Metformin: clinical trials recruiting now
45
Recruiting trials
15
Conditions studied
28
US states with sites
26
Countries
FDA drug label
- FDA-approved
- Yes. Metformin appears in the FDA drug-label database. Marketed as Metformin Hydrochloride.
- Boxed warning
- The FDA label for Metformin carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
& USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-03-15 |
| Failed Moisture Limits: Out of specification for water content — SUN PHARMACEUTICAL INDUSTRIES INC | Class III (FDA: unlikely to cause harm) | Terminated | 2021-03-25 |
| Presence of Foreign Tablets/Capsules. — A-S Medication Solutions LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-02-25 |
| CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Marksans Pharma Limited | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-06-05 |
| CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level — Amneal Pharmaceuticals of New York, LLC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2020-05-29 |
Phase breakdown
Early Phase 1 3
Phase 1 8
Phase 2 15
Phase 3 9
Phase 4 10
Not applicable 4
Conditions being studied
Recruiting trials involving Metformin
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
- A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
- A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- Acupuncture or Metformin for Insulin Resistance in Women With PCOS
- Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity
- Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
- Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
- Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis
- Cardiovascular and Endothelial Markers During OGTT Before and at Six and Twelve Months Post-treatment in Women With PCOS
- Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients
- Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI)
- Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
- Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension
- Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
- Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study
- Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
- Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
- Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome
- First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
- Fish Oil, Metformin and Heart Health in PCOS
- Glycemic Variability of Combination Therapies in T2DM
- Impact of P53 and SIRT1 in Type 2 Diabetes
- Liraglutide Treatment in Obese Infertile PCOS Women
- Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
- Metformin Safety and Efficacy in Osteoarthritis.
- Metformin Treatment of Patients with Hand Osteoarthritis
- Metformin as Added on Therapy in Patients With Ulcerative Colitis
- Metformin as Adjunct Therapy in Depression-obesity Comorbidity: Clinical and Genetic Evaluation
- Metformin as a Neuroprotective Therapy for Glaucoma
- Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
- Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
- Metformin for Fibromyalgia Symptoms (INFORM Trial)
- Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
- Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
- Precision Dosing of Metformin in Youth With T2D
- Preventing Injured Knees From osteoArthritis: Severity Outcomes
- Prevention of Progression of Prediabetes, Obesity and CV Risk
- SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes
- Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity
- The EMPA-FIT Study
- The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus
- The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Common questions
Is Metformin FDA-approved?
Yes, marketed as Metformin Hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve Metformin?
45 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.