Floatz Rating
B60/100
Confidence
Indicative
Sponsor
National Cancer Institute (NCI)
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
58High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07153497CT.gov Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy) | — | Not Yet Recruiting | — | — | — |
NCT07396480CT.gov Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial | — | Recruiting | — | — | — |
NCT07283094CT.gov FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT07228273CT.gov Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT07183878CT.gov Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study) | — | Recruiting | — | — | — |
NCT07044544CT.gov Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies | — | Recruiting | — | — | — |
NCT06454409CT.gov Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Suspended | — | — | — |
NCT05766514CT.gov Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction | — | Withdrawn | — | — | — |
NCT06651229CT.gov A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms | — | Recruiting | — | — | — |
NCT06548230CT.gov A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) | — | Recruiting | — | — | — |
Show 58 more trialsShow fewer
NCT06778187CT.gov Oral-ATO for TP53-mutated Myeloid Malignancies | — | Recruiting | — | — | — |
NCT06765928CT.gov Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT | — | Not Yet Recruiting | — | — | — |
NCT06337331CT.gov Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant | — | Withdrawn | — | — | — |
NCT06399640CT.gov Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT06536959CT.gov VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS | — | Recruiting | — | — | — |
NCT06501196CT.gov A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT05564390CT.gov MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | — | Recruiting | — | — | — |
NCT06419634CT.gov Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT05986240CT.gov Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML | — | Recruiting | — | — | — |
NCT06156579CT.gov Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML | — | Recruiting | — | — | — |
NCT05665530CT.gov A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies | — | Completed | — | — | — |
NCT05807932CT.gov Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML | — | Recruiting | — | — | — |
NCT05292664CT.gov Venetoclax Basket Trial for High Risk Hematologic Malignancies | — | Recruiting | — | — | — |
NCT05564650CT.gov Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT05829226CT.gov A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS) | — | Completed | — | — | — |
NCT05226455CT.gov Venetoclax in Patients With MDS or AML in Relapse After AHSCT | — | Active Not Recruiting | — | — | — |
NCT05583175CT.gov Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies | — | Unknown | — | — | — |
NCT05455294CT.gov Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms | — | Active Not Recruiting | — | — | — |
NCT05005299CT.gov Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation | — | Unknown | — | — | — |
NCT05428969CT.gov A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies | — | Active Not Recruiting | — | — | — |
NCT05342584CT.gov Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS | — | Recruiting | — | — | — |
NCT05184842CT.gov Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML | — | Recruiting | — | — | — |
NCT05107856CT.gov PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies | — | Terminated | — | — | — |
NCT05275439CT.gov Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML | — | Terminated | — | — | — |
NCT04988555CT.gov A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) | — | Recruiting | — | — | — |
NCT05168202CT.gov A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes | — | Terminated | — | — | — |
NCT04937166CT.gov A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies | — | Terminated | — | — | — |
NCT04874194CT.gov Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1 | — | Terminated | — | — | — |
NCT04708054CT.gov Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS | — | Recruiting | — | — | — |
NCT05010122CT.gov ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT04912063CT.gov Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome | — | Terminated | — | — | — |
NCT04752163CT.gov DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT04603001CT.gov Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations | — | Active Not Recruiting | — | — | — |
NCT04581512CT.gov Study to Evaluate the Safety and Tolerability of EP0042 | — | Recruiting | — | — | — |
NCT04146038CT.gov Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease | — | Completed | — | — | — |
NCT04227847CT.gov A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies | — | Recruiting | — | — | — |
NCT04487106CT.gov Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT04278768CT.gov Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) | — | Suspended | — | — | — |
NCT04256317CT.gov A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | — | Recruiting | — | — | — |
NCT03969446CT.gov Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory | — | Recruiting | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT04068597CT.gov Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies | — | Recruiting | — | — | — |
NCT04017546CT.gov CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS | — | Completed | — | — | — |
NCT03940352CT.gov HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) | — | Terminated | — | — | — |
NCT03862157CT.gov Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT03661307CT.gov Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT03613532CT.gov Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN | — | Active Not Recruiting | — | — | — |
NCT03471260CT.gov Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies | — | Recruiting | — | — | — |
NCT03404193CT.gov Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome | — | Terminated | — | — | — |
NCT03214562CT.gov Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT03176277CT.gov A Study of ONO-7475 in Patients With Acute Leukemias | — | Terminated | — | — | — |
NCT03113643CT.gov SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) | — | Recruiting | — | — | — |
NCT02942290CT.gov A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS) | — | Active Not Recruiting | — | — | — |
NCT02392572CT.gov ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT02397720CT.gov Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02250937CT.gov Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT02115295CT.gov Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia | — | Recruiting | — | — | — |
NCT01211457CT.gov Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) | — | Unknown | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Myelodysplastic Syndrome
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Venetoclax (this asset) | National Cancer Institute (NCI) | P3 | B · 60 |
| Cyclophosphamide | Sawa Ito, MD | P4 | BB |
| Nivestim | City of Hope Medical Center | P4 | BB |
| Busulfanum | Sawa Ito, MD | P4 | BB |
| Daunomycin | OHSU Knight Cancer Institute | P3 | BB |
| Cytarabine | The First Affiliated Hospital of Soochow University | P4 | BB |
| Fludarabine | City of Hope Medical Center | P4 | BB |
| Idarubicin | OHSU Knight Cancer Institute | P4 | BB |
| Sitagliptin | Indiana University | P2 | BB |
+42 more in the Myelodysplastic Syndrome cohort
Other indications for Venetoclax
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | P4 | BB · 70 |
| Acute Myeloid Leukemia | — | P4 | BB · 69 |
| Chronic Myelomonocytic Leukemia | — | P2/3 | BB · 68 |
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. Venetoclax in Myelodysplastic Syndrome. 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/venetoclax-myelodysplastic-syndrome
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