Donidalorsen
As of the edition of 20 October 2026, Donidalorsen is an oligonucleotide: marketed, first approved in 2025 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Oligonucleotide
- Brand name
- Dawnzera (autoinjector)
- First approved
- 21 August 2025 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Otsuka; 3 holders in all
- Registered trials
- 7, 0 stopped early
- Disease areas
- Heart and blood vessels; Immune system; Inherited and neonatal; Skin and connective tissue
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 3 | 1 | 2 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Akcea Therapeutics | Originator and Lead sponsor of trials | 2025 to now |
| Otsuka | Applicant | 2026 to now |