TheraRadar
Data updated: May 26, 2026

TOUJEO SOLOSTAR (insulin glargine recombinant)

Metabolic Approved 2015-02-25
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2015-02-25
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Sanofi
Active Ingredient: INSULIN GLARGINE RECOMBINANT

TOUJEO SOLOSTAR Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2015 to 2024 · 1 indication expansions
Aug 2024 SUPPL
Label · Labeling
FDA Letter Label
Aug 2022 SUPPL
Label · Labeling
FDA Letter Label
Nov 2019 SUPPL
Efficacy
Label

What TOUJEO SOLOSTAR Treats

2 FDA approvals

Originally approved for its first indication in 2015 . Covers 2 distinct patient populations.

  • Other (2)
📋

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NCT00943709 060601 AVENTIS-CINJ-060601, 0220070268 Ph 3 withdrawn Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Track TOUJEO SOLOSTAR with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: BLA206538 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.