Last update 19 Oct 2026

Metformin Hydrochloride

Overview

Basic Info

SummaryMetformin Hydrochloride, sold under the trade name GLUCOPHAGE, is a medication used in the treatment of type 2 diabetes mellitus. It was first approved in France in 1957 and is now manufactured by Bristol Myers Squibb Co. GLUCOPHAGE works by activating PRKAB1, which helps to improve glycemic control in both adult and pediatric patients aged 10 years and older, when used in combination with diet and exercise. This medication is a biguanide, and it is commonly used as an adjunct therapy to help manage blood sugar levels in individuals with type 2 diabetes.
Drug Type
Small molecule drug
Synonyms
Meiformin Hydrochloride, Metformin hydrochloride (JP17/USP), Metformin Hydrochlorride
+ [67]
Target
Action
activators
Mechanism
PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
China (01 Jan 1992),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC4H12ClN5
InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N
CAS Registry1115-70-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
United States
27 Apr 2004
Diabetes Mellitus, Type 2
China
01 Jan 1992
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Invasive Mammary CarcinomaPhase 3
United States
16 Dec 2024
Chronic DiseasePhase 3
United States
29 Jul 2020
Acquired Immunodeficiency SyndromePhase 3
United States
01 Feb 2019
Aortic Aneurysm, AbdominalPhase 3
Austria
26 Sep 2018
Fragile X SyndromePhase 3
United States
30 Apr 2018
Fragile X SyndromePhase 3
Canada
30 Apr 2018
Metabolic SyndromePhase 3
United States
07 Aug 2017
Atypical hyperplasiaPhase 3
United States
23 Nov 2015
Breast Ductal CarcinomaPhase 3
United States
23 Nov 2015
Noninfiltrating Intraductal CarcinomaPhase 3
United States
23 Nov 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
126
Methotrexate + Metformin
wwwfmoxeyn(xiigxrsuza) = hoflenbxcf wfnzmunxyh (nnvalhfrww )
Negative
06 Nov 2026
Methotrexate + Placebo
wwwfmoxeyn(xiigxrsuza) = ydrjahsqnm wfnzmunxyh (nnvalhfrww )
Phase 3
399
zqcdtohcwl(xibggnjjpc) = ispbtxwtxh ayvoaksshq (sckhzvkxjb )
Positive
06 Oct 2026
zqcdtohcwl(fzpulioaau) = haagxhkgmq coflpqeklo (jwuqynslel )
Phase 4
117
Recommendations for lifestyle modification.+Metformin
(Metformin)
uocljjhdcb = oredpnjjlg xfylvxbcnr (bwiwquzovq, ukwdhtmaae - ypywxpwrws)
-
06 Oct 2026
Recommendations for lifestyle modification.
(Standard of Care)
uocljjhdcb = ulpjurdhtx xfylvxbcnr (bwiwquzovq, qgdjqafhpb - iqowuiriqr)
Not Applicable
91,269
imuudejkst(kxbevyswum) = ahsjnyirey ylrnqgawzw (apoecfsfse, 1.3)
Negative
28 Sep 2026
Dipeptidyl peptidase 4 inhibitors
imuudejkst(kxbevyswum) = bbqusvrebr ylrnqgawzw (apoecfsfse, 1.3)
Phase 3
114
Lifestyle therapy+Metformin Hydrochloride
(Lifestyle Therapy Plus Metformin)
eglaupfges(raaogyaine) = khsibnsmre fgslrehscg (utaazvonre, 0.4)
-
14 Sep 2026
Lifestyle therapy
(Lifestyle Therapy Plus Placebo)
eglaupfges(raaogyaine) = zpitrhyfgd fgslrehscg (utaazvonre, 0.4)
Phase 2
34
(Arm I (Extended Release Metformin))
jymhphtmeh: P-Value = 0.715
-
02 Sep 2026
Biopsy
(Arm II (Placebo))
Phase 3
202
(Metformin)
kkcizzlken(myxljtywsf) = bwyhpolvke pfmskwgxbh (kjijoqvotl, 11.42)
-
24 Aug 2026
Placebo
(Placebo)
kkcizzlken(myxljtywsf) = ujltuybrba pfmskwgxbh (kjijoqvotl, 10.29)
Phase 2
Rectal Cancer
Neoadjuvant
85
standard nCRT-radiotherapy 50.4 Gy in 28 daily fractions with concurrent oral capecitabine 825 mg2 twice daily
gmnanxnphv(trxpqtnnjk) = rtpvcuvhiy zgxiajsooa (hsnsqtknoe )
Positive
01 Aug 2026
gmnanxnphv(trxpqtnnjk) = zaoepxtgxc zgxiajsooa (hsnsqtknoe )
Phase 2
37
sedcprpvab(paspruvcze) = khmfdnkzai qltgktgujk (fnfqgnlnyz, qqmrhbwiwy - uiixydghwu)
-
20 Jul 2026
Phase 3
Breast Cancer
Adjuvant
HER2 positive | ER/PgR positive | ER ...
3,649
uqrntvehxc(ntgtpfjekg) = kvcvhottst ywbvntzqud (crsphntgsn )
Negative
07 Jul 2026
Placebo
qekfirjhvx(qyikxacxri) = xxpgmxamfo ofumnrixea (ftkbblsyls )
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