Delving into the Latest Updates on Evogliptin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Evogliptin (INN), SUGANON, Sugarnon

+ [2]

Target

DPP-4

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors)

Therapeutic Areas

Endocrinology and Metabolic DiseaseCardiovascular DiseasesUrogenital Diseases+ [1]

Active Indication

Diabetes Mellitus, Type 2Aortic Valve, Calcification OfCongenital Bilateral Aplasia of Vas Deferens

Inactive Indication

Bicuspid Aortic Valve DiseaseGilbert DiseaseNephrosis+ [1]

Originator Organization

Dong-A Pharmaceutical Co., Ltd.

Active Organization

Dong-A ST Co., Ltd.

Alkem Laboratories Ltd.Rednvia Co. Ltd.

Inactive Organization

Dong-A Pharmaceutical Co., Ltd.

Tobira Therapeutics, Inc.

Luye Pharma Group Ltd.

+ [1]

Drug Highest PhaseApproved

First Approval Date

IN (12 Oct 2019),

Diabetes Mellitus, Type 2

Regulation-

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Structure/Sequence

Molecular FormulaC19H27ClF3N3O3

InChIKeyQHQXWMKKQNSBTC-VQZRABBESA-N

CAS Registry1246960-27-9

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.

Start Date01 Aug 2023

Sponsor / Collaborator

Ajou University

[+1]

NCT05918094

/ RecruitingPhase 3IIT

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.

Start Date30 Apr 2023

Sponsor / Collaborator

Sun Yat-Sen University

NCT05143177

/ Active, not recruitingPhase 2/3

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.

Start Date27 Jun 2022

Sponsor / Collaborator

Rednvia Co. Ltd.

100 Clinical Results associated with Evogliptin

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100 Translational Medicine associated with Evogliptin

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100 Patents (Medical) associated with Evogliptin

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84

Literatures (Medical) associated with Evogliptin

01 Nov 2024·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

Author: Yoo, Soon Jib ; Han, Kyung Ah ; Lee, Won Young ; Kim, Kyoung‐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.

01 Nov 2024·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

Author: 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.

01 Sep 2024·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Effect of Evogliptin on the Progression of Aortic Valvular Calcification

Article

Author: Park, Yong-Hyun ; Song, Jong-Min ; Park, Sung-Ji ; 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

News (Medical) associated with Evogliptin

06 Sep 2022

·www.biospace.com

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

PROTACsBiosimilarSmall molecular drugCollaborate

100 Deals associated with Evogliptin

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External Link

KEGG	Wiki	ATC	Drug Bank
D11023	Evogliptin	A10BH07	DB12625

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	IN	Alkem Laboratories Ltd.	12 Oct 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aortic Valve, Calcification Of	Phase 3	US	Rednvia Co. Ltd.	-
Bicuspid Aortic Valve Disease	Phase 2	KR	Dong-A ST Co., Ltd.	26 Aug 2019
Congenital Bilateral Aplasia of Vas Deferens	Phase 2	KR	Dong-A ST Co., Ltd.	26 Aug 2019
Nephrosis	Phase 1	KR	Dong-A ST Co., Ltd.	10 Jul 2020
Gilbert Disease	Phase 1	KR	Dong-A ST Co., Ltd.	22 Sep 2016
Nonalcoholic Steatohepatitis	Phase 1	US	Tobira Therapeutics, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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)	Phase 2	Aortic Valve, Calcification Of	228	Evogliptin 5 mg	tdeifpjiem(vfmnjfkjmm) = fjewniobot cvsvkupoop (vqzhoqugwz, -55.36 to 44.82)	Negative	01 Sep 2024
				Evogliptin 10 mg	tdeifpjiem(vfmnjfkjmm) = ecompmjbfl cvsvkupoop (vqzhoqugwz, -32.43 to 70.10)
ADA2023	Not Applicable	Diabetes Mellitus, Type 2 Add-on	198	Dapagliflozin 10mg	zbxrrhfnwt(cdmthpjttj) = qtvdmqyanb bgkfpnztss (fpnxgslcyl, [ - 0.91, to 0.48])	Positive	20 Jun 2023
NCT04170998 (EASD2022)	Phase 3	Diabetes Mellitus, Type 2 Add-on	283	Evogliptin 5 mg	eznkjnyjta(xnxskzfhkt) = Adverse events were similar between groups, and no serious adverse drug reactions were reported in evogliptin group kgvyexejrd (ufeiehzuzl )	Positive	20 Sep 2022
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	-	Evogliptin plus Metformin	khcajiqlez(qdzpahrnbl) = vkkogpgmvh prtfwbqpdl (gmhnczgqff ) View more	-	01 Jun 2021
ENDO2021	Not Applicable	Add-on	185	Evogliptin 5 mg OD	jgjllkjxup(etebxcdwoj) = fkkzfkxmst bqhtffrftu (toppbymhdi )	Positive	03 May 2021
				Metformin and Glimepiride Combination	jgjllkjxup(etebxcdwoj) = rcpsoabhiu bqhtffrftu (toppbymhdi )
NCT05817097 (Pubmed \| Diabetes Obes Metab)	Not Applicable	Diabetes Mellitus, Type 2	-	Evogliptin	peqabkdtnd(usqbimauvx): aHR = 1.35 (95% CI, 0.82 - 2.21) View more	-	27 Jan 2021
				Glimepiride
NCT02689362 (Pubmed \| Diabetol Metab Syndr)	Phase 2	Diabetes Mellitus, Type 2	146	EVO 2.5 mg	erplpdoope(kpxqjvpxew) = fyugzcyhhr cwkvjvspwp (tbnjvjdrnb )	-	01 Jan 2019
NCT02946541 (Pubmed) Manual	Phase 3	Diabetes Mellitus, Type 2	160	evogliptin	rhdvcdjrvj(zsypglyfzt) = ihhyervsyt qbygwkajth (pcwathmqed ) View more	Positive	01 Dec 2017
				Placebo	rhdvcdjrvj(zsypglyfzt) = kvznvimgku qbygwkajth (pcwathmqed ) View more
NCT02949193 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	222	evogliptin	gonnhggcnx(tsppqqeyfq) = rgzclqofeb hcjmoytpal (twdaksuczj ) View more	Non-inferior	01 May 2017
				sitagliptin	gonnhggcnx(tsppqqeyfq) = wzqtinypfq hcjmoytpal (twdaksuczj ) View more
NCT00961025 (Pubmed \| Clin Ther)	Phase 1	-	-	DA-1229	vsvzisvtmu(ijinaehoit) = Twenty-one adverse events were reported; all were mild, and all subjects recovered spontaneously otlcdzhkvw (iftxspessi )	-	01 Sep 2012