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131I-apamistamab

Phase 3

Acute Leukemia | Small molecule | Oncology |Actinium Pharmaceuticals, Inc. (Delaware)|Last Updated: Sep 9, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment306
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07157514Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AMLPHASE2/PHASE3 NOT YET_RECRUITING 306Jan 1, 2026Feb 1, 2034Sep 9, 2025 -
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Study Design & Arms
Interventions
NameTypeDescription
131I-apamistamabDRUGIodine-131 radiolabeled anti-CD45 monoclonal antibody (apamistamab). Administered IV as a dosimetric dose followed by treatment dose.
FludarabineDRUGFludarabine phosphate, 30 mg/m² IV daily on Days -6 through -2.
CyclophosphamideDRUGCyclophosphamide
Total Body Irradiation (TBI)RADIATIONTBI, 200 cGy on Day -1 prior to HSCT.
Allogeneic Hematopoietic Stem Cell Transplant (HSCT)BIOLOGICALUnmodified, G-CSF-mobilized donor stem cells infused on Day 0.
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07157514studyFirstPostDate: changed