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PUBLISHER: DelveInsight | PRODUCT CODE: 1648553

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PUBLISHER: DelveInsight | PRODUCT CODE: 1648553

Chronic Hepatitis Delta Virus (HDV) Infection - Pipeline Insight, 2025

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DelveInsight's, "Chronic Hepatitis Delta Virus (HDV) Infection - Pipeline Insight, 2025" report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Chronic Hepatitis Delta Virus (HDV) Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

  • Global coverage

Chronic Hepatitis Delta Virus (HDV) Infection: Understanding

Chronic Hepatitis Delta Virus (HDV) Infection: Overview

Hepatitis D virus (HDV) was first identified in 1977 and is unique because it requires hepatitis B virus (HBV) to replicate. Chronic HDV infection is considered the most severe form of viral hepatitis, leading to significantly higher rates of cirrhosis and hepatocellular carcinoma compared to HBV mono-infection. Despite the discovery of HDV over 40 years ago, no FDA-approved treatment currently exists, and interferon alpha, the main therapeutic option, offers limited efficacy. Consequently, liver transplantation remains the final treatment option for those with advanced disease, though promising new therapies are under investigation. The virus is mainly transmitted through blood and bodily fluids, with higher prevalence in regions where HBV is endemic. Researchers are focusing on developing antiviral drugs that specifically target HDV replication. Early diagnosis and monitoring are crucial to managing the progression and complications of chronic HDV infection.

Chronic hepatitis B virus (HBV) infection affects approximately 587 million people globally, with 62-72 million chronically infected with hepatitis D virus (HDV). Eight HDV genotypes have been identified, with genotype 1 being the most widespread, while genotypes 2 and 4 are primarily found in Asia, genotype 3 in the Amazon Basin, and genotypes 5-8 in Africa. The prevalence of HDV varies significantly by region, with higher rates observed in Africa and South America. Retrospective studies have shown that HDV infection is more common in men, and high-risk groups include individuals from endemic areas, intravenous drug users, men who have sex with men, those co-infected with HIV or HCV, and individuals with multiple sexual partners. A decline in new cases of acute HBV and HDV infections was noted in Spain between 1983 and 2008, likely due to policy changes such as the inclusion of HBV vaccination for all newborns and adolescents. Today, immigration and sexual transmission are considered the primary risk factors for HDV infection.

The pathogenesis of chronic hepatitis D virus (HDV) infection is complex, with interactions between HDV and hepatitis B virus (HBV) leading to more severe liver damage than HBV alone. Studies show that HDV replication can either dominate or coexist with HBV, and this co-infection accelerates liver damage, including necrosis and cirrhosis. HDV induces direct cytotoxic damage through its delta antigen (HDAg), while immune responses involving cytokines, the JAK-STAT pathway, and CD8+ T cells contribute to the disease process. Additionally, genomic studies highlight specific pathways in HDV-related hepatocellular carcinoma (HCC) that drive liver damage and tumor progression. These findings suggest that HDV's pathogenic effects are not only immune-mediated but also directly linked to viral-induced cellular changes. Research continues to investigate how the virus and immune system interact to better understand disease mechanisms. Targeting these pathways may open new avenues for therapeutic interventions.

Treatment for chronic hepatitis D virus (HDV) infection has seen limited progress since the 1980s, with interferon-alpha (IFN-a) and pegylated interferon-alpha (PEG-IFN-a) being the main therapies used off-label. The goal of treatment is to suppress HDV replication and prevent liver damage, though achieving complete eradication of both HDV and HBV is rare. While sustained HDV RNA undetectability is possible in a subset of patients, the benefit is often not long-lasting. If HBV DNA is also present, nucleoside analogues like entecavir or tenofovir may be used to suppress HBV replication, but they have no effect on HDV. Current guidelines recommend antiviral therapy for all HBV DNA-positive patients to manage co-infection. Despite the limited efficacy of current treatments, ongoing clinical trials are exploring new therapies that may offer better outcomes for chronic HDV infection.

"Chronic Hepatitis Delta Virus (HDV) Infection- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chronic Hepatitis Delta Virus (HDV) Infection pipeline landscape is provided which includes the disease overview and Chronic Hepatitis Delta Virus (HDV) Infection treatment guidelines. The assessment part of the report embraces, in depth Chronic Hepatitis Delta Virus (HDV) Infection commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Chronic Hepatitis Delta Virus (HDV) Infection collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Hepatitis Delta Virus (HDV) Infection R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Hepatitis Delta Virus (HDV) Infection.

Chronic Hepatitis Delta Virus (HDV) Infection Emerging Drugs Chapters

This segment of the Chronic Hepatitis Delta Virus (HDV) Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Chronic Hepatitis Delta Virus (HDV) Infection Emerging Drugs

  • VIR-2218: Vir Biotechnology, Inc.

VIR-2218 is a combination of Tobevibart and Elebsiran. Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. VIR-2218 has also received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD) Currently, the drug is in Phase II stage of its development for the treatment of Chronic Hepatitis Delta Virus (HDV) Infection.

  • JNJ-73763989: Janssen Research & Development, LLC

JNJ-73763989 (ARO-HBV), is being developed in collaboration with GSK to be a potentially curative therapy for patients with chronic hepatitis D infection, when used in combination with other direct antivirals. ARO-HBV is a sub-cutaneous, ribonucleic acid interference (RNAi) therapy candidate which is designed to silence all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act. The company believes this may allow the body's natural immune defenses to clear the virus and potentially lead to a functional cure. Currently, the drug is in Phase II stage of its development for the treatment of Chronic Hepatitis Delta Virus (HDV) Infection.

  • HH-1270: Huahui Health Ltd.

HH-1270 is an innovative therapeutic agent developed by Huahui Health for the treatment of hepatitis D infection. The mechanism of action of HH-1270 involves the inhibition of the viral entry process into hepatocytes by targeting specific receptors utilized by HDV, particularly the Sodium Taurocholate Cotransporting Polypeptide (NTCP). By blocking this receptor, HH-1270 effectively prevents HDV from entering liver cells, thereby reducing viral replication and associated liver damage. This targeted approach not only aims to improve liver function but also addresses the underlying pathophysiology of hepatitis D, offering a promising new strategy for managing this challenging viral infection. Currently, the drug is in Preclinical stage of its development for the treatment of Chronic Hepatitis Delta Virus (HDV) Infection.

Chronic Hepatitis Delta Virus (HDV) Infection: Therapeutic Assessment

This segment of the report provides insights about the different Chronic Hepatitis Delta Virus (HDV) Infection drugs segregated based on following parameters that define the scope of the report, such as:

  • Major Players in Chronic Hepatitis Delta Virus (HDV) Infection
  • There are approx. 8+ key companies which are developing the therapies for Chronic Hepatitis Delta Virus (HDV) Infection. The companies which have their Chronic Hepatitis Delta Virus (HDV) Infection drug candidates in the most advanced stage, i.e. Phase II include, Vir Biotechnology, Inc.
  • Phases

DelveInsight's report covers around 10+ products under different phases of clinical development like

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration

Chronic Hepatitis Delta Virus (HDV) Infection pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy
  • Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chronic Hepatitis Delta Virus (HDV) Infection: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Chronic Hepatitis Delta Virus (HDV) Infection therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chronic Hepatitis Delta Virus (HDV) Infection drugs.

Chronic Hepatitis Delta Virus (HDV) Infection Report Insights

  • Chronic Hepatitis Delta Virus (HDV) Infection Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Chronic Hepatitis Delta Virus (HDV) Infection Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Chronic Hepatitis Delta Virus (HDV) Infection drugs?
  • How many Chronic Hepatitis Delta Virus (HDV) Infection drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Hepatitis Delta Virus (HDV) Infection?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Hepatitis Delta Virus (HDV) Infection therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Chronic Hepatitis Delta Virus (HDV) Infection and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Vir Biotechnology, Inc.
  • Janssen Research & Development, LLC
  • Huahui Health Ltd.
  • REPLICor
  • Ribocure Pharmaceuticals AB
  • PharmaEssentia

Key Products

  • VIR-2218
  • JNJ-73763989
  • HH-1270
  • REP 2139
  • RBD1016
  • P1101
Product Code: DIPI1166

Table of Contents

Introduction

Executive Summary

Chronic Hepatitis Delta Virus (HDV) Infection: Overview

  • Introduction
  • Causes
  • Pathophysiology
  • Signs and Symptoms
  • Diagnosis
  • Treatment

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Chronic Hepatitis Delta Virus (HDV) Infection- DelveInsight's Analytical Perspective

Late Stage Products (Phase III)

  • Comparative Analysis

Drug Name: Company Name

  • Product Description
  • Research and Development
  • Product Development Activities

Mid Stage Products (Phase II)

  • Comparative Analysis

VIR-2218: Vir Biotechnology, Inc.

  • Product Description
  • Research and Development
  • Product Development Activities

Early Stage Products (Phase I)

  • Comparative Analysis

Drug Name: Company Name

  • Product Description
  • Research and Development
  • Product Development Activities

Preclinical and Discovery Stage Products

  • Comparative Analysis

HH-1270: Huahui Health Ltd.

  • Product Description
  • Research and Development
  • Product Development Activities

Inactive Products

  • Comparative Analysis

Chronic Hepatitis Delta Virus (HDV) Infection Key Companies

Chronic Hepatitis Delta Virus (HDV) Infection Key Products

Chronic Hepatitis Delta Virus (HDV) Infection- Unmet Needs

Chronic Hepatitis Delta Virus (HDV) Infection- Market Drivers and Barriers

Chronic Hepatitis Delta Virus (HDV) Infection- Future Perspectives and Conclusion

Chronic Hepatitis Delta Virus (HDV) Infection Analyst Views

Chronic Hepatitis Delta Virus (HDV) Infection Key Companies

Product Code: DIPI1166

List of Tables

  • Table 1 Total Products for Chronic Hepatitis Delta Virus (HDV) Infection
  • Table 2 Late Stage Products
  • Table 3 Mid Stage Products
  • Table 4 Early Stage Products
  • Table 5 Pre-clinical & Discovery Stage Products
  • Table 6 Assessment by Product Type
  • Table 7 Assessment by Stage and Product Type
  • Table 8 Assessment by Route of Administration
  • Table 9 Assessment by Stage and Route of Administration
  • Table 10 Assessment by Molecule Type
  • Table 11 Assessment by Stage and Molecule Type
  • Table 12 Inactive Products

List of Figures

  • Figure 1 Total Products for Chronic Hepatitis Delta Virus (HDV) Infection
  • Figure 2 Late Stage Products
  • Figure 3 Mid Stage Products
  • Figure 4 Early Stage Products
  • Figure 5 Preclinical and Discovery Stage Products
  • Figure 6 Assessment by Product Type
  • Figure 7 Assessment by Stage and Product Type
  • Figure 8 Assessment by Route of Administration
  • Figure 9 Assessment by Stage and Route of Administration
  • Figure 10 Assessment by Molecule Type
  • Figure 11 Assessment by Stage and Molecule Type
  • Figure 12 Inactive Products
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Jeroen Van Heghe

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+32-2-535-7543

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Christine Sirois

Manager - Americas

+1-860-674-8796

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