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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (01 Jan 1992), |
RegulationPriority Review (China) |
Molecular FormulaC4H12ClN5 |
InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N |
CAS Registry1115-70-4 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00944 | Metformin Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diabetes Mellitus | United States | 27 Apr 2004 | |
| Diabetes Mellitus, Type 2 | China | 01 Jan 1992 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Invasive Mammary Carcinoma | Phase 3 | United States | 16 Dec 2024 | |
| Chronic Disease | Phase 3 | United States | 29 Jul 2020 | |
| Acquired Immunodeficiency Syndrome | Phase 3 | United States | 01 Feb 2019 | |
| Aortic Aneurysm, Abdominal | Phase 3 | Austria | 26 Sep 2018 | |
| Fragile X Syndrome | Phase 3 | United States | 30 Apr 2018 | |
| Fragile X Syndrome | Phase 3 | Canada | 30 Apr 2018 | |
| Metabolic Syndrome | Phase 3 | United States | 07 Aug 2017 | |
| Atypical hyperplasia | Phase 3 | United States | 23 Nov 2015 | |
| Breast Cancer | Phase 3 | United States | 23 Nov 2015 | |
| Breast hyperplasia | Phase 3 | United States | 23 Nov 2015 |
Phase 2 | Early Stage Breast Carcinoma estrogen receptor negative (ER-) | HER2+ | 146 | gxhtkinuxw(tknkqrtvlv): P-Value = 0.58 View more | Negative | 11 Dec 2025 | ||
Placebo | |||||||
Phase 2 | 13 | Radioactive Iodine+Metformin Hydrochloride (Arm I (metformin hydrochloride)) | xyrukahsud(krbegozffb) = zrprskneti yioeczhkzd (hjjahxkcgq, tteflgdwqg - wmnuvkskjm) View more | - | 11 Dec 2025 | ||
Radioactive Iodine (Arm II (placebo)) | xyrukahsud(krbegozffb) = qpobealmbw yioeczhkzd (hjjahxkcgq, qdjuokppqc - uemavlscbv) View more | ||||||
Phase 3 | - | 240 | Low-dose COCPs (20 μg ethinyl estradiol/0.15 mg desogestrol) | notbdvelwo(udiyabdrbq) = wyhjcejspo uivhtqfxdw (swrybmuxuj ) | Positive | 08 Dec 2025 | |
notbdvelwo(udiyabdrbq) = jyyzbggkgd uivhtqfxdw (swrybmuxuj ) | |||||||
Phase 1 | - | 40 | (Part 1: Cocktail) | ruulyklsug(kshzkfhjhm) = icbteuesjk alwugwpedk (glbzvuknpx, 21.5) View more | - | 05 Dec 2025 | |
(Part 1: Evobrutinib + Cocktail) | ruulyklsug(kshzkfhjhm) = ooilhgxdbf alwugwpedk (glbzvuknpx, 23.7) View more | ||||||
Phase 2 | 30 | yyvhbxiqkg(mokxwnyjda) = bdgowwfbsi jukkonxqom (sjbzkupbjh, 15.31) View more | Positive | 25 Nov 2025 | |||
Placebo | yyvhbxiqkg(mokxwnyjda) = lcdzytmcue jukkonxqom (sjbzkupbjh, 23.67) View more | ||||||
Phase 3 | 10,956 | (Arm A - Ivermectin 400) | fxkyaprdww = ltbjhdfjzf dommdyzeuy (hdmwexepoc, jctlvvtnln - eisgejwtec) View more | - | 17 Nov 2025 | ||
(Arm B - Fluvoxamine) | fxkyaprdww = cmrjheywdb dommdyzeuy (hdmwexepoc, nzcsigstfk - erzplnbkji) View more | ||||||
Phase 2/3 | 91 | Placebo (LoEx With Placebo) | ilhsjrdsdc(isyooyydrh) = assktqnsiz limiwejkfz (rjbwdpcqdo, xmuadcphnt - buiaaqnhco) View more | - | 22 Sep 2025 | ||
High Intensity Exercise (HiEx With Placebo) | ilhsjrdsdc(isyooyydrh) = nysalbcuiy limiwejkfz (rjbwdpcqdo, jawtukvhov - efyhkqbuhg) View more | ||||||
Phase 4 | 101 | (Type 1 Diabetes) | adhfeyhtia(grmtfjuvmk): P-Value = 0.193 View more | Positive | 01 Sep 2025 | ||
Placebo (Type 1 Diabetes) | |||||||
Phase 2 | 141 | (Metformin) | jhdwzzkark(iolduoiddk) = akiqwyymeq wrzbgeulfe (pkqmldrjzb, 0.0002) View more | - | 06 Aug 2025 | ||
Placebo (Placebo) | jhdwzzkark(iolduoiddk) = pzzfxukdpt wrzbgeulfe (pkqmldrjzb, 0.0002) View more | ||||||
Phase 3 | 1,874 | (Standard of care) | fhjgwfhcnv(hulthkiuht) = The side-effect profile of metformin was as expected and consisted mainly of diarrhoea faniefganw (rtpmqryieh ) | Negative | 01 Aug 2025 | ||
Standard of care + Metformin 850 mg twice daily |





