Wednesday, July 8, 2026

Drug profile · INN

glimepiride

glimepiride (ARX-GLIMEPIRIDE) is a sulfonylurea receptor 1, kir6.2 blocker. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 2
Pipeline programs 7
News articles 0
Drug details — glimepiride
US status
approved
Class
Route
ORAL
Patents
2
Programs
7
Data quality
0.89

Quick answer

glimepiride (ARX-GLIMEPIRIDE) is a sulfonylurea receptor 1, kir6.2 blocker. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN glimepiride
Brand ARX-GLIMEPIRIDE
Mechanism Sulfonylurea receptor 1, Kir6.2 blocker
Target Sulfonylurea receptor 1, Kir6.2
Route ORAL
Formulation TABLET

Mechanism of action

Sulfonylurea receptor 1, Kir6.2 blocker

Primary target: Sulfonylurea receptor 1, Kir6.2

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Alogliptin and glimepiride Phase 3 · Takeda · Type 2 Diabetes Mellitus
  2. CT-L03-301 Phase 3 · Celltrion Healthcare Australia · Type 2 diabetes mellitus (T2DM)
  3. Glimepiride Phase 3 · Janssen Cilag International · Diabetes Mellitus, Type 2
  4. Pioglitazone and Glimepiride Phase 3 · Takeda · Diabetes Mellitus
  5. Glimepiride 4 mg Tablets Phase 1 · Teva Pharma · Healthy
  6. TAK-875 and Glimepiride Phase 1 · Takeda · Pharmacokinetics
  7. Glimepiride Unknown · Takeda · Type 2 Diabetes

Related & competitor drugs

  1. acetohexamide Sulfonylurea receptor 1, Kir6.2 blocker
  2. chlorpropamide Sulfonylurea receptor 1, Kir6.2 blocker
  3. glipizide Sulfonylurea receptor 1, Kir6.2 blocker
  4. glyburide Sulfonylurea receptor 1, Kir6.2 blocker
  5. nateglinide Alimentary tract and metabolism (A10)
  6. repaglinide Alimentary tract and metabolism (A10)
  1. US 8071130

    Solid preparation

    Expires Mon Dec 01 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 7700128

    Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester

    Expires Mon Apr 15 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is glimepiride?

glimepiride (ARX-GLIMEPIRIDE) is a sulfonylurea receptor 1, kir6.2 blocker. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for glimepiride?

ARX-GLIMEPIRIDE is a marketed brand name for glimepiride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of glimepiride?

glimepiride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.