A Randomized, Double-Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, Enavogliflozin Compared to Placebo on Reducing Major Cardiovascular Events or Worsening Heart Failure in Patients with Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement (TAVR) and with Heart Failure with Preserved Ejection Fraction (HFpEF)

The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.

开始日期2024-12-28

申办/合作机构

Asan Medical Center

[+1]

NCT06647888 / Not yet recruitingN/A

A Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Enavogliflozin in Patients With Type II Diabetes Mellitus Accompanied by Hypertension or Dyslipidemia

This observational study is a non-interventional, multi-center, prospective observational study aimed at tracking the efficacy and safety of Envlo or Envlomet SR tablets for 24 weeks in patients with type 2 diabetes and hypertension or dyslipidemia who are currently taking or are scheduled to take Envlo or Envlomet SR tablets in an actual clinical setting.

开始日期2024-12-02

申办/合作机构

Daewoong Pharmaceutical Co., Ltd.

NCT06644404 / Not yet recruiting临床1期

A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults

This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults

开始日期2024-10-26

申办/合作机构

Daewoong Pharmaceutical Co., Ltd.

100 项与 Enavogliflozin 相关的临床结果

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100 项与 Enavogliflozin 相关的转化医学

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100 项与 Enavogliflozin 相关的专利（医药）

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项与 Enavogliflozin 相关的文献（医药）

2024-10-01·Diabetes, Obesity and Metabolism

Long‐term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52‐week extension of a Phase 3 randomized controlled trial

Article

作者: Kim, Kyung‐Soo ; Kim, Eun Sook ; Choi, Sung Hee ; Park, Kyong Soo ; Kim, Chong Hwa ; Won, Jong Chul ; Cho, Seung Ah ; Chun, SungWan ; Oh, Seungjoon ; Kim, Yong Hyun ; Kwak, Soo Heon ; Yu, Jae Myung ; Kim, Da Hye ; Han, Kyung Ah ; Yoo, Hye Jin

AbstractAimsTo evaluate the long‐term safety and efficacy of enavogliflozin monotherapy (0.3 mg/day) in individuals with type 2 diabetes mellitus (T2DM).Materials and MethodsFollowing a 24‐week randomized, double‐blind treatment period with enavogliflozin 0.3 mg/day (n = 77) or placebo (n = 69), consenting participants received enavogliflozin 0.3 mg/day for an additional 28 weeks during an open‐label extension (OLE) period. The safety and efficacy of enavogliflozin were assessed at Week 52.ResultsA total of 37 participants continued enavogliflozin (maintenance group), and 26 participants switched from placebo to enavogliflozin (switch group). No additional adverse drug reactions related to enavogliflozin were observed during the OLE period. At Week 52, glycated haemoglobin (HbA1c) and fasting plasma glucose were significantly lower than at the baseline, by 0.9% and 24.9 mg/dL, respectively, in the maintenance group (p < 0.0001 for both), and by 0.7% and 18.0 mg/dL, respectively, in the switch group (p < 0.0001 and p = 0.002). 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. A significant increase in urine glucose‐to‐creatinine ratio was observed at Week 52, by 84.9 g/g and 67.1 g/g in the maintenance and switch groups, respectively (p < 0.0001 for both). Body weight in both groups decreased significantly (p < 0.0001) from baseline to Week 52, by 3.5 kg and 3.8 kg in the maintenance and switch groups, respectively.ConclusionsEnavogliflozin 0.3 mg monotherapy provides long‐term glycaemic control in T2DM and is safe and well tolerated during a 52‐week treatment period.

2024-07-01·Diabetes, Obesity and Metabolism

The effect of renal function on the pharmacokinetics and pharmacodynamics of enavogliflozin, a potent and selective sodium‐glucose cotransporter‐2 inhibitor, in type 2 diabetes

Article

作者: Cho, Jae Min ; Huh, Wan ; Kim, Sejoong ; Lim, Soo ; Jeong, Sae Im ; Na, Jae Jin ; Park, Min‐Kyu ; Ban, Mu Seong ; Hwang, Jun‐Gi ; Chung, Jae‐Yong ; Kwon, Soon Kil ; Kim, Yoonjin

AbstractAimsTo explore the effect of renal function on the pharmacokinetic (PK) and pharmacodynamic (PD) profile and safety of enavogliflozin, a selective sodium‐glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes mellitus (T2DM).MethodsAn open‐label, two‐part clinical trial was conducted in T2DM patients, stratified by renal function: Group 1, normal renal function; Group 2, mild renal impairment (RI); Group 3, moderate RI; and Group 4, severe RI. In Part A, Groups 2 and 4 received enavogliflozin 0.5 mg once. In Part B, Groups 1 and 3 received enavogliflozin 0.5 mg once daily for 7 days. Serial blood and timed urine samples were collected to analyse the PK and PD characteristics of enavogliflozin. Pearson's correlation coefficients were calculated to assess the correlations between PK or PD parameters and creatinine clearance (CrCL).ResultsA total of 21 patients completed the study as planned. The area under the curve (AUC) for enavogliflozin was not significantly correlated with CrCL, although the maximum concentration slightly decreased as renal function decreased. By contrast, daily urinary glucose excretion (UGE) was positively correlated with CrCL after both single‐ (r = 0.7866, p < 0.0001) and multiple‐dose administration (r = 0.6606, p = 0.0438).ConclusionsSystemic exposure to oral enavogliflozin 0.5 mg was similar among the patients with T2DM regardless of their renal function levels. However, the glucosuric effect of enavogliflozin decreased with RI. Considering the UGE observed and approved therapeutic use of other SGLT2 inhibitors, the efficacy of enavogliflozin with regard to glycaemic control could be explored in patients with mild and moderate RI (estimated glomerular filtration rate ≥30 or ≥45 mL/min/1.73 m2) in a subsequent larger study.

2024-06-01·Diabetes, Obesity and Metabolism

A 52‐week efficacy and safety study of enavogliflozin versus dapagliflozin as an add‐on to metformin in patients with type 2 diabetes mellitus: ENHANCE‐M extension study

Article

作者: Son, Jang Won ; Na, JaeJin ; Hong, Eun-Gyoung ; Han, Kyung-Ah ; Huh, Wan ; Kim, Yonghyun ; Cho, Jae Min ; Yoon, Kun-Ho ; Jeong, In-Kyung ; Sohn, Tae Seo ; Lee, Byung-Wan ; In Cho, Seong ; Chon, Suk

AbstractAimTo evaluate the long‐term safety and efficacy of enavogliflozin 0.3 mg/day added to metformin in patients with type 2 diabetes mellitus.Materials and MethodsAfter 24 weeks of a randomized, double‐blind treatment period with enavogliflozin 0.3 mg/day (n = 101) or dapagliflozin 10 mg/day (n = 99) added to metformin, all patients received enavogliflozin 0.3 mg/day plus metformin for an additional 28 weeks during the open‐label extension period.ResultsEighty‐two patients continued enavogliflozin (maintenance group), and 77 were switched from dapagliflozin to enavogliflozin (switch group). All adverse drug reactions (ADR) were mild in severity. In the maintenance group, ADRs (cystitis and vaginal infection) were reported in two patients (2.44%) during 52 weeks. In the switch group, ADR (hypoglycaemia) was reported in one patient (1.30%) during a 28‐week open‐label extension period. At week 52, glycated haemoglobin and fasting plasma glucose were significantly lower than at the baseline, by 0.85% and 29.08 mg/dl, respectively, in the maintenance group (p < .0001 for both), and by 0.81% and 32.77 mg/dl, respectively, in the switch group (p < .0001 for both). At week 52, 68.92% of patients from the maintenance group and 64.29% from the switch group achieved glycated haemoglobin <7%. A significant increase in the urine glucose‐creatinine ratio was observed at week 52, by 58.81 g/g and 63.77 g/g in the maintenance and switch groups, respectively (p < .0001).ConclusionsEnavogliflozin added to metformin was tolerated well for up to 52 weeks and provided continual glycaemic control in type 2 diabetes mellitus, along with a significant increase in the urine glucose‐creatinine ratio.

项与 Enavogliflozin 相关的新闻（医药）

2024-10-10

·美通社

Daewoong Pharmaceutical在米兰发布"创新给药技术"

包括全球首款微针疗法以及每月使用一次的肥胖症疗法米兰 2024年10月11日 /美通社/ -- Daewoong Pharmaceutical（大熊制药）（联席首席执行官Seongsoo Park和Chang-jae Lee）于10月9日宣布，他们将在意大利米兰的全球最大制药与生物技术展"2024年世界制药原料展"(CPHI Worldwide 2024)上展示其尖端给药技术，包括全球首款微针疗法药物。此外，Daewoong还将继续扩大其创新新药Fexuprazan（非苏拉赞）和Enavogliflozin（依那格列净）的全球影响力。 Daewoong曾参展了2023年在巴塞罗那举办的CPHI，连续第二年展示了其创新药物开发的成果。在今年的米兰CPHI上，Daewoong的目标是通过扩大全球影响力和发布新的给药技术来实现其"一个产品，一万亿韩元"(One Product, One Trillion Won )的愿景。微针技术是Daewoong创新技术中的佼佼者，有望彻底改变给药系统。虽然传统的注射药物能可靠地将药物输送到体内，但它们往往伴随着疼痛，而且需要到医院就诊。相比之下，由微小针头组成的微针消除了人们对注射的恐惧，减少了去医院就诊的需要，大大改善了病人的依从性。尽管许多公司都在研究微针药物，但至今尚未有成功将其商业化的案例。迄今为止，可用的微针产品仅限于美容贴片。 Daewoong的子公司Daewoong Therapeutics开发了一种名为"CLOPAM ® "的创新微针平台，它通过空气动力学工艺和密封包装提高了药物的均匀性和稳定性。该平台克服了以往微针技术中存在的污染和药物不一致性问题。 CLOPAM ® 微针贴片面积为1平方厘米，内含约100根微针，一经皮肤穿透即溶解释放药物。CLOPAM ® 已获得六项国际专利申请和23项国内专利（其中五项已注册），被视为Daewoong未来的一项关键技术。此外，Daewoong Therapeutics最近还获得了韩国食品药品安全部(Ministry of Food and Drug Safety)的批准，可以进行人体生长激素微针贴片的一期临床试验，这也是韩国首例可溶解微针。该公司还在积极开发使用索马鲁肽(Semaglutide)治疗糖尿病和肥胖症的微针疗法，以及使用肉毒杆菌毒素治疗神经系统疾病的微针疗法。除了微针技术外，Daewoong还将展示用于治疗肥胖症的长效索马鲁肽注射剂。这种每月注射一次的注射剂可缓慢释放索马鲁肽，治疗剂量能维持30天。此方法弥补了当前市场的一大空白，因为现有的肥胖治疗方法往往需要每天或每周注射。Daewoong正在开发的微针贴片和每月一次的注射剂有望超越竞争对手，为患者提供一种痛苦更小、更为便捷的治疗方案。 Daewoong还将推出一款新型的、便于患者使用的结肠镜检查肠道准备药物(DWRX1010)。传统的结肠镜检查准备药物通常味道不佳，需要饮用大量水，或需要吞服大药丸，这不仅给患者带来不适，有时甚至让患者不愿接受检查。大熊制药新研发的小型片剂易于吞服，为准备接受结肠镜检查的患者提供了更为便捷的解决方案。 Daewoong全球业务中心负责人Doyoung Kim表示："这是我们第十年参加CPHI展会，如今市场不仅需要原材料和成品，还需要满足消费者需求的技术。随着每年的发展，Daewoong在全球的地位不断提升，尤其是在新药和技术推出方面。我们致力于通过创新的给药技术，培育畅销产品，在Fexuprazan和Enavogliflozin取得成功的基础上，进一步巩固我们在全球医疗市场的领先地位。"

微生物疗法临床1期

2024-10-09

·PRNewswire

Daewoong Pharmaceutical Unveils 'Innovative Drug Delivery Technologies' in Milan--From World's First Microneedle Therapy to Once-a-Month Obesity Treatment

MILAN, Oct. 9, 2024 /PRNewswire/ -- Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-jae Lee) announced on the 9th that they will present their cutting-edge drug delivery technologies, including the world's first microneedle-based drugs, at 'CPHI Worldwide 2024'—the world's largest pharmaceutical and biotech exhibition—held in Milan, Italy. In addition, Daewoong will continue to expand the global reach of its innovative new drugs, Fexuprazan and Enavogliflozin. Daewoong participated in CPHI in 2023, held in Barcelona, where it showcased its success in developing innovative drugs for the second consecutive year. At this year's CPHI in Milan, Daewoong aims to achieve its 'One Product, One Trillion Won' vision by expanding its global footprint and unveiling new drug delivery technologies. At the forefront of Daewoong's innovations is the microneedle technology, which is poised to revolutionize drug delivery systems. While traditional injectable drugs reliably deliver medication into the body, they often come with pain and require clinical visits. In contrast, microneedles—composed of tiny needles—eliminate the fear of injections and reduce the need for hospital visits, significantly improving patient-compliance. Though many companies have pursued microneedle-based drugs, none have successfully commercialized them. To date, available microneedle products are limited to cosmetic patches. Daewoong's subsidiary, Daewoong Therapeutics, has developed an innovative microneedle platform called 'CLOPAM ® ,' which enhances drug uniformity and stability through Aerodynamic crafting and Hermetic packaging. This platform overcomes the issues of contamination and drug inconsistency that have plagued previous microneedle technologies. The CLOPAM ® microneedle patch, measuring1 cm² and contains approximately 100 microneedles, dissolves upon skin penetration to release the medication. With recognition as a key future technology for Daewoong, CLOPAM ® has garnered six international patent applications (PCT) and 23 domestic patents (five registered). Additionally, Daewoong Therapeutics recently received approval from Korea's Ministry of Food and Drug Safety to conduct a Phase 1 clinical trial for a human growth hormone microneedle patch—the first case of a dissolvable microneedle in Korea. The company is also actively developing microneedle-based treatments for diabetes and obesity using Semaglutide, as well as a neurological treatment using its botulinum toxin. In addition to its microneedle technology, Daewoong will showcase its long-acting Semaglutide injection for obesity treatment. This once-monthly injectable slowly releases Semaglutide, maintaining therapeutic levels for 30 days. This approach addresses a significant gap in the market, where current obesity treatments often necessitate daily or weekly injections. Daewoong's microneedle patch and once-monthly injection, both under development, are poised to outpace competitors, offering patients a less painful and more convenient solution. Daewoong will also introduce a new patient-friendly colonoscopy bowel preparation (DWRX1010). Traditional preparations for colonoscopy often involve unpleasant tastes, large water intake, or swallowing large pills, causing discomfort for patients and sometimes deterring them from undergoing the procedure. Daewoong's newly developed mini tablet is easy to swallow, offering a more convenient solution for patients preparing for a colonoscopy. Doyoung Kim, head of Daewoong's global business center, commented, "This marks our 10th year participating in CPHI, and the market now demands not just raw materials and finished products but also technologies that meet consumer needs. With each year, Daewoong's global standing rises, especially with the launch of new drugs and technologies. We are committed to fostering blockbuster products through innovative drug delivery technologies, further solidifying our leadership in the global healthcare market alongside the success of Fexuprazan and Enavogliflozin." 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

临床1期上市批准

2024-06-19

·药明康德

约70%患者血糖有效降低！小分子疗法3期试验积极结果公布

▎药明康德内容团队编辑今日，大熊制药（Daewoong Pharmaceutical）公布其SGLT-2抑制剂enavogliflozin临床3期试验的汇总分析结果。分析显示，与活性对照药物相较，enavogliflozin可有效降低轻度肾功能不全患者的糖化血红蛋白（HbA1c）水平，这些患者在入组前血糖控制困难。详细数据将于今年的美国糖尿病协会（ADA）大会上公布。研究表明，与达格列净（dapagliflozin）相比，enavogliflozin具有更优的降血糖效果，可显著降低HbA1c水平。24周内，enavogliflozin使HbA1c降低0.94个百分点，而活性对照药物则为0.77个百分点。Enavogliflozin的其他益处包括降低空腹血糖水平、增加尿糖排泄量和改善胰岛素抵抗。 Enavogliflozin是一款SGLT-2小分子抑制剂，其可在0.3 mg的低剂量下就显著降低患者的HbA1c水平，目标血糖达成率（HbA1c<7%）高达约70%，且患者的心血管风险因素得到改善，该药物已在2022年于韩国批准。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Daewoong Presents Enavogliflozin's Phase 3 Pooled Analysis Results at 84th ADA Conference. Retrieved June 19, 2024 from https://www.prnewswire.com/news-releases/daewoong-presents-enavogliflozins-phase-3-pooled-analysis-results-at-84th-ada-conference-302176658.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床3期临床成功

100 项与 Enavogliflozin 相关的药物交易

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研发状态

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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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适应症	最高研发状态	国家/地区	公司	日期
慢性肾病	临床3期	韩国	Daewoong Pharmaceutical Co., Ltd.	2024-09-23
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
2型糖尿病	临床3期	中国	Daewoong Pharmaceutical Co., Ltd.	2022-08-31
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


PRNewswire 人工标引	临床3期	2型糖尿病	-	Enavogliflozin	(選願蓋糧願醖淵蓋網簾) = 鑰膚網鬱膚艱鏇壓醖衊選廠齋鹽獵遞願齋膚鑰 (蓋鹹構獵網簾餘選壓艱 )	积极	2024-06-19
				dapagliflozin	(選願蓋糧願醖淵蓋網簾) = 範憲憲顧餘鑰衊積製構選廠齋鹽獵遞願齋膚鑰 (蓋鹹構獵網簾餘選壓艱 )
NCT04632862 (ENHANCE-A, Biospace) 人工标引	临床3期	2型糖尿病	160	Enavogliflozin	(選襯膚築蓋廠遞範築窪): P-Value = <0.001	积极	2022-01-25
				Placebo
NCT03364985 (DWP16001, EASD2019)	临床1期	糖尿 glucosuria	-	DWP16001 0.2 mg	(願膚鹽觸醖鑰淵顧觸網) = DWP16001 was well tolerated in all dose groups, and all adverse events were mild in severity 繭憲壓憲衊廠襯鑰鏇蓋 (糧築衊鹽淵窪鹹構鹽網 ) 更多	积极	2019-09-19
				DWP16001 0.5 mg