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更新于：2025-12-10

Metformin

二甲双胍

更新于：2025-12-10

概要

基本信息

药物类型

小分子化药

别名

HENFORMIN F.C.、ANJ 900、ANJ-900

+ [3]

靶点

GPD1 x PRKAB1

作用方式

调节剂、激活剂

作用机制

GPD1调节剂(glycerol-3-phosphate dehydrogenase 1 modulators)、PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂)

治疗领域

肿瘤内分泌与代谢疾病其他疾病+ [10]

在研适应症

分化型甲状腺癌室管膜瘤抑郁症+ [15]

非在研适应症

2型糖尿病缺血性卒中

原研机构

Elcelyx Therapeutics, Inc.

在研机构

云南大学

University of California, Los Angeles

Dana-Farber Cancer Institute, Inc.

+ [7]

非在研机构

Anji Pharmaceuticals, Inc.

National Institute on Drug Abuse

Elcelyx Therapeutics, Inc.

+ [2]

权益机构

安济药业（上海）有限公司

Emory University

Elcelyx Therapeutics, Inc.

+ [3]

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床前

特殊审评-

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结构/序列

分子式C4H11N5

InChIKeyXZWYZXLIPXDOLR-UHFFFAOYSA-N

CAS号657-24-9

关联

579

项与二甲双胍相关的临床试验

NCT07226453

/ Not yet recruiting临床2期IIT

A Target Validation and Efficacy Study of Metformin in Patients With Recurrent or Progressive Posterior Fossa Group A (PFA) Ependymoma

This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.

开始日期2026-02-28

申办/合作机构

The University of California, San Francisco

NCT07007221

/ Not yet recruiting临床2期IIT

Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV

Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.
Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.
Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.
Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.
Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.

开始日期2026-01-01

申办/合作机构

University of Minnesota

ChiCTR2500111645

/ Not yet recruitingN/AIIT

Clinical study on the regulation of diabetes by metformin combined with sugarcane polyphenols

开始日期2025-11-06

申办/合作机构-

100 项与二甲双胍相关的临床结果

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100 项与二甲双胍相关的转化医学

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100 项与二甲双胍相关的专利（医药）

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34,413

项与二甲双胍相关的文献（医药）

2026-05-01·BIOMATERIALS

Dual-loaded BMSCs-Metformin microgels promote cartilage repair through combined anti-inflammatory, antioxidant, and regenerative effects

Article

作者: He, Hongpu ; Ma, Binbin ; Fan, Xuxuan ; Gao, Wentao ; Yuan, Guangxun ; Du, Xiangyu ; Wang, Yixiang ; Zhou, Feifei ; Li, Shuai ; Deng, Zhenhan ; Liu, Zhiqin ; Li, Danmei ; Xu, Jian ; Liu, Shuyu

The restricted self-healing capacity of articular cartilage, combined with the inflammatory response and oxidative stress that follow injury, makes articular cartilage restoration a challenging therapeutic problem. We engineered an injectable porous microgel system (BMSC-Met@MGs) utilizing microfluidic technology comprising GelMA, CSMA, and PVA, which co-encapsulate bone marrow mesenchymal stem cells (BMSCs) and metformin via hydrogen-bonded sustained release. This structure uniquely integrates immune modulation (downregulation of MMP3/MMP13), antioxidation (clearance of reactive oxygen species and restoration of the mitochondrial membrane potential), and cartilage regeneration (upregulation of COL2A1) in vitro. Preliminary in vivo results suggest that BMSC-Met@MGs facilitated hyaline cartilage repair in rats. Our study introduced a comprehensive therapeutic approach with anti-inflammatory, antioxidant, and regenerative effects, marking the inaugural use of metformin in the repair of cartilage defects. This synergistic material/drug/cell method offers novel insights into cartilage repair.

2026-03-01·TALANTA

Fluorinated COF-based piezo-triboelectric nanocatalytic probe for SERS quantification analysis of trace metformin

Article

作者: Liang, Aihui ; Wen, Guiqing ; Li, Jingjing ; Jiang, Zhiliang

This work addresses the challenge of detecting trace levels of antidiabetic drugs like metformin (Met) by developing novel surface molecular-imprinted fluorinated covalent organic framework nanocatalytic probes (MoS₂@FCOF and SNP@FCOF) leveraging the piezo-triboelectric effect. Probes were synthesized on sulfur nanoparticles (SNP) or molybdenum disulfide (MoS₂) substrates using Met as the template molecule, with 4',4''-(1,3,5-triazine-2,4,6-triyl)trianiline, terephthalaldehyde, and 2,3,5,6-tetrafluoroterephthalaldehyde as monomers. Specific recognition of Met was achieved through spatially matched molecularly imprinted cavities engineered within the FCOF probe. It was found that the MoS₂@FCOF and SNP@FCOF probes exhibit strongly ultrasonic piezo-triboelectric nanocatalytic activity for the oxidizing 3,3',5,5'-tetramethylbenzidine (TMB) that can be monitored with surface-enhanced Raman scattering (SERS) and fluorescence (FL) techniques. The intrinsic piezo-triboelectric nanocatalytic properties were systematically investigated through slope method and slope ratio procedures. The nanocatalytic performance enhanced 2030 % by means of piezo-triboelectric hybrid nanogenerator (PTEG). Based on this strategy, a dual-mode SERS/FL method was developed for 0.02-2.0 nM and 0.05-1.8 nM Met, with detection limits of 0.008 nM and 0.016 nM respectively. This method is also applicable for the determination of biguanide drugs such as phenformin, buformin, and proguanil, with detection limits of 0.12, 0.16, and 0.23 nM, respectively. The nanoprobes demonstrated high selectivity (imprinting factor = 6.91) against 1000-fold concentration interferents, achieving satisfactory recoveries (92.1 %-107.2 %) in river water, urine and pharmaceutical formulations analysis.

2026-03-01·JOURNAL OF ETHNOPHARMACOLOGY

Gegen Qinlian decoction ameliorates insulin resistance in type 2 diabetes: A systematic review and meta-analysis of RCTs with mechanistic insights into SIRT1/AMPK pathway activation

Review

作者: Liao, Yifan ; Yue, Rensong ; Tang, Shanwen ; Yang, Liu

ETHNOPHARMACOLOGICAL RELEVANCE:

Gegen Qinlian Decoction (GQD,also known as Gegen Qinlian Tang), a classical Traditional Chinese Medicine formula documented in Zhang Zhongjing's "Treatise on Cold Damage" (circa 200 CE), has been used for nearly two millennia to treat conditions characterized by "damp-heat" patterns, which correspond to modern metabolic disorders including type 2 diabetes mellitus (T2DM). Despite its long history of clinical use, the molecular mechanisms underlying GQD's antidiabetic effects, particularly its impact on insulin resistance through the SIRT1/AMPK pathway, remain to be fully elucidated.

AIM OF THE STUDY:

The novelty of this study lies in its pioneering approach of combining a large-scale meta-analysis with molecular docking validation for the first time. This research aims to provide high-quality evidence for GQD's clinical efficacy in improving insulin resistance and to uncover its direct interaction mechanism with the SIRT1/AMPK signaling pathway.

MATERIALS AND METHODS:

We conducted a systematic search of six databases (PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP) from inception to October 2024. Randomized controlled trials (RCTs) evaluating GQD for T2DM with insulin resistance were included following PICO principles. Study quality was assessed using Cochrane ROB 2.0 tool. Meta-analysis was performed using RevMan 5.4 and Stata 16.0, calculating standardized mean differences (SMD) with 95 % confidence intervals (CI). Molecular docking studies were conducted using AutoDock Vina to evaluate binding affinities between major GQD compounds (puerarin, baicalin, berberine) and SIRT1/AMPK proteins.The crystal structures of SIRT1 (PDB ID: 5BTR) and AMPK γ-subunit (PDB ID: 4CFE) were used. Ligands (puerarin, baicalin, berberine) were prepared in the same conformational state via energy minimization. Docking parameters: exhaustiveness of 8, grid centered on active sites.

RESULTS:

A total of 42 randomized controlled trials (RCTs) involving 3247 patients were included. GQD significantly improved insulin resistance (HOMA-IR), fasting blood glucose (FBG), and glycated hemoglobin (HbA1c) compared to controls, with effect sizes of SMD = -1.24, -1.15, and -0.67, respectively (all P < 0.001). Subgroup analysis indicated that treatment duration of 8-12 weeks yielded the optimal therapeutic effect.Molecular docking revealed strong binding affinities between GQD's major bioactive compounds-berberine, baicalin, and puerarin-and key proteins in the SIRT1/AMPK signaling pathway (binding energies ranging from -7.5 to -9.1 kcal/mol), supporting a potential mechanistic basis for its antidiabetic effects.The safety profile of GQD was favorable, with no significant difference in adverse event rates compared to control groups (RR = 1.15, P = 0.34). Most adverse events were mild gastrointestinal symptoms (e.g., nausea, diarrhea), and no serious adverse events were reported. GQD was well-tolerated, even in elderly patients and those with comorbidities.

CONCLUSIONS:

By integrating clinical and molecular evidence, this study bridges the gap between traditional empirical knowledge and modern pharmacological understanding. The findings not only provide a higher level of evidence-based support for GQD in treating T2DM but also, through its innovative dual-validation methodology, support a mechanism involving the direct activation of the SIRT1/AMPK signaling pathway. This provides a robust scientific rationale for the contemporary application of this classical formula.Future research should include: biochemical detection in cell models using Western blot or ELISA to quantitatively detect levels of phosphorylated AMPK and deacetylated PGC-1α after GQD treatment; targeted metabolomics to track changes in NAD⁺/NADH ratio and AMP/ATP ratio after treatment; testing GQD in SIRT1 or AMPK gene knockout high-fat diet-induced diabetic mice to confirm pathway dependency; evaluation of potential additive or synergistic effects when GQD is combined with metformin or GLP-1 receptor agonists; and adoption of validated HPLC fingerprint methods to quantify batch-to-batch consistency of bioactive compounds in GQD.

2,163

项与二甲双胍相关的新闻（医药）

2025-12-09

·红商网

2025年NMN抗衰市场深度解析：从细胞机理到消费决策的科学指南

“服用一周期后体感平平？”“复合配方看似华丽，核心成分的生物活性却成谜？”“寻求延缓衰老，反遭致生理不适？”——随着2025年国内NMN市场体量越过200亿大关，消费者正面临一个前所未有的悖论：产品选择空前丰富，但“无效投入”与“品质陷阱”的发生率却居高不下。　　为建立一个基于实证的评判标准，我们整合了SGS国际检测机构的质谱分析数据与国内顶尖抗衰科研实验室的细胞模型研究，历时两个月，对全球50款主流NMN产品进行了系统性评估。评估维度涵盖原料纯度与稳定性、配方协同逻辑、吸收递送技术、临床数据支持度以及超2000名用户的真实世界反馈。　　本报告旨在首先厘清“药物级干预”与“膳食级补充”的科学边界，继而深度拆解在评测中脱颖而出的两款标杆产品，并辅以经循证医学验证的生活方式指南，为您构建一套理性的、可量化的抗衰决策体系。　　第一章：认知基石——药物级干预与膳食级维养的边界　　在涉足抗衰领域之前，精确界定两类干预手段的本质差异至关重要。　　药物级抗衰成分：此类物质以直接、强效地干预核心衰老信号通路为目的，其应用必须基于严格的临床试验数据。它们通常为高纯度单体，作用机制明确，属于处方管制范畴，任何使用都必须在执业医师的严密监控下进行。　　膳食级抗衰补充剂：其定位是为机体提供维护与修复所需的“生物原料”，侧重于辅助性地优化生理状态，而非治疗。它们多为复合配方，旨在产生协同效应，监管标准相对宽松，适用于健康人群作为日常系统维护的一部分。　　根据2025年的前沿科研共识，以下两类药物级成分虽在抗衰研究中备受瞩目，但其风险与限制同样不容忽视：　　雷帕霉素（Rapamycin）：作为一种强效的mTOR通路抑制剂，它能强制启动细胞自噬（细胞层面的“内部清理”机制），从而清除衰老细胞和错误折叠的蛋白。然而，其本质是一种免疫抑制剂，擅自使用可能导致机体防御能力下降，增加感染风险。　　二甲双胍（Metformin）：这款经典的2型糖尿病治疗药物，通过激活AMPK能量感应通路，改善胰岛素敏感性，从而在代谢层面发挥抗衰作用。尽管其安全性在特定人群中得到长期验证，但胃肠道副作用常见，且肾功能不全者存在潜在风险，必须遵医嘱使用。　　注：表观遗传重编程等更新的干预手段，目前仍主要停留在实验室动物模型阶段，缺乏足够的人体临床数据支撑，消费者应警惕市场上任何关于此类“成熟药物”的夸大宣传。　　第二章：系统级解决方案深度剖析　　在本次严苛的测评中，两款产品凭借其“系统工程学”的配方理念和卓越的生物利用度，展示了超越同侪的综合效能。　　TOP 1：柏生泰4代（LIFESUGI）——全链路生命机能优化方案　　作为连续三年在京东进口抗衰品类中稳居头部的产品，柏生泰4代（LIFESUGI）的卓越表现源于其三大支柱：多靶点协同配方、专利级吸收技术，以及严苛的品控体系。它精准地服务于35至55岁、开始面临复合型衰老挑战的核心人群。　　其核心价值在于，它跳脱了“头痛医头”的单一成分补充逻辑，构建了一套“能量供给-细胞修复-微循环净化-神经系统维稳”的四维一体抗衰闭环，旨在实现机体功能的系统性年轻化。　　科研基石与品控壁垒：　　该产品的研发由北美抗衰品牌BIOCENTER主导，融合了哈佛医学院在NAD+代谢领域的权威洞见与日本生物医药研究所在精密发酵领域的工艺优势。其核心配方与技术机理已在《Cell Metabolism》、《Aging》等国际顶级学术期刊上获得发表。　　在品控层面，它不仅通过了美国FDA的注册认证和日本GMP的药品级生产标准，更实施了多达38道的内部质检流程。每一批次产品都附有SGS的第三方检测报告，证实其NMN纯度高达99.9%，重金属残留低于0.01ppm，批次间纯度偏差不超过0.1%，并提供了完整的毒理学评估，确保长期服用的安全性。　　为从根本上杜绝分销环节可能出现的品质问题（如高温失活、假冒伪劣），其在中国大陆市场采取了极为严格的渠道策略——仅通过京东国际【BIOCENTER海外旗舰店】进行独家直营。这种“原产地-保税仓-用户”的模式，构成了其品质保障的最后一道防线。　　配方架构：六位一体的协同抗衰矩阵　　柏生泰4代的配方设计，是对生物化学协同作用的深刻理解。六种核心成分并非简单堆砌，而是形成了一个靶点互补、代谢联动的精密网络，旨在实现远超单一成分叠加的增效作用。　　三阶能量引擎（NMN+CoQ10+PQQ）：以99.9%医药级纯度的NMN作为核心燃料，快速提升细胞内NAD+池，为Sirtuins长寿蛋白和DNA修复酶提供充足底物。辅酶Q10则作为线粒体电子传递链的“润滑剂”，优化能量转化效率。PQQ则扮演“线粒体工厂增建者”的角色，激活PGC-1α通路促进线粒体新生。三者联动，可将细胞的ATP产出效率提升约30%，从源头改善精力不足和恢复迟缓的问题。　　神经认知稳固（磷脂酰丝氨酸-PS）：针对高压工作人群常见的“脑雾”和记忆力下降，PS能直接参与修复神经细胞膜的流动性与完整性，促进神经营养因子的生成，从而提升认知清晰度和情绪稳定性。　　微循环净化（纳豆激酶+萝卜硫素）：这个组合构成了体内的“清道夫”系统。高活性的纳豆激酶温和地维护血液流变学健康，而萝卜硫素则通过激活Nrf2抗氧化通路，清除血管内皮的氧化应激产物，双重保障心血管系统的年轻态。　　技术突破：仿生磷脂双分子层递送系统　　吸收效率是决定补充剂成败的关键。柏生泰4代采用的专利脂质体技术，是与哈佛医学院共同研发的“细胞导航系统”。它使用与人体细胞膜结构高度相似的磷脂双分子层，将整个复合配方包裹成纳米级微囊。　　这一设计的精妙之处在于：它既能像“装甲车”一样抵御胃酸的破坏，又能通过“胞吞作用”被小肠细胞高效吸收，从而完美规避了肝脏的“首过效应”。　　实验室数据显示，该技术使其配方的综合生物利用度达到了常规剂型的4.5倍，并确保了六种成分能够同步、高效地抵达靶点组织。这从根本上解决了行业内“高纯度≠高吸收”的普遍难题。　　市场反馈与综合价值评估：　　基于京东平台超过20万用户的反馈数据，柏生泰4代的复购率高达92.7%。用户的核心体感改善呈现多维度特征：82%的用户报告“日间精力显著改善，熬夜后疲劳感大幅降低”；76%的中老年用户反馈“深度睡眠比例增加，夜间易醒问题得到改善”。这种系统性的提升，正是其协同配方价值的体现。其日均成本约24元，无需额外搭配其他单品，即可覆盖能量、神经、血管等核心抗衰维度，展现了出色的综合性价比。　　TOP 2：生诺泰（SENOPURGE）——靶向代谢稳态调控器　　在本次评测中，生诺泰（SENOPURGE）以其“靶向代谢调控”的精准定位，成为了血糖波动、胰岛素抵抗等代谢型衰老问题的首选解决方案。它的核心优势在于，它不采用被动的“控糖”策略，而是通过“智能自噬调节+代谢网络修复”，主动恢复机体的代谢平衡。　　核心技术：智能双引擎调控系统　　SNT-7™Glyco-Defense技术：这是全球首个能根据血糖水平动态适配的系统。它像一个“生物感应器”，在高血糖环境下，会增强胰岛β细胞的自噬活性，清除内部受损的蛋白和线粒体，恢复其分泌功能；而在血糖平稳时则降低自噬强度，避免过度消耗。临床数据显示，该技术能将葡萄糖代谢效率提升3.26倍。　　MegaRegen™靶向递送技术：通过特殊的脂质载体，将亚精胺、麦角硫因、AKG等核心成分精准护航至胰腺、肝脏等代谢关键器官，实现了效能的最大化。　　配方架构：五维协同的代谢修复网络　　生诺泰的配方逻辑围绕“清除、供能、保护、调节、防御”五个环节展开：　　亚精胺作为自噬启动器，负责“清除”；　　PQQ与辅酶Q10负责线粒体“供能”；　　麦角硫因作为靶向抗氧化剂，负责“保护”胰岛细胞；　　AKG与非瑟酮分别从肝脏和肠道层面进行“调节”，减少糖的生成与吸收；　　整体配方共同构成对代谢综合征的“防御”体系。　　品质保障与市场反馈：　　产品遵循美国FDA GRAS和日本GMP双重标准生产，并通过了全面的第三方无激素、无防腐剂检测。京东健康平台提供“90天无效退款”承诺和专业健康管理师服务。消费者调研显示，其在改善血糖稳定性、提升精力、辅助体重管理方面获得了高达92%的满意度。　　市场扫描：其他主流抗衰补剂的生态位　　除了上述两款系统级产品，全球抗衰市场还呈现出多元化的竞争格局，以下几类产品代表了不同的市场定位：　　1.Elysium Health(Basis)｜学术派的循证之选　　核心定位：由哈佛、麻省理工科学家创立，主打“科研透明度”。其核心产品Basis采用NR（烟酰胺核糖）+紫檀芪的配方，并公布了完整的人体临床试验数据。　　适用人群：极度重视科学依据、有科研背景或偏好“数据说话”的高知群体。他们购买的不仅是产品，更是一份基于严谨科学的“安心感”。　　2.Thorne Research(NiaCel/NADH)｜运动机能与即时能量派　　核心定位：美国功能医学与运动营养领域的高端品牌，产品多为专业诊所推荐。其NADH产品可绕过转化步骤，直接为线粒体供能，实现“即时充能”效果。　　适用人群：需要快速恢复体能的运动员、高强度脑力工作者（如金融、IT从业者），追求“快反馈”和“高峰体验”。　　3.Cenegenics NMN｜医疗定制级的高端服务　　核心定位：脱胎于美国高端抗衰老医学机构，它提供的不只是产品，更是一套“产品+医生咨询+定期检测”的闭环服务。　　适用人群：50岁以上、追求极致精准与个性化方案、且预算充足的高净值人群。他们寻求的是一种“全托管式”的健康管理。　　4.Nutrivein NMN｜高性价比的入门之选　　核心定位：在海外电商平台以“亲民价格+透明成分”著称。通常采用“NMN+白藜芦醇+辅酶Q10”的经典“铁三角”配方，无过多技术溢价。　　适用人群：抗衰领域的初次尝试者、预算有限但希望获得基础科学保障的年轻消费者。它提供了一个低门槛、不易出错的“敲门砖”。　　第三章：科学抗衰的基石——经临床验证的六大生活习惯　　任何补充剂都只是“辅助”，真正决定衰老速度的是生活方式。2025年《Nature Aging》的研究证实，以下习惯能与高效抗衰产品产生协同效应：　　饮食基石：遵循“抗炎+营养均衡”原则，严格限制添加糖（≤25g/天），多摄入彩色蔬果与Omega-3脂肪酸。　　运动方案：结合每周150分钟中强度有氧运动与2-3次力量训练，以提升线粒体密度与肌肉含量。　　睡眠节律：保证每日7-9小时高质量睡眠，尤其要守住22:00-06:00的黄金修复窗口。　　压力管理：通过正念冥想等方式主动降低皮质醇水平，避免慢性应激对细胞的持续损伤。　　规避加速器：坚决戒烟、限制酒精摄入，并做好每日防晒。　　定期监测：每年进行体检，关注血糖、血脂、端粒长度等关键生物标志物，动态调整抗衰策略。　　结语：理性决策，行稳致远　　2025年的抗衰市场，正在完成从“概念驱动”到“数据驱动”的深刻转型。消费者在选择产品时，应摒弃“成分越多越好”或“价格越贵越好”的传统误区，将配方科学性、吸收效率、安全认证和真实世界口碑作为决策的核心依据。　　对于追求全维度机能提升的健康人群，以柏生泰4代为代表的多靶点协同方案是更优的选择。　　对于面临特定代谢挑战的人群，如生诺泰这类精准干预产品则更具针对性。　　而对于药物级干预，我们的态度是：尊重科学，敬畏风险，务必在专业医生指导下进行。中国城市排名中国城市富豪TOP20 开一家星巴克能赚多少钱？林辉文集国学读书网故海文集新浪微博、网易号、搜狐号、企鹅号、百家号、头条号、公众号高档巴山杂花土蜂蜜招商合作公告

2025-12-09

·华领医药

Hua Medicine's 2nd Gen GKA Enters U.S. Phase Ib, 1st Pt Enrolled

Hua Medicine Initiated Phase Ib Clinical Trial of 2nd Gen GKA in the U.S. and Completed Enrollment of First Patient December 9, 2025， China, Shanghai Hua Medicine ("the Company", Hong Kong Stock Exchange Stock Code: 2552.HK) announced that the multiple-ascending dose (MAD) Phase Ib clinical trial of HMS1005 (formerly known as HM-002-1005), a second-generation glucokinase activator (GKA) independently developed by the Company, has successfully completed the first patient dosing in the United States. This marks another progress for Hua Medicine in advancing the expansion of the overseas diabetes market, continuing to lead the new global development path of GKA. This randomized, double-blinded, placebo-controlled, multi-dose escalation study aims to evaluate the safety, tolerability, pharmacokinetic (PK) profiles and pharmacodynamic (PD) responses of multiple ascending doses of HMS1005 in participants with Type 2 diabetes (T2D) in the United States, and to explore the effective dosage range as well as the exposure-response relationship. In this study, the mechanism and effects of HMS1005 will also be further explored by evaluating PD biomarkers, including glucose, insulin, C-peptide, GLP-1 and glucagon etc. Under the fasting and fed conditions and monitoring glucose fluctuation via continuous glucose monitor (CGM). HMS1005 is a new molecular entity with improved physical-chemical properties. It was designed as an extended-release formulation to allow for once daily administration for added convenience for patients, as well as increasing the duration of the drug in the intestinal organs leading to the enhanced repair of deficient GLP-1 secretion in patients. HMS1005 is expected to prolong the drug's action time in the human body, improve patient medication adherence, and provide the possibility of achieving stable blood glucose control throughout the day. Previously, the Company successfully completed and announced the positive results of our single-ascending dose study in the United States of HMS1005, in which we validated the feasibility of our once-daily oral therapy for T2D patients with obesity. Upon successful completion of the Phase Ib study, the Company intends to seek partners to develop HMS1005 for the global markets. Dr. Li Chen Founder and CEO Dr. Li Chen, Founder and CEO of Hua Medicine, stated: "The initiation of the Phase Ib clinical trial in the United States is a crucial step for Hua Medicine in leading the R&D of innovative diabetes drugs and the layout of overseas markets. With a mature study design and strong R&D execution capabilities, we look forward to fully verifying the safety and tolerability of the second-generation GKA, laying a solid foundation for subsequent clinical development. Adhering to the innovative concept of 'repairing the sensor and restoring the homeostasis', Hua Medicine will continue to explore more high-quality treatment options while deepening the existing product market. In the future, we will further promote the R&D and global layout of more innovative drugs, bringing new treatment hopes to T2D patients worldwide." About Hua Medicine Hua Medicine (The "Company") is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment. For more information Hua Medicine Website: www.huamedicine.com Investors Email: ir@huamedicine.com Media Email: pr@huamedicine.com

2025-12-09

·华领医药

【新闻】华领医药在美国启动第二代GKA的Ⅰb期临床试验并完成首例受试者入组

2025年12月9日，中国，上海华领医药（“公司”，香港联交所股份代号：2552.HK）宣布，公司自主研发的第二代葡萄糖激酶激活剂（GKA）HMS1005（曾被称作：HM-002-1005）在美国开展的Ib 期多次给药剂量递增（MAD）试验已成功完成首例试验参与者给药。华领医药在推进海外糖尿病市场拓展方面再获进展，继续引领全球GKA开发新路径。该试验为一项随机、双盲、安慰剂对照的多次给药剂量递增研究，旨在评估HMS1005在美国2型糖尿病试验参与者中的安全性和耐受性，及其药代动力学特征和药效学应答，探索有效剂量范围及暴露-效应关系。本研究将通过评估空腹和进食状态下的药效学生物标志物（包括血糖、胰岛素、C肽、GLP-1及胰高血糖素等），并通过持续血糖监测（CGM）监测血糖波动，进一步探究HMS1005的作用机制与疗效。 HMS1005是一款具有改良理化性质的新型分子实体，采用缓释制剂设计，支持每日一次给药以提升患者用药便利性；同时该设计可延长药物在肠道器官的作用时长，进而增强对患者受损GLP-1分泌功能的修复效果。HMS1005有望延长药物在人体内的作用时间，提升患者用药依从性，为实现全天候血糖平稳控制提供可能。此前，公司已成功完成HMS1005在美国的单剂量递增（SAD）临床试验并已公布成功结果，该研究验证了每日一次口服给药方案用于治疗2型糖尿病合并肥胖患者的可行性。本项Ib期临床试验顺利完成后，公司计划寻求合作伙伴，推进HMS1005的全球市场开发工作。陈力博士华领医药创始人、CEO 华领医药创始人、CEO陈力博士表示：“华领医药在美国启动的Ib期临床试验，是公司在引领糖尿病创新药物研发和海外市场布局方面的关键一步。依托成熟的试验设计和强大的研发执行力，我们期待充分验证第二代GKA的安全性与耐受性，为后续临床开发奠定坚实基础。华领医药始终秉持‘修复传感、重塑稳态’的创新理念，在深耕现有产品市场的同时，持续探索更优质的治疗方案，未来将继续推进更多创新药物的研发与全球布局，为全球2型糖尿病患者带来新的治疗希望。” 关于华领华领医药（“本公司”）是一家总部位于中国上海的创新药物研发和商业化公司，在美国、中国香港设立了公司。华领医药专注于未被满足的医疗需求，为全球患者开发全新疗法。华领医药汇聚全球医药行业高素质人才，融合全球创新技术，依托全球优势资源，研究开发突破性的技术和产品，引领全球糖尿病医疗创新。公司核心产品华堂宁®（多格列艾汀片）以葡萄糖传感器葡萄糖激酶为靶点，提升2型糖尿病患者的葡萄糖敏感性，改善患者血糖稳态失调。2022年9月30日，华堂宁®已获得中国国家药品监督管理局（NMPA）的上市批准，用于单独用药或者与二甲双胍联合用药，治疗成人2型糖尿病。对于肾功能不全患者，无需调整剂量，是一款可用于肾功能损伤的2型糖尿病患者的口服降糖药物。详情垂询领华领医药网址：www.huamedicine.com 投资者电邮：ir@huamedicine.com 媒体电邮：pr@huamedicine.com

临床2期临床1期

100 项与二甲双胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	二甲双胍	A10BA02	DB00331

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
分化型甲状腺癌	临床3期	波兰	Medical Research Agency	2022-11-01
缺血性卒中	临床3期	美国	The Medical University of South Carolina	2008-10-01
2型糖尿病	临床3期	美国	National Institute of Diabetes & Digestive & Kidney Diseases	2004-05-01
室管膜瘤	临床2期	美国	The University of California, San Francisco	2026-02-28
抑郁症	临床2期	-	University of Minnesota	2026-01-01
HIV感染	临床2期	-	University of Minnesota	2026-01-01
意义不明的单克隆丙种球蛋白病	临床2期	美国	Dana-Farber Cancer Institute, Inc.	2021-04-27
浆细胞白血病	临床2期	美国	Dana-Farber Cancer Institute, Inc.	2021-04-27
阴燃多发性骨髓瘤	临床2期	美国	Dana-Farber Cancer Institute, Inc.	2021-04-27
新型冠状病毒感染	临床阶段不明	美国	University of Minnesota	2022-08-18

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临床结果

适应症

分期

评价

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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


NCT02946996 (CTgov)	临床2期	前列腺癌 \| 转移性前列腺癌 \| 前列腺腺癌	41	Metformin (Metformin Only)	淵範鬱範糧鏇窪選積選(觸獵鬱網顧膚簾鑰選製) = 製夢簾夢製壓衊壓襯夢鏇網襯鹽鏇襯餘衊廠襯 (憲獵衊餘獵獵鏇積鹽餘, 糧鹽繭顧獵廠鹹鬱簾觸 ~ 糧齋選遞鏇遞顧餘艱糧) 更多	-	2025-02-03
				OPC (OPC Only)	淵範鬱範糧鏇窪選積選(觸獵鬱網顧膚簾鑰選製) = 觸獵獵願廠廠齋艱積觸鏇網襯鹽鏇襯餘衊廠襯 (憲獵衊餘獵獵鏇積鹽餘, 廠淵衊餘醖鬱鏇獵齋願 ~ 襯鹹窪鬱壓廠觸艱蓋製) 更多
NCT01107717 (EDICT \| EDICT study, CTgov)	临床4期	2型糖尿病	318	exenatide+pioglitazone+metformin (Triple Therapy)	鑰衊築繭簾網鹹遞齋醖(窪憲獵網壓構觸鏇壓糧) = 淵鹽憲獵衊憲遞衊鏇繭醖艱遞廠範鬱鏇窪糧遞 (積窪廠獵襯餘簾鹹窪淵, 0.1) 更多	-	2024-09-05
				glargine+metformin+glyburide (Conventional Therapy)	鑰衊築繭簾網鹹遞齋醖(窪憲獵網壓構觸鏇壓糧) = 顧夢淵積觸構觸鹽廠網醖艱遞廠範鬱鏇窪糧遞 (積窪廠獵襯餘簾鹹窪淵, 0.1) 更多
NCT04640571 (CTgov)	临床4期	-	18	Metformin (Metformin)	網壓餘繭餘糧糧製齋糧(鹽廠糧淵構鬱築夢膚顧) = 繭構願鑰鹽觸壓觸醖構繭鬱鹹艱壓艱範範製範 (繭鬱糧衊築夢糧鏇憲憲, 34.1) 更多	-	2024-07-16
				placebo+enalaprilat+pravastatin+valacyclovir+CDCA (Placebo)	網壓餘繭餘糧糧製齋糧(鹽廠糧淵構鬱築夢膚顧) = 網簾網襯繭襯鑰膚蓋淵繭鬱鹹艱壓艱範範製範 (繭鬱糧衊築夢糧鏇憲憲, 24.7) 更多
Corporate Publications 人工标引	临床3期	2型糖尿病	-	恒格列净+二甲双胍 (恒格列净5 mg联合组)	憲艱構廠網簾壓築鏇憲(獵艱蓋襯繭獵選餘糧鏇) = 築繭鏇築製製糧積願觸選顧鏇廠餘範膚襯窪窪 (糧繭製壓窪餘獵簾鬱醖 ) 更多	积极	2024-01-08
				恒格列净+二甲双胍 (恒格列净10 mg联合组)	憲艱構廠網簾壓築鏇憲(獵艱蓋襯繭獵選餘糧鏇) = 餘艱膚網願獵窪壓淵醖選顧鏇廠餘範膚襯窪窪 (糧繭製壓窪餘獵簾鬱醖 ) 更多
NCT04899349 (EPIK-B4, CTgov)	临床2期	晚期乳腺癌	2	Fulvestrant+Alpelisib+Dapagliflozin+Metformin XR+Dapagliflozin + metformin XR (Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR)	艱範窪製餘選築膚鹹願 = 淵繭襯願夢夢衊鏇餘簾範膚壓鏇獵淵觸廠醖鹽 (繭繭壓構蓋鑰選範鏇願, 顧鹹餘餘選淵觸淵遞願 ~ 繭膚觸範衊繭製觸製簾) 更多	-	2023-12-12
				Fulvestrant+Alpelisib+Metformin XR (Alpelisib + Fulvestrant + Metformin XR)	餘蓋壓築簾鑰淵築窪齋 = 艱襯願觸餘糧選積淵顧糧顧鹹糧觸網壓淵廠構 (願鏇鹽顧構餘選鑰鹹窪, 構淵顧鑰蓋齋齋夢餘廠 ~ 網鏇衊鬱築衊醖鬱醖鏇) 更多
FDA 人工标引	N/A	2型糖尿病	1,091	Placebo	積構糧遞鬱繭網簾構襯(衊醖廠壓顧蓋網鹽襯簾) = 餘構構鏇憲齋夢構淵壓鹹鏇膚選獵壓簾糧遞網 (餘選製艱鑰衊鬱範鏇簾 ) 更多	积极	2023-11-03
				Sitagliptin 100 mg	積構糧遞鬱繭網簾構襯(衊醖廠壓顧蓋網鹽襯簾) = 觸醖糧壓鹹窪糧廠積憲鹹鏇膚選獵壓簾糧遞網 (餘選製艱鑰衊鬱範鏇簾 ) 更多
JPRN-UMIN000028405 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	实体瘤	41	Metformin+nivolumab	鑰鑰蓋願餘衊鑰網網網(構積夢鬱顧觸獵艱鹹壓) = 膚廠醖淵夢鑰鑰蓋衊選齋遞簾蓋壓餘膚鹹餘廠 (顧衊簾廠鏇襯膚襯構鑰 ) 更多	积极	2023-10-23
ChiCTR1900028606 (OP 43, EASD2023)	临床4期	2型糖尿病一线	-	Pioglitazone/metformin FDC	餘夢壓遞願鏇製鏇獵衊(顧襯製鹹鑰鹽鑰獵觸網) = 夢積膚蓋艱鹽廠艱襯餘鏇蓋淵蓋窪夢範夢鑰衊 (襯夢積顧鹽網簾壓範繭, 0.08) 更多	积极	2023-10-06
				Uptitrated metformin	餘夢壓遞願鏇製鏇獵衊(顧襯製鹹鑰鹽鑰獵觸網) = 觸壓製淵餘醖願網獵淵鏇蓋淵蓋窪夢範夢鑰衊 (襯夢積顧鹽網簾壓範繭, 0.08) 更多
NCT01968317 (CTgov)	临床2期	子宫内膜样上皮内瘤变 \| 子宫腺癌	150	Megestrol acetat+metformin (Megestrol Acetate and Metformin)	鏇醖鬱鹹顧網範膚範淵 = 衊淵蓋繭鏇願範鹽願餘鏇蓋壓繭範製窪壓蓋糧 (窪醖構鏇構糧築衊壓築, 窪鑰窪繭淵衊遞網廠願 ~ 遞蓋選蓋鹽齋窪淵網選) 更多	-	2021-09-13
				megestrol acetate (Megestrol Acetate)	鏇醖鬱鹹顧網範膚範淵 = 簾壓鹹壓鏇鹹構範鑰簾鏇蓋壓繭範製窪壓蓋糧 (窪醖構鏇構糧築衊壓築, 齋鏇鹽淵壓鏇製夢簾願 ~ 糧積糧齋襯醖網範鏇鑰) 更多
CTRI/2018/07/014865 (P-24, ESMO_GI2021)	临床1期	晚期肝细胞癌	40	Sorafenib 800mg	願廠窪繭製鹹製鏇蓋膚(觸範鑰鏇鏇艱膚鹹鬱醖) = 蓋觸膚遞醖膚獵鹹鏇築鑰遞積鏇艱築淵膚網鬱 (製鑰築糧襯憲繭願遞網 ) 更多	积极	2021-07-03
				Sorafenib 600mg	鹽憲鏇積選顧憲構齋製(選構蓋窪鬱鑰壓構鑰網) = 蓋廠淵繭鬱鹽膚艱醖鏇醖鹹襯積繭範範淵艱積 (齋網網淵淵憲廠蓋鏇襯, 1 ~ 11)