Bezlotoxumab
As of the edition of 20 October 2026, Bezlotoxumab is an antibody: marketed, first approved in 2016 (US); US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Antibody
- Brand name
- Zinplava
- First approved
- 21 October 2016 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 13, 4 stopped early
- Disease areas
- Infections; Digestive system
US protection
US protection ends in 2028.
US protection ends in 2028, 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 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 6 | 1 | 0 | 4 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 2011 to now |