Pegunigalsidase alfa
As of the edition of 20 October 2026, Pegunigalsidase alfa is an enzyme: marketed, first approved in 2023 (EU); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Enzyme
- Brand name
- Elfabrio
- First approved
- 4 May 2023 (EU)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Chiesi Farmaceutici
- Registered trials
- 14, 1 stopped early
- Disease areas
- Heart and blood vessels; Inherited and neonatal; Nervous system; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2035.
US protection ends in 2035, 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 Chiesi Farmaceutici. 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 not stated | 4 | 0 | 3 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 8 | 5 | 2 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Chiesi Farmaceutici | Applicant and Lead sponsor of trials | 2023 to now |