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A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)

Trial Profile

A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Lisaftoclax (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms GLORA-4
  • Sponsors Ascentage Pharma

Most Recent Events

  • 17 Aug 2025 According to Ascentage Pharma media release, company announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study.
  • 19 Feb 2025 Status changed from not yet recruiting to recruiting.
  • 17 Oct 2024 Status changed from planning to not yet recruiting.

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