NDAORALTABLETPriority Review
Approved
Mar 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
GLUCOPHAGE (metformin hydrochloride) by Teva is 2 diabetes, lowering both basal and postprandial plasma glucose. First approved in 1995.
Drug data last refreshed 21h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLUCOPHAGE (metformin hydrochloride) is an oral small-molecule antidiabetic agent approved in 1995 for type 2 diabetes mellitus. It works by decreasing hepatic glucose production, reducing intestinal glucose absorption, and improving insulin sensitivity through increased peripheral glucose uptake without stimulating insulin secretion. GLUCOPHAGE remains a foundational first-line therapy in diabetes management globally.
LOE Approaching
As LOE approaches, commercial teams are transitioning from growth focus to market defense and cost optimization, with reduced headcount expansion but sustained opportunities in generic optimization.
Mechanism of Action
2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
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
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
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator
Started Jun 2024
34 enrolled
Healthy Subjects
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator
Started Apr 2024
34 enrolled
Healthy Subjects
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.