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Flonoltinib

Phase 2

MF | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: May 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07443306A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk MyelofibrosisPHASE2 RECRUITING 64Mar 18, 2026Mar 30, 2028May 13, 20262 China
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Study Endpoints
Primary Endpoints
Percentage of subjects with >=35% reduction in spleen volume from baseline
Week 24
Secondary Endpoints
Spleen response time
Week 12,week 24
MPN-SAF TSS Total Symptom Score and Baseline Comparison Decrease
Week 2,week 4,week 8,week 12,week 24
Overall survival period
Week 2,week 4,week 8,week 12,week 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Flonoltinib maleateEXPERIMENTALAllocate 50mg or 75mg flonoltinib maleate tablets once daily on an empty stomach based on platelet count levels during the screening period
Interventions
NameTypeDescription
Flonoltinib MaleateDRUGAllocate flonoltinib maleate tablets 50mg or 75mg once daily on an empty stomach based on platelet count levels during the screening period
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Age range of 18-80 years old (including threshold), gender not limited; 2. Patients diagnosed with primary myelofibrosis (PMF) according to WHO criteria (2016 edition) or patients diagnosed with post polycythemia vera myelofibrosis (PPV-MF) or post thrombocytopenia myelofibro...

Countries:China
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