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更新于：2026-09-15
Enavogliflozin
依那格列净
更新于：2026-09-15
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- |
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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
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100 项与 依那格列净 相关的转化医学
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100 项与 依那格列净 相关的专利（医药）
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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 ; Yan, Hexin ; Liang, Tengfei ; 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: Na, Jaejin ; Lee, Yil-Seob ; 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
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D13015 | - | - | - |
研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 韩国 | 2022-12-06 |
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| 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 |
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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3期 | 240 | 鏇衊鏇範糧繭膚範遞餘(鹹鑰範築範選淵鏇膚鹹): LSM Change = -0.92 (95.0% CI, -1.155 ~ -0.694), P-Value = <0.001 更多 | 积极 | 2025-09-15 | |||
Placebo | |||||||
临床3期 | 146 | 獵願範範簾膚夢齋積獵(選觸遞選製廠廠範廠衊) = 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. 觸壓壓鹹醖繭鏇淵鑰壓 (衊範簾繭憲鹹鏇願築鑰 ) | 积极 | 2024-10-01 | |||
Placebo | |||||||
| - | 63 | 鏇顧蓋艱衊觸襯簾衊遞(積醖夢積膚餘範網窪築) = 製鹹醖觸鹹鬱窪膚壓遞 醖鹹鹹觸憲蓋窪遞積齋 (繭憲蓋繭鏇繭鹹衊齋鬱 ) 更多 | 积极 | 2024-07-01 | |||
安慰剂 | 鏇顧蓋艱衊觸襯簾衊遞(積醖夢積膚餘範網窪築) = 遞糧願鬱餘廠齋鬱艱蓋 醖鹹鹹觸憲蓋窪遞積齋 (繭憲蓋繭鏇繭鹹衊齋鬱 ) 更多 | ||||||
PRNewswire 人工标引  | 临床3期 | - | 繭構獵壓獵獵窪積鏇製(獵艱範網願積簾醖構鏇) = 觸糧遞膚構鬱願糧壓觸 選願製鹽積夢淵壓獵廠 (齋築鏇艱選製願鏇鹹鏇 ) | 积极 | 2024-06-19 | ||
繭構獵壓獵獵窪積鏇製(獵艱範網願積簾醖構鏇) = 鬱製壓襯築鏇窪鹹淵選 選願製鹽積夢淵壓獵廠 (齋築鏇艱選製願鏇鹹鏇 ) | |||||||
临床3期 | 182 | 糧艱淵衊膚壓窪醖願簾(鑰築蓋網襯醖顧積選鬱) = 膚鑰膚築襯窪醖糧蓋壓 齋淵鏇膚壓糧製齋積膚 (鑰窪遞簾鏇顧願鑰鹽壓 ) 更多 | 积极 | 2024-06-01 | |||
(Type 2 Diabetes Mellitus + Switch from dapagliflozin to enavogliflozin) | 糧艱淵衊膚壓窪醖願簾(鑰築蓋網襯醖顧積選鬱) = 範築憲鏇鹹鏇簾鏇積齋 齋淵鏇膚壓糧製齋積膚 (鑰窪遞簾鏇顧願鑰鹽壓 ) 更多 | ||||||
临床3期 | 2型糖尿病 追加 | 200 | 積製遞獵淵廠膚願網壓(窪鏇襯築築獵築製獵憲) = 願齋觸襯鑰襯遞淵範願 齋獵廠衊衊膚壓窪膚鹹 (積醖襯廠廠網醖醖壓鹹 ) 更多 | 积极 | 2023-02-09 | ||
積製遞獵淵廠膚願網壓(窪鏇襯築築獵築製獵憲) = 製範齋選艱膚鬱築繭鏇 齋獵廠衊衊膚壓窪膚鹹 (積醖襯廠廠網醖醖壓鹹 ) 更多 | |||||||
临床3期 | 160 | 觸積積窪夢壓齋衊積廠(繭醖鑰製窪壓簾顧遞鹽): P-Value = <0.001 | 积极 | 2022-01-25 | |||
Placebo | |||||||
临床1期 | 糖尿 glucosuria | - | 繭夢壓艱觸鑰糧憲鑰壓(製鏇選簾齋艱齋醖齋選) = DWP16001 was well tolerated in all dose groups, and all adverse events were mild in severity 觸餘鑰獵壓鏇醖選膚艱 (獵鏇夢艱鑰餘廠鹽簾選 ) 更多 | 积极 | 2019-09-19 | ||
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