Belinostat
As of the edition of 20 October 2026, Belinostat is a small molecule: marketed, first approved in 2014 (US); US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Beleodaq
- First approved
- 3 July 2014 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Acrotech Biopharma
- Registered trials
- 53, 14 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Lungs and airways; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ended in 2026.
The last listed US drug-substance patent ended in 2026. The application that gives this date is held by Acrotech Biopharma.
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.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 27 | 15 | 3 | 9 |
| Phase 2 | 26 | 17 | 3 | 5 |
| All trials | 53 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Zydus Worldwide DMCC | Originator and Lead sponsor of trials | 2008 to now |
| Acrotech Biopharma | Acquired holder and Lead sponsor of trials | 2010 to now |