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A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia

Trial Profile

A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Aug 2026

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At a glance

  • Drugs Ofirnoflast (Primary) ; Darbepoetin-alfa; Epoetin alfa
  • Indications Myelodysplastic syndromes
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Halia Therapeutics

Most Recent Events

  • 04 Aug 2026 Planned End Date changed from 25 May 2026 to 14 Aug 2026.
  • 15 Jun 2026 According to a Halia Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ofirnoflast (HT-6184) for the treatment of adult patients with lower-risk myelodysplastic syndromes (LR-MDS).
  • 12 May 2026 According to a Halia Therapeutics media release, data from this study will be presented in an oral session at the European Hematology Association (EHA) 2026 Hybrid Congress, June 11-14, 2026, in Stockholm, Sweden.

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