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.
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 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.
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:
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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.This product will be delivered within 3-5 business days.
Table of Contents
1 Preface
3 Overview of Renal Impairment
4 Patient Profile: Renal Impairment
5 Renal Impairment: Epidemiology Snapshot
6 Renal Impairment: Market Dynamics
7 Renal Impairment: Key Facts Covered
8 Renal Impairment, Drug Pipeline Assessment
9 Drug Pipeline Comparative Analysis
10 Renal Impairment Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
11 Renal Impairment Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
12 Renal Impairment Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
13 Renal Impairment Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
14 Renal Impairment, Key Drug Pipeline Companies