AMARYL
LOE ApproachingNDAORALTABLET
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
3/8 — Basic
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMARYL (glimepiride) is an oral small-molecule sulfonylurea approved in 1995 for Type 2 Diabetes Mellitus management. It stimulates insulin secretion from pancreatic beta cells to improve glycemic control. The drug is administered as a tablet and represents a foundational oral antidiabetic class.
$0.197BPart D
LOE ApproachingDeclining
less than 2% of Type 2 Diabetes market
AMARYL faces declining market share as newer mechanistic classes dominate; team focus is on defending remaining patient base against erosion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.
Started May 2015
0Healthy
Initiation and Titration of Amaryl
Started May 2010
172 enrolled
Diabetes Mellitus, Type 2
Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus
Started May 2009
110 enrolled
Type 2 Diabetes Mellitus
Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg
Started Oct 2008
33 enrolled
Healthy
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
Started Dec 2007
192 enrolled
Type 2 Diabetes Mellitus
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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.