AKPKD Pipeline 2025: MOA And ROA Insights, Clinical Trials Status, And Key Companies Involved By Delveinsight Acelink Therapeutics, Sanofi, Dinaqor AG, Poxel, Acelink Therapeutics, Regulus Therapeut

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(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Autosomal Dominant Polycystic Kidney Disease pipeline constitutes 13+ key companies continuously working towards developing 14+ Autosomal Dominant Polycystic Kidney Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Autosomal Dominant 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.

“Autosomal Dominant Polycystic Kidney Disease Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Autosomal Dominant Polycystic Kidney Disease Market.

Some of the key takeaways from the Autosomal Dominant Polycystic Kidney Disease Pipeline Report:

• Companies across the globe are diligently working toward developing novel Autosomal Dominant Polycystic Kidney Disease treatment therapies with a considerable amount of success over the years.

• Autosomal Dominant Polycystic Kidney Disease companies working in the treatment market are AceLink Therapeutics, DiNAQOR AG, Poxel, AceLink Therapeutics, Regulus Therapeutics, Reata Pharmaceuticals, Sanofi, Galapagos NV, Janssen Pharmaceuticals, Xortx Therapeutics, and others, are developing therapies for the Autosomal Dominant Polycystic Kidney Disease treatment

• Emerging Autosomal Dominant Polycystic Kidney Disease therapies in the different phases of clinical trials are- AL1311, DINAK 001, PXL770, AL01211, RGLS8429, Bardoxolone methyl, Tesevatinib/KD019, GLPG2737, AT-20494, XRx-008, and others are expected to have a significant impact on the Autosomal Dominant Polycystic Kidney Disease market in the coming years.

• In April 2025, Rege Nephro is conducting a Phase 2 clinical trial in Japan to evaluate Tamibarotene (RN-014), a retinoic acid receptor agonist, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Following confirmation of its efficacy and safety in Japan, the company plans to begin clinical trials in the United States. Previously, Syros Pharmaceuticals investigated Tamibarotene in a Phase 3 trial for conditions such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

• In March 2025, Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company developing microRNA-targeted medicines, announced encouraging topline data from all patients in the fourth cohort of its Phase 1b multiple ascending dose (MAD) study of farabursen in autosomal dominant polycystic kidney disease (ADPKD). The double-blind, placebo-controlled trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics (PK/PD) of farabursen in adults with ADPKD. Treatment was administered over three months with a one-month follow-up, across three weight-based dose levels (1, 2, and 3 mg/kg) and one fixed dose (300 mg). Primary outcomes measured changes in urinary PC1 and PC2, proteins encoded by PKD1 and PKD2 genes that are inversely associated with disease severity, while exploratory endpoints included changes in htTKV growth rate, a marker known to inversely correlate with kidney function.

• In October 2024, Regulus Therapeutics Inc. (Nasdaq: RGLS) , a biopharmaceutical company specializing in microRNA-targeted therapies, announced the completion of patient enrollment in the fourth cohort of its Phase 1b MAD study of RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), with 26 patients enrolled.

• In May 2024, Rege Nephro CO., Ltd. announced that patient enrollment for the second stage of its Phase II clinical trial evaluating tamibarotene (RN-014) for autosomal dominant polycystic kidney disease (ADPKD) began in April. The decision to proceed was based on a thorough review of safety data from the first stage, which commenced in December of the previous year.

• In March 2024, Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the FDA has cleared the Investigational New Drug (IND) application for VX-407, an investigational first-in-class small molecule corrector designed to address the root cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with specific PKD1 genetic variants. ADPKD, the most common inherited kidney disease, affects approximately 250,000 individuals across the U.S. and Europe, yet no existing treatments currently target its underlying biological cause.

• In January 2024, Regulus Therapeutics completed the recruitment of patients for the third cohort in the Phase Ib multiple-ascending dose (MAD) trial of RGLS8429, a prospective therapy for ADPKD. RGLS8429 aims to block miR-17 and specifically target the kidneys. This Phase Ib MAD study is structured to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RGLS8429 in adults diagnosed with ADPKD.

Autosomal Dominant Polycystic Kidney Disease Overview

AKPKD stands for Autosomal Dominant Polycystic Kidney Disease. It is a genetic disorder characterized by the formation of fluid-filled cysts in the kidneys, which can lead to progressive kidney damage and impairment of renal function over time. Autosomal dominant means that only one copy of the defective gene, inherited from one parent, is sufficient to cause the condition. AKPKD is the most common inherited kidney disorder, affecting millions of people worldwide.

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Emerging Autosomal Dominant Polycystic Kidney Disease Drugs Under Different Phases of Clinical Development Include:

• AL1311: AceLink Therapeutics

• DINAK 001: DiNAQOR AG

• PXL770: Poxel

• AL01211: AceLink Therapeutics

• RGLS8429: Regulus Therapeutics

• Bardoxolone methyl: ReataPharmaceuticals

• Tesevatinib/KD019: Sanofi

• GLPG2737: Galapagos NV

• AT-20494: Janssen Pharmaceuticals

• XRx-008: Xortx Therapeutics

• Bardoxolone methyl: Reata Pharmaceuticals

Autosomal Dominant Polycystic Kidney Disease Route of Administration

Autosomal Dominant 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

• Inhalation

• Inhalation/Intravenous/Oral

• Intranasal

• Intravenous

• Intravenous/ Subcutaneous

• NA

• Oral

• Oral/intranasal/subcutaneous

• Parenteral

• Subcutaneous

Autosomal Dominant Polycystic Kidney Disease Molecule Type

Autosomal Dominant Polycystic Kidney Disease Products have been categorized under various Molecule types, such as

• Antibody

• Antisense oligonucleotides

• Immunotherapy

• Monoclonal antibody

• Peptides

• Protein

• Recombinant protein

• Small molecule

• Stem Cell

• Vaccine

Autosomal Dominant Polycystic Kidney Disease Pipeline Therapeutics Assessment

• Autosomal Dominant Polycystic Kidney Disease Assessment by Product Type

• Autosomal Dominant Polycystic Kidney Disease By Stage and Product Type

• Autosomal Dominant Polycystic Kidney Disease Assessment by Route of Administration

• Autosomal Dominant Polycystic Kidney Disease By Stage and Route of Administration

• Autosomal Dominant Polycystic Kidney Disease Assessment by Molecule Type

• Autosomal Dominant Polycystic Kidney Disease by Stage and Molecule Type

DelveInsight's Autosomal Dominant Polycystic Kidney Disease Report covers around 14+ 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 Autosomal Dominant Polycystic Kidney Disease product details are provided in the report. Download the Autosomal Dominant Polycystic Kidney Disease pipeline report to learn more about the emerging Autosomal Dominant Polycystic Kidney Disease therapies

Some of the key companies in the Autosomal Dominant Polycystic Kidney Disease Therapeutics Market include:

Key companies developing therapies for Autosomal Dominant Polycystic Kidney Disease are - Galapagos NV, Reata Pharmaceuticals, Kadmon Pharmaceuticals, Sanofi, Anakuria Therapeutics, Regulus Therapeutics, AceLink Therapeutics, Healx, XORTX Therapeutics, Poxel, Alebund Pharmaceuticals, Chinook Therapeutics, and others.

Autosomal Dominant Polycystic Kidney Disease Pipeline Analysis:

The Autosomal Dominant Polycystic Kidney Disease pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Autosomal Dominant 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 Autosomal Dominant Polycystic Kidney Disease Treatment.

• Autosomal Dominant Polycystic Kidney Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Autosomal Dominant 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 Autosomal Dominant 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 Autosomal Dominant Polycystic Kidney Disease drugs and therapies

Autosomal Dominant Polycystic Kidney Disease Pipeline Market Drivers

• Increase in the prevalence of Autosomal Dominant Polycystic Kidney Disease, increase in the number of research and development activities are some of the important factors that are fueling the Autosomal Dominant Polycystic Kidney Disease Market.

Autosomal Dominant Polycystic Kidney Disease Pipeline Market Barriers

• However, side-effects associated with the treatment of Autosomal Dominant Polycystic Kidney Disease, high cost associated with the treatment and other factors are creating obstacles in the Autosomal Dominant Polycystic Kidney Disease Market growth.

Scope of Autosomal Dominant Polycystic Kidney Disease Pipeline Drug Insight

• Coverage: Global

• Key Autosomal Dominant Polycystic Kidney Disease Companies: AceLink Therapeutics, DiNAQOR AG, Poxel, AceLink Therapeutics, Regulus Therapeutics, Reata Pharmaceuticals, Sanofi, Galapagos NV, Janssen Pharmaceuticals, Xortx Therapeutics, and others

• Key Autosomal Dominant Polycystic Kidney Disease Therapies: AL1311, DINAK 001, PXL770, AL01211, RGLS8429, Bardoxolone methyl, Tesevatinib/KD019, GLPG2737, AT-20494, XRx-008, and others

• Autosomal Dominant Polycystic Kidney Disease Therapeutic Assessment: Autosomal Dominant Polycystic Kidney Disease current marketed and Autosomal Dominant Polycystic Kidney Disease emerging therapies

• Autosomal Dominant Polycystic Kidney Disease Market Dynamics: Autosomal Dominant Polycystic Kidney Disease market drivers and Autosomal Dominant Polycystic Kidney Disease market barriers

Request for Sample PDF Report for Autosomal Dominant Polycystic Kidney Disease Pipeline Assessment and clinical trials

Table of Contents

1. Autosomal Dominant Polycystic Kidney Disease Report Introduction

2. Autosomal Dominant Polycystic Kidney Disease Executive Summary

3. Autosomal Dominant Polycystic Kidney Disease Overview

4. Autosomal Dominant Polycystic Kidney Disease- Analytical Perspective In-depth Commercial Assessment

5. Autosomal Dominant Polycystic Kidney Disease Pipeline Therapeutics

6. Autosomal Dominant Polycystic Kidney Disease Late Stage Products (Phase II/III)

7. Autosomal Dominant Polycystic Kidney Disease Mid Stage Products (Phase II)

8. Autosomal Dominant Polycystic Kidney Disease Early Stage Products (Phase I)

9. Autosomal Dominant Polycystic Kidney Disease Preclinical Stage Products

10. Autosomal Dominant Polycystic Kidney Disease Therapeutics Assessment

11. Autosomal Dominant Polycystic Kidney Disease Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Autosomal Dominant Polycystic Kidney Disease Key Companies

14. Autosomal Dominant Polycystic Kidney Disease Key Products

15. Autosomal Dominant Polycystic Kidney Disease Unmet Needs

16 . Autosomal Dominant Polycystic Kidney Disease Market Drivers and Barriers

17. Autosomal Dominant Polycystic Kidney Disease Future Perspectives and Conclusion

18. Autosomal Dominant Polycystic Kidney Disease Analyst Views

19. Appendix

20. About DelveInsight

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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