Glucophage

(Metformin Hydrochloride)

ApprovedSmall molecule

Metformin is used to treat type 2 diabetes by helping your body control blood sugar levels. It works by decreasing the amount of sugar your liver produces and helping your body use insulin more effectively.[2] Glucophage is currently approved and in use across 32 indications[4].[1]

Glucophage is one of 722 small molecule programs targeting Precocious Puberty. It is currently in Approved.

Indications

142

Total Trials

Active Trials

721

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Precocious PubertyActive, not recruiting

OsteoarthritisActive, not recruiting

Diabetes MellitusUnknown

Cesarean SectionActive, not recruiting

ErythroplakiaActive, not recruiting

Pelvic PainActive, not recruiting

Non-Alcoholic Fatty Liver DiseaseActive, not recruiting

Chronic PeriodontitisActive, not recruiting

Bladder CancerActive, not recruiting

Heart FailureCompleted

Precocious PubertyPreclinical

Active, not recruiting

OsteoarthritisPreclinical

Active, not recruiting

Diabetes MellitusPreclinical

Unknown

Cesarean SectionPreclinical

Active, not recruiting

ErythroplakiaPhase 2

Active, not recruiting

Pelvic PainPhase 2

Active, not recruiting

Non-Alcoholic Fatty Liver DiseaseApproved

Active, not recruiting

Chronic PeriodontitisApproved

Active, not recruiting

Bladder CancerApproved

Active, not recruiting

Heart FailureApproved

Completed

Showing 10 of 32 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Glucophage

EMD Serono

Approved

7 2

Voltaren

Novartis

Preclinical

1 3

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 5

Tricor

JJagotec

Preclinical

1 6

Rilvegostomig

AstraZeneca

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 9

Ablavar

LLantheus Medical Imaging

Preclinical

2 10

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Obese Patients

NCT06707012

Phase 2Active, not recruiting

Erythroplakia

NCT05237960

Phase 1Recruiting

Study completion

NCT07785934

Phase 1Active, not recruiting

Pancreatic Cancer

NCT02336087

Phase 2Active, not recruiting

Breast Cancer

NCT05023967

Phase 2Active, not recruiting

Erythroplakia

NCT02581137

Clinical

Trials by Indication[1]

Metformin20 trials

Pharmacokinetics of Metformin Intolerance

Completed·NNHS Tayside·Phase 4·NCT03361878·20 enrolled

Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet

Completed·DDexa Medica Group·N/A·NCT01677260·38 enrolled

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

Recruiting·DDonald Mabbott·Phase 3·NCT05230758·140 enrolled

Show 17 more trials

A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT04859452·56 enrolled

Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS

Completed·—·Phase 2·NCT05981742·75 enrolled

Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06654960·20 enrolled

Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject

Completed·PPT. Pyridam Farma Tbk·N/A·NCT05753371·24 enrolled

Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00778466·32 enrolled

Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects

Completed· AbbVie logo

AbbVie·Phase 1·NCT00986401·44 enrolled

Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian Volunteers

Completed· GSK logo

GSK·N/A·NCT01561976·30 enrolled

Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Recruiting·OOctober 6 University·Phase 2/3·NCT06142656·60 enrolled

Comparison of Myoinositol and Metformin in PCO

Unknown status·RRashid Latif Medical College·Phase 1·NCT04204044·126 enrolled

A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06504862·32 enrolled

OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

Completed·SS.C.B. Medical College and Hospital·Phase 4·NCT03236740·101 enrolled

Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00015691·105 enrolled

A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06655220·14 enrolled

Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity

Recruiting·UUniversity of Virginia·Phase 4·NCT06638671·20 enrolled

Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Unknown status·LLaboratorios Silanes S.A. de C.V.·Phase 2/3·NCT02064881·72 enrolled

A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05768360·6 enrolled

Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00929201·61 enrolled

Type 2 Diabetes9 trials

Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT04373967·424 enrolled

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00680745·597 enrolled

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes

Completed·LLaboratorios Silanes S.A. de C.V.·Phase 3·NCT01386671·203 enrolled

Show 6 more trials

Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes

Unknown status·UUniversity of Arizona·N/A·NCT02548741·120 enrolled

Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00660907·1,217 enrolled

Chiglitazar Added to Metformin for Type 2 Diabetes

Completed·CChipscreen Biosciences, Ltd.·Phase 3·NCT04807348·533 enrolled

Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

Completed·LLaboratorios Silanes S.A. de C.V.·Phase 2/3·NCT00940472·20 enrolled

Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes

Completed·SShenzhen People's Hospital·Phase 4·NCT04426422·52 enrolled

Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes

Suspended·LLaboratorios Silanes S.A. de C.V.·Phase 3·NCT04943692·500 enrolled

Breast Cancer7 trials

Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer

Completed·AAnna Maria Storniolo·Phase 1·NCT01793948·24 enrolled

Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO)

Completed·—·Phase 2·NCT04170465·70 enrolled

Metformin and Nightly Fasting in Women With Early Breast Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05023967·120 enrolled

Show 4 more trials

Metformin Hydrochloride in Treating Women With Stage I or Stage II Breast Cancer That Can Be Removed By Surgery

Terminated·VVanderbilt-Ingram Cancer Center·N/A·NCT00984490·5 enrolled

A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

Completed·CCanadian Cancer Trials Group·Phase 3·NCT01101438·3,649 enrolled

Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32

Unknown status·CCancer and Leukemia Group B··NCT01666171·458 enrolled

Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 3·NCT01905046·86 enrolled

Interaction5 trials

Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06727838·54 enrolled

A Study Evaluating Drug-Drug Interaction (DDI) Between HSK16149 Capsules and Metformin Hydrochloride Tablets

Unknown status· Haisco Pharmaceutical Group Co., Ltd. logo

Haisco Pharmaceutical Group Co., Ltd.·Phase 1·NCT04841720·22 enrolled

Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02231931·24 enrolled

Show 2 more trials

Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT04621669·18 enrolled

Transporter Cocktail Mutual Interaction

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02854527·30 enrolled

Prostate Cancer5 trials

Metformin Prostate Cancer Adjuvant Trial

Completed·NNYU Langone Health·Phase 2·NCT02176161·59 enrolled

Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer

Completed·UUniversity of California, Davis·Phase 1·NCT02339168·25 enrolled

Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy

Terminated·RRutgers, The State University of New Jersey·Phase 2·NCT02420652·27 enrolled

Show 2 more trials

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01433913·20 enrolled

Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer

Withdrawn·NNew Mexico Cancer Research Alliance·Phase 2·NCT01478308

76 more indications

Pancreatic Cancer4 trials

Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery

Active, not recruiting·—·Phase 1·NCT02336087·21 enrolled

Stereotactic Radiosurgery and Metformin in Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer

Completed·—·Phase 1·NCT02153450·8 enrolled

Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery

Withdrawn·—·Phase 1·NCT01954732

Show 1 more trial

Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer

Completed·—·Phase 2·NCT01666730·50 enrolled

Heart Failure4 trials

Metformin in Heart Failure Without Diabetes

Terminated·—·Phase 2·NCT03331861·6 enrolled

Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients

Completed·—·Phase 4·NCT05177588·70 enrolled

The Influence of Metformin on Chronic Heart Failure Clinical Course in Patients With Prediabetes

Completed·—·Phase 4·NCT04549415·97 enrolled

Show 1 more trial

Study on the Effect of Metformin in Improving Cardiac Function After Implantation of Left Ventricular Assist Devices

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Preclinical·NCT07666698·108 enrolled

Overweight3 trials

Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Recruiting·JJohns Hopkins University·Phase 2·NCT06273072·100 enrolled

Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects

Completed·BBeijing Dongfang Biotech Co., Ltd.·Phase 1·NCT06247748·28 enrolled

A Study of BGM0504 in Overweight or Obese Participants

Completed·BBrightGene Bio-Medical Technology Co., Ltd.·Phase 1·NCT06920056·28 enrolled

Endometrial Cancer3 trials

Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer

Active, not recruiting·NNorthwestern University·Phase 2·NCT04576104·51 enrolled

Comparison of the Effectiveness Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·N/A·NCT03618472·50 enrolled

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

Unknown status·GGynecologic Oncology Group·Phase 2/3·NCT02065687·469 enrolled

Gestational Diabetes2 trials

RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects

Completed·NNational University of Ireland, Galway, Ireland·Phase 3·NCT02980276·535 enrolled

Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes

Recruiting·—·Phase 1·NCT05917587·30 enrolled

Diabetes Mellitus2 trials

Perioperative Continuation of Metformin Therapy in Patients With Typ 2 Diabetes Mellitus Undergoing Non-cardiac Surgery

Unknown status·KKepler University Hospital·Phase 4·NCT04284722·400 enrolled

A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)

Completed·—·Phase 3·NCT05451147·48 enrolled

Polycystic Ovary Syndrome2 trials

Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome

Recruiting·PPeking University First Hospital·Phase 4·NCT05702905·75 enrolled

Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

Unknown status·PPing Li,MD·Phase 4·NCT06256289·50 enrolled

Oral Submucous Fibrosis2 trials

Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis

Completed·ZZiauddin University·Phase 1/2·NCT06871904·45 enrolled

Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial

Completed·ZZiauddin University·Phase 1/2·NCT06332612·30 enrolled

Non-Small Cell Lung Cancer2 trials

Nivolumab and Metformin Hydrochloride in Treating Patients With Stage III-IV Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Unknown status·NNorthwestern University·Phase 2·NCT03048500·17 enrolled

Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations

Unknown status·IInstituto Nacional de Cancerologia de Mexico·Phase 3·NCT05445791·312 enrolled

Primary Peritoneal Cancer2 trials

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT02122185·110 enrolled

Metformin Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Withdrawn·FFox Chase Cancer Center·Phase 1·NCT02050009

Combination Therapy2 trials

A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT04218734·214 enrolled

Metformin vs Inositol vs Diet vs Combination Therapy in PCOS

Completed·IIslamabad Medical and Dental College·N/A·NCT07380841·192 enrolled

Erythroplakia2 trials

M4OC-Prevent 2.0: Phase IIb Trial of Metformin for Oral Cancer Prevention

Active, not recruiting·UUniversity of Arizona·Phase 2·NCT05237960·34 enrolled

M4OC-Prevent: Metformin for Oral Cancer Prevention

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02581137·26 enrolled

Phase 11 trial

Phase 1 Bioavailability Study of SYR-322MET

Completed· Takeda logo

Takeda·Phase 1·NCT02508168·24 enrolled

Lymphoma1 trial

Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma

Completed·LLondon Health Sciences Centre·Phase 1·NCT00659568·28 enrolled

Uterine Cancer1 trial

Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer

Unknown status·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02874430·27 enrolled

Probiotic Intervention1 trial

Probiotic Intervention in PCOS

Completed·MMedical University of Graz·Phase 4·NCT04593459·112 enrolled

Clinical Trial1 trial

An Open Label Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Not yet recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT04530383·30 enrolled

Lung Adenocarcinoma1 trial

Metformin Plus/Minus Fasting Mimicking Diet to Target the Metabolic Vulnerabilities of LKB1-inactive Lung Adenocarcinoma

Unknown status·MMarina Garassino·Phase 2·NCT03709147·64 enrolled

PCOS1 trial

Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Completed·ZZagazig University·Phase 1·NCT06170463·210 enrolled

Insulin Resistant1 trial

Metformin Effect on Brain Function in Insulin Resistant Elderly People

Completed·MMayo Clinic·Phase 2·NCT03733132·40 enrolled

Pilot Study1 trial

Pilot Study on Evaluating the Geroprotective Effect of Metformin

Recruiting·XXuanwu Hospital, Beijing·Phase 2·NCT06459310·130 enrolled

Vaccination1 trial

Vaccination Efficacy With Metformin in Older Adults

Completed·UUConn Health·Phase 1·NCT03996538·26 enrolled

Systemic Inflammation1 trial

Metformin and Systemic Inflammation in HIV

Unknown status·HHospital Civil de Guadalajara·Phase 4·NCT03774108·40 enrolled

PreDiabetes1 trial

Effect of Green Tea on Obese Pediatrics With Prediabetes

Completed·—·Phase 3·NCT06229795·90 enrolled

Cesarean Section1 trial

Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect

Recruiting·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·N/A·NCT05205317·100 enrolled

PCO1 trial

of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO

Unknown status·—·Phase 3·NCT05601336·200 enrolled

Bladder Cancer1 trial

The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

Recruiting·—·Phase 4·NCT06215976·78 enrolled

Chronic Periodontitis1 trial

Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis

Active, not recruiting·—·Phase 4·NCT06856369·120 enrolled

Osteoarthritis1 trial

Effect of Metformin on Patients With Osteoarthritis

Unknown status·GGuangzhou First People's Hospital·N/A·NCT05034029·262 enrolled

Tics1 trial

Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.

Completed·CCelon Pharma SA·Phase 1·NCT04622111·68 enrolled

Prevention1 trial

Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions

Unknown status·—·Phase 3·NCT03685409·62 enrolled

Multiple Sclerosis1 trial

Metformin Add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination And Neurodegeneration

Active, not recruiting·UUniversity Hospital, Antwerp·Phase 2·NCT05893225·120 enrolled

Non-Alcoholic Fatty Liver Disease1 trial

Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease

Completed·XXijing Hospital·Phase 4·NCT03796975·120 enrolled

Precocious Puberty1 trial

Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty

Not yet recruiting·—··NCT05957991·1,500 enrolled

Metabolic Syndrome1 trial

Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome

Completed·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 3·NCT02960711·1,600 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00778427·32 enrolled

Insulin resistance1 trial

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

Recruiting·—·Phase 3·NCT06763328·200 enrolled

Lung Cancer1 trial

Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer

Active, not recruiting·NNorthwestern University·Phase 2·NCT04931017·50 enrolled

Polycystic Ovarian Syndrome (PCOS)1 trial

Myoinositol vs. Metformin for Polycystic Ovarian Syndrome (PCOS): Impact on Metabolic Health and Fertility

Completed·—·N/A·NCT07058675·156 enrolled

Clinical Efficacy and Safety1 trial

Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics

Completed·—·N/A·NCT05759442·46 enrolled

Colorectal Adenoma1 trial

Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMI

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01312467·45 enrolled

Brain Injury1 trial

Metformin Treatment in Infants After Perinatal Brain Injury

Terminated·TThe Hospital for Sick Children·Phase 1·NCT05590676·1 enrolled

Obese Patients1 trial

Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients

Recruiting·—·Phase 4·NCT06707012·140 enrolled

Genetic Polymorphism1 trial

Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS

Active, not recruiting·—·Phase 4·NCT05680805·100 enrolled

Infertility1 trial

Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility

Not yet recruiting·MMedical University of Bialystok·Phase 2·NCT06012682·200 enrolled

Esophageal Cancer1 trial

Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01447927·93 enrolled

Relapsed/Refractory AML1 trial

Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML

Terminated·NNorthwestern University·Phase 1·NCT01849276·2 enrolled

Concentration1 trial

A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00830076·18 enrolled

Thyroid Cancer1 trial

Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT03109847·13 enrolled

Multiple Myeloma1 trial

Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma

Completed·MMayo Clinic·Phase 1·NCT03829020·9 enrolled

Efficacy and Safety1 trial

Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy

Unknown status·PPegBio Co., Ltd.·Phase 3·NCT05326490·546 enrolled

Bone Sarcoma1 trial

Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse

Recruiting·IIstituto Ortopedico Rizzoli·Phase 2·NCT04758000·67 enrolled

Type 2 Diabetes Mellitus1 trial

Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects

Completed·—·Phase 4·NCT01589445·77 enrolled

Heart1 trial

DANHEART (H-HeFT and Met-HeFT)

Completed·HHenrik Wiggers·Phase 4·NCT03514108·1,100 enrolled

Viral Infection1 trial

Modulate Cellular Stress in the Immune Cells to Reduce Rate of Symptomatic Viral Infection

Completed·SSingapore General Hospital·Phase 2·NCT04267809·32 enrolled

Vitiligo1 trial

Evaluating the Efficacy and Safety of Metformin in Vitiligo

Withdrawn·UUniversity of Massachusetts, Worcester·Phase 2·NCT05607316

Patients With Advanced Solid Tumors1 trial

A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors

Withdrawn·TTurning Point Therapeutics, Inc.·Phase 1·NCT05828303

Pancreatic Ductal Adenocarcinoma1 trial

The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma

Unknown status·BBritish Columbia Cancer Agency·Phase 2·NCT02978547·20 enrolled

Advanced NSCLC1 trial

Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT03874000·43 enrolled

Type 2 Diabetic Patients1 trial

Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy

Completed· Takeda logo

Takeda·Phase 3·NCT02068443·374 enrolled

Head and Neck Cancer1 trial

Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT03109873·9 enrolled

Oral leukoplakia1 trial

Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia

Recruiting·—·Phase 2·NCT07387900·34 enrolled

Preeclampsia1 trial

Preeclampsia Intervention Netherlands

Not yet recruiting·AAmsterdam UMC·Phase 3·NCT06452498·180 enrolled

Colon Cancer1 trial

Metformin Treatment for Colon Cancer

Completed·ZZealand University Hospital·Phase 2·NCT03359681·48 enrolled

Ovarian Clear Cell Carcinoma1 trial

Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

Unknown status·FFudan University·Phase 1/2·NCT05759312·20 enrolled

Chronic Lymphocytic Leukemia1 trial

Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

Completed·—·Phase 1·NCT02948283·3 enrolled

Autoimmune Diabetes1 trial

Autoimmune Diabetes Accelerator Prevention Trial

Withdrawn·—·Phase 4·NCT02881528

Glioblastoma Multiforme1 trial

Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT01430351·144 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT03076281·7 enrolled

Kidney Disease1 trial

Metformin as RenoProtector of Progressive Kidney Disease

Unknown status·UUniversiteit Antwerpen·Phase 3·NCT03831464·290 enrolled

Frailty1 trial

Lifestyle Intervention Plus Metformin to Treat Frailty in Older Veterans With Obesity

Completed·VVA Office of Research and Development·Phase 3·NCT04221750·114 enrolled

Advanced Solid Malignancies1 trial

A Modular Phase I, Open-label Study to Assess the Safety, Pharmacokinetics, and Drug Interaction Potential and Relative Bioavailability of Saruparib in Patients With Advanced Solid Malignancies

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT06899061·41 enrolled

Retinopathy1 trial

Oral Metformin for Treatment of ABCA4 Retinopathy

Active, not recruiting·NNational Eye Institute (NEI)·Preclinical·NCT04545736·55 enrolled

TP53 Y220C Mutation1 trial

A Phase 1, Open-label, 2-part, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.

Recruiting·PPMV Pharmaceuticals, Inc·Phase 1·NCT07372625·14 enrolled

Pelvic Pain1 trial

Glycemic Regulation as Endometriosis Adjunct Treatment

Active, not recruiting·BBoston Children's Hospital·Phase 2·NCT06611501·14 enrolled

Unspecified3 trials

Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT00290940·400 enrolled

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.

Recruiting·TThe United Bio-Technology (Hengqin) Co., Ltd.·Phase 1·NCT07785934·48 enrolled

Investigation of the Effect of BI 764198 on the Pharmacokinetics of Metformin Following Multiple Oral Administration in Healthy Male and Female Trial Participants (an Open-label, Randomised, Two-way Crossover Trial)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT07368569·14 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 5, 1998

GLUCOPHAGE

NDA NDA020357

Oct 13, 2000

GLUCOPHAGE XR

NDA NDA021202

Sep 11, 2003

RIOMET

NDA NDA021591

Apr 27, 2004

FORTAMET

NDA NDA021574

Jun 3, 2005

GLUMETZA

NDA NDA021748

Aug 29, 2019

RIOMET ER

NDA NDA212595

Sources

References

[1]
ClinicalTrials.gov — 142 trial records for Metformin Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Glucophage drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Metformin Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Metformin Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212595). U.S. Food & Drug Administration.
[6]
SEC EDGAR — EMD Serono company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mitochondrial Complex I (NADH Dehydrogenase) Inhibitor; Mitochondrial Glycerol-3-Phosphate Dehydrogenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EMD Serono