Recent Updates
Recently added Catalysts

DISC-3405

Phase 2

Polycythemia Vera (PV) | Small molecule | Hematology |Disc Medicine, Inc.|Last Updated: Jun 4, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

DISC-3405 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT06985147A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)Polycythemia Vera (PV)
RECRUITING60 Analytics
PHASE2RECRUITING
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)Unlock trial analytics
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

Safety and tolerability of DISC-3405 administration in participants with SCD
Up to 36 weeks

Proportion of participants with treatment-emergent adverse events (TEAEs), changes in vital signs, changes in physical examinations, changes in electrocardiograms (ECGs), and changes in clinical laboratory results

Incidence of adverse events
up to 99 days
Incidence of treatment-emergent clinically abnormal physical exam
up to 99 days
Incidence of treatment-emergent clinically significant laboratory test results
up to 99 days
Incidence of treatment-emergent clinically significant electrocardiograms (ECGs)
up to 99 days
Incidence of treatment-emergent clinically abnormal vital signs
up to 99 days
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
Unlock Study Endpoints
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.
Single Ascending Dose of DISC-3405EXPERIMENTAL -
Single Ascending Dose of PlaceboPLACEBO_COMPARATOR -
Multiple Ascending Dose of DISC-3405EXPERIMENTAL -
Multiple Ascending Dose of PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DISC-3405DRUGDISC-3405 is administered subcutaneously.
PlaceboDRUGPlacebo is administered as a single dose IV infusion or subcutaneous injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 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
Unlock Eligibility Criteria
Competitive Landscape -Polycythemia Vera 11 trials (matched to "Polycythemia Vera (PV)")
Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07187973lastUpdatePostDate: changed
LOWJun 4, 2026NCT07187973lastUpdatePostDate: changed
LOWJun 4, 2026NCT07187973lastUpdatePostDate: changed
LOWJun 4, 2026NCT07187973lastUpdatePostDate: changed
LOWMay 29, 2026NCT06985147lastUpdatePostDate: changed
LOWMay 29, 2026NCT06985147lastUpdatePostDate: changed
LOWMay 29, 2026NCT06985147lastUpdatePostDate: changed
LOWMay 26, 2026NCT07187973primaryCompletionDate: changed
LOWMay 26, 2026NCT06985147primaryCompletionDate: changed
LOWMay 24, 2026NCT07187973studyFirstPostDate: changed
LOWMay 24, 2026NCT06985147studyFirstPostDate: changed