Delving into the Latest Updates on Metformin Hydrochloride with Synapse

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

PRKAB1

Action

activators

Mechanism

PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

Endocrinology and Metabolic DiseaseNeoplasmsImmune System Diseases+ [12]

Active Indication

Diabetes Mellitus, Type 2Invasive Mammary CarcinomaChronic Disease+ [49]

Inactive Indication

Acinar Cell CarcinomaAcquired Immunodeficiency SyndromeAdenocarcinoma of large intestine+ [70]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Zhengzhou University Hospital

National Cancer Institute

Curative Biotechnology, Inc.

+ [31]

Inactive Organization

National Institute of Diabetes & Digestive & Kidney Diseases

Eli Lilly & Co.

The Case Comprehensive Cancer Center

+ [23]

License Organization

Merck KGaA

The Fox Chase Cancer Center

Sylvester Comprehensive Cancer Center

+ [3]

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 1992),

Diabetes Mellitus, Type 2

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS Registry1115-70-4

Phase III, Adaptive, Multicenter, Randomized, Superiority, Double-Dummy, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of a Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitor and a Thiazolidinedione in the Treatment of Type 2 Diabetes Mellitus, Compared to Monotherapy, in Patients Treated With Metformin

This clinical trial is studying whether combining two commonly used diabetes medications into a single pill works better than taking them separately for people with type 2 diabetes who are already on metformin. Both medications work in different ways to lower blood sugar - one helps remove excess sugar through urine while the other helps the body use insulin better.
The study has two main goals:
To see if the combined pill controls blood sugar more effectively than either medication alone
To check if combining them reduces common side effects like weight gain and swelling that can occur with one of the medications
Participants will be randomly assigned to one of three groups:
The new combination pill
One of the standard diabetes medications alone
The other standard diabetes medication alone
All participants will take their assigned treatment daily and attend regular clinic visits for monitoring. Doctors will track blood sugar control, weight changes, and any side effects throughout the study period.
This research could lead to a simpler treatment option that combines the benefits of both medications while potentially minimizing side effects. For people with diabetes who often need multiple medications, a combined pill might make treatment easier to manage while providing better blood sugar control.

Start Date01 Sep 2026

Sponsor / Collaborator

Eurofarma Laboratórios SA

NCT05910554

/ WithdrawnPhase 2IIT

Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial

This is a double blinded, randomized, placebo controlled clinical trial of 40 participants with pulmonary sarcoidosis.
Primary Objective: To assess the steroid-sparing efficacy and safety of oral metformin therapy in participants with confirmed progressive pulmonary sarcoidosis for participants with steroid dependent disease.

Start Date10 Dec 2025

Sponsor / Collaborator

University of Maryland Baltimore

CTRI/2024/10/074853

/ Not yet recruitingPhase 4IIT

Efficacy and safety of Curcuma longa either alone or in combination with metformin on glycemic status in prediabetes population: A Randomized, double-blinded, double-dummy, placebo-controlled, factorial design trial - NIL

Start Date15 Oct 2025

Sponsor / Collaborator-

100 Clinical Results associated with Metformin Hydrochloride

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100 Translational Medicine associated with Metformin Hydrochloride

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100 Patents (Medical) associated with Metformin Hydrochloride

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22,443

Literatures (Medical) associated with Metformin Hydrochloride

25 Dec 2025·Oriental Journal of Chemistry

Quantitative UV-Spectrophotometric Method for the Analysis of Teneligliptin HBr and Metformin HCl in Pharmaceutical Dosage form: Development and Validation

Author: Gahtori, Archana ; Khanduri, Praveen

This study developed a UV-spectrophotometric method for the simultaneous quantification of Metformin HCl and Teneligliptin HBr. Both active pharmaceutical ingredients were found to be soluble in 0.1N sulfuric acid, which was thus chosen as the solvent for analysis. The maximum absorption wavelengths for Metformin HCl and Teneligliptin HBr were identified at 220 nm and 240 nm, respectively. Standard stock solutions were prepared, and samples from commercially available tablets were accurately measured and dissolved for testing. Method validation included evaluations of linearity, precision (intra-day and inter-day), accuracy, robustness, as well as detection (LOD) and quantification limits (LOQ). The method exhibited strong precision and accuracy, with %RSD values less than 2%. Both LOD and LOQ demonstrated sufficient sensitivity, and the method proved effective for analyzing commercial formulations, achieving compliance levels of 99.20% for Metformin and 102.00% for Teneligliptin.

01 Dec 2025·IMMUNOLOGIC RESEARCH

Metformin suppresses gammadelta T17 cell differentiation alleviating DSS-induced colitis

Article

Author: Wang, Yungang ; Zhi, Yaru ; Tang, Qinfang ; Shen, Langping ; Yan, Dongmei ; Liu, Hongli ; Xiao, Lihua ; Cai, Aiting ; Sun, Mingzhong ; Ju, Huixiang ; Yang, Rui ; Chen, Hongmei

Ulcerative colitis (UC) is a chronic, nonspecific, relapsing inflammatory bowel disease. Metformin has pleiotropic effects including anti-inflammatory properties and a notable impact on the gut microbiome. γδT17 cells play crucial role in initiating and maintaining intestinal inflammation. The effect of metformin on γδT17 cells remains unclear. This study aims to explore the connection between metformin-mediated ameliorated response in colitis mice and γδT17 cell activity. The role of γδT17 cell inhibition in metformin-mediated colitis amelioration was evaluated in mice. The effect of metformin on γδT17 differentiation and the possible mechanism were evaluated in a set of in vitro experiments. Results showed that the accumulation of γδT17 cells was negatively correlated with metformin treatment in DSS-induced colitis mice. Exogenous γδT17 cells blocked metformin-mediated colitis inhibition. Furthermore, metformin inhibited γδT17 differentiation, which was related to the inhibition of mTOR/RORγt activity. Our results reveal that metformin ameliorates colitis symptoms by suppressing γδT17 differentiation, suggesting a viable strategy against UC, although the mechanism of metformin in inhibiting γδT17 differentiation remains to be further studied.

01 Dec 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Poly (lactic-co-glycolic acid) (PLGA) nanoparticles for sustained release of metformin hydrochloride within cells: A therapy for Type 2 diabetes mellitus

Article

Author: Sun, Qinyu ; Li, Jianfeng ; Song, Xinzhong ; Li, Jianyong ; Zhang, Yongqi ; Ji, Maocheng ; Man, Jia

Type 2 diabetes mellitus (T2DM) is the third leading chronic disease threatening human health, with patients primarily managing their blood glucose levels through oral administration of metformin hydrochloride (MH). However, oral delivery of the pure drug faces challenges such as low bioavailability and significant gastrointestinal side effects. To address these, we employed a high-pressure homogenizer to prepare PLGA nanoparticles encapsulating the drug via a double emulsion method. Orthogonal experiments revealed that both shear pretreatment and high-pressure homogenization significantly influenced the particle properties, which were subsequently characterized. The average particle size could reach as small as 113.00 nm, with an encapsulation efficiency up to 64.69 %. The surface of these nanoparticles was negatively charged, enabling sustained drug release for 36 h in vitro. They exhibited excellent biocompatibility, maintaining a 95.74 % cell survival rate after 48 h of co-culture with hepatocytes, and were capable of being internalized by cells. In vivo experiments demonstrated that orally administered MH-PLGA nanoparticles could sustain blood glucose lowering effects for 8-10 h. Compared with traditional oral metformin hydrochloride, MH-PLGA nanoparticles offer higher bioavailability and lower gastrointestinal side effects, which are expected to bring better therapeutic effects to patients.

378

News (Medical) associated with Metformin Hydrochloride

18 Jul 2025

·pharma.economictimes.indiatimes.com

Regulator to drop Metformin-Voglibose combo from unapproved FDC list

New Delhi: The Fixed Dose Combination (FDC) of popular anti-diabetes medicine Metformin Hydrochloride and Voglibose is set to be excluded from the list of unapproved FDCs notified by the CDSCO in April this year. In a statement before the Delhi High Court over a petition challenging the classification of the combination as an unapproved drug, the Drugs Controller General of India ( DCGI ) has formally stated to exclude the above combination from the notified list. In April this year, the apex drug regulator issued a list of 35 unapproved fixed dose combinations (FDCs) and directed state regulatory authorities to prohibit their manufacture, sale, and distribution, citing concerns over “ patient safety .” However, Mumbai-based Macleods Pharmaceuticals challenged the directive and sought the exclusion of ‘Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet’ from the notified list. During the earlier proceedings the counsel for the petitioner (Macleods) stated that it is “completely erroneous and appears to be a result of oversight / clerical error.” Macleods Pharma markets one such drug under the brand name Voglimac MF’ and during the proceedings the drugmaker highlighted that “it has been manufacturing and marketing the said formulation since 2016 under valid licences.” Giving its response on the arguments at the most recent hearing, the regulator informed the single judge bench presided over by Justice Sachin Datta, that the concerned FDC shall stand “excluded from the list of unapproved FDCs.” “It is stated by learned counsel for the respondents (DCGI) on instructions that the concerned FDC of Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet, shall stand excluded from the list of unapproved FDCs,” the court order stated. In its order Justice Datta pronounced that the grievance of the petitioner stands “redressed and taking on record the aforesaid statement, the court has disposed of the petition. Metformin Hydrochloride and Voglibose is a widely prescribed oral FDC formulation indicated for the treatment of Type-2 diabetes. The drug helps to reduce glucose production in the liver, improve insulin sensitivity (metformin function) and slow down the digestion and absorption of carbohydrates in the intestines to prevent post-meal sugar spikes (voglibose function). Metformin is also widely used in fixed-dose combinations with other notable antidiabetic agents such as empagliflozin, dapagliflozin, and several others, to enhance glycemic control through complementary mechanisms. Notably, besides the above-mentioned FDC, the list issued by the regulator also includes three other anti-diabetes combinations that have metformin as an active ingredient. According to PharmaTrack data, of India’s total ₹21,000 crore anti-diabetic (OAD) therapy market, OAD combos account for nearly 60 per cent of the total market. The monthly sales tracker suggests that in June this year, OAD combos recorded total sales of ₹1079 crore, where metformin combos accounted for over 21 per cent of the total share with a MTH value of ₹230 crore. By Online Bureau ,

17 Jul 2025

·www.echemi.com

Emcure Seals Exclusive Deal for Sanofi’s Oral Diabetes Brands Millions of Indian Patients to Benefit

Emcure Pharmaceuticals has signed an exclusive agreement to distribute and promote Sanofi’s oral anti-diabetes (OAD) medicines in India, a move set to impact millions living with type-2 diabetes. Under this arrangement, Sanofi will continue manufacturing its OAD brands—such as Glimepiride (Amaryl) and Metformin (Cetapin)—at its facilities, while Emcure gains the sole rights to market and distribute them across India. This partnership expands Emcure’s diabetes portfolio, promising broader access to these leading therapies for patients nationwide. CEO Satish Mehta highlighted that Sanofi’s trusted OAD medicines will now reach even more people, thanks to Emcure’s robust distribution network. Importantly, the deal will not involve any employee transfers between the two firms. The collaboration aims to create a comprehensive diabetes care offering, supporting those affected by the disease and strengthening both companies’ positions in the Indian pharmaceutical market.

License out/in

16 Jul 2025

·www.fiercepharma.com

Bankrupt Nostrum Labs recalls ulcer drug after shutting down operations

Bankrupt and shuttered Nostrum Labs issued a voluntary recall for all lots of 1 gram sucralfate tablets that are used to treat ulcers. Nostrum Labs, which declared bankruptcy last year and has since ceased operations, issued a voluntary recall for all lots of its 1-gram sucralfate tablets that are used to treat ulcers.The recall was announced in a press release posted on the FDA’s enforcement website and covers “all lots” with a future expiration date that were produced by the formerly Missouri- and New Jersey-based company after June of 2023.“It cannot be guaranteed that any lots of this product that are still within expiry will meet all intended specifications through the labeled shelf life of the product,” the company said in the July 11 notice.Nostrum did not disclose the number of lots being recalled. To date, the company has not received any reports of adverse events related to the drug lots, which were distributed nationwide.The company is not accepting any returns of the product and is advising that all lots should be destroyed. In October of 2023, the company settled a dispute with the U.S. Attorney’s Office in the District of Massachusetts for allegedly failing to pay the required rebate amounts owed for Nitro OS (used to treat and prevent angina) under Medicaid programs.More recently, Nostrum declared bankruptcy in September of 2024.Nostrum was among a number of companies involved in the 2020-21 mass recall of the diabetes drug metformin due to the presence of higher-than-allowed levels of the possible carcinogen N-nitrosodimethylamine (NDMA). Nostrum issued at least two recalls related to that product.

100 Deals associated with Metformin Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00944	Metformin Hydrochloride	A10BA02	DBSALT000114

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	United States	Andrx Labs LLC	27 Apr 2004
Diabetes Mellitus, Type 2	China	Ankang Zhengda Pharmaceutical Co. Ltd.	01 Jan 1992

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Invasive Mammary Carcinoma	Phase 3	United States	City of Hope National Medical Center	16 Dec 2024
Chronic Disease	Phase 3	United States	Oklahoma Medical Research Foundation	29 Jul 2020
Acquired Immunodeficiency Syndrome	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Feb 2019
Aortic Aneurysm, Abdominal	Phase 3	Austria	Merck Serono GmbH	26 Sep 2018
Fragile X Syndrome	Phase 3	United States	University of California, Davis	30 Apr 2018
Fragile X Syndrome	Phase 3	Canada	University of California, Davis	30 Apr 2018
Metabolic Syndrome	Phase 3	United States	Rutgers State University of New Jersey	07 Aug 2017
Atypical hyperplasia	Phase 3	United States	Alliance Foundation Trials LLC	23 Nov 2015
Breast Cancer	Phase 3	United States	Alliance Foundation Trials LLC	23 Nov 2015
Breast hyperplasia	Phase 3	United States	Alliance Foundation Trials LLC	23 Nov 2015

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02570672 (CTgov)	Phase 2	Frailty Syndrome	141	metformin (Metformin)	jsewiajopr(vvzvbmdpic) = ljybdnesnf mjganrzdnn (ervqdvlbvc, 0.0002) View more	-	06 Aug 2025
				Placebo (Placebo)	jsewiajopr(vvzvbmdpic) = pqunkacpqm mjganrzdnn (ervqdvlbvc, 0.0002) View more
NCT06042855 (CTgov)	Phase 3	COVID-19	3,214	Metformin (Arm G - Metformin)	ropopgyfki(bqigekwyxn) = prfmooyrnp lsiptmpnuy (slolfxqhyi, umaoeybalx - ibbitjghao) View more	-	20 Jul 2025
				Placebo (Arm G - Placebo)	ropopgyfki(bqigekwyxn) = jcnuucetmn lsiptmpnuy (slolfxqhyi, xmuxmwrgxi - qtahxhmtdg) View more
NCT00268476 (STAMPEDE, Pubmed \| Lancet Oncol)	Phase 3	Metastatic Prostate Carcinoma	1,874	Metformin (Standard of care)	gorjzgtzsl(qinczmzrpr) = The side-effect profile of metformin was as expected and consisted mainly of diarrhoea cvngahxsmz (hjyfncglgo )	Negative	01 Jul 2025
				Standard of care + Metformin 850 mg twice daily
NCT05288153 (Pubmed \| Chin Med J (Engl))	Phase 4	Gastritis, Hypertrophic Helicobacter pylori tests	140	Metformin 500 mg daily	ttxvrgwoxr(naipfhiclk) = dpuckshxhu ukswjwwqqm (weprklngat, 34/70)	Positive	16 Jun 2025
				Folate 5 mg three times daily	ttxvrgwoxr(naipfhiclk) = wkdsusiamd ukswjwwqqm (weprklngat, 22/70)
NCT01697566 (CTgov)	Phase 3	Endometrial Carcinoma \| Hyperinsulinism	29	Metformin (Metformin + Lifestyle)	gbpklysemy(rfcxlwxudx) = xlgidmofha vrvdlktibn (mybiwpzkng, 22.51) View more	-	11 Jun 2025
				Metformin (Metformin + No Lifestyle)	gbpklysemy(rfcxlwxudx) = otoersgowq vrvdlktibn (mybiwpzkng, 15.36) View more
JPRN-jRCTs031200326 (Phase I/II study of maintenance therapy with metformin and temozolomide for newly diagnosed glioblastoma, ASCO2025)	Phase 1/2	Glioblastoma Maintenance	22	Metformin	jbtumjzemo(aqzounvrei) = plrtelujzw bsxoljbkmo (ehuxwgkxff, 29.2 - 64.0)	Positive	30 May 2025
				Temozolomide	spzhnastxp(xbiwrmfuac) = vuciwbsoiz sijefcztic (wlqjtsaoar )
NCT01905046 (CTgov)	Phase 3	Breast hyperplasia \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma ... View more	86	metformin hydrochloride (Arm I)	cjyewmgffz: Odds Ratio (OR) = 0.97 (95% CI, 0.36 - 2.62), P-Value = 0.951	-	13 Apr 2025
				placebo+Metformin (Arm II)
NCT03709147 (FAME, ESMO_ELCC2025)	Phase 2	Non-Small Cell Lung Cancer First line Stk11 mutations \| LKB1-negative \| KRAS co-mutations ... View more	157	FAME (chemotherapy + Immunotherapy + Metformin + FMD)	ctnfonpsow(ziaskixtlw) = unxrkqxfku rbmwiqturr (trjkfzhvjc, 0.4 - 10.8) View more	Negative	26 Mar 2025
				MERCY (chemotherapy + Immunotherapy + Metformin)	ctnfonpsow(ziaskixtlw) = csgjrmnmfx rbmwiqturr (trjkfzhvjc, 2.0 - 14.0) View more
NCT02980276 (2016-001644-19 \| ###DELETE \| EMERGE, CTgov)	Phase 3	Diabetes, Gestational	535	Metformin Hydrochloride (Treatment)	yfsprmjsng = josrceyjae grkklspmec (ewprkcsnnd, lrkftafeqi - vpolqcuelf) View more	-	17 Mar 2025
				Placebo (Control)	yfsprmjsng = trhysnhlwm grkklspmec (ewprkcsnnd, inbiejjihk - hcacnpahqs) View more
NCT03229057 (COMET-PCOS, CTgov)	Phase 3	Polycystic Ovary Syndrome \| Obesity	240	OCP + Placebo (OCP + Placebo)	ebjkblvqju = liopzikgrx lqauwpbiqi (dszumtcihi, idlmomkdqs - dspyzlcijr) View more	-	10 Mar 2025
				Metformin + Placebo (Metformin + Placebo)	ebjkblvqju = sletbeyfig lqauwpbiqi (dszumtcihi, ulhxrrpjlo - ouoaldduks) View more