NCT07317700

A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis

A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• MF

Interventions

Type	Name	Description
DRUG	Flonoltinib 75mg	Flonoltinib 75mg，qd
DRUG	Ruxolitinib Phosphate	Ruxolitinib Phosphate ,control group

Timeline

• Start date: 2026-02-13
• Primary completion: 2027-12-30
• Completion: 2028-03-30
• First posted: 2026-01-05
• Last updated: 2026-03-04

Locations

2 sites across 1 country: China