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Overt Hepatic Encephalopathy Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102732
Several studies suggest that 35 to 45% of patients having cirrhosis experience overt hepatic encephalopathy. The cumulative incidence of hepatic encephalopathy in cirrhosis is 5% to 20% at five years and 7% to 40% at 10 years. Treatment of hepatic encephalopathy includes several ammonia-lowering therapies like non-absorbable disaccharides and antimicrobial agents such as rifaximin and l-ornithine l-aspartat. Approximately 25 clinical studies are ongoing to develop innovative treatments for overt hepatic encephalopathy, including antimicrobials, and osmotic laxative among others.

Report Coverage

The Overt Hepatic Encephalopathy Drug Pipeline Insight Report by the publisher gives comprehensive insights into overt hepatic encephalopathy clinical trials. It covers various aspects related to the details of each of these drugs under development for overt hepatic encephalopathy. The report includes the analysis of over 20+ pipeline drugs and 10+ companies. The overt hepatic encephalopathy 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 overt hepatic encephalopathy.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration and ongoing overt hepatic encephalopathy product development activities.

Overt Hepatic Encephalopathy Drug Pipeline Outlook

Overt hepatic encephalopathy is a reversible neurological complication of cirrhosis which is caused by liver dysfunction. This disease affects the central nervous system and affects how a person thinks, feels, and acts. The symptom of overt hepatic encephalopathy varies and ranges from disorientation to erratic behavior and personality changes.

The disorder is caused by neurotoxins (substances which are toxic to the brain and nervous system) in the blood. When the liver doesn’t filter these toxins from the blood, these neurotoxins continue to circulate, eventually entering and affecting the brain. It usually occurs in advanced liver disease when the function of the liver begins to fail. The disorder can affect personality, mood, consciousness, sleep patterns, concentration and thinking, behavior along with impulse control among others.

There are three types of hepatic encephalopathy including type A, type B and type C. Type A is caused by acute liver failure. It is a sudden loss of liver function due to severe liver injury. Type B is caused by a portosystemic shunt when blood flow bypasses its normal route through a new and abnormal passageway and type C is caused by chronic liver failure. The medications given to treat the conditions include rifaximin, and lactulose among others. Rifaximin antibiotic is nonabsorbable by intestines and actulose is a synthetic laxative that draws water into the bowel. The supplemental medications given are amino acids to build muscle and clear ammonia from blood and probiotics to encourage healthy gut bacteria to compete with the less helpful types of bacteria which produce neurotoxins. Several pharma companies and research institutes are developing innovative treatments to manage overt hepatic encephalopathy. According to the National Institute of Health, several clinical trial studies suggest that rifaximin has shown significant beneficial effect on the improvement of overt hepatic encephalopathy. The increasing clinical trials and changing dynamics are impacting the overt hepatic encephalopathy clinical trial landscape significantly.

Overt Hepatic Encephalopathy - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of overt hepatic encephalopathy 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 overt encephalopathy assessment report covers 100+ drug analyses based on drug classes:

  • Peptides
  • Recombinant Proteins
  • Small Molecule

By Route of Administration

The pipeline assessment report covers 100+ drug analyses based on the route of administration:

  • Oral
  • Parenteral
  • Others

Overt Hepatic Encephalopathy - 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 IV covers a major share of the total clinical trials for overt hepatic encephalopathy.

Overt Hepatic Encephalopathy - Pipeline Assessment Segmentation, By Drug Class

The drug molecules categories covered under overt hepatic encephalopathy pipeline analysis include peptides, recombinant proteins, and small molecules. L-ornithine and L-aspartate are endogenous amino acids which help with ammonia detoxification. Several trials are suggesting the potential beneficial role of L-ornithine and L-aspartate for the treatment of overt hepatic encephalopathy. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for overt hepatic encephalopathy.

Overt Hepatic Encephalopathy Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for the overt hepatic encephalopathy drug insights covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed overt hepatic encephalopathy therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in Overt Hepatic Encephalopathy clinical trials:
  • Bausch Health Americas, Inc.
  • Axcella Health, Inc.
  • Ocera Therapeutics, Inc.
  • Mallinckrodt
  • Others

Overt Hepatic Encephalopathy - 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 overt hepatic encephalopathy. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of overt hepatic encephalopathy drug candidates.

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

Drug: 40 mg Rifaximin SSD

The trial is designed to evaluate the safety of Rifaximin Soluble Solid Dispersion tablets and Lactulose for overt hepatic encephalopathy treatment. The trial is sponsored by Bausch Health Americas and is currently under phase II.

Drug: AXA1665

The objective of the study is to compare and assess the safety and tolerability of AXA1665. It is an orally active mixture of amino acids. The trial is sponsored by Axcella Health and is currently under phase II.

Drug: Ornithine Phenylacetate

Ocera Therapeutics, Inc. is developing the drug and is currently under phase II. The study is being conducted to determine whether ornithine phenylacetate can speed up recovery from an acute hepatic encephalopathy episode in cirrhotic patients.

Reasons To Buy This Report

The Overt Hepatic Encephalopathy Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for overt hepatic encephalopathy. 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 rovert hepatic encephalopathy collaborations, regulatory environments, and potential growth opportunities within overt hepatic encephalopathy pipeline insights.

Key Questions Answered in the Overt Hepatic Encephalopathy - Pipeline Insight Report

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

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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 Overt Hepatic Encephalopathy
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Types of Overt Hepatic Encephalopathy
3.5 Diagnosis
3.6 Treatment
4 Patient Profile: Overt Hepatic Encephalopathy
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Overt Hepatic Encephalopathy: Epidemiology Snapshot
5.1 Overt Hepatic Encephalopathy Incidence by Key Markets
5.2 Overt Hepatic Encephalopathy - Patients Seeking Treatment in Key Markets
6 Overt Hepatic Encephalopathy: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Overt Hepatic Encephalopathy: 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 Overt Hepatic Encephalopathy, 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 Overt Hepatic Encephalopathy 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 Overt Hepatic Encephalopathy 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: Rifaximin
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: MNK-6105
10.2.3 Drug: Lactulose
10.2.4 Other Drugs
11 Overt Hepatic Encephalopathy 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: AXA1665
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: Ornithine Phenylacetate
11.2.3 Other Drugs
12 Overt Hepatic Encephalopathy 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 1
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 Other Drugs
13 Overt Hepatic Encephalopathy 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 Overt Hepatic Encephalopathy, Key Drug Pipeline Companies
14.1 Bausch Health Americas, Inc.
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 Axcella Health, Inc.
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 Ocera Therapeutics, 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 Mallinckrodt
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products