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Polycystic Kidney Disease Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | Otsuka Pharma, Sanofi S.A, Reata Pharma, Galapagos N.V, Janssen Pharma, Regulus Therapeutics
The Polycystic Kidney Disease 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.
"Polycystic Kidney Disease Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Polycystic Kidney Disease Market.
Some of the key takeaways from the Polycystic Kidney Disease Pipeline Report: https://www.delveinsight.com/sample-request/polycystic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Polycystic Kidney Disease treatment therapies with a considerable amount of success over the years.
• Polycystic Kidney Disease companies working in the treatment market are Hannover Medical School, Otsuka Pharmaceutical, Rege Nephro Co., Ltd., Otsuka Pharmaceutical, and others, are developing therapies for the Polycystic Kidney Disease treatment
• Emerging Polycystic Kidney Disease therapies in the different phases of clinical trials are- Empagliflozin, Tolvaptan (OPC-41061), Tamibarotene, Tolvaptan Suspension, and others are expected to have a significant impact on the Polycystic Kidney Disease market in the coming years.
• In January 2025, Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company specializing in developing innovative medicines targeting microRNAs, has announced positive clinical and regulatory updates from its ADPKD program. The update includes encouraging topline results from an interim analysis of the fourth cohort in its Phase 1b Multiple Ascending Dose (MAD) study of farabursen (RGLS8429) for treating ADPKD. Additionally, the company provided insights into its recent successful End-of-Phase 1 meeting with the FDA.
• In April 2024, Eloxx Pharmaceuticals, Inc. (OTC: ELOX), a leading company in ribosomal RNA-targeted genetic therapies for rare diseases, has provided updates on its programs for ELX-02 and ZKN-013, including the Orphan Drug Designation (ODD) for ELX-02. The company has made significant progress in developing ELX-02 for treating Alport syndrome with nonsense mutations (NMAS). Furthermore, following its global licensing partnership with Almirall in March, Eloxx has initiated the development of ZKN-013 for Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Familial Adenomatous Polyposis (FAP) in patients with nonsense mutations. A recent publication on Autosomal Dominant Polycystic Kidney Disease (ADPKD) further highlights ELX-02's potential in addressing rare genetic kidney diseases caused by nonsense mutations.
• In January 2024, Regulus Therapeutics completed patient enrollment for the third cohort in its Phase Ib multiple-ascending dose (MAD) study of RGLS8429, a potential treatment for ADPKD. RGLS8429 aims to inhibit miR-17 and specifically target the kidneys. The Phase Ib MAD study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RGLS8429 in adults with ADPKD.
Polycystic Kidney Disease Overview
Polycystic Kidney Disease (PKD) is a genetic disorder characterized by the growth of numerous fluid-filled cysts in the kidneys. These cysts can enlarge the kidneys and interfere with their ability to function properly.
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Emerging Polycystic Kidney Disease Drugs Under Different Phases of Clinical Development Include:
• Empagliflozin: Hannover Medical School
• Tolvaptan (OPC-41061): Otsuka Pharmaceutical
• Tamibarotene: Rege Nephro Co., Ltd.
• Tolvaptan Suspension: Otsuka Pharmaceutical
Polycystic Kidney Disease Route of Administration
Polycystic Kidney Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Polycystic Kidney Disease Molecule Type
Polycystic Kidney Disease Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
Polycystic Kidney Disease Pipeline Therapeutics Assessment
• Polycystic Kidney Disease Assessment by Product Type
• Polycystic Kidney Disease By Stage and Product Type
• Polycystic Kidney Disease Assessment by Route of Administration
• Polycystic Kidney Disease By Stage and Route of Administration
• Polycystic Kidney Disease Assessment by Molecule Type
• Polycystic Kidney Disease by Stage and Molecule Type
DelveInsight's Polycystic Kidney Disease 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 Polycystic Kidney Disease product details are provided in the report. Download the Polycystic Kidney Disease pipeline report to learn more about the emerging Polycystic Kidney Disease therapies
https://www.delveinsight.com/sample-request/polycystic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
Some of the key companies in the Polycystic Kidney Disease Therapeutics Market include:
Key companies developing therapies for Polycystic Kidney Disease are - Otsuka Pharmaceutical, Sanofi S.A, Reata Pharmaceuticals, Galapagos N.V, Janssen Pharmaceuticals, Regulus Therapeutics, Xortx Therapeutics, AceLink Therapeutics Inc., Pano Therapeutics, Inc., Exelixis, Inc., and others.
Polycystic Kidney Disease Pipeline Analysis:
The Polycystic Kidney Disease pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Polycystic Kidney Disease 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 Polycystic Kidney Disease Treatment.
• Polycystic Kidney Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Polycystic Kidney Disease 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 Polycystic Kidney Disease 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 Polycystic Kidney Disease drugs and therapies
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Polycystic Kidney Disease Pipeline Market Drivers
• Advancements in Genetic Research, Innovative Treatment Approaches, Increased Funding and Investments, Rising Prevalence, Enhanced Diagnostic Techniques, Patient Advocacy and Awareness, are some of the important factors that are fueling the Polycystic Kidney Disease Market.
Polycystic Kidney Disease Pipeline Market Barriers
• However, High Development Costs, Regulatory Challenges, Limited Treatment Options, Complex Disease Mechanism, Side Effects and Safety Concerns, Market Competitionand other factors are creating obstacles in the Polycystic Kidney Disease Market growth.
Scope of Polycystic Kidney Disease Pipeline Drug Insight
• Coverage: Global
• Key Polycystic Kidney Disease Companies: Hannover Medical School, Otsuka Pharmaceutical, Rege Nephro Co., Ltd., Otsuka Pharmaceutical, and others
• Key Polycystic Kidney Disease Therapies: Empagliflozin, Tolvaptan (OPC-41061), Tamibarotene, Tolvaptan Suspension, and others
• Polycystic Kidney Disease Therapeutic Assessment: Polycystic Kidney Disease current marketed and Polycystic Kidney Disease emerging therapies
• Polycystic Kidney Disease Market Dynamics: Polycystic Kidney Disease market drivers and Polycystic Kidney Disease market barriers
Request for Sample PDF Report for Polycystic Kidney Disease Pipeline Assessment and clinical trials
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Table of Contents
1. Polycystic Kidney Disease Report Introduction
2. Polycystic Kidney Disease Executive Summary
3. Polycystic Kidney Disease Overview
4. Polycystic Kidney Disease- Analytical Perspective In-depth Commercial Assessment
5. Polycystic Kidney Disease Pipeline Therapeutics
6. Polycystic Kidney Disease Late Stage Products (Phase II/III)
7. Polycystic Kidney Disease Mid Stage Products (Phase II)
8. Polycystic Kidney Disease Early Stage Products (Phase I)
9. Polycystic Kidney Disease Preclinical Stage Products
10. Polycystic Kidney Disease Therapeutics Assessment
11. Polycystic Kidney Disease Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Polycystic Kidney Disease Key Companies
14. Polycystic Kidney Disease Key Products
15. Polycystic Kidney Disease Unmet Needs
16 . Polycystic Kidney Disease Market Drivers and Barriers
17. Polycystic Kidney Disease Future Perspectives and Conclusion
18. Polycystic Kidney Disease Analyst Views
19. Appendix
20. About DelveInsight
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Contact Us:
Gaurav Bora
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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