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Last update 28 Feb 2026

Metformin Hydrochloride

Last update 28 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

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+ [11]

Active Indication

Diabetes Mellitus, Type 2Invasive Mammary CarcinomaChronic Disease+ [50]

Inactive Indication

Acinar Cell CarcinomaAcquired Immunodeficiency SyndromeAdenocarcinoma of large intestine+ [78]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

The University of Texas MD Anderson Cancer Center

The University of California, San FranciscoMerck Santé SASU

+ [27]

Inactive Organization

Fournier Laboratories Ireland Ltd.

Mayo Clinic

The Case Comprehensive Cancer Center

+ [36]

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)

Structure/Sequence

Molecular FormulaC4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS Registry1115-70-4

2,798

Clinical Trials associated with Metformin Hydrochloride

CTRI/2025/09/094234

/ Not yet recruitingPhase 2IIT

A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus - NIL

Start Date01 Oct 2027

Sponsor / Collaborator-

NCT07057479

/ WithdrawnPhase 3

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

NCT07300059

/ Not yet recruitingPhase 1

Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults

This is an open-label, randomized study evaluating the short-term glycemic effects of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Participants will receive single or short-term doses of study treatments in a randomized sequence. Blood glucose measurements and other glycemic indicators will be collected to assess short-term pharmacodynamic effects. Safety and tolerability will also be monitored.

Start Date15 Jul 2026

Sponsor / Collaborator

Aspargo Labs, Inc.

100 Clinical Results associated with Metformin Hydrochloride

100 Translational Medicine associated with Metformin Hydrochloride

100 Patents (Medical) associated with Metformin Hydrochloride

18,219

Literatures (Medical) associated with Metformin Hydrochloride

01 Mar 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Development and characterization of metformin hydrochloride hydrogels as potential wound dressings for diabetic foot ulcers

Article

Author: Mendyk, Aleksander ; Migdał, Arkadiusz ; Lekka, Małgorzata ; Górska, Anna ; Witek, Karolina ; Kurek, Mateusz ; Latacz, Gniewomir ; Kudrycka, Maja ; Zemła, Joanna

Diabetic foot ulcers are a severe complication of diabetes mellitus, characterized by chronicity and high risk of infection. Their effective management requires wound-specific dressings, as no universal system adequately addresses the full spectrum of wounds. Hydrogel dressings offer promising local therapeutic strategies; however, materials combining mechanical robustness, prolonged drug release, and microenvironment modulation remain limited. Herein, we present a rational design strategy for a physically crosslinked, multi-component PVA-based hydrogel membrane incorporating metformin hydrochloride (MET) as the active pharmaceutical ingredient. Although conventionally administered orally, MET has been increasingly recognized for its anti-inflammatory and pro-regenerative properties, supporting its repurposing for localized wound applications. The developed dressings were comprehensively characterized in terms of rheology, pH modulation, morphology (optical microscopy, SEM), mechanical performance, liquid uptake, MET release, cytocompatibility, and in vitro antibacterial and anti-inflammatory activity. An optimized hydrogel formulation based on PVA (Mw ∼ 195,000 Da) and six freeze-thaw cycles (-80 °C/∼22 °C) exhibited high elasticity (ε > 380%), tensile strength (σ ∼ 0.23 MPa), and minimal permanent deformation (ε ≤ 3%). It enabled prolonged MET release over 72 h while maintaining a mildly acidic environment (pH ∼ 5.5-6.3) favorable for wound healing. Compared with commercial drug-free hydrogel dressings, the optimized formulation showed superior mechanical strength, pH-modulating capacity, antibacterial activity against Escherichia coli and Pseudomonas aeruginosa, as well as attenuation of IL-6 expression in LPS-stimulated keratinocytes, indicating anti-inflammatory activity. Collectively, these findings highlight the early-stage potential of MET-loaded solid-sheet hydrogels as multifunctional dressings for chronic, low-exudate diabetic foot ulcers.

16 Jan 2026·MEDICINE

Comparative effectiveness of immediate-release and extended-release metformin on gastrointestinal tolerability, quality of life, and treatment satisfaction: A prospective cohort study

Article

Author: Elodemi, Mahmoud ; Alrasheed, Tariq ; Alshadfan, Hisham ; Mirghani, Hyder ; Abdullah, Muhammad Nazrul Hakim ; Alanazi, Mansuor ; Alatawi, Amirah

Gastrointestinal (GI) side effects from metformin often limit its use and can impact patient quality of life (QoL) and satisfaction. The extended-release (XR) formulation is thought to cause fewer GI adverse events than immediate-release (IR) metformin, potentially improving tolerability, treatment satisfaction, and adherence. To compare metformin IR vs XR in terms of GI tolerability (incidence of GI side effects), patient-reported QoL, and medication satisfaction over 6 months in Saudi patients with type 2 diabetes. In a prospective cohort of 119 newly diagnosed patients with type 2 diabetes (62 on IR, 57 on XR), we tracked GI adverse events using a standardized questionnaire at baseline and 6-month follow-up. Diabetes-specific QoL was measured with the diabetes therapy-related quality of life questionnaire (DTR-QOL), and treatment satisfaction was assessed with the oral hypoglycemic agent questionnaire version 2 (OHA-Q ver. 2). Metformin XR was associated with significantly better GI tolerability. By 6 months, 45.2% of IR patients and only 24.5% of XR patients reported any GI side effect ( P <.05). Rates of bothersome symptoms, such as diarrhea, were notably higher in the IR group. Patients on XR reported fewer interruptions of therapy due to GI upset. The DTR-QOL global score improved in both groups ( P <.05), but there was no significant difference in total DTR-QOL scores between groups ( P = .390). The OHA-Q ver. 2 global score improved in both groups ( P <.05), but the XR group had higher scores in domains related to satisfaction (median treatment satisfaction domain score 100 vs 77.78 for IR, P < .05), with a significant difference in OHA-Q ver. 2 global score (92.59 vs 86.31 for IR; P <.05). Metformin XR demonstrated superior GI tolerability, which translated into improved treatment satisfaction compared to IR. While the overall quality of life related to diabetes management improved similarly with both, the XR formulation reduced side effect burden, and the lower daily dosing led to higher patient-reported satisfaction. These findings support the use of metformin XR to enhance tolerability and adherence, potentially leading to improved long-term outcomes.

02 Jan 2026·DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Bioequivalence and pharmacokinetic prediction of oral marketed metformin extended-release tablets in Saudi Arabia

Article

Author: Alomary, Abdulaziz Abdulrrahman ; Aljutyali, Abdullah S. ; Amin, Mohammed A. ; Alwadi, Aiman Y. ; Ameer, Omar Z. ; Alrashidi, Talal S. ; Abdellatif, Ahmed A. H. ; Maswadeh, Hamzah M. ; Ibrahim, Mohamed A.

OBJECTIVE:

The Saudi market offers dosages of metformin that have varying release rates and can lead to different pharmacological reactions. Studying formulation bioequivalences helps patients choose the optimum medicine without affecting pharmacological responses.

SIGNIFICANCE:

This study affects patient care clinically, which can improve Saudi diabetes management by improving efficacy, safety, adherence, access, and cultural relevance.

METHOD:

The bioequivalence and pharmacokinetic parameters were studied using the convolution method. Similarity factor f₁ and different factors f₂ of different types of metformin tablets were calculated. Furthermore, the pharmacokinetic parameters were estimated using the convolution method.

RESULTS:

At pH = 6.8 (phosphate buffer) and 50 rpm, 100% of metformin was released within 2 h. While, after two hours in HCl at pH = 1.1 followed by five hours in phosphate buffer at pH = 6.8, 100% of the medication was released after 7 h. The release kinetics showed zero-order kinetics with r² = 0.961 for Formit^® and 0.971 for Glucophage^®, while the release mechanism showed that it follows the Higuchi equation with r² = 0.974 for Formit^® and 0.971 for Glucophage^®, respectively, indicating that the mechanism of drug release was controlled by diffusion. The two brands were lyo-equivalent, with a similarity factor and difference factor equal to 59.36 and 7.26, respectively.

CONCLUSION:

The convolution approach indicated that Glucophage^® and Formit^® have bioequivalent C_max of 601 and 592 ng/ml, respectively. The two products had the same projected T_max of 2.0 h and a modest AUC_∞ differential that did not violate the FDA's 80-125% limit.

413

News (Medical) associated with Metformin Hydrochloride

26 Feb 2026

·www.prnewswire.com

Lilly's oral GLP-1, orforglipron, delivered superior blood sugar control and weight loss compared to oral semaglutide in head-to-head type 2 diabetes trial published in The Lancet

For the primary endpoint, orforglipron 36 mg lowered A1C by 2.2% vs. 1.4% with oral semaglutide 14 mg in ACHIEVE-3 In a key secondary endpoint, participants on orforglipron 36 mg lost 19.7 lbs (9.2%) compared to 11.0 lbs (5.3%) with oral semaglutide 14 mg, representing a 73.6% greater relative weight loss Lilly has submitted orforglipron to regulators in over 40 countries, with potential U.S. action for obesity in Q2 2026 INDIANAPOLIS, Feb. 26, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-3, the first head-to-head Phase 3 trial evaluating the safety and efficacy of orforglipron, a small molecule oral GLP-1 without food or water restrictions, compared with oral semaglutide in adults with type 2 diabetes inadequately controlled with metformin. The 52-week trial enrolled 1,698 participants across four treatment arms: orforglipron 12 mg and 36 mg, and oral semaglutide 7 mg and 14 mg. In ACHIEVE-3, orforglipron outperformed oral semaglutide across the primary and all key secondary endpoints, delivering significantly greater improvements in A1C and weight.1,2 The results were published today in The Lancet. "ACHIEVE-3 gives us the first head-to-head comparison between two oral GLP-1 receptor agonist therapies in adults with type 2 diabetes, and the differences were clinically meaningful," said Dr. Julio Rosenstock, clinical professor of medicine at the University of Texas Southwestern Medical Center and lead investigator. "Orforglipron 12 mg and 36 mg doses outperformed oral semaglutide 7 mg and 14 mg diabetes-related doses on every key endpoint we measured, including A1C and weight loss, with improvements appearing as early as four weeks and sustained throughout the study." Orforglipron also showed clinically meaningful improvements from baseline across key cardiovascular risk factors, including non-HDL cholesterol, HDL cholesterol, VLDL cholesterol, total cholesterol, systolic blood pressure and triglycerides.4 "The results of ACHIEVE-3 highlight the potential advantages of orforglipron over oral semaglutide for type 2 diabetes: greater A1C reduction, more weight loss, and the ability to take it without food or water timing restrictions — that's a combination that could matter significantly to people managing their disease day in and day out," said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. "With global submissions underway and FDA action on obesity expected next quarter, we're focused on making this option available as quickly as possible." The overall safety and tolerability profile of orforglipron in ACHIEVE-3 was consistent with previous trials. For orforglipron and oral semaglutide, the most common adverse events were nausea, diarrhea, vomiting, dyspepsia and decreased appetite. Treatment discontinuation rates due to adverse events were 8.7% (12 mg) and 9.7% (36 mg) for orforglipron vs. 4.5% (7 mg) and 4.9% (14 mg) for oral semaglutide. Lilly has submitted orforglipron to regulators in over 40 countries, with submission for type 2 diabetes in the U.S. planned later this year. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.6 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea (OSA) and hypertension in adults with obesity. About ACHIEVE-3 and ACHIEVE clinical trial program ACHIEVE-3 (NCT06045221) is a Phase 3, 52-week, randomized, open-label trial evaluating the efficacy and safety of orforglipron compared with oral semaglutide in adults with type 2 diabetes inadequately controlled with metformin. The trial randomized 1,698 participants across the U.S., Argentina, China, Japan, Mexico and Puerto Rico to receive either 12 mg or 36 mg orforglipron or 7 mg or 14 mg oral semaglutide in a 1:1:1:1 ratio. The primary objective of the study was to demonstrate that orforglipron is non-inferior in A1C reduction from baseline after 52 weeks compared with oral semaglutide when comparing the lower and higher doses. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals until reaching their randomized maintenance dose of 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). All participants in the oral semaglutide treatment arms started the study at a dose of oral semaglutide 3 mg once-daily and then increased the dose in a step-wise approach at four-week intervals until reaching their final randomized maintenance dose of 7 mg (via a step at 3 mg) or 14 mg (via steps at 3 mg and 7 mg). If participants were unable to tolerate a dose of orforglipron or oral semaglutide, they were allowed, once during the study, to reduce to the previous dose, with a minimum dose of orforglipron 3 mg or oral semaglutide 7 mg. The ACHIEVE Phase 3 global clinical development program for orforglipron has enrolled more than 6,000 people with type 2 diabetes across five global registration trials. The program began in 2023 with detailed results from the three remaining registrational trials anticipated later this year. Endnotes and References All measures except for body weight for orforglipron 12 mg vs. oral semaglutide 14 mg and percentage of participants achieving A1C <5.7% were controlled for family-wise type 1 error using the efficacy estimand and treatment-regimen estimand. Body weight for orforglipron 12 mg vs. oral semaglutide 14 mg and percentage of participants achieving A1C <5.7% were prespecified secondary endpoints and showed nominal statistical significance using the efficacy estimand. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 52 weeks without initiating additional antihyperglycemic medications (>14 days of use). The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of additional antihyperglycemic medications. Not controlled for family-wise type 1 error. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. . Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. Kawai T, Sun B, Yoshino H, Feng D, Suzuki Y, Fukazawa M, Nagao S, Wainscott DB, Showalter AD, Droz BA, Kobilka TS, Coghlan MP, Willard FS, Kawabe Y, Kobilka BK, & Sloop KW, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with type 2 diabetes, and the timeline for regulatory submissions and actions, future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for type 2 diabetes, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Clinical ResultPhase 3Drug Approval

03 Feb 2026

·www.biospace.com

Novo Nordisk A/S: CagriSema demonstrated superior HbA1c reduction of 1.91%-points and weight loss of 14.2% in adults with type 2 diabetes in the REIMAGINE 2 trial

CagriSema achieved superior weight loss of up to 14.2%, where up to 43% of the people achieved ≥15% weight loss and up to 24% achieved ≥20% weight loss 1 . CagriSema achieved superior HbA 1c reduction of up to 1.91%-points 1 from a mean HbA 1c baseline of 8.2%. Superiority was established on both weight loss and HbA 1c versus the individual components. In the trial, CagriSema appeared to have a safe and well-tolerated pro with incretin and amylin-based therapies. Bagsværd, Denmark, 2 February 2026 – Novo Nordisk today announced headline results from REIMAGINE 2, a phase 3 trial from the global REIMAGINE clinical trial programme. CagriSema demonstrated both superior HbA 1c reduction and weight loss at week 68 versus semaglutide, across all tested doses in the trial. REIMAGINE 2 was a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of the amylin receptor agonist, cagrilintide, and the GLP-1 receptor agonist, semaglutide) in two different doses (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) compared to two different doses of semaglutide (2.4 mg and 1.0 mg), cagrilintide (2.4 mg), and placebo. The trial included 2,728 people with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. Approximately 40% of all people were using an SGLT2 inhibitor before initiating the trial. When evaluating the effects of treatment, if all people adhered to treatment 1 , and from a mean HbA 1c baseline of 8.2%, people treated with CagriSema 2.4 mg/2.4 mg achieved superior HbA 1c reduction of 1.91%-points after 68 weeks compared to 1.76%-points with semaglutide 2.4 mg. From a mean baseline body weight of 101 kg, people treated with CagriSema 2.4 mg/2.4 mg achieved superior weight loss of 14.2% after 68 weeks compared to 10.2% with semaglutide 2.4 mg. No weight loss plateau was observed at week 68 for CagriSema. With CagriSema 2.4 mg/2.4 mg, 43% of the people achieved ≥15% weight loss and 24% achieved ≥20% weight loss. Efficacy estimand results From week 0 to 68 HbA 1c reduction Weight loss CagriSema 2.4 mg/2.4 mg -1.91%-points a -14.2% a Semaglutide 2.4 mg -1.76%-points -10.2% Placebo +0.09%-points -1.5% a Statistically significant compared to semaglutide (2.4 mg), estimated mean. When applying the treatment-regimen estimand 2 , people treated with CagriSema 2.4 mg/2.4 mg achieved superior HbA 1c reduction of 1.80%-points after 68 weeks compared to 1.68%-points with semaglutide 2.4 mg. In addition, people treated with CagriSema 2.4 mg/2.4 mg achieved superior weight loss of 12.9% after 68 weeks compared to 9.2% with semaglutide 2.4 mg. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with incretin and amylin-based therapies. “We are very pleased by the clinical pro CagriSema in type 2 diabetes patients, including a confirmation of the very strong weight loss data seen with CagriSema in the obesity trials”, said Martin Holst Lange, executive vice president, chief scientific officer and head of Research and Development at Novo Nordisk. “By combining semaglutide and cagrilintide, we're seeing superior outcomes in both blood glucose control and weight reduction beyond those achieved with each therapy individually. The results strengthen our belief that CagriSema could be the first amylin-based combination therapy and a promising treatment option for individuals with type 2 diabetes, who also has a focus on weight loss.” Following the results of REIMAGINE 1 and REDEFINE 3, Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes. The detailed results from REIMAGINE 2 will be presented at a scientific conference in 2026. CagriSema for weight management was submitted to the US FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials. About CagriSema Once-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin receptor agonist, cagrilintide, and a long-acting GLP-1 receptor agonist, semaglutide. About the REIMAGINE programme REIMAGINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in type 2 diabetes. The global clinical trial programme consists of several phase 3 trials. REIMAGINE 1 – a 40-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg and CagriSema 1.0 mg/1.0 mg versus placebo in 180 adults with type 2 diabetes inadequately controlled on diet and exercise. REIMAGINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg, and placebo, and CagriSema 1.0 mg/1.0 mg versus semaglutide 1.0 mg and placebo in 2,728 adults with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. REIMAGINE 3 – a 40-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg and CagriSema 1.0 mg/1.0 mg versus placebo in 270 adults with type 2 diabetes inadequately controlled with basal insulin with or without metformin. REIMAGINE 4 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus once-weekly tirzepatide 15 mg in 1,000 adults with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. REIMAGINE 5 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 1.0 mg/1.0 mg versus once-weekly tirzepatide 5 mg in 1,000 adults with type 2 diabetes inadequately controlled with metformin, an SGLT2 inhibitor or both. REDEFINE 3 – an event-driven and long-term safety and efficacy cardiovascular outcomes phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 7,000 adults with established cardiovascular disease and overweight or obesity, with or without type 2 diabetes. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . Publication of inside information pursuant to Market Abuse Regulation, Article 17. Contacts for further information Media: Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com Investors: Michael Novod +45 3075 6050 nvno@novonordisk.com Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com Max Ung +45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com Alex Bruce +45 3444 2613 axeu@novonordisk.com Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com Company announcement No 2 / 2026 1 Based on the efficacy estimand according to the trial protocol, regardless of dose modification 2 Based on the treatment-regimen estimand: treatment effect regardless of treatment adherence Attachment CA260202-REIMAGINE2

Phase 3Clinical Result

30 Jan 2026

·www.prnewswire.com

Galmed Pharmaceuticals Announces Receipt of Nasdaq Minimum Bid Price Notification

TEL AVIV, Israel, Jan. 30, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, today announced that the Company received a letter from the Nasdaq Listing Qualifications (the "Letter"), indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Further, the Nasdaq Listing Rules also provide the Company a compliance period of 180 calendar days to regain compliance. According to the Letter, the Company has from January 29, 2026, or until July 28, 2026, to regain compliance with the minimum bid price requirement. The Company can regain compliance, if at any time during this 180 day period, the closing bid price of its ordinary shares is at least $1 for a minimum of ten consecutive business days, in which case the Company will be provided with a written confirmation of compliance and this matter will be closed. In the event the Company does not regain compliance after the initial 180-day period, the Company may then be eligible for an additional time if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company cannot demonstrate compliance by the end of the 180-day period, the Nasdaq's staff will notify the Company that its ordinary shares are subject to delisting. The Letter has no immediate effect on the Company's Nasdaq listing or the trading of its ordinary shares, and during the grace period, as may be extended, Galmed's ordinary shares will continue to trade on the Nasdaq Capital Market under the symbol "GLMD". About Galmed Pharmaceuticals Ltd. We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver diseases, and continue to actively advance Aramchol for the treatment of combination therapy for NASH. We are also seeking to develop Aramchol for certain oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in drug development. Forward-Looking Statements Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. For example, the Company is using forward-looking statements when it discusses regaining compliance with Nasdaq's continued listing requirements, and timing and effect thereof. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to the potential synergistic effect of Aramchol, Stivarga® and Metformin as a new fixed-dose combination treatment, the expected timing of clinical trials, future clinical development and creating value for investors and stakeholders. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; the commercial launch and future sales of Aramchol and any future product candidates; our ability to comply with all applicable post-market regulatory requirements for Aramchol, or any other product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for Aramchol, or any other product candidate; third-party payor reimbursement for Aramchol, or any other product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; the security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel, risks relating to our digital asset management strategy, including the highly volatile nature of the price of cryptocurrencies and other digital assets, the risk that our share price may be highly correlated to the price of the cryptocurrencies and other digital assets that we may hold, risks related to increased competition in the industries in which we do and will operate, risks relating to significant legal, commercial, regulatory and technical uncertainty regarding cryptocurrencies and other digital assets generally, risks relating to the treatment of crypto assets for U.S. and foreign tax purposes and those risks and uncertainties identified in Exhibit 99.2 to our Report of Foreign Private Issuer on Form 6-K filed with the Securities and Exchange Commission ("SEC") on August 25, 2025. We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on April 2, 2025 in greater detail under the heading "Risk Factors." Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. Logo - SOURCE Galmed Pharmaceuticals Ltd. 21% more press release views with Request a Demo

100 Deals associated with Metformin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00944	Metformin Hydrochloride	A10BA02	DBSALT000114

R&D Status

Approved

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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

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03076281 (CTgov)	Phase 2	Lymphoid Interstitial Pneumonia \| Squamous Cell Carcinoma of Head and Neck \| Laryngeal Diseases	7	Metformin Hydrochloride (Arm A (Metformin Hydrochloride))	yhxaaydvio(gzdqwdbtju) = lrqkkfmzcx pgrafdkpsx (kigcxgyowb, yhjpvvfrae - zihzpyfbnv) View more	-	29 Jan 2026
				Doxycycline (Arm B (Doxycycline))	yhxaaydvio(gzdqwdbtju) = hkzeqghncj pgrafdkpsx (kigcxgyowb, ozmzbplxvv - ornkhnhmmj) View more
NCT05741372 (CTgov)	Not Applicable	Liver Cirrhosis	28	Rosuvastatin+digoxin+Metformin hydrochlorid+furosemide (Group 1: Healthy Participants)	ybjtlqjzdw(qlcfslvyhe) = xknqkziymy rzymaackbl (bpufmwrfsr, NA) View more	-	13 Jan 2026
				Rosuvastatin+digoxin+Metformin hydrochlorid+furosemide (Group 2: F4 Child-Turcotte-Pugh Class A (Child-Pugh A) Subjects (Compensated))	ybjtlqjzdw(qlcfslvyhe) = akdjltzbsd rzymaackbl (bpufmwrfsr, NA) View more
NCT06504862 (CTgov)	Phase 1	-	32	Dabigatran-etexilate (Dabigatran-etexilate (R))	cpmaiueyak(zslwucjomp) = qqjcztqigo gyjrznfmpr (oikzmrhdkb, NA) View more	-	09 Jan 2026
				Zongertinib+dabigatran-etexilate (T (Zongertinib and dabigatran-etexilate (T))	cpmaiueyak(zslwucjomp) = frxmagilkx gyjrznfmpr (oikzmrhdkb, NA) View more
NCT01666171 (Alliance A211201, SABCS2025)	Phase 2	Early Stage Breast Carcinoma estrogen receptor negative (ER-) \| HER2+	146	Metformin	dytlyeydrz(fqesrvumxl): P-Value = 0.58 View more	Negative	11 Dec 2025
				Placebo
NCT03109847 (CTgov)	Phase 2	Differentiated Thyroid Gland Carcinoma \| Thyroid Dysgenesis	13	Radioactive Iodine+Metformin Hydrochloride (Arm I (metformin hydrochloride))	frhkjzytoc(pxebfkqraz) = nmlqsgerdz xihhfrtllc (fohwzruyql, diadsbhtdq - nupiqovfsk) View more	-	11 Dec 2025
				Radioactive Iodine (Arm II (placebo))	frhkjzytoc(pxebfkqraz) = owgqdbdnit xihhfrtllc (fohwzruyql, vnfezzisyx - lquyrlazwz) View more
NCT03229057 (COMET-PCOS, Pubmed \| PLoS Med)	Phase 3	-	240	Low-dose COCPs (20 μg ethinyl estradiol/0.15 mg desogestrol)	nstckicfpb(oemmegjfvs) = ugpqdliuhg woxodkqiix (djcixrzixi )	Positive	08 Dec 2025
				Metformin XR (2,000 mg)	nstckicfpb(oemmegjfvs) = jmrmflorzb woxodkqiix (djcixrzixi )
NCT05064488 (CTgov)	Phase 1	-	40	rosuvastatin+digoxin+metformin (Part 1: Cocktail)	ziidvghnph(wgdrjarxou) = qxbwwpatrt jjsauwfvfu (kiiyqtgrok, 21.5) View more	-	05 Dec 2025
				Evobrutinib (Part 1: Evobrutinib + Cocktail)	ziidvghnph(wgdrjarxou) = gwaurdxtkn jjsauwfvfu (kiiyqtgrok, 23.7) View more
NCT05120505 (Pubmed \| Mol Autism)	Phase 2	Fragile X Syndrome	30	Metformin	wgdrhguall(frxeykmfjr) = hnqcgvfgrs dqhchkrgpc (sfwsziulgt, 15.31) View more	Positive	25 Nov 2025
				Placebo	wgdrhguall(frxeykmfjr) = ythlbyrtaj dqhchkrgpc (sfwsziulgt, 23.67) View more
NCT04885530 (ACTIV-6, CTgov)	Phase 3	COVID-19	10,956	Ivermectin (Arm A - Ivermectin 400)	pylgfdmxpf = tymqaoeyam zgpbbngbka (qhzlvbdluy, xpvuwvdbtk - nvxmoesbtn) View more	-	17 Nov 2025
				Fluvoxamine (Arm B - Fluvoxamine)	pylgfdmxpf = xesxbdgdjo zgpbbngbka (qhzlvbdluy, rnspkhzrwu - okjrficcdv) View more
NCT03355469 (CTgov)	Phase 2/3	Metabolic Syndrome	91	Placebo (LoEx With Placebo)	qggeveazqi(lvysiaexra) = zqsklcnmut ggxicgprif (jpyekfozjr, zaeackywhd - qaasyspbdv) View more	-	22 Sep 2025
				High Intensity Exercise (HiEx With Placebo)	qggeveazqi(lvysiaexra) = cenxdjalbi ggxicgprif (jpyekfozjr, ixsajtanls - smxdfruyka) View more

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Metformin Hydrochloride

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