预约演示
更新于：2026-08-30
Enavogliflozin
依那格列净
更新于：2026-08-30
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 韩国 (2022-12-06), |
最高研发阶段(中国)申请上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C24H27ClO6 |
InChIKeyKORCWPOBTZTAFI-YVTYUBGGSA-N |
CAS号1415472-28-4 |
关联
47
项与 依那格列净 相关的临床试验NCT07619833
A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus
NCT07240844
Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial
RBR-8ks2vwn
A phase I, single-center, double-blind, randomized, parallel, placebo-controlled clinical study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability after a single dose and multiple doses of 0.3 mg, 0.6 mg, and 1.2 mg Enavogliflozin in healthy adult participants of both sexes - SYN 374.002.24 / AC2025-PK/PD-105-1 - ENVLO - ENVLO ENaVoglifLOzin – Brazil
100 项与 依那格列净 相关的临床结果
登录后查看更多信息
100 项与 依那格列净 相关的转化医学
登录后查看更多信息
100 项与 依那格列净 相关的专利（医药）
登录后查看更多信息
41
项与 依那格列净 相关的文献（医药）2026-11-01NEUROPHARMACOLOGY
Enavogliflozin alleviates motor deficits in rotenone-induced Parkinson's disease mice via attenuation of oxidative stress and neuroinflammation as well as activation of the SIRT1/PINK1/Parkin pathway
Article
作者: Wang, Lixia ; Pang, Xiaoyan ; Sun, Siyu ; Liang, Tengfei ; Yan, Hexin ; Liu, Qiaoqiao
Parkinson's disease is an age-related neurodegenerative disorder characterized by the progressive degeneration of nigrostriatal dopaminergic neurons. Enavogliflozin, a novel sodium-glucose cotransporter 2 (SGLT2) inhibitor, has recently been demonstrated to exert neuroprotective effects. However, whether enavogliflozin can ameliorate motor behavioral deficits in Parkinson's disease currently remains unclear. To this end, this study aimed to investigate the neuroprotective effects of enavogliflozin on Parkinson's disease and explore its underlying molecular mechanisms. We established a Parkinson's disease model using rotenone-induced C57BL/6 mice (1.5 mg/kg/d, 3 weeks, i.p.) to investigate the neuropharmacological modulation effects of enavogliflozin treatment (0.1 and 1 mg/kg/d, 3 weeks, p.o., 2 h after rotenone injection) on Parkinson's disease from the perspectives of motor behavioral evaluation, pathological changes, oxidative stress, neuroinflammation, and SIRT1/PINK1/Parkin signaling pathways in specific brain regions. The results revealed that enavogliflozin alleviated neuropathological alterations of the substantia nigra, upregulated tyrosine hydroxylase and dopamine transporter expression in nigrostriatal dopaminergic neurons, and improved motor behavioral deficits. Administration of enavogliflozin further significantly reduced the levels of inflammatory cytokines (IL-6 and TNF-α), microglial activation, and oxidative damage in rotenone-induced Parkinson's disease mice. Moreover, we found that enavogliflozin activated PINK1/Parkin-mediated mitophagy by SIRT1 signaling pathway. In conclusion, enavogliflozin ameliorates motor dysfunction in rotenone-induced Parkinson's disease mice by attenuating oxidative stress, inhibiting neuroinflammation, and activating SIRT1/PINK1/Parkin pathway. These findings support a neuroprotective and preventive role for enavogliflozin in Parkinson's disease.
2026-04-01NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
Pharmacokinetic comparison between fixed-dose combination and loose combination of enavogliflozin 0.3 mg and metformin HCl 1000 mg in healthy subjects under fasting and fed conditions
Article
作者: Lee, Yil-Seob ; Na, Jaejin ; Yang, A-Young ; Yoon, Seoyeon ; Cho, Jae Min ; Shin, Wonsuk ; Kim, Surim Meagan ; Kim, Anhye ; Yoo, Hyounggyoon
Enavogliflozin is a sodium‒glucose cotransporter 2 inhibitor that can be administered in combination with metformin in patients with type 2 diabetes mellitus. This study aimed to compare the pharmacokinetics (PKs) between the fixed-dose combination (FDC) and the corresponding loose combination of enavogliflozin 0.3 mg and metformin 1000 mg. A randomized, open-label, 2-sequence, 4-period crossover study with a single oral dose was conducted in healthy subjects. Subjects received either the FDC or the corresponding loose combination of enavogliflozin 0.3 mg and metformin hydrochloride (HCl) 1000 mg in fasting and fed states. Serial blood samples were collected up to 72 h post-dose. Forty-four subjects were enrolled, and 37 subjects completed the study. In the fasting state, the geometric mean ratios (GMRs) (90% confidential interval (CI)) of the maximum plasma concentration (Cmax) and the area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) of the FDC to those of the corresponding loose combination were 1.03 (0.97-1.10) and 1.08 (1.03-1.13), respectively. The GMRs (90% CI) of the metformin Cmax and AUClast of the FDC to those of the corresponding loose combination were 1.10 (1.01-1.19) and 1.05 (1.00-1.11), respectively. In a high-fat-fed state, the GMRs (90% CI) of the enavogliflozin Cmax and AUClast of the FDC to those of the corresponding loose combination were 0.88 (0.82-0.93) and 1.03 (0.98-1.09), respectively. The GMRs (90% CI) of the metformin Cmax and AUClast of the FDC to those of the corresponding loose combination were 1.01 (0.98-1.05) and 1.00 (0.97-1.04), respectively. All the results were within the conventional bioequivalence range (0.80-1.25). There were no deaths, serious adverse events in fasting high-fat-fed states. The FDC of enavogliflozin 0.3 mg and metformin HCl and the corresponding loose combination were pharmacokinetically equivalent without safety concerns in fasting and high-fat-fed states. The FDC can be an alternative option for combination therapy with enavogliflozin and metformin HCl with improved compliance.
2026-03-01NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
Evaluation of formulation on the pharmacokinetics, safety, and tolerability of enavogliflozin in healthy Korean adults
Article
作者: Lee, Soyoung ; Shin, Wonsuk ; Yoo, Hyounggyoon ; Kim, Anhye ; Nah, Jae Jin
Enavogliflozin is a recently developed novel sodium‒glucose cotransporter-2 inhibitor that is used to treat type 2 diabetes mellitus. During clinical development, a 0.3 mg daily dose regimen was effective at lowering the blood glucose level, whereas a 0.1 mg dose formulation was used in the early clinical phase. This study aimed to evaluate the pharmacokinetic (PK) properties of a low-strength formulation of 0.1 mg of enavogliflozin and two high-strength formulations of 0.3 mg of enavogliflozin. Two clinical trials designed as randomized, open-label, single-dose, two-way crossover studies were conducted in healthy Korean subjects. In Study A, the subjects received either three tablets of 0.1 mg enavogliflozin or one tablet of 0.3 mg enavogliflozin according to their assigned sequence. In Study B, the subjects received a single dose of 0.3 mg of enavogliflozin in one of two different formulations. Blood samples were collected for up to 72 h to assess the PK of enavogliflozin. The maximum concentration (Cmax) and area under the concentration‒time curve from 0 to the last measurable time (AUClast) were calculated to determine bioequivalence. Safety and tolerability were evaluated throughout the studies. In Study A, 42 subjects were enrolled, 38 of whom completed the study, whereas in Study B, 43 subjects were included, 37 of whom completed the study. The geometric mean ratio (GMR) (90% confidence interval, 90% CI) of 0.3 mg of enavogliflozin (Formulation A) to 0.1 mg of enavogliflozin for the Cmax and AUClast were 1.02 (0.98-1.07) and 0.99 (0.95-1.02), respectively. The GMRs (90% CIs) of 0.3 mg of enavogliflozin (Formulation B) to 0.3 mg of enavogliflozin (Formulation A) for the corresponding parameters were 0.96 (0.91-1.02) and 1.00 (0.95-1.04), respectively, which met the conventional bioequivalence criteria. The most common adverse events were headache and diarrhea in both studies. This study demonstrated that three tablets of 0.1 mg enavogliflozin had PK characteristics similar to those of one tablet of 0.3 mg enavogliflozin. Furthermore, the two high-strength formulations showed bioequivalence and were well tolerated.
36
项与 依那格列净 相关的新闻（医药）2026-07-12
抗体药物偶联物临床3期临床结果申请上市临床申请
2026-03-05
100 项与 依那格列净 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 韩国 | 2022-12-06 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 2型糖尿病肾脏病 | 临床3期 | 韩国 | 2024-09-23 | |
| 射血分数保留型心力衰竭 | 临床3期 | 韩国 | 2023-10-25 | |
| 三尖瓣闭锁不全 | 临床3期 | 韩国 | 2023-10-25 | |
| 糖尿病性视网膜病变 | 临床申请批准 | 韩国 | 2023-09-14 | |
| 黄斑水肿 | 临床申请批准 | 韩国 | 2023-09-14 | |
| 糖尿病 | 临床前 | 韩国 | 2022-01-15 |
登录后查看更多信息
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 | 146 | 構窪鹹膚壓網襯鑰憲齋(觸遞願範膚鑰衊網壓夢) = The proportions of participants reaching HbA1c 7.0% (53 mmol/mol) at Week 52 were 69.4% in the maintenance group and 65.4% in the switch group. 夢繭遞鏇齋憲範願廠鑰 (衊淵糧齋蓋願簾膚構蓋 ) | 积极 | 2024-10-01 | |||
Placebo | |||||||
| - | 63 | 糧壓範淵蓋窪膚鏇憲積(醖糧選鹹襯膚膚襯鹽膚) = 顧選觸醖壓鑰選憲醖獵 醖衊觸憲鬱壓蓋壓艱膚 (窪憲顧網繭繭淵鹽鏇鑰 ) 更多 | 积极 | 2024-07-01 | |||
安慰剂 | 糧壓範淵蓋窪膚鏇憲積(醖糧選鹹襯膚膚襯鹽膚) = 構醖衊醖鹹夢網願範淵 醖衊觸憲鬱壓蓋壓艱膚 (窪憲顧網繭繭淵鹽鏇鑰 ) 更多 | ||||||
PRNewswire 人工标引  | 临床3期 | - | 獵艱遞顧鏇憲壓鹽膚糧(膚窪鏇獵鬱壓簾壓網簾) = 鑰選網遞襯遞衊鏇選鹽 繭衊鬱衊鏇鑰艱願憲簾 (網壓艱衊襯醖鹽襯艱憲 ) | 积极 | 2024-06-19 | ||
獵艱遞顧鏇憲壓鹽膚糧(膚窪鏇獵鬱壓簾壓網簾) = 觸鹽膚積網襯膚鏇繭製 繭衊鬱衊鏇鑰艱願憲簾 (網壓艱衊襯醖鹽襯艱憲 ) | |||||||
临床3期 | 182 | 夢簾醖齋願築鬱築糧觸(願製積選廠壓範觸蓋顧) = 構鏇獵蓋齋淵鏇構遞醖 顧壓齋遞壓鹹製鏇窪醖 (窪壓觸窪衊艱範製願蓋 ) 更多 | 积极 | 2024-06-01 | |||
(Type 2 Diabetes Mellitus + Switch from dapagliflozin to enavogliflozin) | 夢簾醖齋願築鬱築糧觸(願製積選廠壓範觸蓋顧) = 糧鏇夢鹹顧願鏇鬱積襯 顧壓齋遞壓鹹製鏇窪醖 (窪壓觸窪衊艱範製願蓋 ) 更多 | ||||||
临床3期 | 2型糖尿病 追加 | 200 | 淵膚窪鏇廠齋選鬱簾襯(憲願憲夢壓鏇構鏇鑰衊) = 獵醖齋觸鹹顧範艱遞鏇 鑰襯選製膚範遞範鑰鹽 (範築襯構築衊醖鬱憲淵 ) 更多 | 积极 | 2023-02-09 | ||
淵膚窪鏇廠齋選鬱簾襯(憲願憲夢壓鏇構鏇鑰衊) = 積蓋範網製鏇獵築鏇窪 鑰襯選製膚範遞範鑰鹽 (範築襯構築衊醖鬱憲淵 ) 更多 | |||||||
临床3期 | 160 | 築構夢簾觸鹹淵鬱鑰糧(觸淵憲網壓簾夢餘願選): P-Value = <0.001 | 积极 | 2022-01-25 | |||
Placebo | |||||||
临床1期 | 糖尿 glucosuria | - | 遞鏇遞糧築網醖獵鏇膚(網艱願襯獵淵築窪築觸) = DWP16001 was well tolerated in all dose groups, and all adverse events were mild in severity 網鬱願選窪構夢鹹憲醖 (衊願齋積簾鏇餘鹽蓋窪 ) 更多 | 积极 | 2019-09-19 | ||
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用