LANTUS SOLOSTAR (insulin glargine recombinant)
Lantus SoloStar is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It functions as a basal insulin to help manage blood sugar levels over an extended period. This medication is not recommended for the treatment of diabetic ketoacidosis.
How LANTUS SOLOSTAR Works
Insulin glargine regulates glucose metabolism by stimulating peripheral glucose uptake in skeletal muscle and fat while simultaneously inhibiting glucose production in the liver. These combined actions result in a reduction of blood glucose levels. Additionally, the drug inhibits the breakdown of proteins and lipids while enhancing protein synthesis within the body.
Details
- Status
- Prescription
- First Approved
- 2000-04-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LANTUS SOLOSTAR Approval History
What LANTUS SOLOSTAR Treats
1 indicationsLANTUS SOLOSTAR is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
LANTUS SOLOSTAR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LANTUS SOLOSTAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LANTUS SOLOSTAR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LANTUS SOLOSTAR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00943709 | 060601 AVENTIS-CINJ-060601, 0220070268 | Ph 3 | withdrawn | Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia |
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.
LANTUS SOLOSTAR FDA Label Details
Indications & Usage
FDA Label (PDF)LANTUS SOLOSTAR is indicated for the treatment of Diabetes.
Track LANTUS SOLOSTAR with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.