Delving into the Latest Updates on Cofrogliptin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

+ [1]

Target

DPP-4

Action

inhibitors

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication

Glucose IntoleranceRenal Insufficiency

Originator Organization

Sichuan Haisco Pharmaceutical Co., Ltd.

Active Organization

Haisco Pharmaceutical Group Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (18 Jun 2024),

Diabetes Mellitus, Type 2

RegulationSpecial Review Project (China)

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Structure/Sequence

Molecular FormulaC18H19F5N4O3S

InChIKeyGUBOXFWNNXSQNH-SVGFKBNWSA-N

CAS Registry1844874-26-5

AbstractAimsTo assess the efficacy and safety of cofrogliptin for impaired glucose tolerance (IGT).MethodsIn this multicenter, double‐blind, placebo‐controlled phase 2 trial, IGT patients were randomized 1:1:1 to receive cofrogliptin 10 mg, cofrogliptin 25 mg or placebo once biweekly. The primary endpoint was the change from baseline in glucose total AUC0–3 h during meal tolerance test (MTT) at week 12.ResultsAmong 261 subjects screened, 99 were enrolled. At week 12, significant mean reductions from baseline in glucose total AUC0–3 h during MTT were observed in cofrogliptin groups (10 mg: −1.75 mmol h/L, p = 0.01; 25 mg: −1.54 mmol h/L, p = 0.02) versus placebo (0.36 mmol h/L). Significant benefits were also seen with cofrogliptin for secondary endpoints of the change from baseline in Cmax of glucose during MTT 0–3 h at week 12, and the change from baseline in glucose total AUC0–3 h and Cmax of glucose during OGTT 0–3 h at week 10 versus placebo. Additionally, more cofrogliptin‐treated patients achieved normoglycaemia versus placebo at week 10. The incidence of AEs was generally comparable in all groups, and all of AEs were mild or moderate. No serious AEs or severe hypoglycaemia were reported.ConclusionA 12‐week treatment with cofrogliptin provided significant glucose‐lowering, and was safe, well tolerated.

01 Jan 2025·Diabetes, Obesity and Metabolism

Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial

Article

Author: Sun, Jia ; Jiang, Chengxia ; Pan, Tianrong ; Feng, Bo ; Gao, Leili ; Jiang, Hongwei ; Ji, Linong ; Xiao, Jianzhong ; Bian, Fang ; Yan, Pangke

AbstractAimWe conducted a multicentre, randomized phase 3 trial in China to evaluate the efficacy and safety of cofrogliptin (HSK7653), a novel long‐acting dipeptidyl peptidase‐4 inhibitor, in patients with drug‐naïve type 2 diabetes (T2D).Materials and MethodsPatients with inadequately controlled T2D were randomly assigned (1:1:1) to cofrogliptin 10 mg, cofrogliptin 25 mg or placebo, taken orally once every 2 weeks for a 24‐week double‐blind period. Eligible patients then received cofrogliptin 25 mg in a 28‐week open‐label extension. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24.ResultsIn total, 475 patients (median age: 54.0 years) were randomized and received at least one dose of cofrogliptin 10 mg (n = 158), cofrogliptin 25 mg (n = 158) or placebo (n = 159); 401 patients entered the open‐label extension. At week 24, the least‐squares (LS) mean difference (95% confidence interval [CI]) in HbA1c versus placebo was −0.63% (−0.81, −0.46) with cofrogliptin 10 mg and −0.59% (−0.77, −0.42) with cofrogliptin 25 mg (both p < 0.0001). The LS mean (standard error) change in HbA1c from baseline was maintained at the end of the study in patients given open‐label cofrogliptin 25 mg for an additional 28 weeks: cofrogliptin 10 mg: −0.86% (0.07); cofrogliptin 25 mg: −0.74% (0.07); placebo: −0.89% (0.07). Over the entire study, common adverse events were hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection and urinary tract infection. Hypoglycaemic events did not significantly differ between groups.ConclusionsCofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.Clinical Trial RegistrationRegistered on Clinicaltrials.gov with the registration number NCT04556851 (https://clinicaltrials.gov/study/NCT04556851).

01 Nov 2024·Diabetes, Obesity and Metabolism

Cofrogliptin once every 2 weeks as add‐on therapy to metformin versus daily linagliptin in patients with type 2 diabetes in China: A randomized, double‐blind, non‐inferiority trial

Article

Author: Hu, Xiaolin ; Wang, Junmin ; Han, Jie ; Li, Ling ; Qin, Guijun ; Ren, Qian ; Ji, Linong ; Liu, Yu ; Su, Xiuhai

AbstractAimWe evaluated the efficacy and safety of cofrogliptin, a novel dipeptidyl peptidase‐4 inhibitor taken once every 2 weeks (Q2W), compared with linagliptin (taken daily) in patients with type 2 diabetes inadequately controlled on metformin in China.Materials and MethodsIn this phase 3 randomized, double‐blind, active‐controlled, multicentre study, patients were randomly assigned 1:1:1 to receive cofrogliptin 10 mg Q2W, cofrogliptin 25 mg Q2W, or linagliptin 5 mg daily, all as an add‐on treatment to metformin, for 24 weeks. Eligible patients could enter an open‐label extension period and receive cofrogliptin 25 mg Q2W for an additional 28 weeks. The primary endpoint was change in glycated haemoglobin from baseline to 24 weeks, with a non‐inferiority margin of 0.4% for cofrogliptin versus linagliptin treatment.ResultsOverall, 465 patients entered the 24‐week treatment period (median age: 57.0 years). The least‐squares mean (standard error) change in glycated haemoglobin from baseline to week 24 was −0.96 (0.063), −0.99 (0.064) and −1.07 (0.065) for the cofrogliptin 10 mg, cofrogliptin 25 mg and linagliptin 5 mg groups, respectively. The between‐group difference met the predefined margin for non‐inferiority of cofrogliptin (10 and 25 mg) versus linagliptin treatment. The incidence of common adverse events (≥5% patients) during the 24‐week treatment period was similar between treatment groups. There were no serious hypoglycaemic events.ConclusionIn Chinese patients with type 2 diabetes inadequately controlled on metformin, the glucose‐lowering effect of cofrogliptin (Q2W) was non‐inferior to linagliptin (daily), with a similar safety profile maintained over 52 weeks of treatment.

100 Deals associated with Cofrogliptin

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	China	Haisco Pharmaceutical Group Co., Ltd.	18 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Insufficiency	Preclinical	China	Haisco Pharmaceutical Group Co., Ltd.	04 Aug 2022
Glucose Intolerance	Preclinical	China	Haisco Pharmaceutical Group Co., Ltd.	19 Mar 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04564872 (HSK7653, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 Add-on	-	HSK7653 10mg	(dagekgqhji) = lopknzlaue kfbemuljnr (awjhyzmzps, -1.08 to -0.83)	Positive	03 Oct 2023
				HSK7653 25mg	(dagekgqhji) = jatoltmjys kfbemuljnr (awjhyzmzps, -1.12 to -0.87)
NCT04564872 (HSK7653, ADA2023)	Not Applicable	Diabetes Mellitus, Type 2	475	HSK7653 10mg	(byutdeszyp) = dzzqcskrfx dongwirbdf (mtudrtoyza )	Positive	20 Jun 2023
				HSK7653 25mg	(byutdeszyp) = gawzeszlyt dongwirbdf (mtudrtoyza )
NCT04564872 (NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	450	Metformin+HSK 7653	(rprrlfygae) = 两个剂量组均能有效降低患者糖化血红蛋白，且每两周服用一次 HSK7653 片与每天服用一次阳性对照药利格列汀片的降幅相当 zhtpbwwioa (mpjbhnozzj )	Non-inferior	25 Aug 2022
				Metformin+Linagliptin
NCT04556851 (NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	462	HSK 7653	(tfrzieqpav) = HSK7653 片的两个剂量组均达到了临床终点，均能有效降低 2 型糖尿病患者的糖化血红蛋白，且显著优于安慰剂组，安全性与安慰剂类似 kjadudnuuq (arbcasvong )	Positive	25 Aug 2022
				Placebo