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Amaryl (GLIMEPIRIDE)
Amaryl works by binding to the sulfonylurea receptor 1 (SUR1) and Kir6.2 subunit of the ATP-sensitive potassium channel, closing the channel and depolarizing the pancreatic beta cell membrane, leading to insulin release.
Amaryl (Glimepiride) is a sulfonylurea medication developed by Sanofi Aventis US, targeting the sulfonylurea receptor 1 (SUR1) and Kir6.2 subunit of the ATP-sensitive potassium channel. It is a small molecule modality, FDA-approved in 1995 for the treatment of type 2 diabetes mellitus and treatment-refractory type 2 diabetes mellitus. Amaryl is now off-patent with 17 generic manufacturers, offering a commercial alternative to branded options. Key safety considerations include hypoglycemia risk, particularly when combined with other diabetes medications. As a sulfonylurea, Amaryl works by stimulating insulin release from pancreatic beta cells.
At a glance
| Generic name | GLIMEPIRIDE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Sulfonylurea [EPC] |
| Target | Sulfonylurea receptor 1, Kir6.2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1995 |
Mechanism of action
Mechanism of Action. The primary mechanism of action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. In addition, extrapancreatic effects may also play role in the activity of sulfonylureas such as glimepiride. This is supported by both preclinical and clinical studies demonstrating that glimepiride administration can lead to increased sensitivity of peripheral tissues to insulin. These findings are consistent with the results of long-term, randomized, placebo-controlled trial in which glimepiride therapy improved postprandial insulin/C-peptide responses and overall glycemic control without producing clinically meaningful increases in fasting insulin/C-peptide levels. However, as with other sulfonylureas, the mechanism by which glimepiride lowers blood glucose during long-term administration has not been clearly established.Glimepiride is effective as initial drug therapy. In patients where m
Approved indications
- Diabetes mellitus type 2
- Treatment Refractory Type 2 Diabetes Mellitus
Common side effects
- Hypoglycemia
- Headache
- Accidental Injury
- Flu Syndrome
- Nausea
- Dizziness
- Weight gain
- Elevated serum alanine aminotransferase (ALT)
- Allergic Reactions
- Pruritus
- Erythema
- Urticaria
Drug interactions
- ciprofloxacin
- levofloxacin
- norfloxacin
- ofloxacin
- voriconazole
Key clinical trials
- A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes (PHASE3)
- Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients (PHASE4)
- Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes (PHASE3)
- Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction. (PHASE3)
- Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
- Comparison of Type 2 Diabetes Pharmacotherapy Regimens
- Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes (PHASE4)
- A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amaryl CI brief — competitive landscape report
- Amaryl updates RSS · CI watch RSS
- Sanofi portfolio CI