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Blood & Immune

Polycythemia Vera (PV) Clinical Trials and Treatments

Also called PV, Primary Polycythemia, Erythremia

Polycythemia Vera is one of the myeloproliferative neoplasms, a group of blood cancers in which bone marrow cells multiply uncontrollably. In PV, the overproduction of red blood cells increases blood volume and viscosity (thickness), which impairs blood flow and oxygen delivery despite elevated hemoglobin levels.

In plain words, polycythemia vera is a blood cancer where the bone marrow makes too many red blood cells. The extra cells thicken the blood, which can cause tiredness and headaches along with a higher chance of blood clots.

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Polycythemia Vera

Where treatments stand, from ClinicalTrials.gov and FDA labels

FDA review0

No decision pending. FDA calendar

FDA-approved medicines3

Besremi · Mimrylo · Jakafi

Polycythemia Vera has 3 FDA-approved medicines, 55 open or active clinical trials, and no pending FDA decision.

Labels checked October 21, 2026. Corticosteroids and immune globulins count once each.Download the data

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More about Polycythemia Vera

The high blood viscosity also increases risk of blood clots (thrombosis) and bleeding complications. About 95% of PV patients carry the JAK2 V617F mutation, and most of the rest have a different change in the same gene, in a region called exon 12.

Keep reading about Polycythemia Vera

These mutations cause uncontrolled cell growth independent of normal growth signal regulation. Patients often present with constitutional symptoms including fatigue, headaches, and visual disturbances. A characteristic symptom, aquagenic pruritus (itching triggered by water contact) occurs in about half of patients. Splenomegaly (enlarged spleen) occurs in 75% of patients. Long-term complications include risk of thrombotic events (stroke, heart attack, deep vein thrombosis) and potential transformation to myelofibrosis or acute leukemia.

What are the symptoms of Polycythemia Vera?

These are common symptoms of Polycythemia Vera, and how strong they are varies from person to person.

  • Fatigue and weakness
  • Headaches and dizziness
  • Vision disturbances or blurred vision
  • Itching, especially after bathing
  • Burning sensations in the hands and feet
  • Easy bruising or bleeding

Who gets Polycythemia Vera?

Polycythemia Vera typically affects older adults, with median age of diagnosis around 65 years, though it can occur at younger ages. It affects males and females approximately equally. The disease occurs across all racial and ethnic groups. Approximately 95% of PV patients carry the JAK2 V617F mutation, which can be detected through blood testing.

Next steps: find trials you might fitsee approved treatmentsget help payingget alerts

Which medicines are FDA-approved for Polycythemia Vera?

There are currently 3 FDA-approved medications for Polycythemia Vera.

Just prescribed one of these?Your first 90 days, step by stepWhat happens before the first fill, the tests and refills to expect, and help paying, with a one-page handout to print.
ropeginterferon alfa-2b-njft
Your first 90 days
PharmaEssentia (PharmaEssentia Corporation, Taipei, Taiwan, through PharmaEssentia USA)
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rusfertide
Your first 90 days
Takeda (discovered by Protagonist Therapeutics)
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

How to get help paying for Polycythemia Vera treatment

Charity funds and drugmaker programs for Polycythemia Vera, checked at the source.

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Charity funds
  • From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)
    Clinical Trials Co-Pay Fund (all blood cancers) fund
    Open

    Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).

  • From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)
    Patient Aid Program fund
    Open

    Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.

    The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.”
  • From a charity · CancerCare Co-Payment Assistance Foundation
    Myeloproliferative Neoplasms fund
    Open

    Pays for: Copays, coinsurance and deductibles for treatment, up to $7,000 per year. Requires Medicare, Medicaid or TRICARE.

    The foundation says: “Status: Open. Grant Amount: $7,000 (Initial Grant Amount $7,000; Program CAP Amount $10,000)”
  • From a charity · TotalAssist (formerly PAN Foundation)
    Myeloproliferative Neoplasms fund
    Open

    Pays for: Out-of-pocket costs for approved medications, up to $9,500 per year. Requires health insurance (any kind).

  • From a charity · The Assistance Fund
    Myeloproliferative Neoplasms (MPN) fund
    Waitlist

    Pays for: Copays, coinsurance, deductibles and other health-related expenses.

Status as each foundation showed it on October 26, 2026.

Every program and fund for Polycythemia Vera, by insurance →

Side effects people have reported to the FDA

Side effects people have reported to the FDA

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Diagnosis and genetic testing

Genetic testing for Polycythemia Vera

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

The JAK2 gene page lists every condition Orphanet links to the gene and the open trials that name it.

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Trusted Polycythemia Vera resources

Reputable organizations and medical references for learning more about Polycythemia Vera, including disease registries, foundation resources, and clinical guidelines.

Recruiting now · study you can followOno's phase 3 sapablursen study: get one email when it opens near you, and check its main requirements privately before talking with your doctor. →

Active clinical trials for Polycythemia Vera

Use this Polycythemia Vera clinical trial finder to see the 14 studies recruiting patients and 1 not yet recruiting in the United States and worldwide, with eligibility criteria in plain English. Of these, 14 test a treatment and 1 is an observational study or registry; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map or the pipeline timeline.

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

55 active trials worldwide
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RecruitingTreatment trialPhase 3Recently updatedNCT07357727

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

Intervention: Pelabresib, Ruxolitinib, Placebo

Sponsor: Novartis Pharmaceuticals

The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essent...

Ages 18 Years+
Started May 2026Updated todayEst. May 2028 (~1y 6m)
RecruitingTreatment trialRecently updatedNCT07734272

Standardized Documentation and Assessments for Polycythemia Vera: A Quality Improvement Initiative

Intervention: Standardized progress note

Sponsor: Massachusetts General Hospital · PharmaEssentia

The purpose of this quality improvement initiative is to explore whether an electronic medical records-based templated progress note for polycythemia vera (PV) in addition to a standard-of-care pharmacist-collaborative ropeginterferon alfa-2b titration service is feasible, accept...

Ages not specified1 location
Started Sep 2026Updated todayEst. Dec 2027 (~1y 1m)
RecruitingTreatment trialPhase 2/3Recently updatedNCT07722611

A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).

Intervention: Bomedemstat, Ruxolitinib, Ropeginterferon alfa-2b

Sponsor: Merck Sharp & Dohme LLC

Researchers are looking for new ways to treat polycythemia vera (PV). People with PV may receive treatment to lower the number of red blood cells in the blood, but the usual treatments may not work for everyone. Researchers want to learn if a trial medicine called bomedemstat, al...

Ages 18 Years+
Started Oct 2026Updated todayEst. Jun 2032 (~5y 7m)
RecruitingTreatment trialPhase 3Recently updatedNCT06351631

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Intervention: Bomedemstat

Sponsor: Merck Sharp & Dohme LLC

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigat...

Ages 18 Years+
Started May 2024Updated 3 days agoEst. Dec 2034 (~8 years)
RecruitingTreatment trialPhase 2Recently updatedNCT06517875

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

Intervention: Momelotinib, Luspatercept

Sponsor: GlaxoSmithKline

The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelo...

Ages 18 Years+
Started Feb 2025Updated 1 week agoEst. Mar 2027 (~4 months)
Find Polycythemia Vera trials near you, ranked by distance →
Active trial locations86 cities in the US
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Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
Always talk to your doctor before considering a clinical trial.

Polycythemia Vera patient communities

Facebook groups, Reddit communities and YouTube channels where Polycythemia Vera patients, caregivers and advocacy groups talk.

Companies developing Polycythemia Vera treatments

Drugmakers that list Polycythemia Vera in their rare disease portfolio, with makers of its treatments first.

Questions people ask about Polycythemia Vera