Floatz Rating
B62/100
Confidence
Indicative
Sponsor
Janssen Research & Development, LLC
Modality
UNKNOWN
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
63High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06651229CT.gov A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms | — | Recruiting | — | — | — |
NCT07514936CT.gov Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia | — | Recruiting | — | — | — |
NCT06561880CT.gov The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation | — | Recruiting | — | — | — |
NCT06470841CT.gov CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML | — | Not Yet Recruiting | — | — | — |
NCT06598384CT.gov VA as Maintenance Therapy Post Allo-HSCT in MDS and AML | — | Not Yet Recruiting | — | — | — |
NCT06536959CT.gov VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS | — | Recruiting | — | — | — |
NCT06928376CT.gov A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients | — | Recruiting | — | — | — |
NCT06084819CT.gov Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT05317403CT.gov Venetoclax to Augment Epigenetic Modification and Chemotherapy | — | Recruiting | — | — | — |
NCT06068621CT.gov Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
Show 16 more trialsShow fewer
NCT05659992CT.gov Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT05362942CT.gov Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT05029141CT.gov New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT03557970CT.gov JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT02829840CT.gov Dose-Escalation Study of Ponatinib, a FLT3 Inhibitor, With and Without Combination of 5-Azacytidine, in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML) | — | Withdrawn | — | — | — |
NCT02845297CT.gov Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients | — | Completed | — | — | — |
NCT02400281CT.gov Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients | — | Completed | — | — | — |
NCT02204020CT.gov Phase II Study of 5-azacytidine Maintenance After Transplant for AML or MDS | — | Withdrawn | — | — | — |
NCT02275663CT.gov Azacytidine Plus FLAG for Relapsed or Refractory AML | — | Unknown | — | — | — |
NCT02319135CT.gov Azacytidine (Vidaza®) Versus Fludarabine and Cytarabine (Fluga Scheme) in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02265731CT.gov Study Evaluating Venetoclax in Subjects With Hematological Malignancies | — | Completed | — | — | — |
NCT02017457CT.gov Azacytidine and Lymphocytes in Relapse of AML or MDS After Allogeneic Stem Cell Transplantation. | — | Completed | — | — | — |
NCT00946647CT.gov A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). | — | Completed | — | — | — |
NCT00339196CT.gov 5-azacytidine Valproic Acid and ATRA in AML and High Risk MDS | — | Completed | — | — | — |
NCT00915785CT.gov Azacytidine for the Treatment of Myelodysplastic Syndromes/Acute Myeloid Leukemia (MDS/AML) With High Risk (Chromosome 7 and or Complex) Cytogenetic Abnormalities | — | Completed | — | — | — |
NCT00382590CT.gov Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Azacytidine (this asset) | Janssen Research & Development, LLC | P3 | B · 62 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Azacytidine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Myelodysplastic Syndrome | — | P3 | BB · 64 |
| Leukemia | — | P2 | B · 62 |
| Diffuse Large B-Cell Lymphoma | — | P2 | B · 61 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Azacytidine in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/azacytidine-acute-myeloid-leukemia
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