Elapegademase
As of the edition of 20 October 2026, Elapegademase is an enzyme: marketed, first approved in 2018 (US); US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Enzyme
- Brand name
- Revcovi
- First approved
- 5 October 2018 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Teijin Pharma; 2 holders in all
- Registered trials
- 2, 0 stopped early
- Disease areas
- Immune system; Inherited and neonatal; Nutrition and metabolism
US protection
US protection ends in 2030.
US protection ends in 2030, 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. 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 3 | 1 | 1 | 0 | 0 |
| All trials | 2 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Leadiant Biosciences | Earlier holder | 2018 to now |
| Teijin Pharma | Applicant | 2019 to now |
| Chiesi | Acquired holder | 2021 to now |