Hepatitis B Virus (HBV) Infection Drug Pipeline Analysis Report 2025
Description
Hepatitis B virus (HBV) infection is a serious liver disease caused by the hepatitis B virus, posing a serious global health challenge. In 2022, it accounted for approximately 257 million cases worldwide, with an annual incidence of 1.5 million new cases. There is a high unmet clinical need for better therapies to treat the disease, as current treatment options, such as antiviral drugs and interferon therapy, have limitations. Furthermore, the growing focus on novel hepatitis B virus (HBV) infection therapeutics, including RNA interference, immunomodulators, and combination therapies, is likely to support pipeline growth in the coming years, improving patient outcomes.
Report Coverage
The Hepatitis B Virus (HBV) Infection Drug Pipeline Insight Report by Expert Market Research provides comprehensive insights into hepatitis B virus (HBV) infection therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs in development for hepatitis B virus (HBV) infection. The hepatitis B virus (HBV) infection report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hepatitis B virus (HBV) infection pipeline landscape includes 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 hepatitis B virus (HBV) infection 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 hepatitis B virus (HBV) infection.
Hepatitis B Virus (HBV) Infection Drug Pipeline Outlook
Hepatitis B virus (HBV) infection is a viral disease that affects the liver, potentially leading to chronic conditions such as cirrhosis or liver cancer. It spreads through contact with infected blood, unprotected sex, and from mother to child during childbirth. The virus enters liver cells, replicates, and triggers an immune response, causing liver inflammation. It can be acute or chronic, with chronic infection posing long-term health risks that require continuous monitoring and management.
Hepatitis B virus (HBV) infection treatment focuses on suppressing viral replication and preventing liver damage. Antiviral medications such as Entecavir, Tenofovir, and interferon therapy help control the virus but do not cure it. For chronic cases, lifelong treatment may be necessary. Researchers are developing novel therapeutics, including RNA interference and immune-based therapies, to achieve a functional cure.
Hepatitis B Virus (HBV) Infection Epidemiology
Hepatitis B Virus (HBV) infection remains a significant global health burden, with an estimated 257 million cases in 2022 and an annual occurrence of 1.5 million new infections. The United States has around 580,000 to 2.4 million cases, while the United Kingdom reported nearly 270,000 cases (0.6% of the population). India records approximately 40 million chronic HBV cases.
Hepatitis B Virus (HBV) Infection Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of hepatitis B virus (HBV) infection drug candidates based on several segmentations, including:
By Phase
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 II accounts for a major share of the total hepatitis B virus (HBV) infection clinical trials.
Hepatitis B Virus (HBV) Infection – Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the hepatitis B virus (HBV) infection pipeline analysis include small molecules, RNA therapeutics, monoclonal antibodies, gene therapies, biologic immunotherapies, and others. The hepatitis B virus (HBV) infection report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hepatitis B virus (HBV) infection.
Hepatitis B Virus (HBV) Infection Clinical Trials Therapeutic Assessment – Competitive Dynamics
The EMR report for the hepatitis B virus (HBV) infection drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hepatitis B virus (HBV) infection therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hepatitis B virus (HBV) infection 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 hepatitis B virus (HBV) infection. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of hepatitis B virus (HBV) infection drug candidates.
Drug: Vemliver Tablet
Vemliver, an antiviral medication, is being evaluated in a Phase IV study sponsored by Daewoong Pharmaceutical Co. Ltd. to assess the efficacy and safety of switching from Entecavir in chronic hepatitis B patients. The study, expected to be completed by December 31, 2025, will enroll approximately 196 participants. It is designed to assess hepatitis B virus (HBV) antiviral inhibition and safety at 24 and 48 weeks.
Drug: Bepirovirsen
Bepirovirsen, an investigational treatment for chronic hepatitis B, is being evaluated in a Phase 3 study sponsored by GlaxoSmithKline. The study aims to assess the drug's efficacy, safety, and durability in nucleos(t)ide analogue-treated participants, focusing on hepatitis B surface antigen (HBsAg) suppression. Expected to be completed by May 2026, it includes around 941 participants across multiple stages of treatment and follow-up.
Drug: GSK3965193
GSK3965193, sponsored by GlaxoSmithKline, is being studied in a Phase 1/2a trial involving healthy participants and those with chronic hepatitis B virus (HBV) infection. This study aims to assess the safety, tolerability, and pharmacokinetics of GSK3965193, both alone and in combination with Bepirovirsen. The study is expected to be completed by October 2027, with an estimated enrollment of 132 participants.
Reasons To Buy This Report
The Hepatitis B Virus (HBV) Infection Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for hepatitis B virus (HBV) infection. 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 hepatitis B virus (HBV) infection collaborations, regulatory environments, and potential growth opportunities.
Key Questions Answered in the Hepatitis B Virus (HBV) Infection – Pipeline Insight Report
Hepatitis B Vaccine Market
Global Hepatitis B Infection Treatment Market
North America Hepatitis B Market
Global Clinical Trials Market
Report Coverage
The Hepatitis B Virus (HBV) Infection Drug Pipeline Insight Report by Expert Market Research provides comprehensive insights into hepatitis B virus (HBV) infection therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs in development for hepatitis B virus (HBV) infection. The hepatitis B virus (HBV) infection report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hepatitis B virus (HBV) infection pipeline landscape includes 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 hepatitis B virus (HBV) infection 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 hepatitis B virus (HBV) infection.
Hepatitis B Virus (HBV) Infection Drug Pipeline Outlook
Hepatitis B virus (HBV) infection is a viral disease that affects the liver, potentially leading to chronic conditions such as cirrhosis or liver cancer. It spreads through contact with infected blood, unprotected sex, and from mother to child during childbirth. The virus enters liver cells, replicates, and triggers an immune response, causing liver inflammation. It can be acute or chronic, with chronic infection posing long-term health risks that require continuous monitoring and management.
Hepatitis B virus (HBV) infection treatment focuses on suppressing viral replication and preventing liver damage. Antiviral medications such as Entecavir, Tenofovir, and interferon therapy help control the virus but do not cure it. For chronic cases, lifelong treatment may be necessary. Researchers are developing novel therapeutics, including RNA interference and immune-based therapies, to achieve a functional cure.
Hepatitis B Virus (HBV) Infection Epidemiology
Hepatitis B Virus (HBV) infection remains a significant global health burden, with an estimated 257 million cases in 2022 and an annual occurrence of 1.5 million new infections. The United States has around 580,000 to 2.4 million cases, while the United Kingdom reported nearly 270,000 cases (0.6% of the population). India records approximately 40 million chronic HBV cases.
Hepatitis B Virus (HBV) Infection Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of hepatitis B virus (HBV) infection drug candidates based on several segmentations, including:
By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
- Small Molecules
- RNA Therapeutics
- Monoclonal Antibodies
- Gene Therapies
- Biologic Immunotherapies
- Others
- 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 II accounts for a major share of the total hepatitis B virus (HBV) infection clinical trials.
Hepatitis B Virus (HBV) Infection – Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the hepatitis B virus (HBV) infection pipeline analysis include small molecules, RNA therapeutics, monoclonal antibodies, gene therapies, biologic immunotherapies, and others. The hepatitis B virus (HBV) infection report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hepatitis B virus (HBV) infection.
Hepatitis B Virus (HBV) Infection Clinical Trials Therapeutic Assessment – Competitive Dynamics
The EMR report for the hepatitis B virus (HBV) infection drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hepatitis B virus (HBV) infection therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hepatitis B virus (HBV) infection clinical trials:
- GlaxoSmithKline
- Epigenic Therapeutics, Inc.
- Gilead Sciences
- Tune Therapeutics, Inc.
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Brii Biosciences Ltd.
- Vir Biotechnology, Inc.
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Barinthus Biotherapeutics
- Arbutus Biopharma Corporation
- Sclnow Biotechnology Co., Ltd.
- Precision BioSciences, 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 hepatitis B virus (HBV) infection. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of hepatitis B virus (HBV) infection drug candidates.
Drug: Vemliver Tablet
Vemliver, an antiviral medication, is being evaluated in a Phase IV study sponsored by Daewoong Pharmaceutical Co. Ltd. to assess the efficacy and safety of switching from Entecavir in chronic hepatitis B patients. The study, expected to be completed by December 31, 2025, will enroll approximately 196 participants. It is designed to assess hepatitis B virus (HBV) antiviral inhibition and safety at 24 and 48 weeks.
Drug: Bepirovirsen
Bepirovirsen, an investigational treatment for chronic hepatitis B, is being evaluated in a Phase 3 study sponsored by GlaxoSmithKline. The study aims to assess the drug's efficacy, safety, and durability in nucleos(t)ide analogue-treated participants, focusing on hepatitis B surface antigen (HBsAg) suppression. Expected to be completed by May 2026, it includes around 941 participants across multiple stages of treatment and follow-up.
Drug: GSK3965193
GSK3965193, sponsored by GlaxoSmithKline, is being studied in a Phase 1/2a trial involving healthy participants and those with chronic hepatitis B virus (HBV) infection. This study aims to assess the safety, tolerability, and pharmacokinetics of GSK3965193, both alone and in combination with Bepirovirsen. The study is expected to be completed by October 2027, with an estimated enrollment of 132 participants.
Reasons To Buy This Report
The Hepatitis B Virus (HBV) Infection Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for hepatitis B virus (HBV) infection. 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 hepatitis B virus (HBV) infection collaborations, regulatory environments, and potential growth opportunities.
Key Questions Answered in the Hepatitis B Virus (HBV) Infection – Pipeline Insight Report
- Which companies/institutions are leading the hepatitis B virus (HBV) infection drug development?
- What is the efficacy and safety profile of hepatitis B virus (HBV) infection pipeline drugs?
- Which company is leading the hepatitis B virus (HBV) infection pipeline development activities?
- What is the current hepatitis B virus (HBV) infection commercial assessment?
- What are the opportunities and challenges present in the hepatitis B virus (HBV) infection drug pipeline landscape?
- What is the efficacy and safety profile of hepatitis B virus (HBV) infection pipeline drugs?
- Which company is conducting major trials for hepatitis B virus (HBV) infection drugs?
- Which companies/institutions are involved in hepatitis B virus (HBV) infection collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in hepatitis B virus (HBV) infection?
Hepatitis B Vaccine Market
Global Hepatitis B Infection Treatment Market
North America Hepatitis B 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 Hepatitis B Virus (HBV) Infection
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Hepatitis B Virus (HBV) Infection
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Hepatitis B Virus (HBV) Infection: Epidemiology Snapshot
- 5.1 Hepatitis B Virus (HBV) Infection Incidence by Key Markets
- 5.2 Hepatitis B Virus (HBV) Infection – Patients Seeking Treatment in Key Markets
- 6 Hepatitis B Virus (HBV) Infection: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Hepatitis B Virus (HBV) Infection: 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 Hepatitis B Virus (HBV) Infection, 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 Hepatitis B Virus (HBV) Infection 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 Hepatitis B Virus (HBV) Infection 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: Vemliver Tablet
- 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: Tenofovir Amibufenamide
- 10.2.3 Drug: Bepirovirsen
- 10.2.4 Drug: Tenofovir Disoproxil Fumarate
- 10.2.5 Other Drugs
- 11 Hepatitis B Virus (HBV) Infection 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: GSK3965193
- 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: HRS-5635 Injection
- 11.2.3 Other Drugs
- 12 Hepatitis B Virus (HBV) Infection 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: EPI-003
- 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 Genetic: Tune-401
- 12.2.3 Other Drugs
- 13 Hepatitis B Virus (HBV) Infection 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 Hepatitis B Virus (HBV) Infection, Key Drug Pipeline Companies
- 14.1 GlaxoSmithKline
- 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 Epigenic Therapeutics, 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 Gilead Sciences
- 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 Tune Therapeutics, Inc.
- 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 Jiangsu Hansoh Pharmaceutical Co., Ltd.
- 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 Brii Biosciences Ltd.
- 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 Vir Biotechnology, Inc.
- 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 Chia Tai Tianqing Pharmaceutical Group 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 Barinthus Biotherapeutics
- 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 Arbutus Biopharma Corporation
- 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 Sclnow Biotechnology Co., Ltd.
- 14.11.1 Company Snapshot
- 14.11.2 Pipeline Product Portfolio
- 14.11.3 Financial Analysis
- 14.11.4 Recent News and Developments
- 14.12 Precision BioSciences, Inc.
- 14.12.1 Company Snapshot
- 14.12.2 Pipeline Product Portfolio
- 14.12.3 Financial Analysis
- 14.12.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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