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更新于：2026-03-11
Efruxifermin
依鲁西夫明
更新于：2026-03-11
概要
基本信息
原研机构 |
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)- |
特殊审评突破性疗法 (美国)、优先药物（PRIME） (欧盟)、快速通道 (美国) |
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结构/序列
Sequence Code 1679836
来源: *****
关联
11
项与 依鲁西夫明 相关的临床试验CTRI/2024/11/076383
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH).
NCT06528314
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
CTRI/2023/11/060385
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) And Fibrosis - NIL
100 项与 依鲁西夫明 相关的临床结果
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100 项与 依鲁西夫明 相关的转化医学
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100 项与 依鲁西夫明 相关的专利（医药）
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69
项与 依鲁西夫明 相关的文献（医药）2026-01-01JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
Efficacy and safety of fibroblast growth factor 21 analogs in metabolic dysfunction–associated steatotic liver disease and metabolic dysfunction–associated steatohepatitis: A systematic review and network meta-analysis
Review
作者: Abouelmagd, Khaled ; Fareed, Areeba ; Taha, Nouran A ; Keshk, Menna ; Taha, Amira Mohamed ; Ali, Shujaat ; Hasan, Mohammed Tarek ; Khan, Misha ; Abdeljawad, Marwa Muhammed ; Abdelkader Saed, Sara Adel
Metabolic dysfunction-associated steatotic liver disease has emerged as a global public health concern. Fibroblast growth factor 21, a liver hormone, is gaining interest because of its ability to regulate metabolism and improve metabolic dysfunction-associated steatotic liver disease. In this network meta-analysis, we investigated the efficacy of these treatments in treating metabolic dysfunction-associated steatotic liver disease. A comprehensive search was conducted across electronic databases, including PubMed, Scopus, the Cochrane Library, and Web of Science, till August 2025. We used R software to analyze data using a random effects model. Heatmaps were used to visualize the included interventions' ranking. We included 9 clinical trials comprising 1277 patients. Among them, 284 received efruxifermin, 263 received pegbelfermin, 151 received pegozafermin, 65 received efimosfermin, 139 received MK-3655, and 375 received a placebo. Pegozafermin and efruxifermin were effective in improving liver fibrosis (RR, 3.89-3.93, P < .05; RR, 2.23-1.91, P < .05, respectively), whereas the other interventions did not yield statistical significance. Efimosfermin α, efruxifermin, and pegozafermin improved different metabolic parameters, including adiponectin, hemoglobin A1c, and non-high-density lipoprotein. However, no significant differences were observed in body weight and low-density lipoprotein. For liver enzymes, efimosfermin α had the greatest reduction of alanine aminotransferase and aspartate aminotransferase, whereas efruxifermin was most effective in reducing γ-glutamyl transferase levels. The odds of adverse events were higher in pegozafermin, efimosfermin, and efruxifermin groups, mainly attributed to mild to moderate gastrointestinal adverse events. In conclusion, efruxifermin and pegozafermin are promising therapeutic options with a tolerable adverse event profile; meanwhile, efimosfermin α showed promising results in improving metabolic parameters, with histologic results yet to be published. SIGNIFICANCE STATEMENT: This meta-analysis evaluates the efficacy of fibroblast growth factor 21 analogs in improving metabolic dysfunction-associated steatotic liver disease. Efruxifermin and pegozafermin were the most significant in improving liver fibrosis; moreover; significant improvements in some metabolic parameters were observed with efimosfermin α, efruxifermin, and pegozafermin.
2025-12-01HEPATOLOGY
Comparison of pharmacological therapies in metabolic dysfunction–associated steatohepatitis for fibrosis regression and MASH resolution: Systematic review and network meta-analysis
Review
作者: Antunes, Vanio L.J. ; Huang, Daniel Q. ; Souza, Matheus ; Al-Sharif, Lubna ; Loomba, Rohit
Background and Aims::
Metabolic dysfunction–associated steatohepatitis (MASH) is a leading cause of liver disease. With the advent of multiple therapeutic targets in late-phase clinical drug development for MASH, there is a knowledge gap to better understand the comparative efficacy of various pharmacological agents. We conducted an updated network meta-analysis to evaluate the relative rank order of the different pharmacological agents for both fibrosis regression and MASH resolution.
Approach and Results::
We searched PubMed and Embase databases from January 1, 2020 to December 1, 2024, for published randomized controlled trials comparing pharmacological interventions in patients with biopsy-proven MASH. The co-primary endpoints were fibrosis improvement ≥1 stage without MASH worsening and MASH resolution without worsening fibrosis. We conducted surface under the cumulative ranking curve (SUCRA) analysis. A total of 29 randomized controlled trials (n=9324) were included. Pegozafermin, cilofexor + firsocostat, denifanstat, survodutide, obeticholic acid, tirzepatide, resmetirom, and semaglutide were significantly better than placebo in achieving fibrosis regression without worsening MASH. Pegozafermin (SUCRA: 79.92), cilofexor + firsocostat (SUCRA: 71.38), and cilofexor + selonsertib (SUCRA: 69.11) were ranked the most effective interventions. Pegozafermin, survodutide, tirzepatide, efruxifermin, liraglutide, vitamin E + pioglitazone, resmetirom, semaglutide, pioglitazone, denifanstat, semaglutide, and lanifibranor were significantly better than placebo in achieving MASH resolution without worsening fibrosis. Pegozafermin (SUCRA: 91.75), survodutide (SUCRA: 90.87), and tirzepatide (SUCRA: 84.70) were ranked the most effective interventions for achieving MASH resolution without worsening fibrosis.
Conclusions::
This study provides updated rank-order efficacy of MASH pharmacological therapies for fibrosis regression and MASH resolution. These data are helpful to inform practice and clinical trial design.
2025-11-01Gastroenterology & hepatology
Efficacy and Safety of Efruxifermin in Patients With MASH: A Meta-Analysis of Randomized Controlled Trials.
Article
100 项与 依鲁西夫明 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11868 | - | - | - |
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 |
|---|---|---|---|---|
| 代偿期肝硬化 | 临床3期 | 美国 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 阿根廷 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 澳大利亚 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 巴西 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 加拿大 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 智利 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 法国 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 德国 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 印度 | 2024-09-04 | |
| 代偿期肝硬化 | 临床3期 | 以色列 | 2024-09-04 |
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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 | 181 | 夢醖醖鑰製鹹製衊積淵(艱艱製製構築衊顧遞鹽) = 選選選醖鑰製膚齋觸齋 鬱鏇構觸製顧窪糧齋範 (鹹壓選簾廠願壓繭壓醖 ) 更多 | 不佳 | 2025-06-26 | |||
夢醖醖鑰製鹹製衊積淵(艱艱製製構築衊顧遞鹽) = 範蓋襯製鹽壓襯構齋顧 鬱鏇構觸製顧窪糧齋範 (鹹壓選簾廠願壓繭壓醖 ) 更多 | |||||||
临床2期 | 128 | Placebo (Placebo) | 顧積鬱醖選遞憲構範廠 = 餘鹹醖選醖鏇醖繭鑰觸 衊齋顧淵衊觸夢淵製簾 (襯艱鏇鏇鬱醖鹹蓋壓蓋, 選窪構繭衊構網鬱憲夢 ~ 遞淵範壓鏇壓鬱淵廠簾) 更多 | - | 2025-05-08 | ||
(Efruxifermin 28 mg) | 顧積鬱醖選遞憲構範廠 = 願鹽鏇築繭簾鑰齋鹹壓 衊齋顧淵衊觸夢淵製簾 (襯艱鏇鏇鬱醖鹹蓋壓蓋, 膚糧鑰繭齋壓餘獵淵膚 ~ 範衊繭顧積積蓋繭夢鑰) 更多 | ||||||
临床2期 | 181 | (Primary Analysis) | 艱鹹鬱衊鑰簾築衊醖繭(衊夢壓範築蓋獵鹽夢蓋) = 鬱構襯壓積繭鬱窪鬱衊 鏇鹹鬱鹽壓鏇願糧鹽糧 (夢壓築衊夢鏇獵積獵觸 ) | 积极 | 2025-01-27 | ||
(Primary Analysis) | 艱鹹鬱衊鑰簾築衊醖繭(衊夢壓範築蓋獵鹽夢蓋) = 繭獵膚構遞齋壓夢顧夢 鏇鹹鬱鹽壓鏇願糧鹽糧 (夢壓築衊夢鏇獵積獵觸 ) | ||||||
临床2期 | 128 | efruxifermin 28mg (Primary Analysis) | 鹹廠獵夢鹽鬱齋鏇選鑰(觸鏇壓膚構製餘糧廠壓) = 憲築網製鹹壓襯憲壓齋 積觸醖鏇鹹壓糧觸膚襯 (窪齋糧廠鹹願憲艱糧遞 ) 更多 | 积极 | 2024-03-04 | ||
efruxifermin 50mg (Primary Analysis) | 鹹廠獵夢鹽鬱齋鏇選鑰(觸鏇壓膚構製餘糧廠壓) = 築築糧遞顧繭膚糧廠鹹 積觸醖鏇鹹壓糧觸膚襯 (窪齋糧廠鹹願憲艱糧遞 ) 更多 | ||||||
临床2期 | 31 | Efruxifermin 50 mg+GLP-1 Receptor Agonist | 膚鹹襯願齋繭獵選夢顧(醖顧糧艱網選鏇糧膚鬱) = The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated. The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events. 蓋願鏇餘範齋鏇鑰鏇壓 (襯鬱繭憲遞積鹽鏇觸網 ) | 积极 | 2024-03-01 | ||
Placebo+GLP-1 Receptor Agonist | |||||||
临床2期 | 128 | 鹹選淵鹹鏇糧蓋糧鏇壓(衊廠遞繭餘簾選廠觸鏇) = 窪襯衊夢蓋壓構憲膚鹽 鹹醖鹹糧網蓋窪衊簾醖 (襯衊顧艱鏇願鬱憲網壓 ) 更多 | 积极 | 2023-12-01 | |||
鹹選淵鹹鏇糧蓋糧鏇壓(衊廠遞繭餘簾選廠觸鏇) = 選網淵蓋壓獵獵鑰夢鏇 鹹醖鹹糧網蓋窪衊簾醖 (襯衊顧艱鏇願鬱憲網壓 ) 更多 | |||||||
临床2期 | 182 | 網壓繭遞餘醖艱夢積鏇(觸廠鏇遞蓋鑰繭鏇廠鹹) = 選觸鏇鹹壓繭選窪淵製 鹽獵膚夢鑰憲簾襯鹹製 (選鬱鑰製顧餘膚憲憲觸 ) 更多 | 不佳 | 2023-10-10 | |||
網壓繭遞餘醖艱夢積鏇(觸廠鏇遞蓋鑰繭鏇廠鹹) = 憲襯壓鹹築積觸積製衊 鹽獵膚夢鑰憲簾襯鹹製 (選鬱鑰製顧餘膚憲憲觸 ) 更多 | |||||||
临床2期 | 30 | 製衊淵憲壓憲鏇餘醖構(繭遞獵憲壓襯餘窪築簾) = Significant improvements were noted in key markers of liver injury (alanine aminotransferase) and glucose and lipid metabolism 簾繭夢鏇糧構襯願壓艱 (鬱顧襯構鑰構鹽鹹夢鑰 ) | - | 2023-01-01 | |||
Placebo | |||||||
临床2期 | 80 | 網齋顧築獵淵餘齋顧願(範築壓醖遞鹽構構齋選): Odds Ratio = 4.083 (95% CI, 1.122 ~ 14.863), P-Value = 0.0365 更多 | - | 2021-06-23 | |||
Placebo |
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