Recent Updates
Recently added Catalysts

Fedratinib Pill

Phase 2

Myeloproliferative Neoplasm | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05177211Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)PHASE2 ACTIVE NOT_RECRUITING 25Mar 1, 2022Apr 1, 2026Apr 17, 20263 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Objective Clinical Response Rate
Up to 24 weeks

Response rate of fedratinib in MDS/MPN and CNL. Investigators will measure the proportion of patients achieving a clinical response from baseline to week 24 as defined by Complete Response (CR), Partial Response (PR) or Clinical Benefit (CB) by modified MDS/MPN IWG Proposed response criteria.

Secondary Endpoints
Proportion of Patients Achieving Spleen Response at 12 Weeks
at 12 weeks
Proportion of Patients Achieving Spleen Response at 24 Weeks
at 24 weeks
Proportion of Patients Who Have a 50% Reduction in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) at 12 Weeks
at 12 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment with FedratinibEXPERIMENTALParticipants will taken Fedratinib by mouth once a day every day of each 28 day cycle.
Interventions
NameTypeDescription
Fedratinib PillDRUGParticipants will be given Fedratinib at a dose of 400 mg PO once daily (4-100 mg capsules). Fedratinib can be given at any time during the day, but patients are advised to take the dose at the same approximate time every day.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patient must understand and voluntarily sign an ICF prior to any study-related assessments/ procedures being conducted * 18 years of age or older on day of signing informed consent. * Morphologically confirmed diagnosis of one of the following in accordance with WHO (2016) dia...

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05177211studyFirstPostDate: changed