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Study · Randomized controlled trial · n = 293 · 2026

6 results

VERIFY: A Phase III Trial of Rusfertide Versus Placebo in Phlebotomy-Dependent Patients With Polycythemia Vera Receiving Standard-of-Care Therapy.

Kuykendall AT, Bankar A, Pettit KM, Shatzel J, Lucchesi A, García-Gutiérrez V, Mayer J, Yacoub A, Gill H, Sasca D, Scandura JM, Kremyanskaya M and 15 more

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Ross DM, Palandri F, Fox ML, Vannucchi AM, Haque T, Koschmieder S, Kiladjian JJ, Oyuela P, Dinh P, Xiao J, Valone FH, Gupta S, Khanna S, Molina A, Pemmaraju N

Journal of clinical oncology : official journal of the American Society of Clinical Oncology13 Oct 2026

PMID42868322 (opens in a new tab)DOI10.1200/jco-26-00992 (opens in a new tab)PepBankPUB-42868322
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In phlebotomy-dependent patients with polycythemia vera, clinical response occurred in 77% with rusfertide versus 33% with placebo.

    In plain wordsIn patients with polycythemia vera, 77% with rusfertide versus 33% with placebo achieved clinical response.

    Peptide
    Rusfertide
    Outcome
    IncreaseClinical response during weeks 20-32
    Study

    n = 293

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Blood counts and hematopoiesis · Whole body
    Studied dose
    Dose not stated · subcutaneous · 32 weeksAs given in this study (human).

    Measurements

    Clinical response
    77%
    rusfertide, n = 113
    Clinical response
    33%
    placebo, n = 48

    Source sentences

    Summary
    Significantly more patients (n = 113, 77%) achieved a clinical response with rusfertide versus placebo (n = 48; 33%; P < .0001).
    3 context sentences
    Summary · context
    The primary efficacy end point was clinical response (absence of phlebotomy eligibility; weeks 20-32).
    Summary · context
    The phase III VERIFY trial evaluated the efficacy and safety of rusfertide in phlebotomy-dependent patients with PV and poorly controlled hematocrit.
    Summary · context
    In VERIFY Part 1a (32 weeks), patients requiring frequent phlebotomy were randomly assigned (1:1, double-blind) to receive rusfertide or placebo with or without cytoreductive therapy.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In phlebotomy-dependent patients with polycythemia vera, rusfertide reduced mean phlebotomies to 0.5 versus 1.8 with placebo.

    In plain wordsIn patients with polycythemia vera, rusfertide reduced mean blood-removal procedures to 0.5 versus 1.8 with placebo.

    Peptide
    Rusfertide
    Outcome
    DecreaseMean number of phlebotomies
    Study

    n = 293

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Blood counts and hematopoiesis · Whole body
    Studied dose
    Dose not stated · subcutaneous · 32 weeksAs given in this study (human).

    Measurements

    Mean number of phlebotomies
    0.5 phlebotomies
    rusfertide
    Mean number of phlebotomies
    1.8 phlebotomies
    placebo

    Source sentences

    Summary
    Compared with placebo, rusfertide reduced mean ± standard deviation number of phlebotomies (0.5 ± 1.2 v 1.8 ± 1.5; P < .0001) and was superior in maintaining hematocrit v n = 21 [14%]; P < .0001).
    2 context sentences
    Summary · context
    The phase III VERIFY trial evaluated the efficacy and safety of rusfertide in phlebotomy-dependent patients with PV and poorly controlled hematocrit.
    Summary · context
    In VERIFY Part 1a (32 weeks), patients requiring frequent phlebotomy were randomly assigned (1:1, double-blind) to receive rusfertide or placebo with or without cytoreductive therapy.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with polycythemia vera, 63% with rusfertide versus 14% with placebo maintained hematocrit below 45%.

    In plain wordsIn patients with polycythemia vera, 63% with rusfertide versus 14% with placebo maintained hematocrit below 45%.

    Peptide
    Rusfertide
    Outcome
    IncreaseMaintenance of hematocrit below 45%
    Study

    n = 293

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Blood counts and hematopoiesis · Whole body
    Studied dose
    Dose not stated · subcutaneous · 32 weeksAs given in this study (human).

    Measurements

    Patients with hematocrit <45%
    63%
    rusfertide, n = 92
    Patients with hematocrit <45%
    14%
    placebo, n = 21

    Source sentences

    Summary
    Compared with placebo, rusfertide reduced mean ± standard deviation number of phlebotomies (0.5 ± 1.2 v 1.8 ± 1.5; P < .0001) and was superior in maintaining hematocrit v n = 21 [14%]; P < .0001).
    2 context sentences
    Summary · context
    The phase III VERIFY trial evaluated the efficacy and safety of rusfertide in phlebotomy-dependent patients with PV and poorly controlled hematocrit.
    Summary · context
    In VERIFY Part 1a (32 weeks), patients requiring frequent phlebotomy were randomly assigned (1:1, double-blind) to receive rusfertide or placebo with or without cytoreductive therapy.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with polycythemia vera, rusfertide significantly improved PROMIS Fatigue SF-8a T-score versus placebo.

    In plain wordsIn patients with polycythemia vera, rusfertide improved the reported fatigue score versus placebo.

    Peptide
    Rusfertide
    Outcome
    Direction not reportedPROMIS Fatigue SF-8a T-score
    Study

    n = 293

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Overall treatment effect · Whole body
    Studied dose
    Dose not stated · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    Rusfertide led to a significant improvement in the PROMIS Fatigue SF-8a T-score and MFSAF TSS7 versus placebo (P = .0252 and .0240, respectively).
    2 context sentences
    Summary · context
    The phase III VERIFY trial evaluated the efficacy and safety of rusfertide in phlebotomy-dependent patients with PV and poorly controlled hematocrit.
    Summary · context
    In VERIFY Part 1a (32 weeks), patients requiring frequent phlebotomy were randomly assigned (1:1, double-blind) to receive rusfertide or placebo with or without cytoreductive therapy.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with polycythemia vera, rusfertide significantly improved MFSAF TSS7 versus placebo.

    In plain wordsIn patients with polycythemia vera, rusfertide improved the reported symptom score versus placebo.

    Peptide
    Rusfertide
    Outcome
    Direction not reportedMFSAF TSS7
    Study

    n = 293

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Overall treatment effect · Whole body
    Studied dose
    Dose not stated · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    Rusfertide led to a significant improvement in the PROMIS Fatigue SF-8a T-score and MFSAF TSS7 versus placebo (P = .0252 and .0240, respectively).
    2 context sentences
    Summary · context
    The phase III VERIFY trial evaluated the efficacy and safety of rusfertide in phlebotomy-dependent patients with PV and poorly controlled hematocrit.
    Summary · context
    In VERIFY Part 1a (32 weeks), patients requiring frequent phlebotomy were randomly assigned (1:1, double-blind) to receive rusfertide or placebo with or without cytoreductive therapy.
  6. 06HumanRandomized controlled trialSafety outcome

    In the polycythemia vera trial, no deaths were reported, including with rusfertide.

    In plain wordsIn the polycythemia vera trial, no deaths were reported, including with rusfertide.

    Peptide
    Rusfertide
    Outcome
    Not applicableDeaths
    Study

    n = 293

    Outcome group
    Mortality · Whole body
    Studied dose
    Dose not stated · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    No deaths were reported.
    2 context sentences
    Summary · context
    The phase III VERIFY trial evaluated the efficacy and safety of rusfertide in phlebotomy-dependent patients with PV and poorly controlled hematocrit.
    Summary · context
    In VERIFY Part 1a (32 weeks), patients requiring frequent phlebotomy were randomly assigned (1:1, double-blind) to receive rusfertide or placebo with or without cytoreductive therapy.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

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