Inotersen
As of the edition of 20 October 2026, Inotersen is an oligonucleotide: marketed, first approved in 2018 (EU); acts on TTR; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Oligonucleotide
- Brand name
- Tegsedi
- First approved
- 6 July 2018 (EU)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- PTC FARMACEUTICA DO BRASIL LTDA.; 3 holders in all
- Registered trials
- 5, 2 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal; Nervous system
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Akcea Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Inotersen.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TTR | Transthyretin | P02766 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 2 | 1 | 0 | 0 | 1 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Akcea Therapeutics | Applicant and Lead sponsor of trials | 2018 to now |