Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
Otsuka Beijing Research Institute
Modality
Small molecule
Development Phase
Phase 2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
57High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT04233346CT.gov The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation | — | Active Not Recruiting | — | — | — |
NCT04188405CT.gov Decitabine, Venetoclax, and Ponatinib for the Treatment of Philadelphia Chromosome-Positive Acute Myeloid Leukemia or Myeloid Blast Phase or Accelerated Phase Chronic Myelogenous Leukemia | — | Completed | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT03934372CT.gov Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors | — | Recruiting | — | — | — |
NCT03709017CT.gov Iclusig PMS in CML or Ph+ALL Patients | — | Unknown | — | — | — |
NCT03576547CT.gov Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia | — | Terminated | — | — | — |
NCT03147612CT.gov Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
NCT03263572CT.gov Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia | — | Recruiting | — | — | — |
NCT01667133CT.gov A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) | — | Completed | — | — | — |
NCT01424982CT.gov Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia | — | Active Not Recruiting | — | — | — |
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NCT01207440CT.gov Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) | — | Completed | — | — | — |
NCT01592136CT.gov Expanded Access Program of Ponatinib | — | Approved For Marketing | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Chronic Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Ponatinib (this asset) | Otsuka Beijing Research Institute | P2 | BB · 66 |
| Nilotinib | Novartis Pharmaceuticals | P4 | BBB |
| Cyclophosphamide | City of Hope Medical Center | P3 | BBB |
| Therapeutic Allogeneic Lymphocytes | University of Chicago | P2 | BBB |
| Romidepsin | Center for International Blood and Marrow Transplant Research | P2 | BBB |
| Sargramostim | Virginia Commonwealth University | P2 | BBB |
| Imatinib | OHSU Knight Cancer Institute | P2 | BB |
| Alemtuzumab | Diane George | P2/3 | BB |
| Cyclosporin A | Fred Hutchinson Cancer Center | P3 | BB |
+42 more in the Chronic Myeloid Leukemia cohort
Other indications for Ponatinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | — | P2 | BB · 65 |
| B-Lymphoblastic Leukemia/Lymphoma With T(9;22)(Q34.1;Q11.2) | — | P3 | BB · 65 |
| Acute Lymphoblastic Leukemia | — | P2/3 | B · 60 |
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. Ponatinib in Chronic 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/ponatinib-chronic-myeloid-leukemia
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