Chronic hepatitis B virus (HBV) is a long-term liver infection caused by the hepatitis B virus, leading to severe complications such as cirrhosis and liver cancer. It accounts for around 257 million cases globally (3.2%), with 1.5 million new cases annually. Better therapies and the growing focus on functional cures are driving advancements in disease therapeutics. The chronic hepatitis B virus pipeline analysis by Expert Market Research focuses on various treatment options for this disease. Recent developments include RNA-based therapies, immune modulators, and gene editing techniques. Increasing research, improved diagnostics, and innovative treatments are expected to fuel the growth of chronic hepatitis B virus drug candidates in the coming years.
Major companies involved in the chronic hepatitis B virus pipeline analysis include GlaxoSmithKline, Tune Therapeutics, Inc., and others.
Leading drugs currently in the pipeline include Bepirovirsen, VIR-2218, ABI-4334, and others.
Advancements in novel antiviral therapies and immune-modulating agents are driving pipeline growth. Increased investment in research and development, along with regulatory support, is accelerating clinical trials and new treatment approvals.
The Chronic Hepatitis B Virus Pipeline Insight Report by Expert Market Research gives comprehensive insights into chronic hepatitis B virus therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for chronic hepatitis B virus therapeutics. The chronic hepatitis B virus therapeutics report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The chronic hepatitis B virus therapeutics 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 chronic hepatitis B virus therapeutics 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 chronic hepatitis B virus therapeutics.
Chronic hepatitis B virus (cHBV) is a long-term liver infection caused by the hepatitis B virus (HBV). It occurs when the immune system fails to clear the virus after acute infection, leading to persistent viral replication. Transmission happens through infected blood, unprotected sex, or from mother to child at birth, increasing the risk of liver damage, cirrhosis, and liver cancer.
Chronic Hepatitis B is managed with antiviral medications that suppress viral replication and reduce liver damage. Nucleos(t)ide analogues like entecavir and tenofovir are first-line treatments, while pegylated interferon is used in select cases. Emerging therapies aim to achieve functional cure by targeting HBV replication and immune response. Regular monitoring and liver health management remain crucial for disease control and prevention of complications. In February 2024, GSK announced that the US FDA has granted fast track designation for Bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B, expediting its development as a potential functional cure for millions worldwide.
Hepatitis B continues to be a major global health challenge. In 2022, an estimated 257 million people were living with HBV worldwide, with approximately 1.5 million new cases reported annually. In the United States, chronic infections range between 880,000 and 1.89 million cases. The United Kingdom reports an estimated 268,000 cases, while Japan has nearly 1 million. India recorded the second-highest number of hepatitis B and C cases in 2022.
This section of the report covers the analysis of chronic hepatitis B virus drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
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 covers a major share of the total chronic hepatitis B virus clinical trials.
In the chronic hepatitis B virus pipeline, most candidates are in Phase II with 41.84% of the projects, followed by 27.55% in Phase I and 19.39% in Phase IV. Additionally, 8.16% are in Phase III and 3.06% are in Early Phase I, demonstrating a broad spectrum of development stages and diverse progress toward potential treatments.
The drug molecule categories covered under the chronic hepatitis B virus pipeline analysis include small molecules, RNA-based therapies, peptides, biologics, and gene editing therapies. The chronic hepatitis B virus report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for chronic hepatitis B virus.
Capsid assembly modulators (CAMs) are emerging as promising agents in the chronic hepatitis B virus pipeline. For example, HAP18, a small molecule assembly agonist, disrupts the HBV core protein dimer’s hydrogen bonding while stabilizing capsids. This dual action results in empty, defective capsids and impedes viral genome release, reducing the formation of new infectious particles.
The EMR report for the chronic hepatitis B virus pipeline analysis covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in chronic hepatitis B virus 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 chronic hepatitis B virus. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of chronic hepatitis B virus drug candidates.
Bepirovirsen, developed by GlaxoSmithKline, is an investigational antisense oligonucleotide (ASO) designed for the treatment of chronic hepatitis B (CHB). It works by targeting and degrading hepatitis B virus RNA, inhibiting viral DNA replication, reducing hepatitis B surface antigen (HBsAg) levels, and stimulating the immune response. The drug candidate is a part of a Phase III study, which aims to confirm its efficacy, safety, and durability in nucleos(t)ide analogue-treated patients.
VIR-2218, VIR-3434, and PEG-IFNα are being evaluated in a Phase II study sponsored by Vir Biotechnology, Inc. The study aims to assess their safety, tolerability, and efficacy in chronic hepatitis B virus (HBV) infection. VIR-3434, a monoclonal antibody, targets HBV surface antigen (HBsAg), while VIR-2218, a small interfering RNA (siRNA), reduces HBV replication.
ABI-4334 is undergoing clinical development to target chronic hepatitis B virus (cHBV). In this Phase I study, sponsored by Assembly Biosciences, researchers are evaluating its safety, pharmacokinetics, and antiviral activity. ABI-4334 disrupts HBV capsids in the cytoplasm, preventing viral entry into the nucleus and blocking the formation of covalently closed circular DNA (cccDNA), essential for HBV replication.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Chronic Hepatitis B Virus Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for chronic hepatitis B virus. 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 chronic hepatitis B virus collaborations, regulatory environments, and potential growth opportunities.
Hepatitis B Virus (HBV) Infection Drug Pipeline Analysis Report
*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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