ADLYXIN (lixisenatide)
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.
Development Insights
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 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 ADLYXIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ADLYXIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ADLYXIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03439943 LixiPark | RC31/16/8912 | Ph 2 | completed | Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease |
| NCT02231658 | GI-Motil | Ph 1 | terminated | Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion |
| NCT02168491 LixiBIT results posted | LixiBIT_V3 2013-005334-37 | Ph 3 | completed | Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin |
| NCT02767596 | LIX001 | Ph 4 | terminated | Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog |
| NCT01973231 LIRA-LIXI™ results posted | NN2211-3867 2012-004984-27, U1111-1136-3644 | Ph 4 | completed | Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes |
| NCT02276196 ELIXIRS | DC2014ELIX001 | Ph 4 | completed | Effect of LIXIsenatide on the Renal System |
| NCT02020629 | 16 2012-004959-36 | Ph 4 | completed | Study on Lixisenatide and Counterregulation to Hypoglycemia |
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
Indications & Usage
FDA Label (PDF)ADLYXIN is indicated for the treatment of Type 2 Diabetes; Diabetic Ketoacidosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment