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End Stage Renal Disease Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102806
End-stage renal disease (ESRD) is the final stage of chronic kidney disease, where kidneys can no longer function effectively, requiring dialysis or a kidney transplant. It accounts for a significant portion of global kidney disease cases, affecting approximately 850 million people worldwide. There is a need for advanced therapies to treat ESRD, as current treatments, such as dialysis, focus on symptom management rather than addressing the root causes. Increasing emphasis on innovative therapeutics, including novel end-stage renal disease drug candidates and advanced biologics, is expected to drive substantial growth in the coming years, enhancing patient outcomes and quality of life.

Report Coverage

The End Stage Renal Disease Drug Pipeline Insight Report by the publisher gives comprehensive insights into end stage renal disease therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for end stage renal disease. The end stage renal disease report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The end stage renal disease pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with end stage renal disease treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to end stage renal disease.

End Stage Renal Disease Drug Pipeline Outlook

End-stage renal disease (ESRD) is the final stage of chronic kidney disease, in which kidneys lose nearly all their function, leading to waste and fluid buildup. It typically occurs due to long-term conditions like diabetes, hypertension, or glomerulonephritis. Without proper treatment, ESRD can be life-threatening as the kidneys can no longer maintain essential bodily functions.

End-stage renal disease (ESRD) treatments focus on replacing lost kidney function. Options include dialysis - hemodialysis or peritoneal dialysis - to remove waste and excess fluid or kidney transplantation for a permanent solution. Managing underlying conditions and lifestyle changes are also crucial. Early diagnosis and treatment improve outcomes and quality of life.

End Stage Renal Disease Epidemiology

End-stage renal disease (ESRD) affects over 2.6 million people globally, with rising incidence, particularly in Asia and the Americas. India reports 1,800 cases per million, with many requiring long-term renal replacement therapy. Hypertensive ESRD constitutes 25% of new cases in the USA, disproportionately impacting Black Americans, Asian Americans, and Alaska Natives.

End Stage Renal Disease - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of end stage renal disease drug candidates based on several segmentations, including:

By 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

  • Small Molecules
  • Biologics
  • Peptides
  • Gene Therapies
  • Cell Therapies

By Route of Administration

  • Oral
  • Parenteral
  • Others

End Stage Renal 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 analysis, phase II covers a major share of the total end stage renal disease clinical trials.

End Stage Renal Disease - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the end stage renal disease pipeline analysis include small molecules, biologics, peptides, gene therapies, and cell therapies. The end stage renal disease report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for end stage renal disease.

End Stage Renal Disease Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for the end stage renal disease drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed end stage renal disease therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in end stage renal disease clinical trials:
  • AstraZeneca
  • Merck Sharp & Dohme LLC
  • Humacyte, Inc.
  • Iperboreal Pharma Srl
  • Veloxis Pharmaceuticals
  • Pathalys Pharma
  • Sangamo Therapeutics
  • Vascular Therapies, Inc.
  • Boehringer Ingelheim
  • Gilead Sciences
  • Launch Therapeutics
  • Parexel

End Stage Renal Disease Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for end stage renal disease. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of end stage renal disease drug candidates.

Drug: Sirolimus

Sirogen, sponsored by Vascular Therapies, is currently being evaluated in the Phase III ACCESS 2 trial to improve arteriovenous (AV) fistula outcomes for hemodialysis patients with kidney disease. This sirolimus-eluting collagen implant delivers sirolimus locally to enhance fistula maturation and reduce failure rates. The study’s primary endpoint is fistula maturation at six months, with results expected by Q2 2025.

Drug: DCR-PHXC

DCR-PHXC, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, is being evaluated in a Phase II open-label study. It is designed to assess its safety and efficacy in patients with Primary Hyperoxaluria Type 1 (PH1) and end-stage renal disease (ESRD), with or without dialysis. This investigational drug targets hepatic oxalate production, aiming to reduce oxalate accumulation and prevent further renal damage.

Drug: AZD4144

AZD4144 is an investigational drug developed by AstraZeneca, currently being evaluated in a Phase I study. It aims to assess its pharmacokinetics, safety, and tolerability in participants with severe renal impairment, including end-stage kidney disease (ESKD), compared to healthy individuals. This open-label, single-dose trial involves multiple cohorts, with findings expected to enhance future ESRD therapeutics and address critical treatment gaps.

Reasons To Buy This Report

The End Stage Renal Disease Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for end stage renal 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 end stage renal disease collaborations, regulatory environments, and potential growth opportunities.

Key Questions Answered in the End Stage Renal Disease - Pipeline Insight Report

  • Which companies/institutions are leading the end stage renal disease drug development?
  • What is the efficacy and safety profile of end stage renal disease pipeline drugs?
  • Which company is leading the end stage renal disease pipeline development activities?
  • What is the current end stage renal disease commercial assessment?
  • What are the opportunities and challenges present in the end stage renal disease drug pipeline landscape?
  • What is the efficacy and safety profile of end stage renal disease pipeline drugs?
  • Which company is conducting major trials for end stage renal disease drugs?
  • Which companies/institutions are involved in end stage renal disease collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in end stage renal disease?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of End Stage Renal Disease
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: End Stage Renal Disease
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 End Stage Renal Disease: Epidemiology Snapshot
5.1 End Stage Renal Disease Incidence by Key Markets
5.2 End Stage Renal Disease - Patients Seeking Treatment in Key Markets
6 End Stage Renal Disease: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 End Stage Renal Disease: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 End Stage Renal Disease, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of End Stage Renal Disease Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 End Stage Renal Disease Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: Sirolimus
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Drug: PLS240
10.2.3 Other Drugs
11 End Stage Renal Disease Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: DCR-PHXC
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Drug: MK-2060
11.2.3 Other Drugs
12 End Stage Renal Disease Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug: AZD4144
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Drug: MK-5684
12.2.3 Other Drugs
13 End Stage Renal Disease Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 End Stage Renal Disease, Key Drug Pipeline Companies
14.1 AstraZeneca
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Merck Sharp & Dohme LLC
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Humacyte, Inc.
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Iperboreal Pharma Srl
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Veloxis Pharmaceuticals
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 Pathalys Pharma
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Sangamo Therapeutics
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Vascular Therapies, Inc.
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
14.9 Boehringer Ingelheim
14.9.1 Company Snapshot
14.9.2 Pipeline Product Portfolio
14.9.3 Financial Analysis
14.9.4 Recent News and Developments
14.10 Gilead Sciences
14.10.1 Company Snapshot
14.10.2 Pipeline Product Portfolio
14.10.3 Financial Analysis
14.10.4 Recent News and Developments
14.11 Launch Therapeutics
14.11.1 Company Snapshot
14.11.2 Pipeline Product Portfolio
14.11.3 Financial Analysis
14.11.4 Recent News and Developments
14.12 Parexel
14.12.1 Company Snapshot
14.12.2 Pipeline Product Portfolio
14.12.3 Financial Analysis
14.12.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products