BYDUREON (exenatide synthetic)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2012-01-27
- Patent Cliff
- 2028
- Routes
- SUBCUTANEOUS
- Dosage Forms
- FOR SUSPENSION, EXTENDED RELEASE
BYDUREON Approval History
What BYDUREON Treats
6 FDA approvalsOriginally approved for its first indication in 2012 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02251431 results posted | 014-149 D5551L00004/ISSEXEN0013 | Ph 3 | completed | Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome |
| NCT02621489 Rebuild | BY2015 | Ph 4 | completed | Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects |
| NCT02533453 Bydureon results posted | D5551L00018 | Ph 4 | completed | A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients. |
| NCT02288273 results posted | D5551L00006 | Ph 4 | completed | Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes. |
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.
BYDUREON FDA Label Details
BYDUREON Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for BYDUREON
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 72 active patents
Trial Analysis
- • 4 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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