NDAORALTABLET2 Generics Approved
Approved
May 1984
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
4/8 — Partial
DIABETA (glyburide) by Sanofi. Approved for sulfonylurea [epc]. First approved in 1984.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIABETA (glyburide) is an oral sulfonylurea antidiabetic agent approved in 1984 for the treatment of type 2 diabetes mellitus. It works by stimulating pancreatic beta cells to increase insulin secretion, lowering blood glucose levels. Glyburide is available as a tablet and represents a foundational class in diabetes management.
LOE Approaching
As a legacy product approaching loss of exclusivity with elevated competitive pressure (60%), the brand team is likely focused on defending market share through cost optimization and managed care partnerships rather than growth expansion.
Mechanism of Action
Pharmacologic Class:
Sulfonylurea
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
Started Mar 2019
87 enrolled
Healthy Volunteers
Glyburide Healthy Volunteer Study
Started Jan 2013
21 enrolled
Healthy Volunteers
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
Started Jul 2011
177 enrolled
Gestational Diabetes Mellitus
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Started Jan 2010
34 enrolled
Traumatic Brain InjuryStroke
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers
Started Jul 2008
29 enrolled
Healthy
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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.