Polycystic Kidney Disease Drug Pipeline Analysis Report 2024

According to the National Institute of Health, autosomal dominant polycystic kidney disease (ADPKD) affects 1 in every 400 to 1,000 people globally. Polycystic kidney disease is one of the most common genetic disorders and affects approximately 500,000 people in the United States. There has been an increasing need for an improved therapy for ADPKD. Major pharma companies and research institutes are developing innovative treatments to manage the disease leading to an increased number of drugs in the pipeline.

Key Takeaways

• Major companies involved in the polycystic kidney disease pipeline drugs market include Novartis Pharmaceuticals, Otsuka Pharmaceutical Development & Commercialization, Inc., and Pfizer among others.

• Leading drugs currently under pipeline include Tolvaptan and Lixivaptan among others.

• Regulatory authorities such as the United States FDA and EMA play an essential role in the drug pipeline for polycystic kidney disease as they are offering breakthrough designations and fast-track approvals to several drugs.

Report Coverage

The Polycystic Kidney Disease Drug Pipeline Report by Expert Market Research gives comprehensive insights into polycystic kidney disease drugs currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for polycystic kidney disease. The report includes the analysis of over 100 pipeline drugs and 50+ companies. It will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from polycystic kidney disease.

The detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration and ongoing product development activities related to polycystic kidney disease are covered.

Polycystic Kidney Disease Drug Pipeline Outlook

Polycystic kidney disease is an inherited disorder, wherein clusters of cysts develop primarily within the kidneys, causing its enlargement and loss of function over time. These cysts are noncancerous round sacs containing fluid, that can vary in size, and grow very large. Polycystic kidney disease can also cause cysts to develop in the liver and other areas of the body. This can cause serious complications such as high blood pressure and kidney failure. According to the National Kidney Foundation, approximately 600,000 people have PKD in the United States and it is the fourth leading cause of kidney failure and causes about 5% of all kidney failures. The symptoms of polycystic kidney disease include high blood pressure, blood in urine, feeling of fullness in the abdomen, back or side pain, headaches, increased size of the abdomen due to enlarged kidneys, kidney stones and failure and urinary tract or kidney infections among others. However, the symptoms can vary, depending on the stage of the disease.

The are two main types of polycystic kidney disease, including autosomal dominant polycystic kidney disease (ADPKD) and autosomal recessive polycystic kidney disease (ARPKD). The signs and symptoms of ADPKD often develop between the ages of 30 to 40 but children can also develop the disorder. If a single parent has ADPKD, each child has a 50% chance of getting the disease. ADPKD is the most common form of polycystic kidney disease while ARPKD is less common. The signs and symptoms often appear shortly after birth.

There is no cure for PKD currently. However, several research is being done to develop effective treatment alternatives. In April 2018, the U.S. FDA tolvaptan for autosomal dominant polycystic kidney disease treatment. This drug is used to slow down the decline of kidney function in adults at risk. Several pharma companies are developing innovative treatments to manage polycystic kidney disease. There has been a significant increase in the clinical trials for polycystic kidney disease. For instance, Otsuka is studying tolvaptan in two phase 3 studies in ARPKD, each evaluating the safety and effectiveness of tolvaptan in patients under the age of 18. Positive results from clinical trials are expected to impact the pipeline landscape significantly in coming years.

Polycystic Kidney Disease – Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of polycystic kidney disease drugs based on several segmentations including:

By Phase

EMR’s pipeline assessment report covers 50+ drug analyses based on phase.

• Late-Stage Products (Phase 3 and Phase 4)

• Mid-Stage Products (Phase 2)

• Early-Stage Products (Phase I)

• Preclinical and Discovery Stage Products

By Drug Class

EMR’s pipeline assessment report covers 50+ drug analyses based on drug classes.

• Recombinant Fusion Proteins

• Small Molecule

• Monoclonal Antibody

• Peptide

• Polymer

• Gene Therapy

• Kinase Inhibitor

By Route of Administration

EMR’s pipeline assessment report covers 50+ drug analyses based on the route of administration.

• Oral

• Parenteral

• Others

Polycystic Kidney Disease – Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total clinical trials for polycystic kidney disease with 44 pipeline drugs in phase II.

Polycystic Kidney Disease – Pipeline Assessment Segmentation, By Drug Classes

The drug molecules categories covered under polycystic kidney disease pipeline analysis include recombinant fusion proteins, small molecules, monoclonal antibodies, peptides, polymer, and gene therapy. A. Manzoni Hospital is conducting a phase II study to evaluate whether the administration of everolimus (a kinase inhibitor) slows down the progression of disease in ADPKD patients. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for polycystic kidney disease.

Polycystic Kidney Disease Clinical Trials Assessment – Competitive Dynamics

The EMR report for the polycystic kidney disease drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in polycystic kidney disease clinical trials:

• Palladio Biosciences

• Regulus Therapeutics Inc.

• Novartis Pharmaceuticals

• Kadmon Corporation, LLC

• Pfizer

• Otsuka Pharmaceutical Development & Commercialization, Inc.

• Rege Nephro Co., Ltd.

• AceLink Therapeutics, Inc.

• Vertex Pharmaceuticals Incorporated

• Advice Pharma Group srl

• Others

Polycystic Kidney Disease – Pipeline Drugs Profile

Drug: RGLS8429

The trial is designed to evaluate the safety and tolerability of RGLS8429 and to assess the impact of RGLS8429 on ADPKD biomarkers. The trial is sponsored by Regulus Therapeutics Inc. and is currently under phase II.

Drug: tolvaptan

The objective of the study is to assess the clinical safety and effectiveness of tolvaptan twice daily in ADPKD patients. The trial is sponsored by Otsuka Pharmaceutical Co., Ltd. and is currently under phase III.

Drug: AL01211

AceLink Therapeutics, Inc. is developing the drug and is currently under phase I. The study is being designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Oral AL01211 in healthy volunteers.

Reasons To Buy This Report

The Polycystic Kidney Disease Drug Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for polycystic kidney disease. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within polycystic kidney disease pipeline insights.

Key Questions Answered in the Polycystic Kidney Disease – Pipeline Assessment Report

• What is the current landscape of polycystic kidney disease pipeline drugs?
• How many companies are developing polycystic kidney disease drugs?
• How many phase III and phase IV drugs are currently present in polycystic kidney disease pipeline drugs?
• Which companies/institutions are leading the polycystic kidney disease drug development?
• What is the efficacy and safety profile of polycystic kidney disease pipeline drugs?
• What are the opportunities and challenges present in the polycystic kidney disease drug pipeline landscape?
• Which company is conducting major trials for polycystic kidney disease drugs?
• What are the geographies covered for clinical trials in polycystic kidney disease?
• What are emerging trends in polycystic kidney disease clinical trials?

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