Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Transfusions

The primary objective of this study is to evaluate the efficacy and safety of ofirnoflast administered orally once daily in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who are transfusion-dependent and have failed one to three prior therapies, in order to identify the optimal dose for continuation into a Phase 3 study. The secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during the dose-selection phase, and to evaluate hematologic improvement with ofirnoflast treatment.

NCT Number	NCT07738510
Lead Sponsor	Halia Therapeutics, Inc. Collaborators: Parexel
Conditions	Myelodysplastic Syndromes, Anemia
Enrollment	50 participants
Start Date	2026-10
Primary Completion	2028-10 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-31