预约演示
更新于：2026-10-21
Cofrogliptin
考格列汀
更新于：2026-10-21
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-06-18), |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
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结构/序列
分子式C18H19F5N4O3S |
InChIKeyGUBOXFWNNXSQNH-SVGFKBNWSA-N |
CAS号1844874-26-5 |
关联
22
项与 考格列汀 相关的临床试验NCT07460336
Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study
NCT07198932
Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)
ChiCTR2600127160
Efficacy and Safety of Cofrogliptin versus Metformin Dose Escalation in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Comorbid Non-Alcoholic Fatty Liver Disease
100 项与 考格列汀 相关的临床结果
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100 项与 考格列汀 相关的转化医学
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100 项与 考格列汀 相关的专利（医药）
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14
项与 考格列汀 相关的文献（医药）2026-10-01Clinical Pharmacology in Drug Development
Pharmacokinetic and Pharmacodynamic Drug‐Drug Interactions Between Cofrogliptin and Metformin in Healthy Subjects: A Single‐Center, Single‐Arm, Phase I Study in China
Article
作者: Huang, Yang ; Li, Fangqiong ; Liu, Dongyang ; Li, Haiyan ; Li, Yaming ; Cui, Cheng ; Liu, Na ; Chu, Chang ; Niu, Shu
Abstract:
This single‐center, single‐arm, Phase I study evaluated drug–drug interactions (DDIs) between cofrogliptin and metformin in healthy Chinese subjects. Twenty‐two subjects sequentially received metformin monotherapy (Days 1–4), cofrogliptin monotherapy (Days 6–34), and combination therapy (Days 38–47). Serial blood/urine samples were collected for pharmacokinetic (PK) and pharmacodynamic (PD) analyses. Cofrogliptin showed no significant impact on metformin's PK and PD properties: the geometric mean ratios (GMRs, metformin + cofrogliptin/metformin) with 90% confidence intervals (CIs) for metformin AUC
0–8 h
, AUC
0–12 h,
C
SS (max)
, Ae
0–8 h
and Ratio
0–8 h
, were 0.872 (0.809, 0.941), 0.900 (0.834, 0.971), 0.840 (0.743, 0.950), 0.899 (0.782, 1.032), and 0.994 (0.871, 1.136), respectively; 90% CIs for plasma glucose AUEC
0–4 h
, AUEC
0–0.5 h
, and EC
max
of combination (combination vs cofrogliptin monotherapy) all fell within 0.80–1.25. Metformin did not statistically affect cofrogliptin's PK and PD properties, as the GMRs (metformin + cofrogliptin/cofrogliptin) (90% CIs) for cofrogliptin AUC over the dosing interval and C
ss (max)
were 1.12 (1.072, 1.169) and 1.14 (1.057, 1.220), and AUEC
0–168 h
, EC
max
, and EC
min
for dipeptidyl peptidase‐4 inhibition rate were 1.01 (1.003, 1.015), 1.00 (1.001, 1.009), and 1.03 (1.005, 1.040), respectively. No deaths, serious adverse events, or severe hypoglycemia occurred. In conclusion, the combination of cofrogliptin and metformin had no clinically significant PK or PD DDIs in healthy Chinese subjects.
2026-02-01DIABETES OBESITY & METABOLISM
Efficacy and safety of bi‐weekly cofrogliptin treatment replacing daily dipeptidyl peptidase‐4 inhibitors in Chinese patients with type 2 diabetes mellitus: A multicenter, open‐label, randomized controlled phase 2 trial
Article
作者: Zhou, Yusen ; Li, Fangqiong ; Chen, Liming ; Li, Yaming ; Pan, Congqing ; Jiang, Hongwei ; Wang, Suijun ; Zhang, Zhanhui ; Wang, Zhongjing ; Feng, Yi ; Zhang, Jin
Abstract:
Aim:
This study aimed to investigate the efficacy and safety of bi‐weekly cofrogliptin treatment as a replacement for daily dipeptidyl peptidase‐4 inhibitors (DPP‐4is) in Chinese patients with type 2 diabetes mellitus (T2DM).
Methods:
This multicenter, open‐label, randomized controlled study assigned participants in a 1:1 ratio to either the daily DPP‐4i group or the 10 mg cofrogliptin group. The DPP‐4i group continued their original daily DPP‐4i regimen for 24 weeks, whereas the cofrogliptin group discontinued the daily DPP‐4i and received the investigational drug orally once every 2 weeks. All participants underwent 14‐day continuous glucose monitoring at weeks 10–12 and 22–24 during the treatment period. The main endpoint was the change in glucose time in range (TIR; 3.9–10.0 mmol/L) from baseline to week 24. Additionally, the Diabetes Treatment Satisfaction Questionnaire scores, adverse events, and hypoglycaemic events were compared between groups.
Results:
The enrolment period was from 31 January 2024 to 20 November 2024. A total of 64 participants were randomized to receive either cofrogliptin (
n
= 31) or a daily DPP‐4i (
n
= 33). The least squares (LS) mean (standard error) change in TIR from baseline after 24 weeks was 0.037% ± 2.506% in the cofrogliptin group compared to −9.891% ± 2.435% in the daily DPP‐4i group. The LS mean difference was 9.929% (95% confidence interval: 3.064%–16.793%), which was statistically significant (
p
= 0.0046). The incidence, classification, and severity of adverse events were similar between the two groups.
Conclusion:
Bi‐weekly cofrogliptin treatment, instead of daily DPP‐4i, could effectively control blood glucose levels in a 24‐week treatment period and their fluctuations and was well tolerated in Chinese patients with T2DM.
2025-02-01DIABETES OBESITY & METABOLISM
A biweekly
DPP
‐4 inhibitor cofrogliptin monotherapy in Chinese patients with impaired glucose tolerance: A phase 2, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group trial
Article
作者: Guo, Lixin ; He, Qinghua ; Song, Weihong ; Zhang, Zhanhui ; Zhang, Junqing ; Li, Yufeng ; Li, Fangqiong ; Cheng, Zhifeng ; Xing, Xiaoyan ; Li, Liping ; Xu, Lingling ; Li, Xinsheng
Abstract:
Aims:
To assess the efficacy and safety of cofrogliptin for impaired glucose tolerance (IGT).
Methods:
In 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 AUC
0–3 h
during meal tolerance test (MTT) at week 12.
Results:
Among 261 subjects screened, 99 were enrolled. At week 12, significant mean reductions from baseline in glucose total AUC
0–3 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 AUC
0–3 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.
Conclusion:
A 12‐week treatment with cofrogliptin provided significant glucose‐lowering, and was safe, well tolerated.
100 项与 考格列汀 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 中国 | 2024-06-18 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 葡萄糖耐受不良 | 临床2期 | 中国 | 2021-03-19 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 64 | 餘醖網壓築齋窪艱衊糧(獵顧壓衊艱憲獵糧簾襯) = 簾醖構壓廠鬱製顧鬱衊 鹹壓壓夢艱製窪餘選窪 (鹹簾襯壓鑰構醖淵遞範 ) 更多 | 积极 | 2025-06-20 | |||
DPP-4i | 餘醖網壓築齋窪艱衊糧(獵顧壓衊艱憲獵糧簾襯) = 窪鏇鹽鑰繭選艱憲艱廠 鹹壓壓夢艱製窪餘選窪 (鹹簾襯壓鑰構醖淵遞範 ) 更多 | ||||||
临床2期 | 99 | cofrogliptin 10 mg | 襯淵鏇製膚襯鹹鑰窪遞(網積餘鹽壓淵襯製獵衊) = 獵築積廠鹽顧鏇積鏇廠 壓築鬱蓋衊醖衊衊夢醖 (糧鬱膚憲構觸遞簾膚構 ) | 积极 | 2025-02-01 | ||
cofrogliptin 25 mg | 襯淵鏇製膚襯鹹鑰窪遞(網積餘鹽壓淵襯製獵衊) = 獵蓋觸齋壓艱膚襯鹹襯 壓築鬱蓋衊醖衊衊夢醖 (糧鬱膚憲構觸遞簾膚構 ) | ||||||
临床1期 | 6 | 窪淵觸鹹網遞衊顧蓋願(壓鏇淵構壓憲廠窪繭鏇) = The blood-to-plasma ratio (0.573‐0.845) indicated that HSK7653 did not tend to distribute into blood cells 繭糧窪顧網簾齋憲壓糧 (積糧襯觸簾襯餘淵構鏇 ) | 积极 | 2024-07-01 | |||
临床3期 | 2型糖尿病 追加 | - | 艱築獵膚鑰範衊齋襯願(選糧構簾構襯繭製鬱願) = 衊膚衊蓋遞壓餘鏇網淵 積鏇窪襯齋鑰廠築鹽襯 (觸觸簾夢壓齋選鏇醖膚, -1.08 ~ -0.83) | 积极 | 2023-10-03 | ||
HSK7653 25mg | 艱築獵膚鑰範衊齋襯願(選糧構簾構襯繭製鬱願) = 廠繭餘淵窪蓋鏇簾餘選 積鏇窪襯齋鑰廠築鹽襯 (觸觸簾夢壓齋選鏇醖膚, -1.12 ~ -0.87) | ||||||
N/A | 475 | 鹽餘積鏇餘壓鏇餘衊顧(積廠壓淵衊鹽齋憲襯網) = 製範鑰繭醖構壓廠願壓 淵艱獵鏇鹽鹽鬱選衊積 (積廠鑰膚糧簾壓壓鹹廠 ) | 积极 | 2023-06-20 | |||
HSK7653 25mg | 鹽餘積鏇餘壓鏇餘衊顧(積廠壓淵衊鹽齋憲襯網) = 廠艱膚憲廠築壓壓襯鹽 淵艱獵鏇鹽鹽鬱選衊積 (積廠鑰膚糧簾壓壓鹹廠 ) | ||||||
临床3期 | 450 | Metformin+HSK 7653 | 繭醖衊餘鬱鏇範窪鑰繭(餘構築糧壓淵淵簾願網) = 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 網衊範艱廠範鹹壓鹹艱 (觸夢齋構蓋範繭襯餘簾 ) | 非劣 | 2022-08-25 | ||
Metformin+Linagliptin | |||||||
临床3期 | 462 | 顧鏇鹽鑰廠網鑰蓋醖淵(衊觸簾襯觸餘鹽範繭網) = 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 廠夢憲鏇獵鏇範鏇夢餘 (鑰遞齋顧積鏇築鏇觸願 ) | 积极 | 2022-08-25 | |||
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