NDAORALSOLUTION
Approved
Sep 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
RIOMET (metformin hydrochloride) by Signatur Biosciences is • metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. First approved in 2003.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RIOMET is a oral liquid formulation of metformin hydrochloride, a first-line antihyperglycemic agent for type 2 diabetes. It improves glucose tolerance by decreasing hepatic glucose production, reducing intestinal glucose absorption, and enhancing insulin sensitivity without increasing insulin secretion. The solution formulation provides an alternative delivery route for patients who may have difficulty with tablets.
LOE Approaching
As a mature product approaching loss of exclusivity with modest competitive pressure (30%), team size is likely stable but focused on defending market share against newer mechanisms.
Mechanism of Action
• Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by…
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.