Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-07-27
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ADLYXIN Approval History
What ADLYXIN Treats
2 FDA approvalsOriginally approved for its first indication in 2016 . Covers 2 distinct patient populations.
- Other (2)
ADLYXIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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
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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