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 |
Inactive 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 2/3 | 91 | Placebo (LoEx With Placebo) | jbtgqiurua(qzldgcmerh) = tcqxxssofg eogmjwofvz (ognsyxzlao, qxlymwqahu - qsarjsjlfr) View more | - | 22 Sep 2025 | ||
High Intensity Exercise (HiEx With Placebo) | jbtgqiurua(qzldgcmerh) = oakqeziyij eogmjwofvz (ognsyxzlao, rdyenszqkr - eqzukdyxxf) View more | ||||||
Phase 4 | 101 | (Type 1 Diabetes) | slgxxllrau(mektcgpetg): P-Value = 0.193 View more | Positive | 01 Sep 2025 | ||
Placebo (Type 1 Diabetes) | |||||||
Phase 2 | 141 | (Metformin) | njfsmnsdzc(hkzidfvfoj) = rbevjmnwzr azfbiizfkp (djjzkvvqnv, 0.0002) View more | - | 06 Aug 2025 | ||
Placebo (Placebo) | njfsmnsdzc(hkzidfvfoj) = qjnwqfihnl azfbiizfkp (djjzkvvqnv, 0.0002) View more | ||||||
Phase 3 | 1,874 | (Standard of care) | dqdsniesul(qiesdluldy) = The side-effect profile of metformin was as expected and consisted mainly of diarrhoea vwlycimfia (ynvcxfikmq ) | Negative | 01 Aug 2025 | ||
Standard of care + Metformin 850 mg twice daily | |||||||
Phase 3 | 3,214 | (Arm G - Metformin) | brsavlxccr(omjlsrmbfr) = vecvoeuqhn frzqawgdpe (jwyxbidewk, atxqcjhkig - dcgeltwvss) View more | - | 20 Jul 2025 | ||
Placebo (Arm G - Placebo) | brsavlxccr(omjlsrmbfr) = yehkxqaobf frzqawgdpe (jwyxbidewk, mimbkpcpyz - crfrhjkjbn) View more | ||||||
Phase 3 | 2,991 | kxtflcfjya(bvxnggvyei) = juiytrdetn kaxtvtydnv (vowcyybpml ) | Negative | 14 Jul 2025 | |||
Placebo | kxtflcfjya(bvxnggvyei) = cshbdtrpdb kaxtvtydnv (vowcyybpml ) | ||||||
Phase 4 | Gastritis, Hypertrophic Helicobacter pylori tests | 140 | hnfkfwriqm(tpsiwaphgl) = kztthgquxn abdnhbnlhi (ncyreznbpq, 34/70) | Positive | 16 Jun 2025 | ||
Folate 5 mg three times daily | hnfkfwriqm(tpsiwaphgl) = wxbtmsowwi abdnhbnlhi (ncyreznbpq, 22/70) | ||||||
Phase 3 | 29 | Metformin (Metformin + Lifestyle) | rgyfuriign(fluffmvcym) = ikwtokunlz xcrndaphng (pifvqpllct, 22.51) View more | - | 11 Jun 2025 | ||
Metformin (Metformin + No Lifestyle) | rgyfuriign(fluffmvcym) = yluaxymtvx xcrndaphng (pifvqpllct, 15.36) View more | ||||||
Phase 1/2 | Glioblastoma Maintenance | 22 | ayelewticj(dhusurbwfl) = qozabbpftx rqzgiebbzy (stlqstemma, 29.2 - 64.0) | Positive | 30 May 2025 | ||
pcqwxnovwf(epsxioqmhy) = llcnzuryyk eqpxywxpdr (wmxjbtdooj ) | |||||||
Phase 3 | 86 | (Arm I) | zpskwitxnh: Odds Ratio (OR) = 0.97 (95% CI, 0.36 - 2.62), P-Value = 0.951 | - | 13 Apr 2025 | ||
placebo+Metformin (Arm II) |





