Friday, July 10, 2026

Drug profile · INN

insulin glargine

insulin glargine (OPTISULIN) is a insulin receptor agonist. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Alimentary tract and metabolism (A10) A10AE04
US status approved
Patents linked 0
Pipeline programs 9
News articles 3
Drug details — insulin glargine

Quick answer

insulin glargine (OPTISULIN) is a insulin receptor agonist. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN insulin glargine
Brand OPTISULIN
Mechanism Insulin receptor agonist
Target Insulin receptor
Therapeutic class Alimentary tract and metabolism (A10)
Route INJECTION
Formulation INJECTABLE
ATC code A10AE04

Mechanism of action

Insulin receptor agonist

Primary target: Insulin receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. Insulin glargine/Lixisenatide (HOE901/AVE0010) Phase 3 · Sanofi Pasteur MSD · Type 2 Diabetes Mellitus
  2. J2A-MC-GZGW Phase 3 · Eli Lilly and · Type 2 Diabetes
  3. NN9388-7637 Phase 3 · NovoThirteen · Type 2 diabetes
  4. albiglutide + insulin glargine Phase 3 · GSK Glaxo Smith · Diabetes Mellitus, Type 2
  5. BioPhenoT2D Approved · Telethon Foundation · type 2 diabetes
  6. INSULIN GLARGINE Approved · Sanofi-Aventis U.S · Diabetes mellitus II
  7. INSULIN GLARGINE (HOE901) Approved · Sanofi Pasteur MSD · Diabetes Mellitus, Type 2
  8. Insulin Glargine Approved · Sanofi Pasteur MSD · Diabetes Mellitus, Type 2

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  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is insulin glargine?

insulin glargine (OPTISULIN) is a insulin receptor agonist. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for insulin glargine?

OPTISULIN is a marketed brand name for insulin glargine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of insulin glargine?

insulin glargine 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.