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

This is an open-label, randomized, three-period, crossover, single-dose study to evaluate the effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the safety and tolerability of DBPR108 under different fed states in healthy adult subjects.

开始日期2022-05-29

申办/合作机构

石药集团中奇制药技术（天津）有限公司

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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项与普卢格列汀相关的文献（医药）

2025-06-01·IRISH 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.

2025-05-01·CLINICAL 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.

2025-03-01·DIABETES 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.

169

项与普卢格列汀相关的新闻（医药）

2026-10-24

·国际糖尿病idiabetes

曾天舒教授专访：聚焦多重共病T2DM，解析肝肾功能不全人群DPP-4i的安全用药与全程管理

点击“蓝字”关注我们曾天舒教授专访曾天舒教授聚焦多重共病T2DM，解析肝肾功能不全人群DPP-4i的安全用药与全程管理编者按：我国2型糖尿病（T2DM）患者常常合并肝肾功能损伤、心血管疾病等多重共病，在多病共存、多重用药场景下，用药安全成为临床突出难点。二肽基肽酶-Ⅳ抑制剂（DPP-4i）是指南推荐的重要降糖药物，但不同药品的代谢通路存在差异，在特殊人群中的使用风险各有不同。近日，国产创新药DPP-4i福格列汀在用药说明书中补充了肝肾功能不全人群的用药研究资料，为这部分人群的安全、规范用药提供指引。本期特邀华中科技大学同济医学院附属协和医院曾天舒教授长期致力于多重共病T2DM患者的规范化安全管理，本期特邀曾天舒教授，围绕多重共病T2DM的临床痛点、指南推荐原则、DPP-4i药物代谢特性、福格列汀更新内容和临床处方要点等展开深度访谈。《国际糖尿病》：我国合并多种共病的T2DM患者十分常见。您一向十分关注共病人群、多重用药的临床安全管理，结合您一线临床工作体会，该类患者在降糖治疗过程中主要面临哪些现实临床痛点？为何临床诊疗需要高度重视这一特殊群体的药物合理使用？曾天舒教授华中科技大学同济医学院附属协和医院我国T2DM患者合并多重共病已成常态，其中合并肝肾功能不全更是国内T2DM患者非常普遍的共病情形。老年T2DM人群慢性肾脏病患病率居高不下，非酒精性脂肪肝等肝脏损害亦高发；且此类患者常伴随高龄、多种慢性疾病共存，显著增加了血糖综合管理难度。对于合并肝肾功能损伤的T2DM患者，临床实践主要存在以下痛点： 1 可选降糖药物范围受限多数口服降糖药根据肝肾功能水平设置剂量下调、慎用甚至禁用条款，许多药物往往需要随肝肾功能进行梯度剂量调整，一旦进展至中重度脏器功能损伤，临床可选用的降糖药物将进一步缩减。 2 疗效与安全难以兼顾临床既要追求个体化糖化血红蛋白（HbA1c）达标，又需要防范药物蓄积带来的低血糖以及脏器进一步受损风险；对于衰弱老年患者，还需要权衡降糖目标阈值，容易陷入治疗两难局面。 3 多重用药带来相互作用风险（DDI）该类患者往往同时服用降压、调脂、降尿酸等多种药物，发生DDI的风险显著升高，增加临床处方评估的难度。 4 器官功能分层评估难执行肾功能需依据估算肾小球滤过率（eGFR）划分CKD1-5期，肝功能采用Child-Pugh分级标准，不同分层对应的用药要求各不相同，临床工作中容易出现评估不充分、剂量把控不当等问题。临床重点关注这部分人群，也是为了在面对如此庞大的患病群体时，尽可能规避不合理用药带来的脏器损伤、严重低血糖等相关风险，改善患者长期脏器与心血管预后，这也契合以患者为中心、兼顾靶器官保护的糖尿病综合管理理念。《国际糖尿病》： DPP-4i是目前临床十分常用的口服降糖药物，目前它在我国T2DM整体治疗中处于怎样的地位？针对肝肾功能不全等特殊T2DM人群，现有指南、共识对于DPP-4i的应用作出了哪些推荐？曾天舒教授华中科技大学同济医学院附属协和医院《中国糖尿病防治指南（2024版）》《中国老年糖尿病诊疗指南（2024版）》等指南明确指出，DPP-4i在我国T2DM治疗中占据重要位置，是主要的联合用药之一[1]，也是老年T2DM患者的一级推荐降糖药物[2]。对有二甲双胍禁忌证的T2DM及老年T2DM患者，DPP-4i可作为单药起始的治疗选择；对二甲双胍不耐受的T2DM患者，推荐换用DPP-4i；另外，对于基线HbA1c较高的T2DM患者，DPP-4i可作为起始联合治疗的选择[3]。在T2DM的早期治疗中，以DPP-4i为基础的联合治疗，特别是与二甲双胍或SGLT2i的联合治疗，在控制血糖、改善β细胞功能、延缓疾病进展方面具有显著优势，且安全可靠[4]。针对肝肾功能不全等多重共病人群，考虑到不同DPP-4i的代谢路径并不相同，各大糖尿病指南的核心原则为：DPP-4i不能一概而论，需严格遵循对应药品说明书进行剂量调整。2022年发布的《基层医疗机构二肽基肽酶4抑制剂临床应用常见问题专家指导建议》[5]指出，在开始DPP‐4i治疗前先评估患者肝、肾功能，并在开始治疗后定期进行评估，同时对部分DPP-4i在肝、肾功能不全患者的使用剂量调整方案做出了规定（表1）。表1.DPP-4i在肝肾功能不全患者的应用《国际糖尿病》：近期福格列汀完善了肝肾功能不全人群的用药研究资料，请您为我们介绍更新后说明书针对不同肝肾功能分层患者的剂量调整有哪些细则？曾天舒教授华中科技大学同济医学院附属协和医院福格列汀给药后，大部分最终以原型药物形式排泄，其中主要经由尿液（肾脏）排出，部分经粪便清除，极少通过肝脏代谢。基于这一代谢特征，新版药品说明书对不同肝、肾功能分层患者制定了精细化、差异化的剂量管理标准[6]： 1 肾功能方面开始使用前建议评估肾功能，之后应定期评估。轻度肾功能不全患者(肾小球滤过率[GFR]≥60mL/min/1.73m2且<90 mL/min/1.73m2)不需要调整剂量。中度肾功能不全患者(肾小球滤过率[GFR]≥30 mL/min/1.73m2且<60 mL/min/1.73m2)和重度肾功能不全患者(肾小球滤过率[GFR]15~29 mL/min/1.73m2)剂量调整为6 mg，每日一次。中度和重度肾功能不全患者使用本品的经验有限，使用时应谨慎，并监测这些患者的疗效和不良反应。目前尚无终末期肾功能衰竭患者服用本品的临床研究数据。 2 肝功能方面轻度(Child-Pugh分级A)、中度(Child-Pugh分级B)肝功能不全患者不需要调整剂量。中度肝功能不全患者使用本品的经验有限，使用时应谨慎，并监测这些患者的疗效和不良反应。目前尚无重度肝功能不全患者服用本品的临床研究数据。《国际糖尿病》：对于合并肝肾功能不全的T2DM患者，临床除了需要依据药物代谢排泄特点把控用法用量之外，同时服用多种药物带来的DDI风险同样不容忽视。请您谈谈福格列汀在多重用药场景下的整体DDI风险表现，背后蕴含着什么样的药理机制？曾天舒教授华中科技大学同济医学院附属协和医院对于合并肝肾功能不全或其他共病的T2DM人群，多重用药带来的DDI风险也不容忽视。《老年T2DM患者DPP-4i多重用药安全管理专家共识（2026版）》针对老年多重用药场景下的DDI风险，给出了常见DPP-4i的临床应用建议[7]，同时明确指出：对于多重用药的T2DM患者，需警惕同代谢路径药物的竞争性抑制，建议使用发生药物代谢性DDI风险较少的药物，如普卢格列汀、阿格列汀、考格列汀和福格列汀（强推荐）（表2）。表2.T2DM多重用药患者DPP-4i治疗DDI风险福格列汀之所以被共识认定为代谢性DDI风险较低的DPP-4i，核心源于其独特的代谢通路特征。临床多数DPP-4i不同程度依赖肝脏CYP450酶代谢或作为P-gp底物存在，当多病共存老年患者联用降压、调脂、抗栓等药物时，易发生竞争性抑制或干扰，引发DDI、血药浓度波动等问题。而福格列汀几乎不经过肝脏CYP450酶系代谢，同时不属于P-gp底物，规避了常见的代谢性DDI发生通路，与常用慢病治疗药物联用几乎无明显代谢层面的相互作用，高度适配多重用药的临床场景。《国际糖尿病》：立足真实世界临床场景，针对合并肝肾功能不全的T2DM患者，在福格列汀治疗全过程中，应遵循怎样的管理流程？曾天舒教授华中科技大学同济医学院附属协和医院一、治疗前进行全面综合评估首先，脏器功能基线评估：准确计算eGFR，完善全套肝功能检测，明确患者CKD分期以及Child-Pugh分级，鉴别肝损伤的病因，作为剂量选择的核心依据。其次，患者个体情况评估：评估年龄、衰弱程度、营养状态，采集既往低血糖发生史；排查DPP-4i过敏史、胰腺炎既往病史，规避用药禁忌。最后，全面梳理合并用药情况，识别潜在DDI风险：避免采用“一刀切”的降糖方案，合理规划药物联用。二、治疗期间落实安全性监测一方面定期复查eGFR与肝功能，一旦脏器功能出现动态恶化，应当及时调整药物剂量，必要时停药；另一方面监测空腹及餐后血糖水平，尤其是联合促泌剂、胰岛素治疗时，重点防范低血糖事件。同时需警惕DPP-4i类药物共性的罕见不良反应，一旦出现可疑表现及时停药并给予对应处置。三、做好患者健康教育向患者进行用药科普教育，明确规范服药要求以及漏服后的正确处理方案，指导患者识别危险症状以及把握复诊指征，提升患者治疗依从性，加强患者自我管理。《国际糖尿病》：从临床一线实践角度，对于合并肝肾功能异常的T2DM患者，在疾病整体综合管理层面，您还有哪些建议？展望未来，在创新降糖药的特殊人群循证证据建设、真实世界研究布局，以及指南共识配套完善方面，还有哪些发展方向？曾天舒教授华中科技大学同济医学院附属协和医院 1.个体化评估肝肾功能，注重病因鉴别对合并肝肾功能异常的T2DM患者，临床管理要坚持综合管理思路。例如，在评估肝功能时，除Child-Pugh分级外，还需要重视肝功能损伤的病因鉴别：如果是病毒性肝炎、酒精性肝硬化等非代谢因素所致肝损伤，临床用药需要更加审慎；若为代谢相关脂肪性肝病（MASLD），DPP-4i则可能具有潜在的肝脏获益。我们团队此前发表的一项研究发现[8]，DPP-4i可能有助于改善肝脏胰岛素抵抗、减轻肝脏脂肪变性。 2.综合管控危险因素，动态调整降糖策略除降糖外，血压、血脂、尿酸、体重都要同步管控，结合生活方式干预，减少心肾靶器官损害。肝肾功能会随感染、脱水、用药及病情进展动态变化，不能依靠一次化验结果就固定长期用药方案，需要定期复查脏器功能，动态调整降糖药。降糖目标也要个体化，老年、衰弱或并发症多的患者可适当放宽标准，重点防范严重低血糖；可借助多学科协作，联合内分泌、肾内科、肝病科与临床药师，做好用药审核，同时加强患者宣教和持续随访，提高用药依从性。 3.完善特殊人群的本土循证证据创新降糖药在特殊人群中的循证证据还有待完善。在伦理许可和安全保障的前提下，新药临床试验可尝试纳入轻、中度肝肾功能损伤受试者，进一步积累本土原始临床数据。药物进入临床后，可开展大样本真实世界研究，纳入不同基线特征的糖尿病患者，除降糖疗效外，同步观察低血糖、肝肾不良事件和DDI等安全指标。 4.推进指南更新与临床转化从指南共识建设角度，待相关研究证据充分积累之后，也期待能够推动相关指南、专项共识的及时迭代更新，通过补充特殊人群用药数据，完善对应的用药推荐；同时结合药品说明书细化分层用药要求，为临床医师、药师提供更加明确的参考依据，指导特殊人群规范化用药。后续也要配套开展医师和药师继续教育，让创新降糖药真正服务于临床。小结合并肝肾功能损伤等共病的T2DM患者，多重用药的安全性是临床核心考量。福格列汀几乎不经CYP450酶代谢、非P-gp底物，可降低DDI发生风险；其说明书近期完成更新，为合并肝肾功能损伤的T2DM患者提供了用药依据。期待后续更多本土特殊人群循证与真实世界证据得以积累，助力指南共识迭代，进一步规范DPP-4i在此类人群中的临床应用。专家简介曾天舒教授华中科技大学同济医学院附属协和医院医学博士、教授、主任医师、博士研究生导师华中科技大学同济医学院附属协和医院内分泌科主任中国医师协会内分泌代谢科医师分会副主任委员，肝病与代谢学组组长中华医学会内分泌学分会委员，肥胖学组成员中国生物物理学会临床罕见代谢病分会主任委员湖北省医学会糖尿病学分会主任委员中国康复医学会糖尿病预防与康复专业委员会副主任委员中国民族卫生协会内分泌代谢分会副主任委员中国卫生信息和健康医疗大数据学会糖尿病专业委员会副主任委员中国肥胖联盟（COF）常务理事湖北省医学会内科学分会常务委员中华糖尿病杂志、Current Medical Science、临床内科杂志、临床心血管病杂志编委；中华内分泌代谢杂志通讯编委武汉市医学伦理委员会副主任委员湖北省医学伦理委员会委员参考文献： 1.中国糖尿病防治指南(2024版).中华糖尿病杂志，2025,17(1):16-139. 2.中国老年糖尿病诊疗指南(2024版).中华糖尿病杂志，2024,16(2):147-189. 3.DPP-4i临床应用专家共识.中华内分泌代谢杂志，2018,34(11):899-903. 4.基于二肽基肽酶Ⅳ抑制剂的T2DM早期联合治疗策略探讨.中华糖尿病杂志，2024,16(6):725-728. 5.基层医疗机构二肽基肽酶4抑制剂临床应用常见问题专家指导建议 [J]. 中华糖尿病杂志，2022,14 (08):761-770. 6.苯甲酸福格列汀片药品说明书[Z].国家药品监督管理局. 7.老年T2DM患者DPP-4i多重用药安全管理专家共识（2026版）[J].中华糖尿病杂志，2026,18(7):597-610. 8.Zheng W, Zhou J, Song S, et al. Dipeptidyl-Peptidase 4 Inhibitor Sitagliptin Ameliorates Hepatic Insulin Resistance by Modulating Inflammation and Autophagy in ob/ob Mice[J]. Int J Endocrinol, 2018, 2018: 8309723. END 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果临床终止临床1期

2026-10-08

·PRNewswire

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market to Reach USD 15,527.66 Million by 2032 - Credence Research

LONDON, Oct. 8, 2026 /PRNewswire/ -- The "Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market – Growth, Share, Opportunities & Competitive Analysis, 2026–2032" report has been added to the Credence Research Inc. offering. The global Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market was valued at USD 11,280.60 million in 2025 and is projected to reach USD 15,527.66 million by 2032, registering a CAGR of 5.47%. Demand is supported by the persistent global burden of type 2 diabetes, continued use of oral glucose-lowering therapies and the expanding availability of generics and fixed-dose combinations. DPP-4 inhibitors remain relevant for selected patients who benefit from simple oral dosing, low hypoglycemia risk and weight-neutral treatment profiles, although newer incretin and cardiometabolic therapies are increasing competitive pressure. Key Takeaways The market is projected to rise from USD 11,280.60 million in 2025 to USD 15,527.66 million by 2032 at a CAGR of 5.47%. Sitagliptin led the drug type segment with a 36.9% share in 2025, supported by long-standing prescribing familiarity, broad availability and generic participation. Retail pharmacies accounted for 44.8% of 2025 revenue, reflecting repeat-refill behavior in chronic outpatient diabetes management. North America led with a 37.8% share in 2025, followed by Europe at 26.1% and Asia Pacific at 23.4%. Fixed-dose combinations with metformin remain strategically important because they can reduce pill burden and support stepwise treatment intensification. Validated core participants include Merck & Co., AstraZeneca, Boehringer Ingelheim, Takeda Pharmaceutical, Novartis, Eli Lilly, Lupin, Sun Pharmaceutical and Dr. Reddy's Laboratories. Scope & Segmentation – Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Market The report provides a comprehensive analysis of the global DPP-4 Inhibitors Market through 2032, covering drug molecules, formulation formats, treatment sequencing, combination strategies, dispensing channels and patient groups. The study evaluates how generic entry, payer formularies, fixed-dose combinations and competition from GLP-1, dual incretin and SGLT2 therapies are reshaping commercial strategies. It also examines regional access, chronic refill infrastructure and molecule-level considerations that influence prescribing. The DPP-4 Inhibitors Market is segmented based on drug type, formulation, therapy line, combination type, distribution channel, patient type and geography. By Drug Type, the market includes Sitagliptin, Saxagliptin, Linagliptin, Alogliptin and Others. By Formulation, the market includes Oral Tablets, Fixed-dose Combinations and Others. By Therapy Line, the market includes First-line Therapy, Second-line Therapy, Add-on Therapy and Others. By Combination Type, the market includes Monotherapy, Combination with Metformin, Combination with SGLT2 and Others. By Distribution Channel, the market includes Hospital Pharmacies, Retail Pharmacies, Online Pharmacies and Others. By Patient Type, the market includes Type 2 Diabetes Adults, Elderly Patients, Renal-impaired Patients and Others. By Geography, the market is analyzed across North America, Europe, Asia Pacific, Latin America and Middle East & Africa. Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. Why This Report Matters The report provides a focused view of a mature but resilient oral diabetes drug class undergoing a transition from branded growth toward access-led generic volume. It helps decision-makers assess molecule-level demand, fixed-dose combination opportunities, distribution dynamics and evolving therapy-line positioning. The study highlights the commercial impact of newer diabetes classes that offer weight-loss or broader cardiometabolic benefits. For pharmaceutical manufacturers, generic drug companies, distributors and investors, the report provides actionable intelligence for portfolio, pricing and market-access decisions. Market Overview • Industry Landscape and Value Chain Assessment • Supply-Side Evaluation • Demand-Side Evaluation • Stakeholder Mapping • Porter's Five Forces Review • PESTLE Environment Assessment • Market Forecast and Future Direction • Short-Term Forecast, 0–2 Years • Mid-Term Forecast, 3–5 Years • Long-Term Forecast, 5–10 Years • Market Entry and Expansion Strategy Market Insights • Patient and Prescriber Analysis • Therapy Sequencing Assessment • Generic Entry and Substitution Review • Fixed-Dose Combination Opportunity Assessment • Distribution and Refill Channel Review • Pricing and Reimbursement Analysis • Competitive Class Substitution Assessment • Regional Access and Diagnosis Review • Lifecycle Management and Portfolio Strategy Key Attributes Segmentation By Drug Type • Sitagliptin • Saxagliptin • Linagliptin • Alogliptin • Others By Formulation • Oral Tablets • Fixed-dose Combinations • Others By Therapy Line • First-line Therapy • Second-line Therapy • Add-on Therapy • Others By Combination Type • Monotherapy • Combination with Metformin • Combination with SGLT2 • Others By Distribution Channel • Hospital Pharmacies • Retail Pharmacies • Online Pharmacies • Others By Patient Type • Type 2 Diabetes Adults • Elderly Patients • Renal-impaired Patients • Others By Geography • North America • Europe • Asia Pacific • Latin America • Middle East & Africa Market Growth Driven by Chronic Type 2 Diabetes Demand and Oral Therapy Preference The persistent global burden of type 2 diabetes supports recurring demand for oral glucose-lowering medicines. DPP-4 inhibitors retain a role in selected patients because they offer simple daily administration, a generally low risk of hypoglycemia and a weight-neutral profile. These characteristics can be valuable in older patients, people managing multiple medicines and treatment plans where tolerability is prioritized. Generic entry is changing the revenue mix. Loss of exclusivity has reduced branded pricing power in several markets, yet lower-cost sitagliptin and other molecules can expand access and preserve prescription volume. Wider retail pharmacy availability and e-pharmacy distribution also support continuity for chronic therapy users. Fixed-dose combinations remain an important lifecycle strategy. Pairing DPP-4 inhibitors with metformin or other oral agents can simplify regimens and support patients who require stepwise treatment intensification without moving immediately to injectable therapy. Competitive Pressure from Newer Diabetes Therapies Reshapes the Market DPP-4 inhibitors face stronger competition from GLP-1 receptor agonists, dual incretin therapies and SGLT2 inhibitors. These newer classes can offer weight reduction or broader cardiovascular and renal benefits in selected patient populations, which can influence guideline positioning and payer preference. This pressure makes affordability, tolerability, oral convenience and combination availability increasingly important sources of differentiation. Manufacturers must manage mature brands carefully while generic suppliers compete on price, supply reliability and pharmacy coverage. Regional Growth Reflects Reimbursement Depth and Expanding Access North America led the market with a 37.8% share in 2025, supported by established diagnosis pathways, structured reimbursement and a mature retail refill infrastructure. Europe accounted for 26.1%, where reference pricing and cost-containment policies accelerate generic uptake while preserving steady outpatient use. Asia Pacific represented 23.4% of the market and offers substantial volume potential due to large diabetes populations, improving diagnosis and expanding pharmacy access. Latin America and Middle East & Africa remain smaller in revenue terms, with growth dependent on affordability, distributor reach and reimbursement development. Future Outlook The DPP-4 inhibitor market is expected to expand steadily rather than rapidly through 2032. Growth will be supported by chronic disease prevalence, generic access and fixed-dose combinations, while class share will remain under pressure from newer therapies with stronger weight and cardiometabolic profiles. Companies with broad generic portfolios, strong local distribution and combination-product capabilities will be better positioned to defend volume. Market opportunities will increasingly center on affordability, emerging-market access and simplified regimens rather than premium pricing. Competitive Landscape Competition is shifting from brand exclusivity toward formulary placement, generic substitution, combination availability and supply reliability. Merck remains closely associated with sitagliptin, while AstraZeneca, Boehringer Ingelheim, Takeda and Novartis have established DPP-4 portfolios or legacy brands. Eli Lilly remains relevant through its long-standing collaboration with Boehringer Ingelheim around linagliptin. Generic manufacturers including Lupin, Sun Pharmaceutical and Dr. Reddy's Laboratories strengthen price competition and expand access in large emerging markets. The strongest commercial positions increasingly depend on distribution coverage, procurement competitiveness and the ability to sustain reliable supply after patent expiry. Key Player Analysis • Merck & Co. • AstraZeneca • Boehringer Ingelheim • Takeda Pharmaceutical • Novartis • Eli Lilly and Company • Lupin • Sun Pharmaceutical • Dr. Reddy's Laboratories Recent Industry Developments In June 2025, Abbott and MSD Pharmaceuticals announced a distribution agreement in India covering sitagliptin, sitagliptin/metformin and the extended-release combination, expanding access to MSD's established DPP-4 portfolio. In January 2025, CSPC Pharmaceutical Group announced that China's National Medical Products Administration granted marketing approval for prusogliptin tablets, a new DPP-4 inhibitor for adults with type 2 diabetes. Report Coverage The research report offers an in-depth analysis based on Drug Type, Formulation, Therapy Line, Combination Type, Distribution Channel, Patient Type and Geography. It assesses market size, regional demand, competitive positioning, generic entry, fixed-dose combinations, reimbursement dynamics and the impact of alternative diabetes drug classes. The study provides strategic recommendations for branded manufacturers, generic companies, distributors and investors navigating a mature therapeutic category with changing treatment preferences. Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. Shape Your Report to Specific Countries or Regions and Enjoy 30% Off! Customize Now Related Reports – About Us Credence Research Inc is a global market intelligence and consulting firm founded in 2015. It delivers deep market insights, quantitative analysis, and strategic guidance to business leaders, investors, governments, NGOs, and non-profit groups worldwide. The company helps organizations evaluate markets, understand trends, reduce risk, and make data-driven decisions that support growth and competitive strategy. Credence Research is known for rigorous research methods and comprehensive analytics. The firm produces detailed reports covering market size, forecasts, growth drivers, trends, and competitive landscapes across many industries. Each report often includes frameworks like PESTLE and Porter's Five Forces to give a complete view of market dynamics and future potential. Credence Research also provides tailored consulting services, due diligence support, go-to-market planning, and pre-IPO research to strengthen client strategies and investment narratives. Its insights come from both primary and secondary research, expert interviews, and advanced data modelling. The firm's client base spans Europe, the Americas, Asia-Pacific, and the Middle East/Africa. To find out more, visit or follow us on X.com, LinkedIn and Facebook Contact Us – Credence Research Inc, Tower C-1105, S 25, Akash Tower, Vishal Nagar, Pimple Nilakh, Haveli, Pune – 411027, India USA: +1 6282 627 656 UK: +44 7453 598 606 Email: [email protected] Visit Our Website: SOURCE Credence Research Inc. 21% more press release views with Request a Demo

上市批准

2026-09-20

·原料药情报局

SYH2069 进 II 期，身后排着 5 个品种：石药的降糖减重"全家桶"

「点击蓝字，关注我们」原料药情报局 · 管线深扫描SYH2069 进 II 期，身后排着 5 个品种：石药的降糖减重"全家桶" 一纸临床公告背后：从 Fc 融合到月制剂，石药 GLP-1 的三条技术路线已经全部摆上桌面石药集团 1093.HK · 2026.09.16 自愿公告本文数据来源：石药集团港交所公告（2026年9月16日、6月18日、6月8日、3月20日、2月16日）· 石药集团2026年中期报告 · 天境生物公告 · 公开行业报道｜全文约 4,600 字 2026年9月16日，石药集团（1093.HK）发布自愿公告：SYH2069 注射液用于治疗成人 2 型糖尿病的 II 期临床试验（SYH2069-003）已在中国首个研究中心正式启动。单看是一条常规的临床推进。但把石药这一年多的公告串起来读，会发现 SYH2069 只是这家公司代谢管线的冰山一角——降糖减重赛道上，石药手里同时压着一条 NDA 双受理的准上市品种、三个不同技术路线的临床阶段新分子、一个卖掉海外权益换来 12 亿美元首付款的月制剂平台。这篇文章把这条"全家桶"管线拆给你看。一、公告主角 SYH2069：双靶点 + 偏向性设计 SYH2069 注射液是一款新型脂肪酸修饰多肽类长效 GLP-1R/GIPR 双靶点双偏向型激动剂——对标的是替尔泊肽（礼来）开辟的"GLP-1 + GIP"双靶机制赛道。先拆这串定语里的两个关键词：双靶点（GLP-1R + GIPR）：选择性激活两个受体，以葡萄糖依赖性方式促进胰岛素分泌，同时抑制食欲、延缓胃排空、增加饱腹感、减少热量摄入——降糖与减重协同。双偏向型（biased agonist）：这是石药在这条管线里最值得注意的技术选择。G 蛋白偶联受体下游有两条通路——cAMP 通路负责疗效信号，β-arrestin 募集则会导致受体内化和脱敏。SYH2069 被设计为选择性激活 cAMP 通路、避开 β-arrestin 募集，从而增强活性并延长药效持续时间。偏向性激动剂是当前 GPCR 药物设计的前沿方向——同一个受体，"激活"不等于"激活"，选择性地走疗效通路、不走脱敏通路，理论上能用同样的靶点做出更好的药。临床前研究显示 SYH2069 展现出良好的靶点活性和可控的安全性特征。时间线上，这个分子的推进节奏很快：时间进展 2025.12超重或肥胖适应症获 NMPA 临床试验批准，随后启动 I 期临床——初步展现了人体安全性、耐受性及药代/药效动力学特征 2026.042 型糖尿病适应症获 NMPA 临床试验批准 2026.09T2DM II 期临床（SYH2069-003）中国首个研究中心启动，受试者招募积极推进中资料来源：石药集团 2026年9月16日公告 II 期试验的设计也有信息量：多中心、随机、双盲、安慰剂及阳性对照、平行分组，评估不同给药方案下的有效性与安全性。设阳性对照，说明石药没打算只跟安慰剂比——上市前就要摸清与标准治疗的相对位置。二、把镜头拉远：石药降糖减重管线全景 SYH2069 之外，石药在这条赛道上还布了这些子：品种技术路线最新进展依达格鲁肽α （TG103）重组人源 GLP-1 Fc 融合蛋白，每周一次，生物制品 1 类NDA 双受理：减重（2025.10）+ T2DM（2026.6）；两项 III 期 TFL 定稿，头对头优于度拉糖肽SYH2069脂肪酸修饰长效多肽，GLP-1/GIP 双偏向激动剂减重 I 期完成初步数据；T2DM II 期启动（2026.9）SYH2082GLP-1/GIP 双偏向激动多肽月制剂（长效制剂平台+长半衰期修饰）中美双 IND：FDA（2026.2）+ NMPA（2026.3），肥胖/超重体重管理SYH9017司美格鲁肽月制剂，皮下注射形成凝胶贮库缓释2024.12 国内 IND；2026.6 获 FDA 临床批准（体重管理），中美双报SYH2092肥胖管线早期分子非临床阶段，入选 2026 年欧洲肥胖大会（ECO）摘要资料来源：石药集团历次公告及 2026 年中报仿制药与改良梯队同样在铺：普卢格列汀二甲双胍缓释片（DPP-4 复方，2026.1 NDA 受理）、西格列汀二甲双胍缓释片（2026.5 NDA 受理）、恩格列净二甲双胍缓释片（2026 年获注册批件）、普卢格列汀片联合达格列净和二甲双胍 III 期已完成末例入组（2026.3）——口服降糖基本盘与创新线并行。三、全家桶里最接近商业化的一张牌：依达格鲁肽α 如果说 SYH2069 是"未来"，那 TG103 就是"现在"。这个分子值得单独展开：依达格鲁肽α（商品名善美宁®，又称 TJ103/TG103）是重组人源 GLP-1 Fc 融合蛋白注射液，每周给药一次，按治疗用生物制品 1 类新药申报，开发主体为石药集团百克（山东）生物制药，原始权益来自天境生物（2018 年授权石药用于中国大陆的研发、注册、生产与商业化）。两项关键 III 期（单药 + 联合二甲双胍）已于 2026 年 2 月 TFL 定稿、结果符合预期，联合用药 III 期还拿到了 2026 年欧洲糖尿病研究协会（EASD）的简短口头报告席位。披露的临床要点：起效快、疗效持久：给药 4 周即明显起效，8 周 HbA1c 较基线降幅超 1%，疗效稳定持续至 52 周；基线 HbA1c 更高的患者降幅可达 2% 以上。头对头赢了度拉糖肽：在联合二甲双胍治疗基础上，与度拉糖肽相比展现出更好的长期血糖控制优势——Fc 融合路线打 Fc 融合路线，数据说话。耐受性差异化：胃肠道不良事件发生率及因不良事件终止治疗率低于已上市同类；剂量递增只需 4 周即达目标维持剂量，方案更简便。上市申请节奏：减重适应症 NDA 已于 2025 年 10 月获受理，T2DM 血糖控制 NDA 于 2026 年 6 月获受理——一个分子、两项适应症、双双在审。这是石药 GLP-1 矩阵里最先见分晓的品种。四、三条技术路线，卡三个生态位把四个临床阶段分子放在一起看，石药的布局逻辑非常清晰——不是在一个点上堆分子，而是用三条不同的技术路线覆盖三个竞争维度：路线代表品种给药频率对标逻辑Fc 融合蛋白依达格鲁肽α 每周一次度拉糖肽同路线，头对头争份额脂肪酸修饰双靶多肽SYH2069 长效替尔泊肽机制赛道+偏向性改良缓释制剂平台（月制剂）SYH9017 / SYH2082 每月一次给药频率降维打击，差异化竞争资料来源：石药集团历次公告整理；SYH2069 给药频率未披露，仅披露"长效" 三条路线的技术纵深不同：Fc 融合靠分子生物学（重组表达），脂肪酸修饰靠多肽化学（侧链偶联），月制剂靠递送技术（凝胶贮库 + 长半衰期修饰双层设计）。等于石药同时押注了"更好的分子"和"更好的递送"两个改进方向——前者解决药效上限，后者解决依从性下限。 SYH9017 的细节最能说明月制剂路线的打法：利用长效递送技术平台，以生物相容性辅料为基础，皮下注射后形成凝胶贮库实现缓释。国内临床研究显示，与已上市的司美格鲁肽周制剂相比，减重效果相当、安全性良好、半衰期明显延长——支持每月给药一次。2026 年 6 月 8 日该产品获 FDA 临床批准（体重管理适应症），是国内公开报道中用药间隔最长的 GLP-1 在研药物之一，也是国产药企首次将月制剂改良型新药推进美国临床。 ▎ 情报局观察 GLP-1 竞赛的评估维度正在换挡：从"减重幅度"转向口服便利性 + 给药频次 + 耐受性。礼来口服小分子 orforglipron 的 III 期（36mg 组体重降 8.2% vs 口服司美格鲁肽 5.3%）、阿斯利康 elecoglipron（75mg 组 36 周减重 11.8%，已启动全球 III 期）在攻"口服"；石药的月制剂在攻"频次"——方向不同，但都是在抢周制剂注射的未来市场。五、12 亿美元首付：月制剂路线已经被阿斯利康"验过货" 石药这条 GLP-1 管线最硬的背书，来自阿斯利康的支票簿。 2026 年 1 月，石药与阿斯利康签订战略合作与授权协议，利用缓释给药技术平台及多肽药物 AI 发现平台，开发创新长效多肽药物。阿斯利康获得每月一次注射用体重管理产品组合的全球独家权利（不含中国内地及港澳台）。对价结构：首付款 12 亿美元——2026 年 5 月 29 日已到账研发里程碑最高 35 亿美元——首笔 2,500 万美元已于 2026 年 7 月 10 日收到销售里程碑最高 138 亿美元 + 最高双位数比例的分层销售提成这笔交易创下国产创新药出海首付款纪录，而交易的底层资产正是月制剂技术平台。换句话说：石药留在手里的中国市场月制剂管线（SYH9017、SYH2082 等），和阿斯利康花 12 亿美元买走的是同一套技术能力——这套能力的成色，全球最顶尖的买方已经用真金白银标过价了。双方还在加码：2026 年 7 月，石药再与阿斯利康就 siRNA 平台达成第二笔合作（3,000 万美元首付，8 月 12 日已到账）；2026 年 8 月，双方签署合资合同，在石家庄建设新一代生物制剂生产基地——石药 51%、阿斯利康 49%，把 GMP 产能也绑进了同盟。六、赛道拥挤度：不是能不能做出来，是排在第几个必须承认，这条赛道的国产竞争已经白热化。仅 2026 年 6 月以来：翰森制药奥莱泊肽（GLP-1/GIP 双靶点）肥胖适应症 NDA 获 NMPA 受理——双靶点赛道上，翰森的申报节奏暂时领先石药。诺和诺德 zenagamtide（GLP-1/胰淀素双激动剂）II 期 36 周减重 14.6%，计划下半年启动 III 期。罗氏/Zealand 的 petrelintide（胰淀素类似物）42 周减重 10.7%。石药的相对位置：单靶周制剂（依达格鲁肽α）NDA 已在审，预计是国产 GLP-1 第二三梯队上市序列；双靶点（SYH2069）刚进 II 期，比头部慢了半程；但月制剂（SYH9017/SYH2082）在给药频率维度上是全球稀缺资产——周制剂和月制剂不是同一张牌桌，后者目前没有已上市竞品。七、对原料药与 CXO 产业链的三点信号多肽 API 的竞争焦点正在上移。司美格鲁肽 API 的价格战已经把"能合成 GLP-1"打成白菜价，下一步的溢价能力在修饰技术——脂肪酸侧链偶联（SYH2069 路线）、Fc 融合表达（TG103 路线）的工艺Know-how，比裸肽合成难得多。石药同时布局两条，等于给上游多功能修饰 CDMO 指了方向。月制剂打开的是辅料与制剂端的新市场。凝胶贮库缓释意味着新型生物相容性辅料、预充式注射器、超长效无菌制剂的验证体系——这不是传统多肽 API 厂的战场，是制剂 CDMO 和药用辅料企业的增量。石药的月制剂管线每往前走一步，这条供应链就多一分确定性。多肽产能过剩是结构性的，不是绝对的。裸肽过剩、修饰肽稀缺；普通注射剂过剩、缓释贮库稀缺。石药在石家庄与阿斯利康合建生物制剂基地（含多肽产线逻辑）说明头部玩家已经在为下一代产品结构配产能——跟着管线结构配产能，而不是跟着当下品种配产能，这个思路值得全行业对照自查。结语：从 2025 年 10 月依达格鲁肽α减重 NDA 受理算起，石药在 11 个月里完成了：一项 NDA 双适应症受理、三个新分子进入临床（含两个 FDA IND）、一次 12 亿美元的管线出海、一座与阿斯利康的合资工厂。SYH2069 的 II 期启动，只是这条时间线上最新的一格。对"原料药情报局"的读者，这家公司值得持续盯的点有两个：一是依达格鲁肽α的上市定价与放量节奏——它将检验石药代谢管线的商业化能力；二是 SYH2069 II 期的剂量-响应数据——偏向性设计能不能转化成临床优势，2027 年见分晓。三条技术路线、五个临床品种、一张海外支票——石药的 GLP-1，已经不是"在做了"，是"做全了"。原料药情报局专注原料药 · 中间体 · 合成生物学产业链研究本文为公开信息整理分析，不构成任何投资建议数据来源：石药集团港交所公告 · 石药集团 2026 年中报 · 天境生物公告 · 医药魔方等公开报道2026年9月 · 第 073 期往期推荐原料药供需对接项目产能医药资讯农化资讯医药中间体农药原药农药中间体营养保健食品饲料合成生物香精香料兽药资讯精细化工产品推荐新材料 IPO 园区推荐印度企业点点赞点分享点喜欢

100 项与普卢格列汀相关的药物交易

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适应症	国家/地区	公司	日期
2型糖尿病	中国	石药集团欧意药业有限公司	2025-01-08

未上市

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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	石药集团中奇制药技术（石家庄）有限公司	2021-06-04
糖尿病	临床1期	中国台湾	健亞生物科技股份有限公司	2012-11-22

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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


NCT04218734 (NEWS) 人工标引	临床3期	2型糖尿病	1,000	Metformin+Prusogliptin	襯襯襯壓淵鹽鏇淵淵窪(繭醖齋艱獵襯窪鏇積夢) = DBPR108片组显著优于安慰剂组艱鬱鏇糧遞廠淵製鏇壓 (鏇窪鏇遞鏇齋鑰醖襯鏇 )	积极	2022-08-22
				Metformin+Placebo
NCT04124484 (Pubmed \| Curr Med Res Opin)	临床2期	2型糖尿病	276	DBPR108 50 mg	構壓壓襯範簾鬱蓋壓淵(蓋憲糧鏇範遞憲襯壓構) = 鹹觸廠襯選餘糧積選窪淵選鬱餘鹹夢衊醖觸夢 (鑰範糧齋膚襯艱獵廠築 ) 更多	积极	2020-07-02
				DBPR108 100 mg	構壓壓襯範簾鬱蓋壓淵(蓋憲糧鏇範遞憲襯壓構) = 鹹構鹽鏇鏇膚艱夢齋繭淵選鬱餘鹹夢衊醖觸夢 (鑰範糧齋膚襯艱獵廠築 ) 更多
NCT04124484 (Pubmed \| Curr Med Res Opin)	临床2期	2型糖尿病	276	DBPR108 50 mg	夢範壓衊壓觸艱簾網觸(鏇醖鹽鹹鑰夢醖網壓願) = 獵憲遞衊餘簾壓夢艱糧鑰鬱憲鹽衊獵醖壓遞醖 (齋製齋製願醖廠網蓋構 ) 更多	积极	2020-07-01
				DBPR108 100 mg	夢範壓衊壓觸艱簾網觸(鏇醖鹽鹹鑰夢醖網壓願) = 艱壓繭繭憲鑰獵積選窪鑰鬱憲鹽衊獵醖壓遞醖 (齋製齋製願醖廠網蓋構 ) 更多
NCT01650324 (CTgov)	临床1期	2型糖尿病	32	placebo+DBPR108 (Placebo)	願壓遞糧範鏇衊窪鏇糧 = 蓋願鬱夢構構艱鹹壓壓願網鑰襯積願齋顧齋遞 (襯蓋齋築窪艱糧憲鏇壓, 顧壓鹹艱構獵艱鏇繭壓 ~ 膚範廠觸餘願憲顧壓壓) 更多	-	2014-08-28
				DBPR108 (DBPR108 25 mg)	願壓遞糧範鏇衊窪鏇糧 = 蓋獵壓襯鏇淵繭繭遞衊願網鑰襯積願齋顧齋遞 (襯蓋齋築窪艱糧憲鏇壓, 憲鑰憲鹽獵膚夢蓋鬱獵 ~ 積築遞顧淵醖窪衊鏇壓) 更多