Data updated: May 26, 2026
TEGSEDI (inotersen sodium)
First-in-Class Orphan Drug Priority Review Fast Track
CNS
Approved 2018-10-05
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-10-05
- Patent Cliff
- 2031
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TEGSEDI Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2018 to 2024
What TEGSEDI Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04306510 results posted | TEG4004 | Ph 4 | terminated | A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
TEGSEDI FDA Label Details
View full patent landscape →
3 OB patents · 1 families ·
58 international docs across 26 countries
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Deep insights for TEGSEDI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.