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Renal Impairment Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102696
Renal impairment refers to the condition in which the kidneys lose their ability to effectively filter waste and excess fluids from the blood. It affects millions of people worldwide, including 700 million individuals with chronic kidney disease (CKD) and those suffering from acute kidney injury (AKI) or kidney failure, such as dialysis and transplant patients. Driven by factors like diabetes and hypertension, renal impairment is a growing global health concern. Despite its high prevalence, there is a significant unmet clinical need for better therapies, as current treatments like dialysis and transplants fail to offer a cure or substantial improvements in quality of life. Advances in early detection, personalized medicine, and nephrology research are expected to drive future pipeline growth and enhance patient outcomes. The renal impairment pipeline analysis by the publisher focuses on various treatment options developing for the disease.

Report Coverage

The Renal Impairment Pipeline Analysis Report by the publisher gives comprehensive insights into renal impairment therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for renal impairment. The renal impairment report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The renal impairment 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 renal impairment 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 renal impairment.

Renal Impairment Pipeline Outlook

Renal impairment refers to the decreased ability of the kidneys to filter waste and maintain fluid balance, leading to an accumulation of toxins in the body. It occurs due to conditions like diabetes, hypertension, or glomerulonephritis. The drug pipeline focuses on therapies targeting kidney function restoration, slowing progression, and alleviating symptoms associated with chronic kidney disease and acute kidney injury, including novel drug candidates and biologics in clinical trials.

Renal impairment treatment aims to manage underlying causes, reduce complications, and slow progression. Medications help to control blood pressure and improve kidney function. Dialysis is used for severe cases, while kidney transplantation offers a long-term solution for end-stage renal disease. Emerging therapies focus on regenerative approaches and reducing fibrosis to preserve kidney function. In September 2024, the U.S. Food and Drug Administration granted an approval to Filspari® (sparsentan) by Travere Therapeutics for treating adults with IgA nephropathy (IgAN) at risk of disease progression. Filspari, a non-immunosuppressive, dual-acting oral therapy, significantly slows kidney function decline.

Renal Impairment Epidemiology

In the United States, an estimated 35.5 million individuals suffer from kidney disease, with 808,000 living with kidney failure, while in India, 13% to 15% of the population is affected. In the United Kingdom, around 7.2 million people have chronic kidney disease, with 3.25 million in advanced stages requiring complex management.

Renal Impairment Pipeline Therapeutic Assessment

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

By Phase

The 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

The renal impairment pipeline assessment report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Monoclonal Antibodies
  • Peptides
  • RNA-based Therapies
  • Immune Modulators

By Route of Administration

The renal impairment therapeutic assessment covers 50+ drug analyses based on the route of administration.
  • Oral
  • Parenteral
  • Others

Renal Impairment 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 I covers a major share of the total renal impairment clinical trials. Phase II holds the largest share at 33%, reflecting strong clinical advancements. Phase III follows with 24%, highlighting promising late-stage developments. Phase I accounts for 21%, showcasing growing early-stage innovations. Phase IV represents 20%, and early phase I holds 2%. These developments drive innovation, enhancing treatment options and positively impacting the Renal Impairment market.

Renal Impairment Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the renal impairment pipeline analysis include small molecules, monoclonal antibodies, peptides, RNA-based therapies, and immune modulators. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for renal impairment. Complement inhibitors are emerging as a promising drug class for renal impairment treatment. For instance, Fabhalta® (iptacopan) by Novartis, a first-in-class alternative complement pathway inhibitor, received FDA accelerated approval for reducing proteinuria in IgA nephropathy (IgAN), marks the first approval from Novartis’ renal pipeline.

Key Players in the Renal Impairment Pipeline

The report for renal impairment pipeline analysis include the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in Renal Impairment clinical trials:
  • Merck KGaA
  • AstraZeneca
  • Celgene Corporation
  • Cerevel Therapeutics, LLC
  • Vir Biotechnology, Inc.
  • Antabio
  • Boehringer Ingelheim
  • Daewoong Pharmaceutical Co. Lld.
  • Sanofi
  • Medac GmbH
  • Synteract, Inc.

Renal Impairment 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 renal impairment. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of renal impairment drug candidates.

Drug: DWP16001 0.3 mg

The Phase 3 clinical study, sponsored by Daewoong Pharmaceutical Co. Ltd., aims to evaluate the efficacy and safety of DWP16001 in patients with type 2 diabetic nephropathy and moderate renal impairment (CKD stage 3). The study is set to begin on September 23, 2024, with an expected completion by January 31, 2027, and will involve 348 participants.

Drug: Isatuximab

Sponsored by the Hellenic Society of Hematology, this Phase 2 study evaluates the efficacy and safety of isatuximab in combination with bortezomib, cyclophosphamide, and dexamethasone, followed by isatuximab and lenalidomide maintenance in newly diagnosed multiple myeloma patients with severe renal impairment. The study, expected to be completed by February 2025, will include 51 participants.

Drug: Enlicitide

Merck Sharp & Dohme LLC is sponsoring this Phase 1 clinical study to assess the pharmacokinetics of Enlicitide in participants with severe renal impairment. The study will compare the drug's behavior in both impaired and healthy individuals. It is set to involve 24 participants, with an expected completion date of May 8, 2025.

Key Questions Answered in the Renal Impairment Pipeline Analysis Report

  • What is the current landscape of renal impairment pipeline drugs?
  • Which companies/institutions are developing renal impairment emerging drugs?
  • How many phase II drugs are currently present in renal impairment pipeline drugs?
  • Which company is leading the renal impairment pipeline development activities?
  • What is the current renal impairment therapeutic assessment?
  • What are the opportunities and challenges present in the Renal Impairment drug pipeline landscape?
  • What is the efficacy and safety profile of renal impairment pipeline drugs?
  • Which companies/institutions are involved in renal impairment collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in renal impairment?

Reasons To Buy This Report

The Renal Impairment Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for renal impairment. 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 renal impairment pipeline insights.

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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 Renal Impairment
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Renal Impairment
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Renal Impairment: Epidemiology Snapshot
5.1 Renal Impairment Incidence by Key Markets
5.2 Renal Impairment - Patients Seeking Treatment in Key Markets
6 Renal Impairment: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Renal Impairment: 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 Renal Impairment, 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 Renal Impairment 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 Renal Impairment 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: DWP16001 0.3mg
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: Balcinrenone/Dapagliflozin 15 Mg/10 Mg
10.2.3 Other Drugs
11 Renal Impairment 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: Isatuximab
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 Other Drugs
12 Renal Impairment 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: Enlicitide
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-8527
12.2.3 Other Drugs
13 Renal Impairment 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 Renal Impairment, Key Drug Pipeline Companies
14.1 Merck KGaA
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 AstraZeneca
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 Celgene Corporation
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 Cerevel Therapeutics, LLC
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 Vir Biotechnology, Inc.
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 Antabio
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 Boehringer Ingelheim
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 Daewoong Pharmaceutical Co. LTD.
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 Sanofi
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 Medac GmbH
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 Synteract, Inc.
14.11.1 Company Snapshot
14.11.2 Pipeline Product Portfolio
14.11.3 Financial Analysis
14.11.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products