SOLIQUA 100/33
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The medication is not recommended for the treatment of diabetic ketoacidosis or for use in combination with other GLP-1 receptor agonists. Additionally, its use has not been studied in combination with prandial insulin. This therapy combines a basal insulin analog with a glucagon-like peptide-1 (GLP-1) receptor agonist to provide a multi-pathway approach to blood sugar management.
How SOLIQUA 100/33 Works
This combination product regulates glucose metabolism through the complementary actions of two active agents. Insulin glargine lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting the liver's production of glucose. Lixisenatide, a GLP-1 receptor agonist, increases glucose-dependent insulin release, suppresses glucagon secretion, and slows the rate of gastric emptying. Together, these mechanisms enhance protein synthesis and inhibit the breakdown of fats and proteins to maintain glycemic control.
Details
- Status
- Prescription
- First Approved
- 2016-11-21
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
SOLIQUA 100/33 Approval History
What SOLIQUA 100/33 Treats
2 indicationsSOLIQUA 100/33 is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
- Diabetic Ketoacidosis
SOLIQUA 100/33 Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
SOLIQUA 100/33 Competitors
Pro6 other drugs also target GLP-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (GLP-1). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
SOLIQUA 100/33 FDA Label Details
ProIndications & Usage
FDA Label (PDF)SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.