Givinostat
As of the edition of 20 October 2026, Givinostat is a small molecule: marketed, first approved in 2024 (US); US protection ends in 2040.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Duvyzat
- First approved
- 21 March 2024 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Italfarmaco
- Registered trials
- 24, 6 stopped early
- Disease areas
- Blood and lymph; Cancer; Bones, joints and muscles; Immune system; Inherited and neonatal; Nervous system
US protection
US protection ends in 2040.
The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Italfarmaco.
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 product4 listings count 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 not stated | 1 | 0 | 0 | 1 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 15 | 7 | 2 | 5 |
| Phase 3 | 3 | 0 | 3 | 0 |
| All trials | 24 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Italfarmaco | Originator and Lead sponsor of trials | 2006 to now |