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APG-2575

Phase 3

Acute Myeloid Leukemia | Small molecule | Oncology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Nov 25, 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment486
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06389292A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid LeukemiaPHASE3 RECRUITING 486Jun 11, 2024Mar 26, 2029Nov 25, 20256 China, China +4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
APG-2575(Lisaftoclax )DRUGQD, oral administration, every 28 days for a dosing cycle.
PlaceboOTHERQD, oral administration, every 28 days for a dosing cycle.
Azacitidine InjectionDRUGQD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06389292studyFirstPostDate: changed