Galsulfase
As of the edition of 20 October 2026, Galsulfase is an enzyme: marketed, first approved in 2005 (US); US protection ended in 2017.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Enzyme
- Brand name
- Naglazyme
- First approved
- 31 May 2005 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Amicus Therapeutics; 3 holders in all
- Registered trials
- 5, 1 stopped early
- Disease areas
- Inherited and neonatal; Nutrition and metabolism; Skin and connective tissue
US protection
US protection ended in 2017.
US protection ended in 2017, 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 Amicus 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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 1 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amicus Therapeutics | Applicant and Lead sponsor of trials | 2000 to now |