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Rusfertide

Phase 2

Polycythemia Vera | Small molecule | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment33

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

Rusfertide · 2 trials · 1 indication

Phase 2 2
NCT07765602A Study of Rusfertide in Adults With Polycythemia Vera in ChinaPolycythemia Vera
NOT YET_RECRUITING24 Analytics
NCT07648030A Study of Rusfertide in Japanese Adults With Polycythemia VeraPolycythemia Vera
RECRUITING9 Analytics
PHASE2NOT YET_RECRUITING
A Study of Rusfertide in Adults With Polycythemia Vera in China
Polycythemia VeraUnlock trial analytics
PHASE2RECRUITING
A Study of Rusfertide in Japanese Adults With Polycythemia Vera
Polycythemia VeraUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving a Response Starting at Week 20 Through Week 32
Week 20 through Week 32

Response is defined as the absence of phlebotomy eligibility. Phlebotomy eligibility is defined as: A confirmed hematocrit ≥45%, which is ≥3% (absolute) higher than the baseline hematocrit or hematocrit ≥48%. Confirmation is defined as 2 consecutive hematocrit assessments that are ≥45% and at least 3% higher than the baseline hematocrit.

Secondary Endpoints

Change From Baseline in Hematocrit Over Time
From Baseline to Week 32
Percentage of Participants Maintaining Hematocrit <45% During Week 0 to Week 32 and Week 0 to Week 52
From Baseline to Weeks 32 and 52
Median Time to First Hematocrit ≥45% After Enrollment
From Baseline to Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RusfertideEXPERIMENTALParticipants will receive rusfertide (TAK-121), subcutaneously (SC) once weekly for 52 weeks.

Interventions

NameTypeDescription
RusfertideDRUGRusfertide injections administered SC.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

* Inclusion Criteria 1. Chinese male and female participants aged 18 years or older at the time of signing of informed consent. 2. Participant understands the trial procedures, is willing and able to adhere to trial requirements, and agrees to participate in the trial by providing written infor...

Countries:Japan
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Competitive Landscape -Polycythemia Vera 11 trials

Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT07648030lastUpdatePostDate: changed
LOWSep 2, 2026NCT07648030lastUpdatePostDate: changed
LOWSep 2, 2026NCT07648030lastUpdatePostDate: changed
LOWAug 28, 2026NCT07765602lastUpdatePostDate: changed
LOWAug 28, 2026NCT07765602lastUpdatePostDate: changed
LOWAug 14, 2026NCT07765602NEW_TRIAL: changed
LOWAug 14, 2026NCT07765602NEW_TRIAL: changed
LOWAug 5, 2026NCT07648030lastUpdatePostDate: changed
LOWJul 30, 2026NCT07648030Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 30, 2026NCT07648030Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07648030NEW_TRIAL: changed
LOWJun 16, 2026NCT07648030NEW_TRIAL: changed
LOWJun 16, 2026NCT07648030NEW_TRIAL: changed
LOWJun 16, 2026NCT07648030NEW_TRIAL: changed

Frequently asked questions about Rusfertide

What is Rusfertide used for?

Rusfertide is an investigational small molecule being studied for the treatment of polycythemia vera, a blood disorder characterized by an overproduction of red blood cells. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does Rusfertide target?

Rusfertide is a peptide-based therapeutic, as indicated by its '-tide' suffix. It is being developed to address polycythemia vera, though its specific molecular target has not been disclosed in available clinical trial information.

Who is developing Rusfertide?

Rusfertide is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with polycythemia vera.

What phase is Rusfertide in?

Rusfertide is currently in Phase 2 clinical development. Two Phase 2 trials are ongoing or planned, one recruiting in Japan and another not yet recruiting in China, both focused on adults with polycythemia vera. The drug is investigational and not yet approved.

What clinical trials is Rusfertide in?

Rusfertide is being studied in two Phase 2 trials. NCT07648030 is a study in Japanese adults with polycythemia vera, currently recruiting with an enrollment target of 9 participants. NCT07765602 is a study in adults with polycythemia vera in China, not yet recruiting, with an enrollment target of 24 participants.

Is Rusfertide the same as any other drug?

Rusfertide is a distinct investigational drug developed by Takeda. No alternative names for Rusfertide have been reported in the context of its clinical development for polycythemia vera.