Chronic Hepatitis Delta Virus (HDV) Infection - Pipeline Insight, 2025
Description
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
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-α) and pegylated interferon-alpha (PEG-IFN-α) 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
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
Further product details are provided in the report……..
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:
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
Current Treatment Scenario and Emerging Therapies:
Geography Covered
- Global coverage
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-α) and pegylated interferon-alpha (PEG-IFN-α) 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.
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.
- JNJ-73763989: Janssen Research & Development, LLC
- HH-1270: Huahui Health Ltd.
Further product details are provided in the report……..
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
- 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
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
- Molecule Type
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
- Product Type
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
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
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?
- Vir Biotechnology, Inc.
- Janssen Research & Development, LLC
- Huahui Health Ltd.
- REPLICor
- Ribocure Pharmaceuticals AB
- PharmaEssentia
- VIR-2218
- JNJ-73763989
- HH-1270
- REP 2139
- RBD1016
- P1101
Table of Contents
60 Pages
- 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
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Comparative Analysis
- VIR-2218: Vir Biotechnology, Inc.
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- Comparative Analysis
- Drug Name: Company Name
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Comparative Analysis
- HH-1270: Huahui Health Ltd.
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- 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
- Appendix
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