Pegloticase
As of the edition of 20 October 2026, Pegloticase is an enzyme: marketed, first approved in 2010 (US); US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Enzyme
- Brand name
- Krystexxa
- First approved
- 14 September 2010 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Amgen
- Withdrawn from market
- 30 June 2016 (in some regions)
- Registered trials
- 18, 0 stopped early
- Disease areas
- Nutrition and metabolism; Bones, joints and muscles; Inherited and neonatal; Pregnancy and women's health; Urinary and reproductive; Blood and lymph
US protection
US protection ended in 2022.
US protection ended in 2022, 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 Amgen. 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 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 4 | 3 | 1 | 0 |
| Phase 4 | 7 | 7 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Horizon Pharma Rheumatology | Earlier holder | 2010 to now |
| Amgen | Acquired holder and Lead sponsor of trials | 2018 to now |