Berdazimer sodium
As of the edition of 20 October 2026, Berdazimer sodium is a small molecule: marketed, first approved in 2024 (US); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Zelsuvmi
- First approved
- 5 January 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Lnhc
- Registered trials
- 20, 0 stopped early
- Disease areas
- Skin and connective tissue; Infections; Immune system; Inherited and neonatal; Urinary and reproductive
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Lnhc.
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 product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 2 | 6 | 6 | 0 | 0 |
| Phase 3 | 6 | 6 | 0 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lnhc | Originator | 2024 to now |