Ascentage Pharma announced on August 17, 2025, that it received clearance from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct the GLORA-4 study (NCT06641414). This is a global registrational Phase III study of lisaftoclax (APG-2575) in combination with azacitidine (AZA) for the first-line treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
This marks the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA, underscoring its global development potential. Lisaftoclax is currently the only Bcl-2 inhibitor being advanced in a registrational Phase III trial for higher-risk MDS globally.
The GLORA-4 study is simultaneously enrolling patients in multiple countries, including China, the U.S., and Europe, to accelerate its path to potential market authorization. This study has the potential to address a longstanding treatment gap in higher-risk MDS, where current therapies offer limited efficacy.
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