依沃格列汀(Evogliptin) - 药物靶点：DPP-4_在研适应症：2型糖尿病，主动脉瓣钙化，先天性双侧输精管发育不全_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Evogliptin (INN)、SUGANON、Sugarnon

+ [2]

靶点

DPP-4

作用机制

DPP-4抑制剂(二肽基肽酶IV抑制剂)

治疗领域

内分泌与代谢疾病心血管疾病泌尿生殖系统疾病+ [1]

在研适应症

2型糖尿病主动脉瓣钙化先天性双侧输精管发育不全

非在研适应症

二叶式主动脉瓣疾病Gilbert病肾病+ [1]

原研机构

Dong-A Pharmaceutical Co., Ltd.

在研机构

Dong-A ST Co., Ltd.

Alkem Laboratories Ltd.Rednvia Co. Ltd.

非在研机构

Dong-A Pharmaceutical Co., Ltd.

Tobira Therapeutics, Inc.

绿叶制药

+ [1]

最高研发阶段批准上市

首次获批日期

印度 (2019-10-12),

2型糖尿病

最高研发阶段(中国)无进展

特殊审评-

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结构/序列

分子式C19H27ClF3N3O3

InChIKeyQHQXWMKKQNSBTC-VQZRABBESA-N

CAS号1246960-27-9

关联

35

项与依沃格列汀相关的临床试验

NCT05817097

/ Not yet recruitingN/AIIT

Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database

The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction.
Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.

开始日期2023-08-01

申办/合作机构

Ajou University

[+1]

NCT05918094

/ Recruiting临床3期IIT

Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

开始日期2023-04-30

申办/合作机构

中山大学

NCT05143177

/ Active, not recruiting临床2/3期

An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS)

This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-1229 10 mg Group.
The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.

开始日期2022-06-27

申办/合作机构

Rednvia Co. Ltd.

100 项与依沃格列汀相关的临床结果

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100 项与依沃格列汀相关的转化医学

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100 项与依沃格列汀相关的专利（医药）

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100

项与依沃格列汀相关的文献（医药）

2024-11-01·DIABETES OBESITY & METABOLISM

Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study

Article

作者: Yoo, Soon Jib ; Kim, Kyoung‐Ah ; Lee, Won Young ; Han, Kyung Ah ; Choi, Kyung Mook ; Kim, In Joo ; Han, Seung Jin ; Jeong, In‐Kyung

Abstract:

Aim:

To evaluate the efficacy and safety of dapagliflozin versus placebo as an add‐on in patients with type 2 diabetes who did not achieve adequate glycaemic control with evogliptin and metformin combination.

Patients and Methods:

In this multicentre, randomized, double‐blind, placebo‐controlled Phase 3 trial, patients with glycated haemoglobin (HbA1c) levels ≥7.0% (≥53 mmol/mol) and ≤10.5% (≤91 mmol/mol) who had received stable‐dose metformin (≥1000 mg) and evogliptin (5 mg) for at least 8 weeks were randomized to receive dapagliflozin 10 mg or placebo once daily for 24 weeks. Participants continued treatment with metformin and evogliptin. The primary endpoint was change in HbA1c level after 24 weeks of treatment from baseline level.

Results:

In total, 198 patients were randomized, and 195 patients were included in the efficacy analyses (dapagliflozin: 96, placebo: 99). At Week 24, dapagliflozin significantly reduced HbA1c levels. The least squares mean difference in HbA1c level change from baseline after 24 weeks of treatment was −0.70% (−7.7 mmol/mol) (p < 0.0001). The proportion of participants achieving HbA1c <7.0% (≥53 mmol/mol) was higher in the dapagliflozin group than in the placebo group. Compared to placebo, dapagliflozin significantly reduced fasting plasma glucose, mean daily glucose, 2‐h postprandial plasma glucose, fasting insulin, uric acid and gamma‐glutamyl transferase levels, homeostatic model assessment for insulin resistance index, body weight, hepatic steatosis index, and albuminuria. Adiponectin level significantly increased from baseline level after 24 weeks of dapagliflozin treatment. Adverse event rates were similar in the two groups.

Conclusion:

Dapagliflozin add‐on to evogliptin plus metformin improved glycaemic control and was well tolerated by the target patients.

2024-11-01·BIOMEDICAL CHROMATOGRAPHY

Analytical quality by design‐based stability‐indicating high performance liquid chromatography method for the estimation of evogliptin tartrate in bulk and tablet dosage form

Article

作者: Kawathekar, Neha ; Srivastava, Shruti ; Dhaneshwar, Suneela

Abstract:

The present study utilized Analytical Quality by Design (AQbD) approach to develop a stability‐indicating high‐performance liquid chromatography (HPLC) method for estimating evogliptin tartrate using design expert software. The key parameters were methodically optimized, contours were plotted, and stability was evaluated using various forced degradation conditions. Using an Agilent HPLC system with a photo diode array (PDA) detector along with Fortis C18 column (250 × 4.6 mm, 5 μm) effectively separated the drug from its degradants. The mobile phase used was methanol: water (pH adjusted to 3.0, 76:24; v/v) at 0.8 mL/min flow rate. Evogliptin was eluted at 2.98 min, at a detection wavelength of 267 nm. The proposed method was found to be specific, precise, linear and robust. The drug was sensitive to acidic, basic, oxidative, thermal, and photodegradation resolving six degradation products. Thus, the developed AQbD‐based stability‐indicating HPLC method is applicable in analyzing evogliptin in bulk, tablet dosage form and stability samples.

2024-09-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Effect of Evogliptin on the Progression of Aortic Valvular Calcification

Article

作者: Park, Yong-Hyun ; Park, Sung-Ji ; Song, Jong-Min ; Han, Sangwon ; Park, Seung-Woo ; Ha, Jong-Won ; Kim, Kye Hun ; Choi, Eui-Young ; Lee, Sahmin ; Lee, Ji Sung ; Kim, Yong-Jin ; Kim, Hyung-Kwan ; Cho, Goo-Yeong ; Yang, Dong Heon ; Song, Jae-Kwan ; Chae, Sun Young ; Yang, Dong Hyun ; Park, Jae-Hyeong

BACKGROUND:

Medical therapy for aortic stenosis (AS) remains an elusive goal.

OBJECTIVES:

This study sought to establish whether evogliptin, a dipeptidyl peptidase-4 inhibitor, could reduce AS progression.

METHODS:

A total of 228 patients (age 67 ± 11 years; 33% women) with AS were randomly assigned to receive placebo (n = 75), evogliptin 5 mg (n = 77), or evogliptin 10 mg (n = 76). The primary endpoint was the 96-week change in aortic valve calcium volume (AVCV) on computed tomography. Secondary endpoints included the 48-week change in active calcification volume measured using ¹⁸F-sodium fluoride positron emission tomography (¹⁸F-NaF PET).

RESULTS:

There were no significant differences in the 96-week changes in AVCV between evogliptin 5 mg and placebo (-5.27; 95% CI: -55.36 to 44.82; P = 0.84) or evogliptin 10 mg and placebo (-18.83; 95% CI: -32.43 to 70.10; P = 0.47). In the placebo group, the increase in AVCV between 48 weeks and 96 weeks was higher than that between baseline and 48 weeks (136 mm³; 95% CI: 108-163 vs 102 mm³; 95% CI: 75-129; P = 0.0485). This increasing trend in the second half of the study was suppressed in both evogliptin groups. The 48-week change in active calcification volume on ¹⁸F-NaF PET was significantly lower in both the evogliptin 5 mg (-1,325.6; 95% CI: -2,285.9 to -365.4; P = 0.008) and 10-mg groups (-1,582.2; 95% CI: -2,610.8 to -553.5; P = 0.0038) compared with the placebo group.

CONCLUSIONS:

This exploratory study did not demonstrate the protective effect of evogliptin on AV calcification. Favorable ¹⁸F-NaF PET results and possible suppression of aortic valve calcification with longer medication use in the evogliptin groups suggest the need for larger confirmatory trials. (A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease; NCT04055883).

1

项与依沃格列汀相关的新闻（医药）

2022-09-06

·BioSpace

Dong-A ST and Beactica Therapeutics mutually agree to conclude oncology collaboration

UPPSALA, Sweden, Sept. 6, 2022 /PRNewswire/ -- Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish precision oncology company, today announced that they have mutually agreed to terminate their collaboration and licensing agreement. The collaboration focused on developing novel candidate compounds against multiple cancer targets of mutual interest. The partnership has been productive, and multiple compound classes are now in various stages of lead generation and optimization. As part of the termination, both Dong-A ST and Beactica Therapeutics will gain exclusive global rights for further development and commercialization for different compounds series developed during the collaboration. No obligations to pay milestone payments or royalties will remain for the assets divided between Dong-A and Beactica. For a limited time, each company is entitled to a revenue share from any related future outlicensing activities by the other party. Full financial details remain undisclosed. "We appreciate the opportunity we have had to collaborate with Beactica Therapeutics over the past five years. Our combined efforts have led to important breakthroughs," said Dr Jae-Hong Park, President and CSO of Dong-A ST. "We will continue to share with Beactica the ambition to make a clinical impact where it is urgently needed." "We have valued the partnership with Dong-A and are pleased by what we have achieved together. Gaining exclusive global rights to certain compounds is perfectly aligned with Beactica's ambition to itself become a clinical-stage precision oncology company," said Dr Per Källblad, CEO of Beactica Therapeutics. "We are excited to now add these assets to our pipeline as wholly-owned programmes." The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018. In December 2019, a key milestone was achieved. About Dong-A ST Dong-A ST Co., Ltd. specializes in the discovery, development, manufacture and markets pharmaceutical products and medical devices worldwide. The company offers various prescription drugs, including Stillen (Gastritis 2002); Zydena (Erectile dysfunction , 2005); Motilitone (Functional dyspepsia, 2011); Suganon (TZDM, 2016) as well as biologics and biosimilar products. Once-daily IV/oral Sivextro (Tedizolid, ABSSSI) was also developed by Dong-A ST which was approved by US FDA and launched in US (2014) and EU (2015) by global partners. Dong-A ST has a strong oncology R&D division with immuno-oncology and epigenetic pipeline. Dong-A ST Co., Ltd. was founded in 1932 and is headquartered in Seoul, South Korea. It is listed on the Korean stock exchange. For more information, visit . About Beactica Therapeutics Beactica Therapeutics AB is a precision oncology company committed to the fight against cancer. The company is advancing a pipeline of novel small molecule therapeutics to treat genetically defined cancers with significant unmet clinical need. Beactica's approach is centered around targeting disease proteins with synthetic lethality vulnerabilities by applying its molecular interaction-based drug discovery engine to generate novel small molecule across synergistic modalities, including allosteric modulators and targeted protein degraders (PROTACs). Beactica deliver value to patients and shareholders by advancing its programmes into early clinical trials. For more information on Beactica Therapeutics, please visit . Dong-A ST Co., Ltd. Contact Hannah Lee R&BD Team e2191946@donga.co.kr Tel: +82 31 260 5833 Beactica Therapeutics AB Contact Per Källblad M.Sc. Ph.D. CEO per.kallblad@beactica.com Tel: +46 18 56 08 80 This information was brought to you by Cision The following files are available for download: View original content: SOURCE Beactica Therapeutics AB

蛋白降解靶向嵌合体生物类似药小分子药物合作

100 项与依沃格列汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11023	依沃格列汀	A10BH07	DB12625

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	印度	Alkem Laboratories Ltd.	2019-10-12

未上市

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
主动脉瓣钙化	临床3期	美国	Rednvia Co. Ltd.	-
二叶式主动脉瓣疾病	临床2期	韩国	Dong-A ST Co., Ltd.	2019-08-26
先天性双侧输精管发育不全	临床2期	韩国	Dong-A ST Co., Ltd.	2019-08-26
肾病	临床1期	韩国	Dong-A ST Co., Ltd.	2020-07-10
Gilbert病	临床1期	韩国	Dong-A ST Co., Ltd.	2016-09-22
非酒精性脂肪性肝炎	临床1期	美国	Tobira Therapeutics, Inc.	-

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临床结果

适应症

分期

评价

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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


NCT04055883 (A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease, Pubmed \| J Am Coll Cardiol)	临床2期	主动脉瓣钙化	228	Evogliptin 5 mg	簾廠範構餘窪繭繭壓廠(觸膚選鑰簾簾積構醖餘) = 選獵願鹹鹽憲製艱鬱構選襯艱鹽鏇積網願繭製 (夢廠鏇壓衊衊製鬱鹽壓, -55.36 ~ 44.82)	不佳	2024-09-01
				Evogliptin 10 mg	簾廠範構餘窪繭繭壓廠(觸膚選鑰簾簾積構醖餘) = 膚餘壓窪鏇襯築齋齋繭選襯艱鹽鏇積網願繭製 (夢廠鏇壓衊衊製鬱鹽壓, -32.43 ~ 70.10)
ADA2023	N/A	2型糖尿病追加	198	Dapagliflozin 10mg	網淵鹹膚繭鬱製艱夢齋(積鏇網選範壓範夢廠範) = 範鏇壓壓夢廠遞繭選簾衊鏇醖齋鑰願網築襯蓋 (餘齋淵築壓夢夢範廠夢, [ ~ 0.91, to 0.48])	积极	2023-06-20
NCT04170998 (EASD2022)	临床3期	2型糖尿病追加	283	Evogliptin 5 mg	膚網鬱齋憲繭衊艱憲淵(鏇獵糧範艱構遞遞廠顧) = Adverse events were similar between groups, and no serious adverse drug reactions were reported in evogliptin group 製鑰鏇觸憲衊鹽鹹製網 (鏇蓋壓艱齋糧鑰衊艱築 )	积极	2022-09-20
ADA2021	N/A	2型糖尿病	-	Evogliptin plus Metformin	蓋製餘窪構廠壓餘選壓(觸遞蓋淵糧憲淵壓餘膚) = 齋襯醖繭鑰遞廠醖願簾製鬱襯蓋醖憲構餘築簾 (衊範遞遞夢製觸鏇觸製 ) 更多	-	2021-06-01
ENDO2021	N/A	追加	185	Evogliptin 5 mg OD	觸壓願糧糧糧選憲鹹鹽(鑰範糧夢壓鏇夢簾鏇鏇) = 廠齋憲顧鬱築壓願襯醖簾夢簾廠醖選夢觸襯鏇 (積願糧網網衊壓餘製齋 )	积极	2021-05-03
				Metformin and Glimepiride Combination	觸壓願糧糧糧選憲鹹鹽(鑰範糧夢壓鏇夢簾鏇鏇) = 鏇範繭衊願窪窪獵廠築簾夢簾廠醖選夢觸襯鏇 (積願糧網網衊壓餘製齋 )
NCT05817097 (Pubmed \| Diabetes Obes Metab)	N/A	2型糖尿病	-	Evogliptin	窪淵窪膚壓膚鏇築壓簾(廠鏇夢鏇糧選簾積觸願): aHR = 1.35 (95% CI, 0.82 ~ 2.21) 更多	-	2021-01-27
				Glimepiride
NCT02689362 (Pubmed \| Diabetol Metab Syndr)	临床2期	2型糖尿病	146	EVO 2.5 mg	鬱餘淵築醖襯夢齋艱鹽(衊鹽鑰鹹鬱鏇遞顧壓範) = 醖鹹艱憲艱鏇蓋觸網襯襯觸窪獵窪蓋選艱廠構 (鏇構膚選襯構襯顧鹽醖 )	-	2019-01-01
NCT02946541 (Pubmed) 人工标引	临床3期	2型糖尿病	160	evogliptin	鹽積繭窪餘積壓廠艱襯(選糧壓願遞糧醖鹽繭構) = 鹹鬱壓艱繭鑰獵醖鬱淵醖製鹽廠艱構壓淵鹹憲 (鑰顧齋艱鏇鹹範餘夢積 ) 更多	积极	2017-12-01
				Placebo	鹽積繭窪餘積壓廠艱襯(選糧壓願遞糧醖鹽繭構) = 構築願膚遞膚醖簾壓壓醖製鹽廠艱構壓淵鹹憲 (鑰顧齋艱鏇鹹範餘夢積 ) 更多
NCT02949193 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	222	evogliptin	壓膚窪簾遞鹽醖齋鏇選(壓鹹淵衊觸憲願製顧獵) = 蓋獵鬱蓋獵鏇簾糧壓蓋鏇製壓鬱鹹鹹鏇淵蓋願 (鏇鏇膚衊積觸蓋鏇淵衊 ) 更多	非劣	2017-05-01
				sitagliptin	壓膚窪簾遞鹽醖齋鏇選(壓鹹淵衊觸憲願製顧獵) = 觸範壓餘壓築鏇壓範鏇鏇製壓鬱鹹鹹鏇淵蓋願 (鏇鏇膚衊積觸蓋鏇淵衊 ) 更多
NCT00961025 (Pubmed \| Clin Ther)	临床1期	-	-	DA-1229	鑰衊簾鬱鏇範夢觸鏇憲(襯鑰餘繭淵鏇顧糧襯願) = Twenty-one adverse events were reported; all were mild, and all subjects recovered spontaneously 鑰網顧選壓餘艱構願衊 (鑰範範願鬱鹹製膚鑰艱 )	-	2012-09-01