Azacitidine
As of the edition of 20 October 2026, Azacitidine is a small molecule: marketed, first approved in 2004 (US); acts on DNMT1 and DNMT3A; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Vidaza
- First approved
- 19 May 2004 (US)
- Approvals on record
- 15 in 6 regions
- Holder of the most recent approval
- Bristol Myers Squibb; 4 holders in all
- Registered trials
- 703, 146 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Lungs and airways; Heart and blood vessels; Digestive system
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Bristol Myers Squibb.
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.
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Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Azacitidine.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 36 | 8 | 13 | 3 |
| Phase 1 | 182 | 79 | 51 | 46 |
| Phase 2 | 406 | 128 | 156 | 84 |
| Phase 3 | 72 | 21 | 33 | 13 |
| Phase 4 | 7 | 2 | 3 | 0 |
| All trials | 703 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Acquired holder, Later holder and Lead sponsor of trials | 2007 to now |
| Nippon Shinyaku | Applicant | 2011 to now |
| Actavis | Later holder | 2016 to now |