Pegademase bovine
As of the edition of 20 October 2026, Pegademase bovine is an enzyme: marketed, first approved in 1990 (US); US protection ended in 2002.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1990
- Kind
- Enzyme
- Brand name
- Adagen
- First approved
- 21 March 1990 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Leadiant Biosciences
- Registered trials
- 1, 0 stopped early
- Disease areas
- Immune system; Inherited and neonatal; Nutrition and metabolism
US protection
US protection ended in 2002.
US protection ended in 2002, 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 Leadiant Biosciences. 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 3 | 1 | 1 | 0 | 0 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Enzon Pharmaceuticals | Earlier holder | 1990 to now |
| Leadiant Biosciences | Acquired holder and Lead sponsor of trials | 2014 to now |