Berahyaluronidase alfa
As of the edition of 20 October 2026, Berahyaluronidase alfa is an enzyme: marketed, first approved in 2025 (US); US protection ends in 2037.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Enzyme
- Brand name
- Keytruda Qlex
- First approved
- 19 September 2025 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 11, 0 stopped early
- Disease areas
- Cancer; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Blood and lymph; Bones, joints and muscles
US protection
US protection ends in 2037.
US protection ends in 2037, 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 Merck & Co.. 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 | 1 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 0 | 3 | 0 |
| Phase 3 | 6 | 0 | 6 | 0 |
| All trials | 11 |