Renal Impairment Pipeline Analysis Report 2025
Description
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 Expert Market Research focuses on various treatment options developing for the disease.
Report Coverage
The Renal Impairment Pipeline Analysis Report by Expert Market Research 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:
The renal impairment pipeline assessment report covers 50+ drug analyses based on drug classes:
The renal impairment therapeutic assessment covers 50+ drug analyses based on the route of administration.
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 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 EMR 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:
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
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.
Related Reports
Global Acute Kidney Injury Treatment Market
Global Clinical Trials Market
Report Coverage
The Renal Impairment Pipeline Analysis Report by Expert Market Research 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
The renal impairment pipeline assessment report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Peptides
- RNA-based Therapies
- Immune Modulators
The renal impairment therapeutic assessment covers 50+ drug analyses based on the route of administration.
- Oral
- Parenteral
- Others
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 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 EMR 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.
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?
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.
Related Reports
Global Acute Kidney Injury Treatment Market
Global Clinical Trials Market
Table of Contents
200 Pages
- 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 EMR 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 EMR 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 Region
- 16 Terminated or Suspended Pipeline Products
Pricing
Currency Rates
Questions or Comments?
Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.
