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DISC-3405

Phase 2

Polycythemia Vera (PV) | Small molecule | Hematology |Disc Medicine, Inc.|Last Updated: May 28, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06985147A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)PHASE2 RECRUITING 60Aug 12, 2025Feb 1, 2029May 28, 202615 United States
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Study Endpoints
Primary Endpoints
Number of participants with treatment-related adverse events as assessed by CTCAE
Up to 365 days

Proportion of participants with treatment-emergent adverse events

Incidence of clinically abnormal vital signs
Up to 365 days

Proportion of participants with changes in vital signs

Incidence of clinically abnormal physical exam
Up to 365 days

Proportion of participants with changes in physical examinations

Incidence of clinically abnormal electrocardiograms
Up to 365 days

Proportion of participants with changes in electrocardiograms (ECGs)

Incidence of abnormal laboratory test results
Up to 365 days

Proportion of participants with changes in clinical laboratory results

Secondary Endpoints
Proportion of participants achieving therapeutic response, defined as absence of phlebotomy eligibility, during the maintenance period
Up to 365 days
Number of phlebotomies during the maintenance and optimization periods
Up to 365 days
Proportion of participants achieving therapeutic response, defined as absence of phlebotomy eligibility, during the optimization period
Up to 365 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Within-participant dose escalationEXPERIMENTALThis is an open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405.
Interventions
NameTypeDescription
DISC-3405DRUGDISC-3405 is administered subcutaneously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Aged 18 years or older at the time of signing the informed consent form (ICF). 2. Meet revised 2022 World Health Organization (WHO) criteria for the diagnosis of PV. 3. Complete blood count values at Screening of HCT \<45% or HCT \<48% if followed by a phlebotomy within 2 wee...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT06985147lastUpdatePostDate: changed
LOWMay 29, 2026NCT06985147lastUpdatePostDate: changed
LOWMay 29, 2026NCT06985147lastUpdatePostDate: changed
LOWMay 26, 2026NCT06985147primaryCompletionDate: changed
LOWMay 24, 2026NCT06985147studyFirstPostDate: changed