Decitabine
As of the edition of 20 October 2026, Decitabine is a small molecule: marketed, first approved in 2006 (US); acts on DNMT1 and DNMT3A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Dacogen
- First approved
- 2 May 2006 (US)
- Approvals on record
- 8 in 6 regions
- Holder of the most recent approval
- Accord Healthcare; 7 holders in all
- Registered trials
- 415, 73 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Inherited and neonatal; Skin and connective tissue; Urinary and reproductive
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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 Decitabine.
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 | 11 | 3 | 1 | 1 |
| Phase 1 | 122 | 52 | 35 | 28 |
| Phase 2 | 229 | 76 | 76 | 42 |
| Phase 3 | 46 | 11 | 9 | 2 |
| Phase 4 | 7 | 1 | 1 | 0 |
| All trials | 415 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Applicant, Acquired holder and Lead sponsor of trials | 2001 to now |
| Eisai | Originator and Lead sponsor of trials | 2005 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2008 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2021 to now |