DrugEvidence

Diseases / Polycythemia Vera

Polycythemia Vera Clinical Trials

Disease

Polycythemia vera is a chronic myeloproliferative neoplasm characterized by clonal overproduction of red blood cells and increased risk of thrombosis, often associated with JAK2 mutations.

Trials
272
Recruiting
35
Completed
147
With results
64

Continuously tracked·last revised

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Follow Polycythemia Vera

Recruiting Phase 3

Polycythemia Vera — Recruiting Phase 3
TrialPhaseStatusSponsorStarted
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) NCT07429266 Phase 3 Recruiting Ono Pharmaceutical Co., Ltd. Started 2026-05
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) NCT06351631 Phase 3 Recruiting Merck Sharp & Dohme LLC Started 2024-05
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera NCT06093672 Phase 3 Recruiting Italfarmaco Started 2024-03
AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms NCT05198960 Phase 3 Recruiting University Hospital, Brest Started 2022-07
Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients NCT04655092 Phase 3 Recruiting PharmaEssentia Japan K.K. Started 2021-01

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Recently started

Polycythemia Vera — Recently started
TrialPhaseStatusSponsorStarted
Standardized Documentation and Assessments for Polycythemia Vera: A Quality Improvement Initiative NCT07734272 Phase n/a Not yet recruiting Massachusetts General Hospital Started 2026-08
ENERGIA: Personalized Exercise Program for Fatigue in Patients With Myeloproliferative Neoplasms and Chronic Myeloid Leukemia NCT07518940 Phase n/a Not yet recruiting Carmen Fava Started 2026-08
Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera NCT06290765 Phase 4 Withdrawn PharmaEssentia Started 2026-08
A Study of Rusfertide in Japanese Adults With Polycythemia Vera NCT07648030 Phase 2 Recruiting Takeda Started 2026-07
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) NCT07429266 Phase 3 Recruiting Ono Pharmaceutical Co., Ltd. Started 2026-05

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Results recently posted

Polycythemia Vera — Results recently posted
TrialPhaseStatusSponsorResults posted
A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004) NCT05558696 Phase 2 Completed Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA) Results posted 2026-05-07
Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms NCT03878199 Phase 1/2 Terminated Ohio State University Comprehensive Cancer Center Results posted 2026-04-24
A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies NCT01384513 Phase 2 Completed Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Results posted 2026-04-15
Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies NCT01760655 Phase 2 Completed Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Results posted 2025-10-30
Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply NCT04182100 Phase 2 Completed PharmaEssentia Japan K.K. Results posted 2025-09-15

See all 64 →

Pipeline

Phase by status

Polycythemia Vera — Phase by status
PhaseRecruitingNot yetActiveCompletedTerminatedWithdrawnUnknownAvailableNo longer availableTotal
Early Phase 1 ———111——— 3
Phase 1 61125732—— 45
Phase 1/2 1—217132—— 26
Phase 2 919531431—— 90
Phase 2/3 1——1————— 2
Phase 3 6—3193—1—— 32
Phase 4 ——1—11——— 3
Not applicable 35—10411—— 24
Unknown 9142112711 47

Trials started per year

2021
3
2022
10
2023
7
2024
14
2025
9
2026
11
2027
2

Conditions studied, by phase

Polycythemia Vera — Conditions studied, by phase
ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Polycythemia Vera 345269023232447 272
Primary Myelofibrosis 239215811511924 180
Thrombocythemia, Essential 2352052117—1828 173
Myeloproliferative Disorders 130184011611522 144
Leukemia, Myeloid, Acute 1261122110197 88
Leukemia, Myelomonocytic, Chronic 12492319—108 85
Precursor Cell Lymphoblastic Leukemia-Lymphoma 123917110—118 80
Leukemia, Lymphocytic, Chronic, B-Cell 121620110—118 78
Myelodysplastic Syndromes 119102016—87 72
Multiple Myeloma 118518—10—118 71

Most active sponsors

Polycythemia Vera — Most active sponsors
#SponsorTrialsPhase 3
1M.D. Anderson Cancer Center160
2National Cancer Institute (NCI)130
3Novartis Pharmaceuticals122
4Fred Hutchinson Cancer Center110
5Incyte Corporation62
6FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS50
7Icahn School of Medicine at Mount Sinai50
8Italfarmaco51
9Mayo Clinic50
10Ronald Hoffman51

Most studied interventions

Polycythemia Vera — Most studied interventions
#InterventionTrials
1fludarabine phosphate29
2ruxolitinib29
3Peripheral Blood Stem Cell Transplantation26
4Cyclophosphamide25
5Busulfan21
6Tacrolimus16
7Whole-Body Irradiation15
8Mycophenolic Acid14
9Methotrexate13
10Cyclosporine12

Terminations

Terminated
32
Withdrawn
14
Stopped for recruitment
5.1%14 of 272 trials

Stated reasons

Other / unclear
21
Recruitment
14
Business decision
6
Lack of efficacy
3
Funding
2

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

Polycythemia Vera — Recently stopped
TrialStatusStated reasonStopped
NCT05853458 Terminated Terminated Sponsor decision 2026-02-26
NCT03878199 Terminated Terminated The study was originally planned to assess four escalating DLs of ruxolitinib (upto 40 mg twice daily), but was closed early due to slow enrollment and changing treatment landscape moving towards less intense approaches. 2025-02-27
NCT03333486 Terminated Terminated Futility analysis determined closure 2023-08-28
NCT03972943 Terminated Terminated Study terminated due to lack of funding 2023-07-28
NCT04637009 Terminated Terminated termination due to portfolio prioritization 2023-02-20
NCT04896112 Withdrawn Withdrawn sponsor decision 2022-10-20
NCT03287245 Terminated Terminated The Sponsor decided to discontinue the development of idasanutlin in the polycythemia vera indication. 2020-03-03
NCT04054245 Withdrawn Withdrawn "Company is in a process of being taken over by another pharma and the new one has different ideas on how to pursue studies with this drug" 2019-07-24
NCT03121599 Terminated Terminated Delayed study materials, poor recruitment 2018-10-16
NCT02421354 Terminated Terminated 2018-04-13

Evidence

Results reported
43.5%64 of 147 completed
Published
14.3%21 of 147 completed
Primary endpoint met
50%6 of 12 analyses
Median months to report
18.5

Documents disclosed

Protocol available
33
Statistical analysis plan
32
PubMed citations
31

Trial profile

Median enrollment
55
Median duration
53.7months
Countries
50
Study sites
2645

Who is enrolled

Adults
270
Children
55
Older adults
256
Healthy volunteers
6

Median enrollment by phase

Early Phase 1
8
Phase 1
36
Phase 1/2
39
Phase 2
40
Phase 2/3
371
Phase 3
186
Phase 4
76
Not applicable
46
Unknown
236

Where trials run

United States
175
Italy
42
France
36
Germany
33
United Kingdom
26
Canada
23
Australia
18
Belgium
18
Spain
18
Poland
13

Busiest cities

Polycythemia Vera — Busiest cities
#CityCountryTrials
1HoustonUnited States43
2New YorkUnited States40
3FlorenceItaly27
4ChicagoUnited States26
5ParisFrance26
6SeattleUnited States22
7LondonUnited Kingdom21
8Salt Lake CityUnited States21
9BaltimoreUnited States20
10PaviaItaly20