Hepatitis B Virus (HBV) Infection Drug Pipeline Analysis Report 2025

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 the publisher 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

By Drug Class

• Small Molecules
• RNA Therapeutics
• Monoclonal Antibodies
• Gene Therapies
• Biologic Immunotherapies
• Others

By Route of Administration

• Oral
• Parenteral
• Others

Hepatitis B Virus (HBV) Infection - 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 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 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.

Hepatitis B Virus (HBV) Infection 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 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?

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