Polycythemia Vera

Hematology
17
Pipeline Programs
8
Companies
14
Clinical Trials
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
6
0
5
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
375%
Peptide
125%
+ 10 programs with unclassified modality

On Market (3)

Approved therapies currently available

PharmaEssentia
BESREMIApproved
ropeginterferon alfa-2b
PharmaEssentia
Interferon alfa-2b [EPC]subcutaneous2021
U
HYDROXYUREAApproved
hydroxyurea
Unknown Company
Antimetabolite [EPC]oral2024
U
XROMIApproved
hydroxyurea
Unknown Company
Antimetabolite [EPC]oral2024

Competitive Landscape

7 companies ranked by most advanced pipeline stage

PharmaEssentia
PharmaEssentiaMA - Burlington
6 programs
1
4
1
Ropeginterferon alfa-2bPhase 41 trial
P1101Phase 31 trial
Peg-P-IFN-alpha-2bPhase 31 trial
Pegylated-Proline-Interferon alpha-2b in a Pre-filled PenPhase 31 trial
Pegylated-Proline-interferon alpha-2bPhase 31 trial
+1 more programs
Active Trials
NCT05485948Active Not RecruitingEst. Jul 2027
NCT05481151Active Not RecruitingEst. Jul 2027
NCT01949805CompletedEst. Jul 2016
+3 more trials
Novartis
NovartisBASEL, Switzerland
1 program
1
HydroxyureaPhase 41 trial
Active Trials
NCT05853458Terminated76Est. Feb 2026
Protagonist Therapeutics
Protagonist TherapeuticsAustralia - Brisbane
3 programs
2
1
Open-label rusfertidePhase 3Peptide1 trial
PTG-300Phase 21 trial
PTG-300Phase 21 trial
Active Trials
NCT04767802CompletedEst. Mar 2023
NCT04057040CompletedEst. Jun 2024
NCT06033586Active Not RecruitingEst. Apr 2027
M&
Merck & Co.RAHWAY, NJ
1 program
1
BomedemstatPhase 2Small Molecule1 trial
Active Trials
NCT05558696CompletedEst. Jul 2025
GSK
GSKLONDON, United Kingdom
1 program
1
MomelotinibPhase 2Small Molecule1 trial
Active Trials
NCT01998828Terminated39Est. May 2015
Teva
TevaIsrael - Petach Tikva
1 program
1
lestaurtinibPhase 2Small Molecule1 trial
Active Trials
NCT00586651Completed39Est. Sep 2010
Silence Therapeutics
Silence TherapeuticsGermany - Berlin
1 program
1
SLN124Phase 1/21 trial
Active Trials
NCT05499013Active Not RecruitingEst. Mar 2030

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
PharmaEssentiaRopeginterferon alfa-2b
NovartisHydroxyurea
Protagonist TherapeuticsOpen-label rusfertide
PharmaEssentiaP1101
PharmaEssentiaPegylated-Proline-Interferon alpha-2b in a Pre-filled Pen
PharmaEssentiaPegylated-Proline-interferon alpha-2b
PharmaEssentiaPeg-P-IFN-alpha-2b
Merck & Co.Bomedemstat
PharmaEssentiaRopeginterferon alfa-2b
Protagonist TherapeuticsPTG-300
Protagonist TherapeuticsPTG-300
GSKMomelotinib
Tevalestaurtinib
Silence TherapeuticsSLN124

Clinical Trials (14)

Total enrollment: 154 patients across 14 trials

NCT06290765PharmaEssentiaRopeginterferon alfa-2b

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

Start: Feb 2026Est. completion: Jun 2027
Phase 4Not Yet Recruiting
NCT05853458NovartisHydroxyurea

Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors

Start: Jul 2023Est. completion: Feb 202676 patients
Phase 4Terminated
NCT06033586Protagonist TherapeuticsOpen-label rusfertide

Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera

Start: Jan 2024Est. completion: Apr 2027
Phase 3Active Not Recruiting
NCT05481151PharmaEssentiaP1101

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

Start: Oct 2022Est. completion: Jul 2027
Phase 3Active Not Recruiting
NCT02523638PharmaEssentiaPegylated-Proline-Interferon alpha-2b in a Pre-filled Pen

Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients

Start: Jul 2015Est. completion: Dec 2015
Phase 3Completed
NCT02218047PharmaEssentiaPegylated-Proline-interferon alpha-2b

AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.

Start: Nov 2014Est. completion: Apr 2021
Phase 3Completed
NCT01949805PharmaEssentiaPeg-P-IFN-alpha-2b

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

Start: Sep 2013Est. completion: Jul 2016
Phase 3Completed
NCT05558696Merck & Co.Bomedemstat

A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

Start: Sep 2023Est. completion: Jul 2025
Phase 2Completed
NCT05485948PharmaEssentiaRopeginterferon alfa-2b

A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Start: Oct 2021Est. completion: Jul 2027
Phase 2Active Not Recruiting
NCT04767802Protagonist TherapeuticsPTG-300

PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit

Start: Feb 2021Est. completion: Mar 2023
Phase 2Completed
NCT04057040Protagonist TherapeuticsPTG-300

Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE)

Start: Oct 2019Est. completion: Jun 2024
Phase 2Completed
NCT01998828GSKMomelotinib

Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

Start: Feb 2014Est. completion: May 201539 patients
Phase 2Terminated
NCT00586651Tevalestaurtinib

Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis

Start: Dec 2007Est. completion: Sep 201039 patients
Phase 2Completed
NCT05499013Silence TherapeuticsSLN124

Study to Assess SLN124 in Patients With Polycythemia Vera

Start: Jan 2023Est. completion: Mar 2030
Phase 1/2Active Not Recruiting

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
8 companies competing in this space

Related Indications

Anemia(92)Myelofibrosis(21)Primary Immune Thrombocytopenia(15)Primary Myelofibrosis(14)Immune Thrombocytopenia(12)Thrombocytopenia(11)Beta-Thalassemia(10)Aplastic Anemia(7)Anemia of Chronic Kidney Disease(7)Iron Deficiency Anemia(6)