A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis

Phase 2 Recruiting 75 enrolled Chengdu Zenitar Biomedical Technology Co., Ltd

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)

Timeline

Start: 2024-05-06
Primary completion: 2026-05-06
Completion: 2026-07-06

Publications

Yang L, Tan K, Liang R, Zhang W, Wang Y, Chen L. Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. Ther Adv Hematol. 2026 Mar 19;17:20406207261424845. doi: 10.1177/20406207261424845. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flonoltinib	Unknown	50 mg	—
Subject	Flonoltinib	Unknown	100 mg	—
Comparator	Ruxolitinib	Small molecule	5 mg	—
Comparator	Ruxolitinib	Small molecule	15 mg	—
Comparator	Ruxolitinib	Small molecule	20 mg	—

Indications

No indication recorded.