Tividenofusp alfa
As of the edition of 20 October 2026, Tividenofusp alfa is a protein: marketed, first approved in 2026 (US); US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Protein
- Brand name
- Avlayah
- First approved
- 24 March 2026 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Denali Therapeutics
- Registered trials
- 3, 0 stopped early
- Disease areas
- Inherited and neonatal; Nervous system; Nutrition and metabolism; Skin and connective tissue
US protection
US protection ends in 2038.
US protection ends in 2038, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Denali Therapeutics. The date is computed, not published.
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.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 2 | 0 | 2 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Denali Therapeutics | Originator and Lead sponsor of trials | 2020 to now |