A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
Key claim: A multicenter, open-label, positive-drug parallel-controlled phase trial is evaluating flonoltinib maleate versus an active comparator in approximately 105 patients with intermediate or high-risk myelofibrosis, stratified by DIPSS score.
Abstract
This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial. Successful trial participants were selected and assigned to either the experimental group or the control group in a 2:1 stratified manner, with the stratification factor being the Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria. Continuously take the test drug/control drug until it meets the withdrawal criteria.
Why this matters
Flonoltinib maleate is one of several novel JAK inhibitors (alongside gecacitinib, TQ05105, AJ1-11095) advancing through controlled trials for intermediate/high-risk myelofibrosis, signaling continued expansion of the JAKi class beyond ruxolitinib, fedratinib, momelotinib, and pacritinib. The use of an active comparator rather than placebo and DIPSS-based stratification suggests a registrational-style design, making outcome data—when reported—directly relevant to positioning this agent in the MF treatment landscape.