KYNAMRO (mipomersen sodium)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2013-01-29
- Patent Cliff
- 2027
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
KYNAMRO Approval History
What KYNAMRO Treats
1 FDA approvalsOriginally approved for its first indication in 2013 .
- Other (1)
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00694109 results posted | 301012-CS6 2005-003450-10 | Ph 3 | completed | An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia |
| NCT00706849 RADICHOL II results posted | 301012-CS7 | Ph 3 | completed | Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease |
| NCT00770146 results posted | 301012-CS12 | Ph 3 | completed | Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients |
| NCT01090661 | MIPO2800209 | Ph 1 | completed | A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects |
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.
KYNAMRO FDA Label Details
KYNAMRO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for KYNAMRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
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