BASAGLAR
BASAGLAR is a long-acting human insulin analog indicated to improve glycemic control in specific patient populations with diabetes. It is approved for use in both adult and pediatric patients with type 1 diabetes mellitus and in adult patients with type 2 diabetes mellitus. This medication is intended for routine glucose management and is not recommended for the treatment of diabetic ketoacidosis.
How BASAGLAR Works
The primary activity of this insulin analog is the regulation of glucose metabolism. It lowers blood glucose levels by stimulating peripheral glucose uptake in skeletal muscle and fat while simultaneously inhibiting the production of glucose in the liver. Additionally, the drug enhances protein synthesis and inhibits the processes of lipolysis and proteolysis.
Details
- Status
- Prescription
- First Approved
- 2015-12-16
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
BASAGLAR Approval History
What BASAGLAR Treats
3 indicationsBASAGLAR is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 1 Diabetes
- Type 2 Diabetes
- Diabetic Ketoacidosis
BASAGLAR Biosimilars
2 FDA-approved2 can be substituted at the pharmacy without calling the prescriber.
What are biosimilars? Lower-cost alternatives to BASAGLAR with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BASAGLAR FDA Label Details
ProIndications & Usage
FDA Label (PDF)BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use : Not recommended for treating diabetic ketoacidosis. Limitations of Use BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.