预约演示
更新于：2026-06-15
Efimosfermin alfa
更新于：2026-06-15
概要
基本信息
药物类型 融合蛋白 |
别名 BOS 580、GSK-6519754、GSK6519754 + [2] |
靶点 |
作用方式 调节剂 |
作用机制 FGF21R modulators |
在研适应症 |
非在研适应症 |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床申请批准 |
特殊审评突破性疗法 (美国)、优先药物（PRIME） (欧盟) |
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结构/序列
Sequence Code 127087
来源: *****
关联
7
项与 Efimosfermin alfa 相关的临床试验NCT07358546
A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease
NCT07335198
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
NCT07221188
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
100 项与 Efimosfermin alfa 相关的临床结果
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100 项与 Efimosfermin alfa 相关的转化医学
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100 项与 Efimosfermin alfa 相关的专利（医药）
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6
项与 Efimosfermin alfa 相关的文献（医药）2026-06-01CURRENT PHARMACEUTICAL DESIGN
FGF21 Analogues and MASLD: A Summary of Preclinical and Clinical Data
Article
作者: Papalavrentios, Lavrentis ; Boutari, Chrysoula ; Sinakos, Emmanouil ; Triantafyllou, Achilleas ; Goulis, Ioannis
Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) is the most frequent chronic
liver disease, which is closely associated with metabolic syndrome and obesity. Although it has now reached
epidemic proportions, the treatment of this disease remains a challenge. Currently, there is only one drug
approved for metabolic dysfunction-associated steatohepatitis (MASH), and various pharmaceutical agents
have reached phase 3 of clinical trials and appear as potential drugs for the disease. Fibroblast Growth Factor
(FGF) 21 has been gaining increasing interest as a possible therapeutic target for MASLD. FGF21 analogues,
with an improved pharmacodynamic and pharmacokinetic profile, exert pleiotropic, favorable effects on liver
function and histology, as well as systemic metabolism. They also appear to be effective in alleviating hepatic
steatosis, steatohepatitis, and fibrosis in MASH. Among various others, efruxifermin, pegozafermin, pegbelfermin,
and BOS-580 are FGF-21 analogues that have resulted in significant improvements in liver fat, fibrosis,
and measures of liver function in the context of phase 2 clinical trials. This review summarizes the preclinical
and clinical data from FGF21 analogues for MASLD and MASH.
2026-02-01LANCET
Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial
Article
作者: Kowdley, Kris V ; Zhao, Jeff ; Odrljin, Tatjana ; Jeglinski, Brenda ; Bain, Gerard ; Loomba, Rohit ; Noureddin, Mazen ; Koziel, Margaret James
BACKGROUND:
The growing prevalence of metabolic dysfunction-associated steatohepatitis (MASH) underscores the unmet need for effective and safe liver-targeted therapies to prevent fibrosis and disease progression. The aim of this study was to evaluate the efficacy and safety of efimosfermin alfa (henceforth referred to as efimosfermin, formerly BOS-580), an FGF21 analogue taken once per month, in patients with MASH and moderate or advanced fibrosis.
METHODS:
This 24-week, randomised, double-blind, placebo-controlled, phase 2 trial evaluated the safety and efficacy of efimosfermin in participants aged 18-75 years with a BMI of at least 27 kg/m2 and MASH and F2 or F3 fibrosis present on a diagnostic liver biopsy done either during screening or within 6 months before the first day of dosing, and total activity Nonalcoholic Fatty Liver Disease Activity Score (NAS) of at least 4 with a minimum score of 1 point for all three NAS components (steatosis, hepatocyte ballooning, and lobular inflammation). The trial was conducted at 34 clinical research study sites in the USA. Participants were randomly assigned 1:1 to efimosfermin 300 mg or placebo administered by subcutaneous injection every 4 weeks (Q4W) over 24 weeks, stratified by MASH fibrosis stage (F2 vs F3 stage). Participants, investigators, and those assessing outcomes were masked to group assignment. The primary endpoint was safety and tolerability (ie, treatment-emergent adverse events, changes from baseline to week 24 in blood pressure and heart rate, and the incidence of grade 3 and grade 4 laboratory abnormalities at week 24), analysed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov (NCT04880031) and was completed on Sept 18, 2024.
FINDINGS:
Between May 4, 2023, and March 22, 2024, of 1171 participants screened, 84 participants were randomly assigned to efimosfermin 300 mg Q4W (n=43) or placebo (n=41); 44 (52%) were female and 40 (48%) were male. 48 (57%) had F2 fibrosis and 36 (43%) had F3 fibrosis; 65 had evaluable week-24 biopsy results. All 43 in the efimosfermin group and 40 of 41 participants in the placebo group received at least one dose. Adverse events were reported in 29 (67%) of 43 participants receiving efimosfermin and 22 (55%) of 40 receiving placebo. The majority of treatment-emergent adverse events were mild (24 [56%] of 43 in the efimosfermin group vs 15 [38%] of 40 in the placebo group) or moderate (18 [42%] vs 14 [35%]) in severity. Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. There were no clinically meaningful changes in vital signs between treatment and placebo groups, and no clinically significant grade 3 or higher laboratory abnormalities observed for either group. No deaths or adverse events greater than grade 3 were observed during the study.
INTERPRETATION:
In this phase 2 trial, treatment with efimosfermin once per month was generally well tolerated in participants with biopsy-confirmed MASH and F2 or F3 fibrosis. These results support the further development of efimosfermin for treatment of MASH-related fibrosis.
FUNDING:
Boston Pharmaceuticals and GSK.
2025-12-01Gastroenterology & hepatology
Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study.
Article
100 项与 Efimosfermin alfa 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 代谢功能障碍相关脂肪性肝炎 | 临床3期 | 美国 | 2025-10-24 | |
| 代偿期肝硬化 | 临床2期 | 美国 | 2025-04-09 | |
| 代谢功能障碍相关的脂肪肝病 | 临床1期 | 新西兰 | 2026-03-05 | |
| 肥胖 | 临床1期 | 美国 | 2018-02-26 | |
| 肝纤维化 | 临床申请批准 | 中国 | 2026-06-12 |
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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2期 | 84 | Efimosfermin 300 mg Q4W | 醖壓鬱醖簾製遞蓋齋醖(糧願糧憲衊鬱餘積夢齋) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. 窪鹽遞壓艱醖淵糧築齋 (夢壓醖醖糧築窪襯廠夢 ) | 积极 | 2026-02-01 | ||
Placebo | |||||||
临床2期 | 65 | 簾觸餘壓蓋壓鏇蓋構襯(範襯鏇觸鹽願構願壓網) = 顧鹹夢夢鏇窪窪網糧糧 獵鑰願觸築簾鹹鹽淵願 (繭夢積築憲鑰選憲鹹廠 ) 更多 | 积极 | 2025-08-01 | |||
(75 mg every 4 weeks) | 簾觸餘壓蓋壓鏇蓋構襯(範襯鏇觸鹽願構願壓網) = 願積壓窪鏇鹹淵鏇範糧 獵鑰願觸築簾鹹鹽淵願 (繭夢積築憲鑰選憲鹹廠 ) 更多 | ||||||
临床2期 | 84 | 築遞膚積齋襯襯窪餘築(夢顧鏇積憲壓鹹窪範積) = 積觸蓋鹽範遞齋襯淵製 觸糧範蓋襯餘鬱膚觸願 (蓋淵襯繭淵觸範積選淵 ) 更多 | 积极 | 2024-11-15 | |||
Placebo | 築遞膚積齋襯襯窪餘築(夢顧鏇積憲壓鹹窪範積) = 憲觸壓壓鑰鹽繭壓襯鏇 觸糧範蓋襯餘鬱膚觸願 (蓋淵襯繭淵觸範積選淵 ) 更多 | ||||||
临床2期 | - | 102 | 夢構蓋蓋蓋淵衊製餘壓(製淵簾鬱襯餘夢淵鏇鑰) = 膚顧廠艱製膚夢窪製選 積齋選網鬱築獵膚齋積 (繭壓遞製顧遞夢齋艱糧 ) | 积极 | 2024-01-04 | ||
Placebo | 夢構蓋蓋蓋淵衊製餘壓(製淵簾鬱襯餘夢淵鏇鑰) = 築顧鹹選築衊網襯艱範 積齋選網鬱築獵膚齋積 (繭壓遞製顧遞夢齋艱糧 ) | ||||||
临床2期 | 102 | overall | 壓觸鹹觸鏇淵鏇鑰艱襯(壓繭醖糧遞鑰積襯選觸) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. 膚廠衊鏇簾餘選製遞膚 (製繭廠範窪選鑰積鹹艱 ) 更多 | 积极 | 2023-11-10 | ||
(HbA1c≥6.5%) | |||||||
临床1期 | 64 | 蓋齋壓範築鏇鬱簾夢範(選構獵壓憲積遞糧網觸) = higher incidence of generally mild to moderate gastrointestinal adverse effects 餘膚鑰鑰觸夢糧獵壓壓 (淵製獵鑰製觸齋廠蓋選 ) | - | 2021-08-25 |
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