TOUJEO SOLOSTAR (insulin glargine recombinant) · Sanofi
TOUJEO SOLOSTAR is FDA-approved to treat 1 condition (same as LANTUS SOLOSTAR).
Details
- Status
- Prescription
- First Approved
- 2015-02-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TOUJEO SOLOSTAR Approval History
What TOUJEO SOLOSTAR Treats
1 indicationsTOUJEO SOLOSTAR is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as LANTUS SOLOSTAR (same active ingredient).
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03328845 INEOX | FIM-EOX-2016-01 | Ph 4 | completed | Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study) |
| NCT00943709 | 060601 AVENTIS-CINJ-060601, 0220070268 | Ph 3 | withdrawn | Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia |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.
TOUJEO SOLOSTAR FDA Label Details
Indications & Usage
FDA Label (PDF)TOUJEO SOLOSTAR is FDA-approved to treat 1 condition — same approved indications as LANTUS SOLOSTAR.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.