Eplontersen
As of the edition of 20 October 2026, Eplontersen is an oligonucleotide: marketed, first approved in 2023 (US); acts on TTR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Oligonucleotide
- Brand name
- Wainua (autoinjector)
- First approved
- 21 December 2023 (US)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- AstraZeneca
- Registered trials
- 10, 1 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Eplontersen.
See the 2 companies 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 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 3 | 1 | 1 | 1 |
| Phase 3 | 5 | 2 | 3 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator and Lead sponsor of trials | 2023 to now |