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更新于：2026-11-05
Prusogliptin
普卢格列汀
更新于：2026-11-05
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2025-01-08), |
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C16H25FN4O2 |
InChIKeyVQKSCYBKUIDZEI-STQMWFEESA-N |
CAS号1186426-66-3 |
关联
21
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评价普卢格列汀、达格列净和二甲双胍三药联合治疗2型糖尿病患者的多中心、随机、双盲、平行对照、有效性和安全性的III期临床试验
CTR20250634
一项评估普卢格列汀片与达格列净片在健康受试者中药物相互作用的I期临床试验
NCT05150626
An Open-label, Randomized, Three-period, Crossover, Single-dose Study to Evaluate the Effect of a Low-fat Meal and a Standard Meal on the Pharmacokinetics of DBPR108 in Healthy Subjects
100 项与 普卢格列汀 相关的临床结果
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100 项与 普卢格列汀 相关的转化医学
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100 项与 普卢格列汀 相关的专利（医药）
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10
项与 普卢格列汀 相关的文献（医药）2025-06-01IRISH JOURNAL OF MEDICAL SCIENCE
Safety and efficacy of prusogliptin in type-2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials
Review
作者: Hamna Ahmed Khan ; Abdul Moeed ; Tooba Saqib ; Salim Surani ; Afia Salman ; Syed Muhammad Muneeb Akhtar ; Hoorain Jamil ; Muhammad Ahmed Ali Fahim ; Hajra Zainab Chaudry ; Laiba Zafar ; Abdul Hannan Siddiqui ; Laiba Sanober ; Alishba Adnan Janjua ; Ayesha Ali ; Muqaddas Parvez ; Hala Najeeb
BACKGROUND:
This study aims to conduct a systematic review and meta-analysis of the currently present literature analyzing the effectiveness and safety profile of prusogliptin, a novel dipeptidyl peptidase-IV (DPP-4) inhibitor, as compared to placebo in type 2 diabetes mellitus (T2DM) patients.
METHODS:
This systemic review and meta-analysis complied with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy based on various MeSH terms was run on: PubMed/Medline, SCOPUS, and Cochrane Central, which were then systematically searched from inception till March 2024 to select all relevant Randomized Control Trials (RCT).
RESULTS:
The analysis of the findings from three RCTs with 957 patients revealed that prusogliptin reduced Hemoglobin A1c (HbA1c)% levels in T2DM patients significantly [Mean Difference (MD): -0.62, 95% Confidence Interval (CI): -0.74 to -0.50, I2 = 0%, p < 0.001] and led to more patients with a HbA1c% ≤ 7% [Odds Ratio (OR): 2.65, 95%CI: 1.94 to 3.61, I2 = 0%, p < 0.00001]. However, prusogliptin led to a non-significant increase in weight when compared with placebo (MD: 0.22, 95% CI: -0.50 to 0.93, I2 = 60%, p = 0.551). The safety profile of prusogliptin revealed a non-significant decrease in treatment-emergent adverse events (OR: 0.90, 95% CI: 0.59 to 1.38, I2 = 43%, p = 0.64) and a non-significant increase in treatment-emergent serious adverse events (OR: 1.02, 95% CI: 0.43 to 2.44, I2 = 0%, p = 0.96) and drug-related adverse events (OR: 1.07, 95%CI: 0.68 to 1.69, I2 = 0%, p = 0.76).
CONCLUSION:
Prusogliptin has a favorable efficacy in attaining glycemic control in patients with T2DM. However, its safety profile yields uncertain outcomes. More literature is required for a definitive result.
2025-05-01CLINICAL PHARMACOKINETICS
Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes
Article
作者: Lingli Yao ; Xiaoli Li ; Xiaofang Zhang ; Rui Jia ; Shan Jing ; Huanhuan Qi ; Kexu Yang ; Huan Zhou ; Wenfang Liu ; Jingyi Liu ; Yang Lin ; Tianhao Zhang ; Chunyan Lu ; Juan Wang
BACKGROUND AND OBJECTIVE:
DBPR108 (prusogliptin) is a novel, orally bioavailable dipeptidyl peptidase-4 (DPP-4) inhibitor. This study investigated the pharmacokinetics and pharmacodynamic characteristics of DBPR108 tablets in patients with type 2 diabetes.
METHODS:
In this randomized, parallel-group, open-label, phase I study, Chinese adults with type 2 diabetes, glycated hemoglobin of 7.0-9.5%, and body mass index of 19-35 kg/m2 were randomized 1:1:1 to once-daily DBPR108 50-, 100-, or 200-mg tablet groups. The primary endpoints included pharmacokinetic and pharmacodynamic characteristics after a single dose and multiple doses of DBPR108.
RESULTS:
In total, 30 patients were randomized with 10 patients in each group. DBPR108 was quickly absorbed with median time to reach the maximum plasma concentration of 1.5-4 h at steady state. Exposure to DBPR108 at steady-state increased dose proportionally with mean maximum steady-state plasma DBPR108 concentration during dosage intervals of 119, 256, and 567 ng/mL in the 50-, 100-, and 200-mg groups, respectively. Accumulation ratio of DBPR108 ranged from 0.85 to 1.3, and steady state was reached after four continuous daily doses. After multiple doses of DBPR108, maximum inhibitory efficacy of DPP-4 increased with higher dose levels ranging from 62.1 to 89.4%. Active glucagon-like peptide-1 levels increased after DBPR108 administration. In addition, six patients experienced treatment-emergent adverse events without leading to treatment interruption or discontinuation.
CONCLUSIONS:
DBPR108 was well tolerated in Chinese patients with type 2 diabetes, and both the pharmacokinetic and pharmacodynamic profiles support once-daily dosage regimens of DBPR108 in future studies.
TRIAL REGISTRATION:
ClinicalTrials.gov (NCT05146869); registered 23 November 2021.
2025-03-01DIABETES OBESITY & METABOLISM
Comparative efficacy and safety of dipeptidyl peptidase‐4 inhibitors in adults with type 2 diabetes mellitus: A network meta‐analysis
Review
作者: Zhai, Jiawei ; Wang, Gongquan ; Fu, Jia ; Du, Bing ; Li, Xiangjun ; Wang, Jiajia
Abstract:
Aims:
We have compiled updated evidence on the benefits and drawbacks of dipeptidyl peptidase‐4 (DPP‐4) inhibitors in treating type 2 diabetes mellitus.
Materials and Methods:
We systematically searched PubMed, Embase, Cochrane Library, and
ClinicalTrials.gov
(as of 20 May 2024). Effect estimates were calculated using network meta‐analysis under the frequentist framework. The P‐score established the ranking of competing treatments.
Results:
The authors incorporated 58 studies containing data from a substantial sample size of 21 332 patients. Based on evidence of high and moderate certainty, respectively, teneligliptin and vildagliptin were found to be superior to all other DPP‐4 inhibitors in lowering haemoglobin A1c (mean difference [MD] −0.81%, 95% CI −1.03, −0.60) and fasting blood glucose (MD −1.18 mmol/L, 95% CI −1.56, −0.81) compared to placebo. The absence of conclusive differences between interventions for serious adverse events was supported by evidence, which was interpreted with low to very low certainty.
Conclusions:
In adults with type 2 diabetes, teneligliptin was most effective for HbA1c control, and vildagliptin for fasting blood glucose. No significant differences in serious adverse events were noted among DPP‐4 inhibitors compared to placebo. Given the therapeutic significance of these findings, more studies are needed to explore this issue more thoroughly.
100 项与 普卢格列汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 中国 | 2025-01-08 |
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 |
|---|---|---|---|---|
| 肝功能不全 | 临床1期 | 中国 | 2021-06-04 | |
| 糖尿病 | 临床1期 | 中国台湾 | 2012-11-22 |
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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3期 | 1,000 | Metformin+Prusogliptin | 衊膚淵願遞壓網襯廠憲(醖糧餘窪窪鬱顧觸窪餘) = DBPR108片组显著优于安慰剂组 繭夢糧蓋襯積鹹淵願顧 (鑰淵壓淵觸繭選築壓願 ) | 积极 | 2022-08-22 | ||
Metformin+Placebo | |||||||
临床2期 | 276 | 遞憲艱淵鑰遞鹽網餘憲(鏇鹹蓋鏇襯齋鑰鑰鬱襯) = 網鑰網選衊繭簾憲願襯 衊膚夢醖積構鑰糧製簾 (艱鬱積蓋顧廠鹹網壓選 ) 更多 | 积极 | 2020-07-02 | |||
遞憲艱淵鑰遞鹽網餘憲(鏇鹹蓋鏇襯齋鑰鑰鬱襯) = 鹽顧襯鑰壓範壓築製餘 衊膚夢醖積構鑰糧製簾 (艱鬱積蓋顧廠鹹網壓選 ) 更多 | |||||||
临床2期 | 276 | 繭糧齋製鹹獵蓋觸襯糧(鑰繭醖鬱範範蓋艱製窪) = 廠衊積選醖餘艱簾襯選 顧網積顧獵鬱糧鹽鏇糧 (選鬱遞廠鹹遞膚廠構範 ) 更多 | 积极 | 2020-07-01 | |||
繭糧齋製鹹獵蓋觸襯糧(鑰繭醖鬱範範蓋艱製窪) = 憲鏇餘製獵顧鬱獵窪觸 顧網積顧獵鬱糧鹽鏇糧 (選鬱遞廠鹹遞膚廠構範 ) 更多 | |||||||
临床1期 | 32 | placebo+DBPR108 (Placebo) | 鹹餘繭淵範網範衊齋製 = 艱夢鏇鏇夢積鏇顧膚壓 鏇襯簾蓋壓範鑰鏇夢鏇 (鑰餘醖膚顧遞蓋鑰選遞, 構艱獵餘構願壓願蓋簾 ~ 齋製齋鹹構蓋淵衊鏇蓋) 更多 | - | 2014-08-28 | ||
(DBPR108 25 mg) | 鹹餘繭淵範網範衊齋製 = 範齋齋鏇觸製壓鹽構糧 鏇襯簾蓋壓範鑰鏇夢鏇 (鑰餘醖膚顧遞蓋鑰選遞, 蓋衊憲艱獵願糧鏇窪顧 ~ 鏇願選衊憲襯膚築艱醖) 更多 |
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