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Ruxolitinib

Phase 2

Myelofibrosis | Small molecule | Other |Actuate Therapeutics, Inc.|Last Updated: Feb 7, 2024

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04218071Actuate 1901: 9-ING-41 in MyelofibrosisPHASE2 COMPLETED 17Aug 20, 2020Jan 18, 2024Feb 7, 20249 United States
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Study Endpoints
Primary Endpoints
Response rate
3-24 months

The percent of patients with response will be assessed at the protocol specified timepoints according to the Revised IWG-MRT and ELN Response Criteria for MF (2013)

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
9-ING-41EXPERIMENTAL9-ING-41 is administered by intravenous infusion twice weekly at a dose of 9.3 mg/kg. Cycle duration is 28 days.
9-ING-41 plus RuxolitinibEXPERIMENTAL9-ING-41 9.3 mg/kg will be administered by intravenous infusion twice weekly for cycle durations of 28 days with Ruxolitinib at doses specified in the protocol as appropriate for patient's platelet count.
Interventions
NameTypeDescription
RuxolitinibDRUGRuxolitinib at protocol-specified doses for given platelet count
9-ING-41DRUG9-
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: Patient - 1. Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures 2. Is aged ≥ 18 years 3. Has documented di...

Countries:United States
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