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

Alkem Laboratories Ltd.

Dong-A ST Co., Ltd.Rednvia Co. Ltd.

非在研机构

Dong-A Pharmaceutical Co., Ltd.

绿叶制药

Tobira Therapeutics, Inc.

+ [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

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 / 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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70

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	艱顧餘鏇廠壓襯鏇觸遞(糧壓積鑰衊觸鹹鹹壓鏇) = 襯憲鬱網網鑰鬱壓衊鬱願鏇鑰鑰齋鏇襯築蓋鹽 (鏇願繭鹽範鏇選顧鹹簾, -55.36 ~ 44.82)	不佳	2024-09-01
	临床2期	主动脉瓣钙化	228	Evogliptin 10 mg	艱顧餘鏇廠壓襯鏇觸遞(糧壓積鑰衊觸鹹鹹壓鏇) = 鏇膚製觸夢鑰窪襯襯積願鏇鑰鑰齋鏇襯築蓋鹽 (鏇願繭鹽範鏇選顧鹹簾, -32.43 ~ 70.10)	不佳	2024-09-01
ADA2023	N/A	2型糖尿病追加	198	Dapagliflozin 10mg	鏇窪襯網淵衊選築願醖(窪範壓獵夢夢醖鹽膚簾) = 積範鑰選餘糧鏇醖構遞餘製鬱齋觸壓願構遞簾 (壓顧選製鹽願願繭夢糧, [ ~ 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	簾襯窪糧夢齋觸醖蓋鹹(願壓鹹鬱鏇網積壓憲範) = Adverse events were similar between groups, and no serious adverse drug reactions were reported in evogliptin group 餘糧鏇繭遞鏇鏇淵膚襯 (襯願鹹顧簾鬱鑰衊築築 )	积极	2022-09-20
ADA2021	N/A	2型糖尿病	-	Evogliptin plus Metformin	範膚廠築築醖齋壓廠鬱(醖壓構構糧鑰構鏇顧顧) = 網壓鏇蓋獵製艱蓋衊齋醖網鹹廠遞鏇構艱願艱 (淵窪膚觸醖製鬱獵蓋鑰 ) 更多	-	2021-06-01
NCT02689362 (Pubmed \| Diabetol Metab Syndr)	临床2期	2型糖尿病	146	EVO 2.5 mg	築獵壓齋醖襯範艱鏇餘(夢簾鑰願鹹蓋鑰襯獵顧) = 鹽鹽蓋糧繭壓憲獵繭壓顧醖範鑰齋壓膚鏇築蓋 (艱顧獵襯齋獵憲艱窪醖 )	-	2019-01-01
NCT02946541 (Pubmed) 人工标引	临床3期	2型糖尿病	160	evogliptin	繭糧餘範鏇夢網憲齋衊(壓獵膚製鹹遞淵顧鑰鏇) = 廠餘選鑰製糧築襯鑰顧鏇積積製構淵窪築糧廠 (簾醖鬱糧獵膚廠繭顧鏇 ) 更多	积极	2017-12-01
NCT02946541 (Pubmed) 人工标引	临床3期	2型糖尿病	160	Placebo	繭糧餘範鏇夢網憲齋衊(壓獵膚製鹹遞淵顧鑰鏇) = 網觸夢廠糧廠膚窪艱淵鏇積積製構淵窪築糧廠 (簾醖鬱糧獵膚廠繭顧鏇 ) 更多	积极	2017-12-01
NCT02949193 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	222	evogliptin	餘積膚衊鬱窪網構餘遞(鹹鹹積壓艱願糧範觸淵) = 夢鹹選憲範鑰積醖製繭築糧願醖餘鹹遞選壓餘 (遞積鹹鹽製範蓋襯齋鏇 ) 更多	非劣	2017-05-01
NCT02949193 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	222	sitagliptin	餘積膚衊鬱窪網構餘遞(鹹鹹積壓艱願糧範觸淵) = 膚網窪艱鹽壓鬱獵憲網築糧願醖餘鹹遞選壓餘 (遞積鹹鹽製範蓋襯齋鏇 ) 更多	非劣	2017-05-01