NCT07443306

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis

Flonoltinib Maleate for the Treatment of Patients With Intermediate- or High-risk Myelofibrosis Who Are Refractory, Relapsed, or Intolerant to JAK Inhibitors a Single-arm, Open-label, Multicenter Phase IIb Clinical Trial Evaluating Efficacy and Safety

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (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 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.

Conditions

• MF

Interventions

Type	Name	Description
DRUG	Flonoltinib Maleate	Allocate flonoltinib maleate tablets 50mg or 75mg once daily on an empty stomach based on platelet count levels during the screening period

Timeline

• Start date: 2026-03-18
• Primary completion: 2027-12-30
• Completion: 2028-03-30
• First posted: 2026-03-02
• Last updated: 2026-04-08

Locations

2 sites across 1 country: China