibitor tigulixostat for lowering serum urate level in gout patients with hyperuricemia.
Methods:
We conducted a multicenter, phase II, randomized, double‐blind, placebo‐controlled, parallel‐group, dose‐finding trial. After screening, gout patients with hyperuricemia were randomly assigned, after appropriate washout, to receive daily oral administration of 50 mg, 100 mg, or 200 mg of tigulixostat, or placebo for 12 weeks. Colchicine gout flare prophylaxis was administered to all patients. The primary end point was the proportion of patients with a serum urate level <5.0 mg/dl at week 12.
Results:
A total of 143 patients were randomized to receive tigulixostat 50 mg (n = 34), 100 mg (n = 38), or 200 mg (n = 37), or placebo (n = 34). A significantly greater proportion of patients in the tigulixostat groups achieved the target serum urate level <5.0 mg/dl at week 12 (47.1% in the 50 mg group, 44.7% in the 100 mg group, and 62.2% in the 200 mg group) compared to the placebo group (2.9%) (P < 0.0001). The mean percentage change in serum urate level from baseline was also significantly greater in the tigulixostat groups (−38.8% to −61.8%) than in the placebo group at all time points (P < 0.0001). The rate of gout flares requiring rescue treatment ranged from 9.4% to 13.2% in the tigulixostat and placebo groups. The incidence of adverse events was 50.0% to 56.8% across all groups, and their severity was mild or moderate.
Conclusion:
Tigulixostat significantly lowered serum urate compared to placebo at all doses studied with an acceptable safety profile.
2023-05-01JHEP reports : innovation in hepatology
Efficacy and safety of frontline systemic therapy for advanced HCC: A network meta-analysis of landmark phase III trials
Article
作者: Silletta, Marianna ; Pinter, Matthias ; Korolewicz, James ; Gennari, Alessandra ; Stikas, Charalampos-Vlasios ; Scotti, Lorenza ; Vincenzi, Bruno ; Pinato, David J ; Cortellini, Alessio ; Fulgenzi, Claudia Angela Maria ; Openshaw, Mark R ; Scheiner, Bernhard ; D'Alessio, Antonio
Background & Aims:
Direct comparisons across first-line regimens for advanced hepatocellular carcinoma are not available. We performed a network metanalysis of phase III of trials to compare first-line systemic treatments for hepatocellular carcinoma in terms of overall survival (OS), progression-free survival (PFS), objective response rate, disease control rate, and incidence of adverse events (AEs).
Methods:
After performing a literature review from January 2008 to September 2022, we screened 6,329 studies and reviewed 3,009 studies, leading to identification of 15 phase III trials for analysis. We extracted odds ratios for objective response rate and disease control rate, relative risks for AEs, and hazard ratios (HRs) with 95% CIs for OS and PFS, and used a frequentist network metanalysis, with fixed-effect multivariable meta-regression models to estimate the indirect pooled HRs, odds ratios, relative risks, and corresponding 95% CIs, considering sorafenib as reference.
Results:
Of 10,820 included patients, 10,444 received active treatment and 376 placebo. Sintilimab + IBI350, camrelizumab + rivoceranib, and atezolizumab + bevacizumab provided the greatest reduction in the risk of death compared with sorafenib, with HRs of 0.57 (95% CI 0.43-0.75), 0.62 (95% CI 0.49-0.79), and 0.66 (95% CI 0.52-0.84), respectively. Considering PFS, camrelizumab + rivoceranib and pembrolizumab + lenvatinib were associated with the greatest reduction in the risk of PFS events compared with sorafenib, with HRs of 0.52 (95% CI 0.41-0.65) and 0.52 (95% CI 0.35-0.77), respectively. Immune checkpoint inhibitor (ICI) monotherapies carried the lowest risk for all-grade and grade ≥3 AEs.
Conclusions:
The combinations of ICI + anti-vascular endothelial growth factor, and double ICIs lead to the greatest OS benefit compared with sorafenib, whereas ICI + kinase inhibitor regimens are associated with greater PFS benefit at the cost of higher toxicity rates.
Impact and Implications:
In the last few years, many different therapies have been studied for patients with primary liver cancer that cannot be treated with surgery. In these cases, anticancer drugs (alone or in combination) are given with the intent to keep the cancer at bay and, ultimately, to prolong survival. Among all the therapies that have been investigated, the combination of immunotherapy (drugs that boost the immune system against the cancer) and anti-angiogenic agents (drugs that act on tumoural vessels) has appeared the best to improve survival. Similarly, the combination of two types of immunotherapies that activate the immune system at different levels has also shown positive results.
Systematic Review Registration:
PROSPERO CRD42022366330.
40
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100 项与 替古索司他 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 高尿酸血症 | 临床3期 | 美国 | 2022-10-25 | |
| 原发性痛风 | 临床3期 | 美国 | 2022-10-25 | |
| 痛风 | 临床2期 | 中国 | 2024-06-04 | |
| 痛风性关节炎 | 临床1期 | 中国 | 2024-03-05 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 143 | 構淵積網淵壓願鏇簾鹹(淵選鹽糧餘構遞繭衊餘) = 餘夢壓糧衊廠襯製醖憲 範糧遞餘蓋鹽簾憲襯選 (範範襯製觸壓網繭淵築 ) | 积极 | 2023-01-17 | |||
構淵積網淵壓願鏇簾鹹(淵選鹽糧餘構遞繭衊餘) = 鹹壓糧網遞廠繭蓋壓願 範糧遞餘蓋鹽簾憲襯選 (範範襯製觸壓網繭淵築 ) | |||||||
临床2期 | 156 | LC350189 50 mg | 鏇簾獵夢範築積鏇積醖(繭餘構築夢構淵鬱鬱壓) = 蓋廠窪憲醖淵鹽築範鬱 醖蓋窪鏇顧廠願膚觸膚 (夢醖鹹獵艱餘淵夢膚壓 ) 更多 | 积极 | 2021-07-01 | ||
LC350189 100 mg | 鏇簾獵夢範築積鏇積醖(繭餘構築夢構淵鬱鬱壓) = 積憲淵鹽淵襯糧鹽壓網 醖蓋窪鏇顧廠願膚觸膚 (夢醖鹹獵艱餘淵夢膚壓 ) 更多 |
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