Polycythemia Vera Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

(Albany, United States) As per DelveInsight's assessment, globally, Polycythemia Vera pipeline constitutes 10+ key companies continuously working towards developing 10+ Polycythemia Vera treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Polycythemia Vera Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Polycythemia Vera Market.
The Polycythemia Vera Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Download DelveInsight's Polycythemia Vera Pipeline Insight 2025 report today to explore breakthrough therapies, key clinical developments, and future market opportunities shaping the treatment landscape @ https://www.delveinsight.com/report-store/polycythemia-vera-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the key takeaways from the Polycythemia Vera Pipeline Report:
• Companies across the globe are diligently working toward developing novel Polycythemia Vera treatment therapies with a considerable amount of success over the years.
• Polycythemia Vera companies working in the treatment market are Protagonist Therapeutics, Italfarmaco, Imago BioSciences, Silence Therapeutics, Ionis Pharmaceutical, Perseus Proteomics, Protagonist Therapeutics, Inc., Novartis, PharmaEssentia, AOP Orphan Pharmaceuticals AG, Incyte Corporation, and others, are developing therapies for the Polycythemia Vera treatment
• Emerging Polycythemia Vera therapies in the different phases of clinical trials are- 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 are expected to have a significant impact on the Polycythemia Vera market in the coming years.
• In July 2025, Imago BioSciences announced results of a Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
• In July 2025, Novartis announced results of a Prospective, Interventional Study to Evaluate HU-resistance in Polycythemia Vera Patients Who Meet Predictive Parameters Identified in the Machine Learning Project PV-AIM
• In May 2025, Biokuris s.a announced results of a 10-week Randomized Double-blinded Crossover Trial of BiOkuris® Chitin-glucan Based Formulation Versus Placebo in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
• In March 2025, Protagonist Therapeutics, Inc. (NASDAQ: PTGX) and Takeda (TSE: 4502/NYSE: TAK) have announced positive topline results from the Phase 3 VERIFY study. The trial involved phlebotomy-dependent polycythemia vera (PV) patients, who were randomly assigned to receive either rusfertide or a placebo alongside standard care. The study successfully achieved its primary endpoint along with all four key secondary endpoints. Rusfertide, an investigational first-in-class hepcidin mimetic peptide therapeutic, has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA).
• In December 2024, Silence Therapeutics plc ("Silence" or the "Company") (Nasdaq: SLN), a global clinical-stage company focused on developing innovative siRNA (short interfering RNA) therapies, today announced the presentation of additional results from the Phase 1 open-label segment of the SANRECO study of divesiran, a siRNA targeting TMPRSS6, in patients with polycythemia vera (PV) at the American Society of Hematology (ASH) Annual Meeting.
• In June 2024, AOP Orphan Pharmaceuticals GmbH (AOP Health) continues its successful hematology/oncology clinical research program with two abstracts accepted for presentation at the European Hematology Association (EHA) 2024 hybrid congress in Madrid, Spain. One abstract includes an oral presentation of the latest findings from the PROUD-PV and CONTINUATION-PV trials. The results demonstrate a link between genetic changes (molecular response) and event-free survival (EFS) in polycythemia vera (PV) patients treated with ropeginterferon alfa-2b (BESREMi®) or the best available treatment.
• In February 2024, Disc Medicine has disclosed that the US FDA has awarded Orphan Drug Designation to DISC-3405 for treating patients with PV. Additionally, in September 2023, the FDA granted fast track designation to MWTX-003, also known as DISC-3405, for PV treatment.
• In January 2024, Takeda and Protagonist Therapeutics have established a global licensing and collaboration agreement for rusfertide.

Polycythemia Vera Overview
Polycythemia Vera is a rare, chronic myeloproliferative neoplasm characterized by the overproduction of red blood cells. Polycythemia Vera leads to increased blood viscosity, raising the risk of thrombosis and cardiovascular complications. Polycythemia Vera is primarily driven by mutations in the JAK2 gene, notably JAK2 V617F, which is present in over 95% of cases. Polycythemia Vera commonly presents with symptoms such as headaches, dizziness, pruritus (especially after warm showers), and a ruddy complexion. Polycythemia Vera may also manifest with splenomegaly due to extramedullary hematopoiesis. Polycythemia Vera diagnosis relies on elevated hemoglobin or hematocrit levels, JAK2 mutation testing, and bone marrow biopsy findings. Polycythemia Vera management focuses on reducing thrombotic risk through phlebotomy, low-dose aspirin, and cytoreductive therapies like hydroxyurea. Polycythemia Vera patients with intolerance or resistance to first-line therapies may benefit from JAK inhibitors such as ruxolitinib. Polycythemia Vera requires lifelong monitoring to track hematologic parameters and assess progression to myelofibrosis or acute leukemia. Polycythemia Vera research continues to explore novel therapeutic targets, including next-generation JAK inhibitors and combination regimens. Polycythemia Vera awareness among healthcare providers is crucial for early diagnosis and intervention to prevent complications. Polycythemia Vera represents a significant area of unmet need, driving ongoing clinical trials and drug development initiatives worldwide.

Get a Free Sample PDF Report to know more about Polycythemia Vera Pipeline Therapeutic Assessment- https://www.delveinsight.com/sample-request/polycythemia-vera-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Emerging Polycythemia Vera Drugs Under Different Phases of Clinical Development 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
Polycythemia Vera pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Polycythemia Vera Molecule Type
Polycythemia Vera Products have been categorized under various Molecule types, such as
• 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 covers around 10+ products under different phases of clinical development 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

Further Polycythemia Vera product details are provided in the report. Download the Polycythemia Vera pipeline report to learn more about the emerging Polycythemia Vera therapies - https://www.delveinsight.com/sample-request/polycythemia-vera-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the key companies in the Polycythemia Vera Therapeutics Market include:
Key companies developing therapies for Polycythemia Vera are - F. Hoffmann-La Roche Ltd, Fujifilm Holdings Corp, Hangzhou Bensheng Pharmaceutical Co Ltd, Protagonist Therapeutics Inc, Ascentage Pharma Group International, Imago BioSciences Inc, and Ionis Pharmaceuticals Inc, and others.

Polycythemia Vera Pipeline Analysis:
The Polycythemia Vera pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Polycythemia Vera with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Polycythemia Vera Treatment.
• Polycythemia Vera key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Polycythemia Vera Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Polycythemia Vera market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Polycythemia Vera drugs and therapies - https://www.delveinsight.com/sample-request/polycythemia-vera-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Polycythemia Vera Pipeline Market Strengths
• The approval of BESREMi in the US and its expected approval in Japan, in both the first and second line of treatment, provides the interferon with an immense opportunity to garner a big market size in Polycythemia Vera.
• Based on increasing sales of JAKAFI/JAKAVI, the drug will be a blockbuster therapy in 2L PV patients

Polycythemia Vera Pipeline Market Opportunities
• An increase in strategic alliances, such as geographical alliances, and granting the designation such as BTD and FTD by the FDA are some of the factors that will drive the market growth.
• Opportunity for drugs with novel and disease-modifying mechanisms and low side effect.

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

Request for Sample PDF Report for Polycythemia Vera Pipeline Assessment and clinical trials - https://www.delveinsight.com/sample-request/polycythemia-vera-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Polycythemia Vera Report Introduction
2. Polycythemia Vera Executive Summary
3. Polycythemia Vera Overview
4. Polycythemia Vera- Analytical Perspective In-depth Commercial Assessment
5. Polycythemia Vera Pipeline Therapeutics
6. Polycythemia Vera Late Stage Products (Phase II/III)
7. Polycythemia Vera Mid Stage Products (Phase II)
8. Polycythemia Vera Early Stage Products (Phase I)
9. Polycythemia Vera Preclinical Stage Products
10. Polycythemia Vera Therapeutics Assessment
11. Polycythemia Vera Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Polycythemia Vera Key Companies
14. Polycythemia Vera Key Products
15. Polycythemia Vera Unmet Needs
16 . Polycythemia Vera Market Drivers and Barriers
17. Polycythemia Vera Future Perspectives and Conclusion
18. Polycythemia Vera Analyst Views
19. Appendix
20. About DelveInsight

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About DelveInsight
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This release was published on openPR.