Nivestim
Acute Promyelocytic Leukemia
Floatz Rating
BB70/100
Confidence
Indicative
Sponsor
Associazione Italiana Ematologia Oncologia Pediatrica
Modality
protein_peptide
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 |
|---|---|---|---|---|---|
NCT04793919CT.gov Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia | — | Recruiting | — | — | — |
NCT02899169CT.gov Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF) | — | Unknown | — | — | — |
NCT01101880CT.gov Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm | — | Completed | — | — | — |
NCT01076270CT.gov Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | — | Terminated | — | — | — |
NCT01031368CT.gov Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00863434CT.gov Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease | — | Terminated | — | — | — |
NCT00602225CT.gov Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00536601CT.gov High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors | — | Completed | — | — | — |
NCT00012376CT.gov Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
95High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Promyelocytic Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivestim (this asset) | Associazione Italiana Ematologia Oncologia Pediatrica | P3 | BB · 70 |
| Cytarabine | Associazione Italiana Ematologia Oncologia Pediatrica | P4 | A |
| Tretinoin | The Affiliated People's Hospital of Ningbo University | P4 | A |
| Idarubicin | Technische Universität Dresden | P4 | A |
| Arsenic Trioxide | Quetzal Therapeutics | P4 | BBB |
| Mitoxantrone | Technische Universität Dresden | P4 | BBB |
| Methotrexate | Technische Universität Dresden | P3 | BBB |
| Daunomycin | Peking University People's Hospital | P4 | BBB |
| Cyclophosphamide | Sumithira Vasu | P3 | BBB |
+42 more in the Acute Promyelocytic Leukemia cohort
Other indications for Nivestim
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Burkitt Lymphoma | — | P4 | BBB · 78 |
| Neutropenia | — | P4 | BBB · 76 |
| Mycosis Fungoides | — | P4 | BBB · 75 |
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.
Citation
Floatz Terminal. Nivestim in Acute Promyelocytic Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 13, 2026. https://terminal.floatz.ai/assets/n-met-g-csf-acute-promyelocytic-leukemia
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