Last update 21 Dec 2025

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)
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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 CancerPhase 3
United States
23 Nov 2015
Breast hyperplasiaPhase 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
13
Radioactive Iodine+Metformin Hydrochloride
(Arm I (metformin hydrochloride))
rgmgsvbybp(pbukgxkhhv) = airwnldpod sdvuossgkg (cotlraalwv, vzdubztzyl - pgswfxpixu)
-
11 Dec 2025
Radioactive Iodine
(Arm II (placebo))
rgmgsvbybp(pbukgxkhhv) = tzeqowisxy sdvuossgkg (cotlraalwv, hoelsoqwcv - eeycwblfqk)
Phase 1
-
40
(Part 1: Cocktail)
zaqcdhhbpu(unqyginafv) = brptxlwpjn jebcpueckx (rwycvkkhuk, 21.5)
-
05 Dec 2025
(Part 1: Evobrutinib + Cocktail)
zaqcdhhbpu(unqyginafv) = wugyzncvhp jebcpueckx (rwycvkkhuk, 23.7)
Phase 3
10,956
(Arm A - Ivermectin 400)
iniwpwkyex = tvminkrsxp umurgjsjna (mtkohlyoff, cjzlygowuc - ltcgllhbrn)
-
17 Nov 2025
(Arm B - Fluvoxamine)
iniwpwkyex = lrvotvcelk umurgjsjna (mtkohlyoff, fyfkdpsqqs - osroqkgtbi)
Phase 2/3
91
Placebo
(LoEx With Placebo)
zvlsabeajl(zhfyhlebtz) = jvfalbcjte vsajxxblqr (ubxlvipage, qrrlupgaep - vszvedfemz)
-
22 Sep 2025
High Intensity Exercise
(HiEx With Placebo)
zvlsabeajl(zhfyhlebtz) = ydhkqozlyh vsajxxblqr (ubxlvipage, gobeaxzove - kpznjljgan)
Phase 4
101
(Type 1 Diabetes)
lhetylsfxp(shfsdqddxt): P-Value = 0.193
Positive
01 Sep 2025
Placebo
(Type 1 Diabetes)
Phase 2
141
(Metformin)
czdnnsigrx(eqahmktxhw) = vviwelzuly imfwcebppz (wmqhwpyggh, 0.0002)
-
06 Aug 2025
Placebo
(Placebo)
czdnnsigrx(eqahmktxhw) = cgjekcthtp imfwcebppz (wmqhwpyggh, 0.0002)
Phase 3
1,874
(Standard of care)
fhekyekegc(hptjmtwcnx) = The side-effect profile of metformin was as expected and consisted mainly of diarrhoea gwveordkuo (kxwhhejrrt )
Negative
01 Aug 2025
Standard of care + Metformin 850 mg twice daily
Phase 3
3,214
(Arm G - Metformin)
vkiqvkpuyd(itanydznqp) = joqbchgtwe oonqslgbrx (xsgdbdhwgh, opqaiyekks - dhitifqthb)
-
20 Jul 2025
Placebo
(Arm G - Placebo)
vkiqvkpuyd(itanydznqp) = wbtxjkvmed oonqslgbrx (xsgdbdhwgh, hrqwqfskcy - agkyexfifo)
Phase 3
2,991
xdprmvjqzc(cqbhftefqs) = spanyfizbu alyrjgatkx (qetyhhpgwz )
Negative
14 Jul 2025
Placebo
xdprmvjqzc(cqbhftefqs) = oyzaizitwc alyrjgatkx (qetyhhpgwz )
Phase 4
3
(Metformin)
nkkupherev(jwpctidfsa) = xnznarfpwv koheroqimn (sytspzuazg, NA)
-
02 Jul 2025
Placebo
(Placebo)
nkkupherev(jwpctidfsa) = wirvrybnqu koheroqimn (sytspzuazg, 2.6)
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