NDAORALFOR SUSPENSION, EXTENDED RELEASE
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
RIOMET ER (metformin hydrochloride) by Fosun Pharma is 2 diabetes, lowering both basal and postprandial plasma glucose. First approved in 2019.
Drug data last refreshed 23m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RIOMET ER is an extended-release oral suspension formulation of metformin hydrochloride approved by the FDA in August 2019 for type 2 diabetes management. It works by decreasing hepatic glucose production, reducing intestinal glucose absorption, and improving insulin sensitivity through increased peripheral glucose uptake and utilization. The mechanism preserves endogenous insulin secretion while potentially lowering fasting insulin levels.
Peak8.9 years to LOE
Product is in peak commercial phase with no reported competitive pressure, suggesting stable but mature market positioning with potential for specialized or niche market development.
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.