GLUCOPHAGE

LOE Approaching

metformin hydrochloride

NDAORALTABLETPriority Review
Approved
Mar 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Clinical Trials (5)

NCT06823856Phase 1Completed

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Started May 2025
64 enrolled
Diabetes Mellitus Type 2
NCT06792968Phase 1Completed

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Started Mar 2025
64 enrolled
Diabetes Mellitus Type 2
NCT06766500Phase 1Completed

Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

Started Jan 2025
64 enrolled
Diabetes Mellitus Type 2
NCT04684420Phase 1Completed

GXR RM (Glucophage® Extended Release Reduced Mass) 500 Milligram (mg) Korea Bioequivalence (BE) Study

Started Dec 2020
81 enrolled
Healthy
NCT04288778Phase 4Completed

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes

Started Nov 2020
276 enrolled
Diabetes Mellitus
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers