Drugs / Azacitidine
Azacitidine
DrugAzacitidine is an antineoplastic nucleoside analogue medicine used in myelodysplastic syndrome and myeloid leukemias. It is marketed under brands including Vidaza and Onureg. Its activity includes hypomethylating and cytotoxic effects depending on dosing context.
- Trials
- 745
- Recruiting
- 161
- Completed
- 246
- With results
- 199
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Approved for marketing | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 3 | — | — | — | 3 | — | 1 | — | — | — | — | 7 |
| Phase 1 | 28 | 4 | 2 | 13 | 82 | 39 | 7 | 4 | 2 | — | — | 181 |
| Phase 1/2 | 26 | 5 | — | 17 | 36 | 27 | 13 | 2 | 9 | — | — | 135 |
| Phase 2 | 72 | 19 | 2 | 23 | 94 | 41 | 8 | — | 32 | — | — | 291 |
| Phase 2/3 | 7 | 2 | 1 | 2 | 2 | — | — | — | 2 | — | — | 16 |
| Phase 3 | 14 | 9 | 1 | 5 | 19 | 13 | 1 | — | 4 | — | — | 66 |
| Phase 4 | 2 | — | — | 2 | 2 | 1 | — | — | 2 | — | — | 9 |
| Not applicable | 7 | 3 | — | 1 | 5 | — | 1 | — | 10 | — | — | 27 |
| Unknown | 2 | — | — | 2 | 3 | — | 2 | — | 2 | 1 | 1 | 13 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Leukemia, Myeloid, Acute | 1 | 102 | 67 | 149 | 11 | 45 | 5 | 12 | 8 | 400 |
| Myelodysplastic Syndromes | 2 | 67 | 48 | 82 | 5 | 14 | 3 | 2 | 5 | 228 |
| Leukemia, Myelomonocytic, Chronic | 1 | 23 | 26 | 21 | 1 | 4 | — | — | — | 76 |
| Leukemia | — | 17 | 14 | 24 | 2 | 7 | — | 1 | — | 65 |
| Recurrence | — | 11 | 9 | 12 | — | 2 | — | 2 | — | 36 |
| Myeloproliferative Disorders | — | 7 | 10 | 8 | — | — | — | — | — | 25 |
| Neoplasms | — | 6 | 7 | 5 | — | 2 | 1 | — | — | 21 |
| Hematologic Neoplasms | — | 9 | 7 | 2 | 1 | 1 | — | — | — | 20 |
| Carcinoma, Non-Small-Cell Lung | — | 6 | 3 | 7 | — | — | — | 1 | — | 17 |
| Multiple Myeloma | — | 8 | 5 | 3 | — | — | — | 1 | — | 17 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | M.D. Anderson Cancer Center | 65 | 1 |
| 2 | National Cancer Institute (NCI) | 37 | 2 |
| 3 | Celgene | 36 | 7 |
| 4 | The First Affiliated Hospital of Soochow University | 29 | 5 |
| 5 | Institute of Hematology & Blood Diseases Hospital, China | 19 | 4 |
| 6 | AbbVie | 13 | 6 |
| 7 | Groupe Francophone des Myelodysplasies | 12 | 0 |
| 8 | Novartis Pharmaceuticals | 12 | 2 |
| 9 | Bristol-Myers Squibb | 9 | 1 |
| 10 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 9 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Azacitidine | 745 |
| 2 | venetoclax | 219 |
| 3 | Cytarabine | 93 |
| 4 | Decitabine | 54 |
| 5 | cc-486 | 37 |
| 6 | Daunorubicin | 37 |
| 7 | Lenalidomide | 31 |
| 8 | Idarubicin | 27 |
| 9 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide | 21 |
| 10 | Specimen Handling | 19 |
Evidence
- Results reported
- 80.9%199 of 246 completed
- Published
- 9.8%24 of 246 completed
- Primary endpoint met
- 36.5%19 of 52 analyses
- Median months to report
- 12
Documents disclosed
Trial profile
- Median enrollment
- 41
- Median duration
- 47.2months
- Countries
- 58
- Study sites
- 8095
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 6
- Phase 1
- 30
- Phase 1/2
- 45
- Phase 2
- 40
- Phase 2/3
- 230
- Phase 3
- 243
- Phase 4
- 44
- Not applicable
- 35
- Unknown
- 112
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Houston | United States | 186 |
| 2 | New York | United States | 118 |
| 3 | Chicago | United States | 93 |
| 4 | Boston | United States | 83 |
| 5 | Los Angeles | United States | 74 |
| 6 | Paris | France | 74 |
| 7 | Barcelona | Spain | 66 |
| 8 | Baltimore | United States | 65 |
| 9 | Cleveland | United States | 62 |
| 10 | Dallas | United States | 61 |
Terminations
- Terminated
- 121
- Withdrawn
- 33
- Suspended
- 6
- Stopped for recruitment
- 4.3%32 of 745 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT06694454 Suspended | Suspended | Placed on voluntary hold to new recruitment pending modification to combination monoclonal antibody treatment. | 2034-12-31 |
| NCT05766514 Withdrawn | Withdrawn | Study disapproved by internal scientific review committee on re-review; study will no longer move forward | 2030-12-31 |
| NCT06454409 Suspended | Suspended | resources | 2030-09-06 |
| NCT05367401 Withdrawn | Withdrawn | waiting for update from Study Lead | 2029-10-26 |
| NCT06598332 Withdrawn | Withdrawn | There is no funding. | 2029-05-01 |
| NCT06180863 Withdrawn | Withdrawn | Lack of funding. | 2029-04-30 |
| NCT07388563 Suspended | Suspended | New recruitment on hold for a protocol design amendment/modification. | 2027-12-31 |
| NCT06514261 Suspended | Suspended | Other - Pending amendment for study expansion. | 2027-09-16 |
| NCT06466798 Withdrawn | Withdrawn | Inability to find participants meeting eligibility critieria | 2027-07-01 |
| NCT06903702 Withdrawn | Withdrawn | Lack of funding | 2027-06-30 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: