A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis
Key claim: A single-arm, open-label, multicenter trial is evaluating flonoltinib maleate tablets in approximately 64 patients with moderate-to-high risk myelofibrosis who are refractory, relapsed, or intolerant to prior JAK inhibitor therapy.
Abstract
This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the moderate to high risk MF trial who are refractory, relapsed, or intolerant to JAK inhibitor . Select successful trial participants and allocate flonoltinib maleate tablets based on platelet count levels during the screening period, qd,Oral administration on an empty stomach until the participants meet the withdrawal criteria.
Why this matters
JAK inhibitor refractory/relapsed/intolerant myelofibrosis is one of the most clinically defined unmet-need subpopulations within PMF, with prognosis after ruxolitinib failure measured in months. Flonoltinib maleate joins a growing constellation of agents (AJ1-11095 Type II JAK2 inhibitor, roginolisib+ruxolitinib, selinexor combinations) targeting precisely this post-JAKi PMF niche, suggesting the field is converging on this subgroup as a distinct natural-history compartment requiring its own therapeutic taxonomy.