Ublituximab
As of the edition of 20 October 2026, Ublituximab is an antibody: marketed, first approved in 2022 (US); acts on MS4A1; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Antibody
- Brand name
- Briumvi
- First approved
- 28 December 2022 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Neuraxpharm Pharmaceuticals; 2 holders in all
- Registered trials
- 43, 15 stopped early
- Disease areas
- Immune system; Cancer; Blood and lymph; Nervous system; Heart and blood vessels; Bones, joints and muscles
US protection
US protection ends in 2034.
US protection ends in 2034, 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 TG Therapeutics. 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.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ublituximab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MS4A1 | B-lymphocyte antigen CD20 | P11836 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 9 | 4 | 1 | 4 |
| Phase 2 | 20 | 5 | 7 | 8 |
| Phase 3 | 10 | 3 | 4 | 3 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 43 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| TG Therapeutics | Originator and Lead sponsor of trials | 2012 to now |
| Neuraxpharm Pharmaceuticals | Applicant | 2023 to now |