Metformin Hydrochloride: clinical trials recruiting now
4
Recruiting trials
8
Conditions studied
0
US states with sites
3
Countries
FDA drug label
- FDA-approved
- Yes. Metformin Hydrochloride appears in the FDA drug-label database. Marketed as Metformin Hydrochloride.
- Boxed warning
- The FDA label for Metformin Hydrochloride 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
Phase 1 2
Phase 2 1
Phase 3 1
Phase 4 1
Conditions being studied
| Condition | Trials |
|---|---|
| Obesity | 2 |
| Depression | 1 |
| Drug Drug Interaction (DDI) | 1 |
| Heart Failure | 1 |
| Left Ventricular Assist Device | 1 |
| Lung cancer | 1 |
| Non Small Cell Lung Cancer | 1 |
| Pharmacokinetics and Pharmacodynamics | 1 |
Recruiting trials involving Metformin Hydrochloride
- A Study of Metformin to Improve Cardiac Function After LVAD Implantation
- Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
- Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
- Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity
Common questions
Is Metformin Hydrochloride FDA-approved?
Yes, marketed as Metformin Hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve Metformin Hydrochloride?
4 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.