Chronic Hepatitis B Virus Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight

Chronic Hepatitis B Virus Clinical Trials

(Albany, USA) DelveInsight’s “Chronic Hepatitis B Virus Pipeline Insight 2025” report delivers in-depth insights into more than 50 companies and over 55 pipeline therapies shaping the Chronic Hepatitis B Virus (HBV) treatment landscape. The report presents comprehensive profiles of pipeline candidates across clinical and preclinical stages. It also evaluates therapeutics by product category, development stage, route of administration, and molecule type, while identifying discontinued or inactive assets within the market.

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Key Takeaways from the Chronic Hepatitis B Virus Pipeline Report

• In April 2025, Vir Biotechnology Inc. unveiled a Phase 1b/2 platform study framework aimed at assessing the safety and therapeutic potential of investigational candidates and combination regimens for adults diagnosed with chronic hepatitis B virus infection.

• In April 2025, GlaxoSmithKline initiated a study to evaluate safety, efficacy, and immune response following sequential administration of its ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in patients aged 18–65 who are stable on nucleos(t)ide analogue (NA) therapy. The trial is designed to measure the added clinical benefit of sequential therapy compared to GSK3228836 monotherapy. It also examines varying treatment durations (12 versus 24 weeks) of GSK3228836 before initiating GSK3528869A.

• DelveInsight’s analysis highlights a dynamic pipeline landscape, with 50+ active companies advancing 55+ therapeutic candidates targeting Chronic Hepatitis B Virus.

• Leading players in the Chronic Hepatitis B Virus domain include Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others.

• Noteworthy pipeline therapies include Peginterferon Alfacon, Daplusiran/Tomligisiran Dose Level 1, Bepirovirsen, Tenofovir disoproxil fumarate (TDF), VIR-2218, PEG-IFNα, and additional emerging candidates.

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Chronic Hepatitis B Virus Emerging Drugs Profile

Pradefovir: Ligand Pharmaceuticals

Pradefovir is an orally administered, liver-targeted prodrug of adefovir that inhibits HBV DNA polymerase/reverse transcriptase. Developed using Ligand’s HepDirect technology, Pradefovir is intended for the treatment of chronic HBV infection. The therapy is currently progressing through Phase III clinical development for Chronic Hepatitis B.

RG6346: Dicerna Pharmaceuticals

RG6346 is an investigational GalXCTM RNA interference (RNAi) therapeutic candidate developed in collaboration with Roche for chronic HBV infection. The therapy leverages RNAi technology to selectively silence genes responsible for HBV messenger RNA (mRNA) production and viral entry into hepatocytes. Preclinical studies have demonstrated more than 99.9% reduction in circulating HBsAg levels in HBV mouse models. Unlike existing treatments that primarily suppress viral replication, RG6346 holds the potential to achieve a functional cure in chronic HBV patients. The candidate is currently in Phase II clinical trials in adult HBV patients.

The Chronic Hepatitis B Virus Pipeline Report Provides Insights into

• Comprehensive profiles of companies actively developing therapies for Chronic Hepatitis B Virus, along with aggregated details of their respective pipelines.

• Categorization of therapeutic candidates across early-stage, mid-stage, and late-stage development.

• Evaluation of active and inactive (discontinued or dormant) research programs.

• Analysis of pipeline drugs based on clinical stage, route of administration, target receptor, monotherapy versus combination therapy approach, mechanism of action, and molecular class.

• In-depth coverage of strategic collaborations, licensing agreements, and funding activities supporting the advancement of Chronic Hepatitis B Virus therapeutics.

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Chronic Hepatitis B Virus Companies

Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm and others.

Chronic Hepatitis B Virus Infection Pipeline Therapeutic Assessment by Route of Administration

Pipeline products are categorized based on multiple routes of administration (ROA), including:

• Oral• Parenteral• Intravenous• Subcutaneous• Topical

Chronic Hepatitis B Virus Molecule Type Classification

Pipeline candidates are further segmented by molecular category, such as:

• Monoclonal Antibody• Peptides• Polymer• Small Molecule• Gene Therapy

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Scope of the Chronic Hepatitis B Virus Pipeline Report

• Coverage – Global

• Chronic Hepatitis B Virus Companies – Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, and others.

• Chronic Hepatitis B Virus Pipeline Therapies – Peginterferon Alfacon, Daplusiran/Tomligisiran Dose Level 1, Bepirovirsen, Tenofovir disoproxil fumarate (TDF), VIR-2218, PEG-IFNα, and additional candidates.

• Chronic Hepatitis B Virus Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination

• Chronic Hepatitis B Virus Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Chronic Hepatitis B Virus Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Chronic Hepatitis B Virus Companies, Key Products and Unmet Needs