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Report Overview

Hepatic Impairment represents progressive liver dysfunction driven by chronic liver diseases affecting an estimated 1.70 billion people globally in 2021. Advanced fibrosis and cirrhosis show global prevalence rates of 3.3% and 1.3%, respectively, while steatotic liver disease impacts nearly 37.5% of adults worldwide. According to Hepatic Impairment pipeline analysis by Expert Market Research, increasing disease burden and biomarker-driven innovation are accelerating targeted therapeutic development across metabolic, inflammatory, and cholestatic liver disorders.

  • Major companies involved in the hepatic impairment pipeline analysis include Celgene, Alumis Inc., and others.

  • Leading drugs currently in the pipeline include RAY1225, Mirvetuximab Soravtansine, and others.

  • The hepatic impairment drug pipeline is propelled by increasing demand for precision-tailored therapies addressing altered drug metabolism and toxicity in liver-compromised patients. Advances in biomarker-guided dosing, organ-on-chip models, and real-world pharmacokinetic studies enable safer, effective treatments, driving novel drug development and investment in targeted therapies for patients with chronic liver disease or hepatic dysfunction.

Report Coverage

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

Hepatic Impairment Pipeline Analysis by Drug Class

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Hepatic Impairment Pipeline Outlook

Hepatic impairment encompasses chronic liver diseases where conventional management includes ursodeoxycholic acid, lifestyle measures, and symptom control, but significant unmet needs remain.

Hepatic impairment treatment is increasingly focused on advancing targeted therapies that address underlying pathology and key biochemical markers. A key milestone occurred in August 2024, when the FDA granted accelerated approval to Livdelzi (seladelpar) for primary biliary cholangitis (PBC), offering a novel option for patients unresponsive to standard therapy and reflecting growing innovation in liver disease treatment.

Hepatic Impairment Epidemiology

Hepatic impairment broadly reflects the clinical consequences of chronic liver disease, which affects a significant share of the global population. In 2021, approximately 1.70 billion people worldwide were living with cirrhosis and other chronic liver conditions, underscoring a substantial public health burden. Globally, the prevalence of advanced liver fibrosis and cirrhosis is estimated at 3.3% and 1.3%, respectively. Steatotic liver disease, a major contributor to hepatic dysfunction, has a pooled prevalence of nearly 37.5% among adults, highlighting the extensive scale of liver impairment across populations.

Hepatic Impairment – Pipeline Therapeutic Assessment

This section of the report covers the analysis of hepatic 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 hepatic impairment pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Monoclonal Antibodies
  • Small Molecules
  • Gene Therapies

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration:

  • Oral
  • Parenteral
  • Others

Hepatic 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 EMR analysis, phase I covers a major share of the total hepatic impairment clinical trials. Phase I dominates with 98% of ichthyosis clinical trials, highlighting the strong focus on early-stage clinical evaluation and safety assessment of therapies in this patient population.

Hepatic Impairment Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the hepatic impairment pipeline analysis include monoclonal antibodies, small-molecule drugs, and gene therapies. The hepatic impairment report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hepatic impairment. In March 2024, the FDA granted accelerated approval to Rezdiffra (resmetirom) for adults with noncirrhotic metabolic dysfunction associated steatohepatitis (MASH/NASH) and moderate to advanced fibrosis. The therapy, a thyroid hormone receptor-β agonist, targets liver fat reduction and fibrosis improvement. This approval marks the first disease specific option for progressive NASH patients, addressing a critical unmet need in hepatic impairment management.

Hepatic Impairment Clinical Trials – Key Players

The EMR report for the hepatic impairment pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hepatic impairment therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hepatic impairment clinical trials:

  • AbbVie
  • Guangdong Raynovent Biotech Co., Ltd
  • Alumis Inc
  • Merck Sharp & Dohme LLC
  • Vir Biotechnology, Inc.
  • Pfizer
  • Boehringer Ingelheim
  • Celgene
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Jiangsu Hansoh Pharmaceutical Co., Ltd.
  • Taiho Oncology, Inc.

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

Drug: BI 1291583

BI 1291583 is a novel cathepsin C (CatC) inhibitor designed to reduce neutrophil‑derived protease activation, including neutrophil elastase and proteinase 3, thereby lowering inflammation and tissue damage. The therapy is being explored in early Phase 1 studies for chronic inflammatory conditions like bronchiectasis. The program is led by Boehringer Ingelheim, which is characterizing its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and planning Phase 2 investigations.

Drug: ASTX727

ASTX727 is an investigational oral fixed‑dose combination of decitabine, a DNA hypomethylating agent, and cedazuridine, a cytidine deaminase inhibitor that enables effective oral delivery. This combination allows decitabine exposure equivalent to intravenous administration for hematologic malignancies such as myelodysplastic syndromes and CMML. Astex Pharmaceuticals, in partnership with Otsuka and Taiho Oncology, is advancing ASTX727 through clinical development to offer a convenient, orally administered epigenetic therapy alternative.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Hepatic Impairment Pipeline Insight Report

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

Reasons To Buy This Report

The Hepatic Impairment Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for hepatic 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 hepatic impairment collaborations, regulatory environments, and potential growth opportunities.

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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Monoclonal Antibodies
  • Small Molecules
  • Gene Therapies

Leading Sponsors Covered

  • AbbVie
  • Guangdong Raynovent Biotech Co., Ltd
  • Alumis Inc
  • Merck Sharp & Dohme LLC
  • Vir Biotechnology, Inc.
  • Pfizer
  • Boehringer Ingelheim
  • Celgene
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Jiangsu Hansoh Pharmaceutical Co., Ltd.
  • Taiho Oncology, Inc.

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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