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

开始日期2026-01-05

申办/合作机构-

NCT07240844

/ Not yet recruiting临床4期IIT

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial

This study aims to evaluate the safety and effectiveness of Enavogliflozin 0.3 mg, an SGLT2 inhibitor, in patients with amyloid cardiomyopathy. Participants will take both the study drug and a placebo in two separate periods, with a wash-out period in between. The goal is to determine whether Enavogliflozin is safe and effective for treating amyloid cardiomyopathy.

开始日期2025-11-24

申办/合作机构

Seoul St. Mary's Hospital

[+1]

NCT07213310

/ Completed临床1期

A Phase 1, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 on the Pharmacokinetics of DWP16001 and Its Metabolite in Healthy Adult Subjects

Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults

开始日期2025-11-09

申办/合作机构

Daewoong Pharmaceutical Co., Ltd.

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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项与依那格列净相关的文献（医药）

2025-12-01·BIOMEDICINE & PHARMACOTHERAPY

Physiologically-based pharmacokinetic modeling of enavogliflozin ophthalmic solution for starting dose selection in diabetic retinopathy treatment

Article

作者: Kim, Ju Hee ; Kang, Dong Wook ; Choi, Go-Wun ; Cho, Seok-Jin ; Cho, Hea-Young

The ophthalmic solution of enavogliflozin has been developed to treat diabetic retinopathy by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the eyes. This study aimed to develop a physiologically based pharmacokinetic (PBPK) model for predicting enavogliflozin exposures in the retina and to determine starting doses in first-in-human clinical trials of the ophthalmic enavogliflozin. Pharmacokinetic (PK) profiles for enavogliflozin in eleven tissues, including four eye segments, were obtained in rats to evaluate tissue distribution and estimate tissue-to-plasma partition coefficients. The rat PBPK model was established by the partition coefficients, physiological, and biochemical parameters, and validated using measured PK data in all tissues. Then, the human PBPK model was developed by substituting or extrapolating rat parameters with human ones for FIH dose selection. The estimated half-life (t_1/2) and time to reach peak concentration (T_max) of ophthalmic enavogliflozin ranged from 3.55 to 9.00 and 0.5-2.0 hr in all tissues except kidney (t_1/2 = ∼36 hr; T_max = 8 hr) in rats. The order of tissue exposures after administration was: Kidney > Choroid > Cornea > GI tract > Vitreous humor > Plasma > Retina > Lung > Liver > Heart > Brain. Using the human model, the average retinal concentration of enavogliflozin was simulated and compared to the IC₅₀ value for SGLT2 inhibition. The optimized starting dose for once-daily dosing simulation was determined to range from 0.0092 to 0.0293 mg. These findings provide a scientific basis for further clinical studies of ophthalmic enavogliflozin as a noninvasive therapeutic formulation for diabetic retinopathy.

2025-11-01·Diabetes & Metabolism Journal

Anti-Senescence Effect of Inhibiting Sodium-Glucose Cotransporter 2 and α-Glucosidase in a Type 2 Diabetes Mellitus Animal Model

Article

作者: Lee, Hyunsuk ; Cho, Young Min ; Kong, Byung Soo ; Hong, Serin

Background: The prevalence of type 2 diabetes mellitus (T2DM) increases with age, and cellular senescence of pancreatic β-cells plays a key role in T2DM pathogenesis. As canagliflozin and acarbose have been shown to increase lifespan in mice, we investigated the effect of sodium-glucose cotransporter 2 (SGLT2) inhibitor, α-glucosidase inhibitor or both on the cellular senescence of β-cells in a T2DM mouse model.Methods: Enavogliflozin (0.3 mg/kg), acarbose (10 mg/kg), or vehicle was orally administered daily to db/db mice for 6 weeks. The levels of senescence markers (p16, p21, and p53) in the pancreas and kidney were measured through real-time polymerase chain reaction (PCR), immunofluorescence staining, and Western blot. In an in vitro analysis, isolated pancreatic islets were exposed to H₂O₂ to induce cellular senescence, then treated with β-hydroxybutyrate (β-HB), and subsequently assessed for levels of senescent markers.Results: Enavogliflozin alone or combined with acarbose effectively lowered blood glucose levels in db/db mice. The combined treatment resulted in the greatest increase in β-cell function calculated using insulinogenic index and homeostasis model assessment of β-cell function compared to the vehicle. Additionally, the combined treatment significantly reversed the increase in p16, with a similar trend observed in p21 and p53 in the islets. Treatment increased circulating β-HB and in vitro analysis suggested the activation of nuclear factor erythroid 2-related factor 2 (Nrf2) by β-HB in reducing senescence in the islets.Conclusion: The combined administration of enavogliflozin and acarbose significantly reduced blood glucose, improved β-cell function, and reduced senescent β-cells in db/db mice. This combination therapy holds potential as a senotherapeutic strategy for managing T2DM.

2025-10-01·CTS-Clinical and Translational Science

Pharmacokinetics and Safety of Fixed‐Dose Versus Separate Enavogliflozin/Gemigliptin Combinations, and Food Effect on Enavogliflozin in Healthy Korean Subjects

Article

作者: Park, Seo Yeong ; Cho, Jae Min ; Choi, Young‐Sim ; Hwang, Jun Gi ; NA, JAEJIN ; Jeong, Yoonhye

ABSTRACT:

Envlo (enavogliflozin) 0.3 mg, an SGLT2 inhibitor, was approved in Korea in 2022 for glycemic control in type 2 diabetes (T2DM). This study evaluates its safety, pharmacokinetics, and food effects. Healthy subjects (age ≥ 19, weight ≥ 50.0 kg, body mass index (BMI) 18.0–30.0 kg/m 2 ) were enrolled. Study I was a randomized, two‐way crossover study with an 8‐day washout, where subjects received either a separate or a fixed‐dose combination (FDC) of enavogliflozin 0.3 mg/gemigliptin 50 mg. Study II, a randomized, open‐label, two‐way crossover design with a 7‐day washout, compared the food effect of a single dose of enavogliflozin in fed versus fasted after a high‐fat meal. In study I, enavogliflozin reached peak plasma concentration at 1.25 h (median) in both groups. The mean half‐life ( t1/2 ) was also comparable, recorded as 12.56 ± 4.04 h for the separate combination and 12.23 ± 3.46 h for the FDC. Gemigliptin peaked at 2.00 h in the separate combination and at 3.00 h in the FDC. The mean t1/2 was 18.04 ± 1.75 h for the separate combination and 18.67 ± 2.54 h for the FDC. In study II, the plasma concentration of enavogliflozin 0.3 mg peaked at 1.25 and 2.00 h (median), indicating a delayed Tmax in the fed group. The average t1/2 was similar at 12.49 ± 2.12 h and 12.30 ± 2.81 h, respectively. The FDC of enavogliflozin and gemigliptin demonstrated pharmacokinetic equivalence and comparable safety to their co‐administration as separate agents. Furthermore, the systemic exposure of enavogliflozin was not affected by food intake, supporting its potential for flexible, meal‐independent use in clinical settings.

项与依那格列净相关的新闻（医药）

2026-01-29

·新药信息合集

新药合集—12月全球新药汇总

12月全球获批新药清单全球共有131款新药（含新适应症）获批上市，中国（包括中国内地及中国香港）约有45种，是本月新药获批最多的地区。美国约有36种，是全球创新药上市的核心市场。日本约有24种。欧洲药品管理局约有9种。其他地区（如加拿大、韩国、马来西亚等）共约有17种。 •肿瘤领域：肿瘤学是绝对主导领域，涵盖了多种血液肿瘤和实体瘤，如治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的新药匹妥布替尼、治疗非小细胞肺癌的新药兰泽替尼、治疗多发性骨髓瘤的新药玛贝兰妥单抗、治疗肝细胞癌的新药安罗替尼、治疗乳腺癌（HR阳性/HER2阴性）的新药Imlunestrant等。 •其他重要领域： ⭐免疫系统疾病：治疗重症肌无力的新药尼卡利单抗、治疗狼疮肾炎的新药阿尼鲁单抗皮下注射剂、治疗斑块状银屑病的新药古塞奇尤单抗、治疗遗传性血管性水肿的新药贝罗曲司他口服颗粒等。 ⭐心血管疾病：治疗高血压的新药司妥吉仑、治疗梗阻性肥厚型心肌病的新药阿夫凯泰等。 ⭐代谢性疾病：治疗肥胖的新药玛仕度肽、治疗2型糖尿病的新药依那格列净、治疗苯丙酮尿症的新药墨蝶蛉等。 •改良型新药趋势明显：皮下注射剂型（如治疗肌层浸润性膀胱癌的新药帕博利珠单抗、治疗非小细胞肺癌的新药埃万妥单抗的皮下制剂）成为改善患者用药体验的重要方向。 12月全球提交申请新药清单 74款药物提交上市申请，中国提交36款，美国约有22款，欧洲药品管理局约有7款，日本约有7款，其他地区（如韩国、马来西亚等）共约有2种。 •肿瘤领域：同样以肿瘤为主，但出现了更多针对特定人群或难治性适应症的申请，如治疗胆道癌的新药替恩戈替尼、治疗肝内胆管癌的新药凡瑞格拉替尼、治疗三阴性乳腺癌的新药德达博妥单抗（ADC药物）、治疗系统性肥大细胞增生症的新药Bezuclastinib等。 •其他重要领域： ⭐免疫系统疾病：治疗斑秃的新药乌帕替尼、治疗斑块状银屑病的新药偌考奇拜单抗、治疗泛发性脓疱型银屑病的新药Imsidolimab、治疗重症肌无力的新药伊奈利珠单抗、治疗慢性自发性荨麻疹的新药度普利尤单抗等。 ⭐代谢性疾病：治疗肥胖的新药Orforglipron、治疗2型糖尿病的新药依那格列净、治疗Menkes综合征的新药组氨酸铜。 ⭐心血管疾病：治疗高血压的新药Baxdrostat、治疗急性缺血性卒中的新药洛贝米柳。 •代谢性疾病竞争激烈：礼来的Orforglipron、诺和诺德的CagriSema（复方制剂）等针对肥胖的药物提交申请。 12月首次进入 Ⅲ 期临床的新药清单 26款药物进入III期临床，中国内地约18种，占据绝对主导地位，美国约有7种，其它有1种。 •肿瘤领域：治疗去势抵抗性前列腺癌的新药镥[177Lu]-HRS-4357（放射性核素偶联药物RDC）、治疗胆道癌的新药Nanvuranlat、治疗多发性骨髓瘤的新药Ramantamig（双特异性/三特异性抗体）。 •其他重要领域： ⭐代谢性疾病：治疗肥胖（多肽药物）的新药MET-097i、治疗慢性肾脏病的新药PDLYT7、治疗慢性阻塞性肺疾病的改良新药福莫特罗+格隆溴铵-JW2202。 ⭐眼科疾病：治疗湿性年龄相关性黄斑变性的新药LX102(朗信启昇)（基因治疗）。 12月研发进度终止新药 4款药物终止研发，其中有 3 款新药研发终止，1 款新药适应症研发终止。终止阶段：终止项目涉及临床III期、II期和I期。终止原因：用于治疗急性肾损伤的新药RMC-035和用于治疗慢性鼻窦炎的新药Brensocatib因疗效未达预期而终止。即使是进入后期临床的项目也可能因各种原因失败，体现了药物研发的不确定性。 •终止的适应症包括：无鼻息肉的慢性鼻窦炎。 END

2025-06-11

·PipelineReview

Salipro Biotech and Daewoong Pharmaceutical Announce Collaboration Agreement to Advance Development of Novel Therapeutics

– The collaboration combines Salipro Biotech’s unique expertise and its Salipro® platform technology to stabilize a challenging drug target and advance Daewoong Pharmaceutical’s drug discovery programs for the generation of small molecule drugs. SEOUL, South Korea I June 11, 2025 I Swedish biotech company Salipro Biotech AB today announced that it has entered into a research collaboration with Daewoong Pharmaceutical Co., Ltd. Daewoong Pharmaceutical gains access to Salipro Biotech’s expertise and Salipro® platform for stabilizing challenging membrane proteins (e.g., GPCRs, ion channels, transporters). The collaboration will target a specific membrane protein to aid Daewoong’s development of novel small molecule drugs. Under the terms of this agreement, the collaboration will enable Daewoong Pharma to leverage Salipro Biotech´s expertise and proprietary platform to advance their drug discovery efforts in the development of novel therapeutic small molecules against a challenging membrane protein drug target. “We are excited to join forces with Daewoong Pharmaceutical and contribute with our proprietary Salipro® platform to accelerate the development of novel therapeutic drugs for Daewoong Pharmaceutical’s pipeline”, said Jens Frauenfeld, CEO of Salipro Biotech. “This partnership is particularly significant as it marks our first collaboration with a partner in South Korea, underscoring the global application and versatility of our expertise and platform to make the undruggable druggable.” Seongsoo Park, CEO at Daewoong Pharmaceutical stated, “Collaborating with Salipro Biotech and accessing their Salipro® platform aligns with our goal to address complex drug targets. Salipro’s expertise in membrane protein stabilization will benefit our research for novel small molecule therapeutics, and we look forward to the results of our joint efforts.” About Salipro Biotech AB Salipro Biotech AB is a privately held biotech company focused on unlocking challenging drug targets for the development of next-generation therapeutics. The company is headquartered in Stockholm, Sweden with a fully owned IP portfolio that covers the Salipro® platform technology for the stabilization of membrane proteins. The majority of drug targets are so-called membrane proteins; however, these targets are inherently unstable and challenging to investigate. The proprietary Salipro® technology stabilizes membrane proteins in their native forms, enabling them to be employed in drug discovery programs for therapeutic antibodies, small molecule drugs and structure-based drug design. To date, Salipro Biotech has signed multiple research collaborations with top-tier pharma and biotech companies. Through in-house and partnered pipelines, Salipro Biotech AB accelerates the discovery of novel drugs. About Daewoong Pharmaceutical Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company’s diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities. Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. SOURCE: Daewoong Pharmaceutical Co.

孤儿药快速通道

2025-06-11

·PRNewswire

Salipro Biotech and Daewoong Pharmaceutical Announce Collaboration Agreement to Advance Development of Novel Therapeutics

- The collaboration combines Salipro Biotech's unique expertise and its Salipro® platform technology to stabilize a challenging drug target and advance Daewoong Pharmaceutical's drug discovery programs for the generation of small molecule drugs. SEOUL, South Korea, June 11, 2025 /PRNewswire/ -- Swedish biotech company Salipro Biotech AB today announced that it has entered into a research collaboration with Daewoong Pharmaceutical Co., Ltd. Daewoong Pharmaceutical gains access to Salipro Biotech's expertise and Salipro® platform for stabilizing challenging membrane proteins (e.g., GPCRs, ion channels, transporters). The collaboration will target a specific membrane protein to aid Daewoong's development of novel small molecule drugs. Continue Reading Salipro Biotech and Daewoong Pharmaceutical Announce Collaboration Agreement to Advance Development of Novel Therapeutics Under the terms of this agreement, the collaboration will enable Daewoong Pharma to leverage Salipro Biotech´s expertise and proprietary platform to advance their drug discovery efforts in the development of novel therapeutic small molecules against a challenging membrane protein drug target. "We are excited to join forces with Daewoong Pharmaceutical and contribute with our proprietary Salipro® platform to accelerate the development of novel therapeutic drugs for Daewoong Pharmaceutical's pipeline", said Jens Frauenfeld, CEO of Salipro Biotech. "This partnership is particularly significant as it marks our first collaboration with a partner in South Korea, underscoring the global application and versatility of our expertise and platform to make the undruggable druggable." Seongsoo Park, CEO at Daewoong Pharmaceutical stated, "Collaborating with Salipro Biotech and accessing their Salipro® platform aligns with our goal to address complex drug targets. Salipro's expertise in membrane protein stabilization will benefit our research for novel small molecule therapeutics, and we look forward to the results of our joint efforts." About Salipro Biotech AB Salipro Biotech AB is a privately held biotech company focused on unlocking challenging drug targets for the development of next-generation therapeutics. The company is headquartered in Stockholm, Sweden with a fully owned IP portfolio that covers the Salipro® platform technology for the stabilization of membrane proteins. The majority of drug targets are so-called membrane proteins; however, these targets are inherently unstable and challenging to investigate. The proprietary Salipro® technology stabilizes membrane proteins in their native forms, enabling them to be employed in drug discovery programs for therapeutic antibodies, small molecule drugs and structure-based drug design. To date, Salipro Biotech has signed multiple research collaborations with top-tier pharma and biotech companies. Through in-house and partnered pipelines, Salipro Biotech AB accelerates the discovery of novel drugs. About Daewoong Pharmaceutical Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company's diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities. Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. SOURCE Daewoong Pharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

孤儿药快速通道

100 项与依那格列净相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	韩国	Daewoong Pharmaceutical Co., Ltd.	2022-12-06

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10 条进展最快的记录,

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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	Daewoong Pharmaceutical Co., Ltd.	2024-09-23
射血分数保留型心力衰竭	临床3期	韩国	Daewoong Pharmaceutical Co., Ltd.	2023-10-25
三尖瓣闭锁不全	临床3期	韩国	Daewoong Pharmaceutical Co., Ltd.	2023-10-25
糖尿病性视网膜病变	临床申请批准	韩国	Daewoong Pharmaceutical Co., Ltd.	2023-09-14
黄斑水肿	临床申请批准	韩国	Daewoong Pharmaceutical Co., Ltd.	2023-09-14
糖尿病	临床前	韩国	GC Biopharma Corp.	2022-01-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05376930 (Pubmed)	-	2型糖尿病	63	enavogliflozin	艱艱鹹鏇願獵廠觸構顧(餘餘蓋壓夢膚齋蓋齋膚) = 範壓鏇夢繭構選鏇範餘積鹹廠選觸鬱壓夢獵艱 (夢鏇齋鹽醖窪廠鑰獵壓 ) 更多	积极	2024-07-01
				安慰剂	艱艱鹹鏇願獵廠觸構顧(餘餘蓋壓夢膚齋蓋齋膚) = 鑰築網範淵蓋選夢選襯積鹹廠選觸鬱壓夢獵艱 (夢鏇齋鹽醖窪廠鑰獵壓 ) 更多
PRNewswire 人工标引	临床3期	2型糖尿病	-	Enavogliflozin	餘餘願製夢選壓糧襯鹹(獵壓製選艱顧憲積顧蓋) = 獵築糧鹹製顧壓鑰築顧網遞壓顧夢夢壓鹽鹹艱 (廠衊憲壓鑰鑰積鹹襯願 )	积极	2024-06-19
				dapagliflozin	餘餘願製夢選壓糧襯鹹(獵壓製選艱顧憲積顧蓋) = 蓋願廠齋憲構憲窪觸餘網遞壓顧夢夢壓鹽鹹艱 (廠衊憲壓鑰鑰積鹹襯願 )
NCT04634500 (Pubmed)	临床3期	2型糖尿病追加	200	Enavogliflozin 0.3 mg/day	醖觸鹹艱繭糧範選糧淵(範遞構積鹽糧顧窪觸鹽) = 壓鑰膚壓網製鹹鑰顧鬱積積積鹽鹽願構顧觸齋 (觸窪繭構構積願觸鏇網 ) 更多	积极	2023-02-09
				Dapagliflozin 10 mg/day	醖觸鹹艱繭糧範選糧淵(範遞構積鹽糧顧窪觸鹽) = 餘淵鹽鹹鏇願廠製鑰積積積積鹽鹽願構顧觸齋 (觸窪繭構構積願觸鏇網 ) 更多
NCT04632862 (ENHANCE-A, Biospace) 人工标引	临床3期	2型糖尿病	160	Enavogliflozin	壓選繭廠蓋簾淵壓膚簾(衊鏇築觸繭齋網構憲艱): P-Value = <0.001	积极	2022-01-25
				Placebo
NCT03364985 (DWP16001, EASD2019)	临床1期	糖尿 glucosuria	-	DWP16001 0.2 mg	膚願繭積範壓鬱窪顧觸(襯鑰鏇構範顧簾獵繭鹹) = DWP16001 was well tolerated in all dose groups, and all adverse events were mild in severity 壓鬱獵遞網遞積壓範築 (製鹹夢鏇範網廠淵艱積 ) 更多	积极	2019-09-19
				DWP16001 0.5 mg