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Rusfertide

Phase 3

Polycythemia Vera | Small molecule | Hematology |Protagonist Therapeutics, Inc.|Last Updated: Aug 7, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment339
FDA Designations
No designations recorded
Clinical trial landscape

Rusfertide · 2 trials · 1 indication

Phase 3 2
NCT06033586Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia VeraPolycythemia Vera
ACTIVE NOT_RECRUITING46 Analytics
NCT05210790A Phase 3 Study of Rusfertide in Patients With Polycythemia VeraPolycythemia Vera
ACTIVE NOT_RECRUITING293 Analytics
PHASE3ACTIVE NOT_RECRUITING
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
Polycythemia Vera
NCT0603358646
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PHASE3ACTIVE NOT_RECRUITING
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Polycythemia Vera
NCT05210790293
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Study Endpoints
Primary Endpoints
Hematocrit
0-2 years

Median hematocrit

Phlebotomies
0-2 years

Number of phlebotomies

Proportion of subjects achieving a response who receive rusfertide compared to placebo.
Week 20 through Week 32

Response is defined as absence of phlebotomy eligibility.

Secondary Endpoints
Comparison of mean number of phlebotomies between rusfertide and placebo.
Week 0 to Week 32
Proportion of subjects with HCT values <45% for rusfertide and placebo.
Week 0 to Week 32
Comparison mean change from baseline in total fatigue score based on PROMIS Short Form between rusfertide and placebo.
Week 32
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label rusfertideEXPERIMENTALOpen-label rusfertide
RusfertideEXPERIMENTALRusfertide (32 Weeks) - Rusfertide (124 Weeks Open-label)
PlaceboEXPERIMENTALPlacebo (32 Weeks) - Rusfertide (124 Weeks Open-label)
Interventions
NameTypeDescription
Open-label rusfertideDRUGsubcutaneous rusfertide
PlaceboDRUGPlacebo
RusfertideDRUGExperimental drug
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 study of rusfertide. * Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to...

Countries:United StatesAustraliaAustriaBelgiumCanadaChileCzechiaFranceGermanyHong KongHungaryIsraelItalyMexicoNetherlandsPolandPortugalSpainTurkey (Türkiye)United Kingdom
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Competitive Landscape -Polycythemia Vera 11 trials
CompanyTickerTrialsLead PhaseDrugs
Protagonist Therapeutics, Inc.PTGX2PHASE3Rusfertide
Merck & Co., Inc.MRK1PHASE3Bomedemstat
Disc Medicine, Inc.IRON1PHASE2DISC-3405
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
Novartis AG Sponsored ADRNVS1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05210790primaryCompletionDate: changed
LOWMay 26, 2026NCT06033586primaryCompletionDate: changed
LOWMay 24, 2026NCT05210790studyFirstPostDate: changed
LOWMay 24, 2026NCT06033586studyFirstPostDate: changed