ADLYXIN
SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This medication is not recommended for the treatment of diabetic ketoacidosis or for use in combination with other GLP-1 receptor agonists. Additionally, the product has not been studied in combination with prandial insulin.
How ADLYXIN Works
The medication regulates glucose metabolism through the complementary actions of its two components. Insulin glargine lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting hepatic glucose production. Lixisenatide acts as a GLP-1 receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying. Together, these mechanisms facilitate glycemic control by managing how the body produces and utilizes glucose.
Details
- Status
- Prescription
- First Approved
- 2016-07-27
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ADLYXIN Approval History
What ADLYXIN Treats
2 indicationsADLYXIN 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
ADLYXIN 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.
ADLYXIN 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.
ADLYXIN 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.