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According to DelveInsight's evaluation, the global Polycythemia Vera pipeline features over 8 key companies actively advancing more than 10 Polycythemia Vera treatment therapies. This includes analysis of clinical trials, therapies, mechanisms of action, routes of administration, and developmental progress by DelveInsight.
The Polycythemia Vera Pipeline report includes thorough commercial and clinical evaluations of pipeline products from the pre-clinical development stage through to the marketed phase. It also provides a detailed description of each drug, covering its mechanism of action, clinical studies, NDA approvals (if applicable), and product development activities such as technology, collaborations, mergers and acquisitions, funding, designations, and other relevant details.
DelveInsight's "Polycythemia Vera Pipeline Insight, 2025" report offers extensive insights into the current clinical development landscape and growth potential in the Polycythemia Vera Market.
Key Insights from the Polycythemia Vera Pipeline Report:
https://www.delveinsight.com/sample-request/polycythemia-vera-pipeline-insight?utm_source=sites&utm_medium=promotion&utm_campaign=kkpr
Organizations worldwide are actively pursuing innovative Polycythemia Vera treatment therapies, achieving notable progress in recent years.
Polycythemia Vera firms involved in the treatment sector include Protagonist Therapeutics, Italfarmaco, Imago BioSciences, Silence Therapeutics, Ionis Pharmaceutical, Perseus Proteomics, Protagonist Therapeutics, Inc., Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals AG, Incyte Corporation, and others, all developing therapies for Polycythemia Vera management.
Promising Polycythemia Vera therapies across various clinical trial phases include Rusfertide (PTG-300), Givinostat (ITF2357), Bomedemstat, SLN124, Sapablursen, PPMX-T003, PTG-300, SLN124, Hydroxyurea, Ropeginterferon alfa-2b, PEG-P-INF alpha-2b (P1101), Ruxolitinib, and others, anticipated to significantly influence the Polycythemia Vera market soon.
In November 2025, SOTIO Biotech, a clinical-stage biotech firm within the PPF Group, shared positive preclinical data for its antibody-drug conjugate SOT106 targeting sarcoma, unveiled at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November.
In August 2025, The FDA granted breakthrough therapy designation to rusfertide for managing erythrocytosis in polycythemia vera (PV) patients, as disclosed by Protagonist Therapeutics. This was supported by outcomes from the Phase 3 VERIFY study (NCT05210790), with results showcased at the 2025 American Society of Clinical Oncology Annual Meeting. Rusfertide represents a pioneering hepcidin-mimetic peptide.
In May 2025, The FDA awarded fast track designation to givinostat (Duvyzat) for polycythemia vera patients, according to Italfarmaco. Givinostat had already secured orphan drug status for this condition from the FDA and EMA. Furthermore, it has gained regulatory approvals from the FDA and UK's MHRA for Duchenne muscular dystrophy.
In March 2025, Protagonist Therapeutics, Inc. (NASDAQ: PTGX) and Takeda (TSE: 4502/NYSE: TAK) released favorable topline data from the Phase 3 VERIFY study. The trial enrolled phlebotomy-dependent polycythemia vera (PV) patients randomized to rusfertide or placebo plus standard care, meeting the primary endpoint and all four secondary ones. Rusfertide, a novel hepcidin mimetic peptide therapy, has received Orphan Drug and Fast Track designations from the FDA.
In December 2024, Silence Therapeutics plc ("Silence" or the "Company") (Nasdaq: SLN), a worldwide clinical-stage entity specializing in siRNA (short interfering RNA) treatments, announced additional findings from the Phase 1 open-label part of the SANRECO study for divesiran, a siRNA aimed at TMPRSS6, in polycythemia vera (PV) patients at the American Society of Hematology (ASH) Annual Meeting.
In June 2024, AOP Orphan Pharmaceuticals GmbH (AOP Health) advanced its hematology/oncology research with two abstracts selected for the European Hematology Association (EHA) 2024 hybrid congress in Madrid, Spain. One featured an oral presentation on recent data from PROUD-PV and CONTINUATION-PV trials, showing a connection between genetic alterations (molecular response) and event-free survival (EFS) in polycythemia vera (PV) patients on ropeginterferon alfa-2b (BESREMi®) or optimal available therapy.
In February 2024, Disc Medicine revealed that the US FDA granted Orphan Drug Designation to DISC-3405 for PV patients. Moreover, in September 2023, the FDA provided fast track status to MWTX-003, also known as DISC-3405, for PV therapy.
In January 2024, Takeda and Protagonist Therapeutics formed a worldwide licensing and partnership deal for rusfertide.
Polycythemia Vera Overview
Polycythemia vera (PV) is a uncommon blood condition marked by excessive red blood cell production in the bone marrow. This excess thickens the blood, hindering flow and raising clotting risks.
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Emerging Polycythemia Vera Drugs in Various Clinical Development Stages Include:
Rusfertide (PTG-300): Protagonist Therapeutics
Givinostat (ITF2357): Italfarmaco
Bomedemstat: Imago BioSciences
SLN124: Silence Therapeutics
Sapablursen: Ionis Pharmaceutical
PPMX-T003: Perseus Proteomics
PTG-300: Protagonist Therapeutics, Inc.
SLN124: Silence Therapeutics plc
Hydroxyurea: Novartis
Ropeginterferon alfa-2b: PharmaEssentia
PEG-P-INF alpha-2b (P1101): AOP Orphan Pharmaceuticals AG
Ruxolitinib: Incyte Corporation
Polycythemia Vera Route of Administration
The Polycythemia Vera pipeline report evaluates pipeline drugs by Route of Administration. Products are classified under routes such as:
Intra-articular
Intraocular
Intrathecal
Intravenous
Oral
Parenteral
Subcutaneous
Topical
Transdermal
Polycythemia Vera Molecule Type
Polycythemia Vera Products are grouped by Molecule types, including:
Oligonucleotide
Peptide
Small molecule
Polycythemia Vera Pipeline Therapeutics Assessment
Polycythemia Vera Assessment by Product Type
Polycythemia Vera By Stage and Product Type
Polycythemia Vera Assessment by Route of Administration
Polycythemia Vera By Stage and Route of Administration
Polycythemia Vera Assessment by Molecule Type
Polycythemia Vera by Stage and Molecule Type
DelveInsight's Polycythemia Vera Report encompasses approximately 10+ products across clinical phases like:
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Additional Polycythemia Vera product information is available in the report. Download the Polycythemia Vera pipeline report to explore emerging Polycythemia Vera therapies further.
https://www.delveinsight.com/sample-request/polycythemia-vera-pipeline-insight?utm_source=sites&utm_medium=promotion&utm_campaign=kkpr
Leading Companies in the Polycythemia Vera Therapeutics Market Include:
Major firms advancing Polycythemia Vera therapies are F. Hoffmann-La Roche Ltd, Fujifilm Holdings Corp, Hangzhou Bensheng Pharmaceutical Co Ltd, Protagonist Therapeutics Inc, Ascentage Pharma Group International, Imago BioSciences Inc, Ionis Pharmaceuticals Inc, and others.
Polycythemia Vera Pipeline Analysis:
The Polycythemia Vera pipeline report delivers insights into:
Detailed information on organizations creating Polycythemia Vera therapies, including total therapies per company.
Categorization of therapeutic candidates into early, mid, and late development stages for Polycythemia Vera treatment.
Polycythemia Vera key companies engaged in targeted drug development, with active and inactive (dormant or halted) initiatives.
Polycythemia Vera Drugs in development, sorted by stage, administration route, target receptor, monotherapy or combination, unique mechanisms, and molecular type.
In-depth examination of partnerships (corporate-corporate and corporate-academic), licensing deals, and funding for Polycythemia Vera market progression.
The report draws from data sourced from proprietary databases, company/university sites, clinical trial registries, conferences, SEC filings, investor presentations, and press releases from company/university websites and specialized third-party sources.
Download a Sample PDF Report for more details on Polycythemia Vera drugs and therapies.
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Polycythemia Vera Pipeline Market Strengths
The US approval of BESREMi and its anticipated Japanese approval for first- and second-line use offer substantial market potential for interferon in Polycythemia Vera.
Growing sales of JAKAFI/JAKAVI position it as a major therapy for second-line PV patients.
Polycythemia Vera Pipeline Market Opportunities
Rising strategic partnerships, including regional alliances, and FDA designations like BTD and FTD will propel market expansion.
Potential for therapies with novel, disease-altering mechanisms and minimal adverse effects.
Scope of Polycythemia Vera Pipeline Drug Insight
Coverage: Global
Key Polycythemia Vera Companies: Protagonist Therapeutics, Italfarmaco, Imago BioSciences, Silence Therapeutics, Ionis Pharmaceutical, Perseus Proteomics, Protagonist Therapeutics, Inc., Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals AG, Incyte Corporation, and others
Key Polycythemia Vera Therapies: Rusfertide (PTG-300), Givinostat (ITF2357), Bomedemstat, SLN124, Sapablursen, PPMX-T003, PTG-300, SLN124, Hydroxyurea, Ropeginterferon alfa-2b, PEG-P-INF alpha-2b (P1101), Ruxolitinib, and others
Polycythemia Vera Therapeutic Assessment: Polycythemia Vera current marketed and Polycythemia Vera emerging therapies
Polycythemia Vera Market Dynamics: Polycythemia Vera market drivers and Polycythemia Vera market barriers
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