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更新于：2026-05-22
Metformin Hydrochloride
盐酸二甲双胍
更新于：2026-05-22
概要
基本信息
简介盐酸二甲双胍，商品名为GLUCOPHAGE，用于治疗2型糖尿病。它于1957年在法国首次获批，现在由Bristol Myers Squibb公司生产。GLUCOPHAGE通过激活PRKAB1，帮助改善10岁及以上成人和儿童患者的血糖控制，配合饮食和运动使用。该药物属于双胍类药物，通常用作辅助疗法，帮助管理2型糖尿病患者的血糖水平。 |
药物类型 小分子化药 |
别名 Meiformin Hydrochloride、Metformin hydrochloride (JP17/USP)、Metformin Hydrochlorride + [67] |
靶点 |
作用方式 激活剂 |
作用机制 PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 中国 (1992-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C4H12ClN5 |
InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N |
CAS号1115-70-4 |
关联
2,840
项与 盐酸二甲双胍 相关的临床试验CTRI/2025/09/094234
A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus - NIL
NCT07511010
A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets
NCT07275359
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
100 项与 盐酸二甲双胍 相关的临床结果
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100 项与 盐酸二甲双胍 相关的转化医学
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100 项与 盐酸二甲双胍 相关的专利（医药）
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20,018
项与 盐酸二甲双胍 相关的文献（医药）2026-05-01Clinical Pharmacology in Drug Development
Comparative Pharmacokinetics and Bioequivalence Assessment of Metformin/Pioglitazone Tablet in Fasting and Fed Conditions: A Randomized Study in Healthy Chinese Subjects.
Article
作者: Wei, Zijie ; Wang, Xintong ; Li, Mengke ; Chen, Lulu ; Ouyang, Dongsheng ; Liu, Bin ; Li, Chao ; Zhou, Ling ; Li, Xiaohui ; Li, Hongcheng ; Fang, Qing
Metformin/pioglitazone tablets are a fixed-dose combination of metformin hydrochloride and pioglitazone. In healthy Chinese subjects, this study evaluated the pharmacokinetics and bioequivalence of metformin/pioglitazone (500/15 mg) tablets. We conducted a single-center, open-label, randomized, two-way crossover study in which subjects were randomized in a 1:1 ratio to either the test formulation or the reference formulation, separated by a 10-day washout period. Blood samples collected at pre-arranged intervals before and after dosing were analyzed using validated liquid chromatography-tandem mass spectrometry techniques to determine metformin and pioglitazone plasma concentrations. Finally, subjects completed fasting and fed studies, respectively. In both studies, the 90% confidence intervals for the geometric mean ratios (test/reference) of Cmax, AUC0-t, and AUC0-∞ were within acceptable bioequivalence limits (0.80-1.25), and no serious adverse events were observed. The study demonstrated that the tested and reference formulations of metformin/pioglitazone tablets are bioequivalent and well tolerated under both fasting and fed conditions.
2026-04-21JOURNAL OF VIROLOGY
Metformin hydrochloride regulates glycolysis and inhibits PEDV replication by inhibition of PI3K-AKT signaling pathway
Article
作者: Song, Ziyan ; Song, Yanwen ; Ding, Jinman ; Yang, Shu ; Sun, Zhiwei ; Zhang, Xingcui ; Song, Zhenhui ; Liao, Guisong ; Li, Yi ; Hu, Xiaoru ; Zhong, Yi ; Li, Qingyang ; Yuan, Jianbo
ABSTRACT:
Viruses rely on energy and biosynthetic materials of host cell from glucose metabolism to support their replication, and glucose plays a crucial role in viral infection. In this study, we found that porcine epidemic diarrhea virus (PEDV) infection significantly increased cellular glucose uptake and stimulated the production of the glycometabolite lactate. Exogenous supplementation of glucose or L-lactate confirmed that it significantly promoted PEDV proliferation, indicating that replication of PEDV was enhanced by regulating host glucose metabolism, particularly reprogramming glycolysis. Based on these findings, we explored the potential antiviral approach targeting the virus through regulating glycolytic processes. Metformin hydrochloride (MH) is a well-known hypoglycemic agent, which has shown notable anti-PEDV activity. After MH treatment, the transcriptome analysis showed the differential genes were mainly enriched in PI3K-AKT signaling pathway, and the expression levels of its downstream molecule GSK3B and MYC were significantly upregulated and downregulated, respectively. The gene expression related to glycolysis was also significantly inhibited. Further experiments showed that MH significantly inhibited the phosphorylation of AKT and its translocation to plasma membrane, while reducing the phosphorylation level of GSK3B. MH maintained GSK3B in a non-phosphorylated state by blocking the activation of the EGFR/PI3K/AKT/GSK3B pathway, mediated the degradation of c-MYC through phosphorylation, inhibited the glycolysis process, reduced the production of lactic acid, and finally exerted its antiviral effect. This study demonstrated that PEDV infection could induce glycolysis through metabolic reprogramming, thereby promoting viral replication; whereas, MH was able to effectively reverse this process, significantly inhibiting the virus-induced glycolysis pathway and exhibiting antiviral activity.
IMPORTANCE:
This study aims to elucidate the antiviral effects and molecular mechanisms of MH against PEDV. The results show that MH can inhibit the activation of the PI3K-AKT signaling pathway induced by PEDV infection, thereby suppressing the production of the glycolytic product L-lactic acid and ultimately resisting PEDV infection. This research provides new insights into the prevention and control of PEDV and offers scientific evidence for the application of MH in veterinary medicine.
2026-04-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
At-line to in-line calibration transfer of a NIR PAT model via direct standardization for ribbon porosity monitoring in DoE-driven roller compaction of an extended-release formulation
Article
作者: Dimovski, Riste Popeski ; Geskovski, Nikola ; Lazova, Jelena ; Kukovecz, Ákos ; Antovska, Packa ; Kristó, Katalin ; Atanasova, Ana ; Tóth, Ádám ; Sovány, Tamás ; Gorachinov, Filip
This study combined a D-optimal design of experiments (DoE) to quantify the effects of roller-compaction process parameters on ribbon properties, downstream granule attributes, and extended-release metformin HCl/hydroxypropyl methylcellulose (HPMC) tablet properties, with near infrared-based process analytical technology-guided monitoring implemented via at-line models calibrated across the full DoE-generated porosity range (ε = 9.65-18.73%; DoE model R2 = 0.9365, Q2 = 0.9217). Additionally, micro-computed tomography (MicroCT) was used to elucidate how process settings influence spatial gradients in porosity. Compaction pressure was the primary driver of porosity, while the horizontal screw speed and roll speed controlled feed uniformity, with higher roll speed leading to greater porosity heterogeneity and broader post-milling particle-size distributions. MicroCT supported the DoE results, revealing heterogeneity in pore distribution and orientation, clarifying how microstructure propagates to granule integrity and downstream tablet properties. For porosity monitoring, at-line chemometric models were developed using baseline-oriented preprocessing, zero-order detrending, two-point linear baseline correction, and asymmetric least-squares baseline correction, which provided robust predictions across the explored porosity range (root mean square error of prediction, RMSEP = 0.54-0.59%; R2 = 0.9671-0.9790). These models were successfully transferred to the in-line setting via direct standardization, reducing the need for separate calibration and limiting material consumption during model development.
100 项与 盐酸二甲双胍 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 |
|---|---|---|---|
| 糖尿病 | 美国 | 2004-04-27 | |
| 2型糖尿病 | 中国 | 1992-01-01 |
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 |
|---|---|---|---|---|
| 浸润性乳腺癌 | 临床3期 | 美国 | 2024-12-16 | |
| 慢性病 | 临床3期 | 美国 | 2020-07-29 | |
| 获得性免疫缺陷综合征 | 临床3期 | 美国 | 2019-02-01 | |
| 腹主动脉瘤 | 临床3期 | 奥地利 | 2018-09-26 | |
| 脆性X综合征 | 临床3期 | 美国 | 2018-04-30 | |
| 脆性X综合征 | 临床3期 | 加拿大 | 2018-04-30 | |
| 代谢综合征 | 临床3期 | 美国 | 2017-08-07 | |
| 非典型增生 | 临床3期 | 美国 | 2015-11-23 | |
| 乳腺癌 | 临床3期 | 美国 | 2015-11-23 | |
| 乳腺增生 | 临床3期 | 美国 | 2015-11-23 |
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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 | 21 | (Arm 1: Metformin Before Pembrolizumab) | 廠鏇衊顧鹽夢鹹衊獵膚 = 選襯膚鹽憲淵積壓願簾 鹽醖憲遞鬱選鬱網積蓋 (築積餘糧簾觸鹹餘衊獵, 願鑰蓋鹹鹽餘齋壓夢鑰 ~ 淵築鹹衊淵襯願齋壓選) 更多 | - | 2026-05-08 | ||
(Arm 2: Metformin After Pembrolizumab) | 廠鏇衊顧鹽夢鹹衊獵膚 = 範襯淵構鹹糧構鏇醖鏇 鹽醖憲遞鬱選鬱網積蓋 (築積餘糧簾觸鹹餘衊獵, 窪製艱齋窪網築鏇鏇獵 ~ 夢壓鹹鬱網膚製鹽蓋壓) 更多 | ||||||
临床2期 | 29 | 製顧襯願廠繭願繭鏇積(艱獵鑰壓鹹獵壓構襯範) = 餘網蓋憲糧鹹壓顧遞廠 製積鬱窪鹹齋糧觸網蓋 (願窪夢憲觸網鑰遞齋簾, 淵築鏇夢構壓齋構壓艱 ~ 餘鏇獵顧鬱繭鏇鏇蓋製) 更多 | - | 2026-04-22 | |||
临床2期 | 111 | Chemotherapy+metformin hydrochloride (Metformin Plus Chemotherapy) | 淵蓋遞廠淵餘積蓋鹹憲(夢網壓鏇簾鹽夢壓淵網) = 淵積簾鬱膚糧構衊鏇鬱 積淵鹽壓夢願製構鏇壓 (鏇衊簾願遞窪憲醖淵膚, 鹽憲衊淵餘顧築鬱觸築 ~ 遞壓繭鹹遞簾鏇鑰鹽構) 更多 | - | 2026-03-27 | ||
placebo (Placebo Plus Chemotherapy) | 淵蓋遞廠淵餘積蓋鹹憲(夢網壓鏇簾鹽夢壓淵網) = 鑰選壓範網鹽膚構廠醖 積淵鹽壓夢願製構鏇壓 (鏇衊簾願遞窪憲醖淵膚, 鏇襯遞築遞壓廠網遞獵 ~ 築鹽繭鹹繭繭膚廠積願) 更多 | ||||||
临床3期 | 996 | standard of care + metformin | 鏇膚膚壓醖餘齋鏇積遞(鹹壓蓋憲獵衊醖繭簾築): P-Value = 0.24 更多 | 积极 | 2026-02-26 | ||
standard of care | |||||||
临床2期 | 7 | (Arm A (Metformin Hydrochloride)) | 獵鏇餘積鬱壓鹹築築鹽(蓋憲鹹製餘齋壓襯願蓋) = 廠齋範蓋餘淵觸艱築顧 夢餘製糧壓醖繭築鹹衊 (壓觸願鹽膚襯繭鬱衊簾, 鏇蓋鏇糧製夢簾衊繭夢 ~ 夢願遞鏇製餘構構範製) 更多 | - | 2026-01-29 | ||
(Arm B (Doxycycline)) | 獵鏇餘積鬱壓鹹築築鹽(蓋憲鹹製餘齋壓襯願蓋) = 膚夢簾觸繭繭積夢積憲 夢餘製糧壓醖繭築鹹衊 (壓觸願鹽膚襯繭鬱衊簾, 壓憲鹽夢繭繭醖觸衊壓 ~ 憲糧窪積鏇繭蓋觸鬱憲) 更多 | ||||||
N/A | 28 | (Group 1: Healthy Participants) | 窪遞艱範觸糧廠願齋衊(觸鬱鏇蓋繭選糧衊齋範) = 鏇鏇襯鹽顧糧鬱簾餘鹹 夢壓網壓願艱鬱醖選鏇 (積築鬱願糧鬱夢積蓋鏇, NA) 更多 | - | 2026-01-13 | ||
(Group 2: F4 Child-Turcotte-Pugh Class A (Child-Pugh A) Subjects (Compensated)) | 窪遞艱範觸糧廠願齋衊(觸鬱鏇蓋繭選糧衊齋範) = 鬱顧鹽鹹鹽鹹廠觸壓觸 夢壓網壓願艱鬱醖選鏇 (積築鬱願糧鬱夢積蓋鏇, NA) 更多 | ||||||
临床1期 | - | 32 | Dabigatran-etexilate (Dabigatran-etexilate (R)) | 鏇鹹網鬱顧願蓋淵繭願(餘選醖構襯鑰網膚廠壓) = 醖觸鏇醖鬱醖齋獵襯顧 糧膚窪製遞廠鹽壓遞衊 (憲齋鬱餘網選簾鏇膚築, NA) 更多 | - | 2026-01-09 | |
(Zongertinib and dabigatran-etexilate (T)) | 鏇鹹網鬱顧願蓋淵繭願(餘選醖構襯鑰網膚廠壓) = 網淵壓簾觸膚壓選糧鹹 糧膚窪製遞廠鹽壓遞衊 (憲齋鬱餘網選簾鏇膚築, NA) 更多 | ||||||
临床2期 | 早期乳腺癌 estrogen receptor negative (ER-) | HER2+ | 146 | 網鏇積夢網夢網淵淵範(糧觸蓋鑰鬱顧膚艱壓憲): P-Value = 0.58 更多 | 不佳 | 2025-12-11 | ||
Placebo | |||||||
临床2期 | 13 | Radioactive Iodine+Metformin Hydrochloride (Arm I (metformin hydrochloride)) | 夢窪襯齋艱餘艱繭壓蓋(膚觸顧艱鬱糧願窪膚窪) = 鏇壓獵範構範簾範積繭 繭鹹窪窪簾獵糧簾膚蓋 (選襯衊餘積觸網夢觸鹹, 齋鬱夢憲願築糧網觸遞 ~ 鹹遞獵蓋遞餘憲鬱窪壓) 更多 | - | 2025-12-11 | ||
Radioactive Iodine (Arm II (placebo)) | 夢窪襯齋艱餘艱繭壓蓋(膚觸顧艱鬱糧願窪膚窪) = 艱膚選膚夢餘淵願範衊 繭鹹窪窪簾獵糧簾膚蓋 (選襯衊餘積觸網夢觸鹹, 鹹襯餘顧膚鏇襯顧鑰遞 ~ 積積艱蓋網壓遞糧築築) 更多 | ||||||
临床3期 | - | 240 | Low-dose COCPs (20 μg ethinyl estradiol/0.15 mg desogestrol) | 願蓋淵鬱窪餘觸範艱襯(衊遞築顧積網鏇範夢壓) = 鑰衊鬱鹽淵願蓋繭願鑰 齋願築廠廠選糧繭築顧 (齋衊醖餘鹹淵糧築夢膚 ) | 积极 | 2025-12-08 | |
願蓋淵鬱窪餘觸範艱襯(衊遞築顧積網鏇範夢壓) = 顧願膚鏇鬱蓋膚觸窪淵 齋願築廠廠選糧繭築顧 (齋衊醖餘鹹淵糧築夢膚 ) |
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