“Hepatitis D Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Hepatitis D Market.
The Hepatitis D Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the Hepatitis D Pipeline Report:
Companies across the globe are diligently working toward developing novel Hepatitis D treatment therapies with a considerable amount of success over the years.
Hepatitis D companies working in the treatment market are Eiger BioPharmaceuticals, Gilead Sciences, Shanghai HEP Pharmaceutical, Hepatera Ltd. Vir Biotechnology, Inc., Soroka University Medical Center, Ribocure Pharmaceuticals AB, Janssen Research & Development, Hoffmann-La Roche, Hepatera Ltd, and others, are developing therapies for the Hepatitis D treatment
Emerging Hepatitis D therapies in the different phases of clinical trials are- lonafarnib, Bulevirtide, Hepalatide, PEG IFN alfa-2a, VIR-2218, Lonafarnib, RBD1016, JNJ-73763989, peginterferon alfa-2a [Pegasys], Myrcludex B, and others are expected to have a significant impact on the Hepatitis D market in the coming years.
In May 2025, In a Phase II trial (NCT05461170) for hepatitis D, Vir Biotechnology’s combination therapy demonstrated promising results, with all six patients achieving a sustained virologic response at their last visit. Additionally, every patient showed either hepatitis D virus RNA levels below the limit of detection (LOD) or a reduction of at least 2 log10 IU/mL from baseline.
In March 2025, The first patient was enrolled in ECLIPSE 1, a Phase 3 clinical trial evaluating Vir Biotechnology’s investigational combination of tobevibart and elebsiran in adults with chronic hepatitis D. This trial marks the start of the Phase 3 ECLIPSE program, which, if successful, is expected to support regulatory submissions for the approval of this dual therapy for hepatitis D (hepatitis delta). ECLIPSE 1 aims to enroll up to 120 participants across the U.S. and selected regions outside Europe, with an additional Phase 3 study, ECLIPSE 2, planned to further advance this effort.
In January 2025, The U.S. FDA granted Breakthrough Therapy designation to brelovitug, an investigational hepatitis D treatment from Bluejay Therapeutics. This designation is given to therapies that show significant potential in addressing serious conditions and demonstrate promising results in early clinical trials. It aims to accelerate the development and approval process, ensuring patients gain faster access to innovative treatments.
In December 2024, Vir Biotechnology’s experimental treatment combination, tobevibart and elebsiran, for chronic hepatitis D has received Breakthrough Therapy designation from the U.S. FDA and PRIME designation from the European Medicines Agency (EMA).
In November 2024, Vir Biotechnology, Inc. (NASDAQ: VIR) announced positive findings from the SOLSTICE Phase 2 trial assessing tobevibart, alone or with elebsiran, in individuals with chronic hepatitis delta (CHD). This investigational monoclonal antibody and siRNA combination, dosed monthly, achieved a 100% virologic response with rapid suppression of hepatitis delta virus (HDV) RNA. By Week 24, 41% (13/32) of participants had HDV RNA below the lower limit of quantification (LLOQ) with target not detected (TND), increasing to 64% (14/22) by Week 36. Among those who reached Week 60, 80% (4/5) achieved HDV RNA TND, demonstrating promising antiviral activity.
Hepatitis D Overview
Hepatitis D, also known as hepatitis delta, is a liver infection caused by the hepatitis D virus (HDV). It is a defective virus that requires the presence of hepatitis B virus (HBV) to replicate. Hepatitis D is transmitted through contact with infected blood or bodily fluids, often occurring in individuals already infected with HBV. It can lead to severe liver disease, including cirrhosis and liver failure. The infection is more aggressive than HBV alone, with a higher risk of complications. Currently, there is no specific antiviral treatment, but HBV vaccination can help prevent hepatitis D infection.
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Emerging Hepatitis D Drugs Under Different Phases of Clinical Development Include:
lonafarnib: Eiger BioPharmaceuticals
Bulevirtide: Gilead Sciences
Hepalatide: Shanghai HEP Pharmaceutical
PEG IFN alfa-2a: Hepatera Ltd.
VIR-2218: Vir Biotechnology, Inc.
Lonafarnib: Soroka University Medical Center
RBD1016: Ribocure Pharmaceuticals AB
JNJ-73763989: Janssen Research & Development
peginterferon alfa-2a [Pegasys]: Hoffmann-La Roche
Myrcludex B: Hepatera Ltd
Hepatitis D Route of Administration
Hepatitis D 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
Parenteral
Intravenous
Subcutaneous
Topical
Hepatitis D Molecule Type
Hepatitis D Products have been categorized under various Molecule types, such as
Monoclonal Antibody
Peptides
Polymer
Small molecule
Gene therapy
Hepatitis D Pipeline Therapeutics Assessment
Hepatitis D Assessment by Product Type
Hepatitis D By Stage and Product Type
Hepatitis D Assessment by Route of Administration
Hepatitis D By Stage and Route of Administration
Hepatitis D Assessment by Molecule Type
Hepatitis D by Stage and Molecule Type
DelveInsight’s Hepatitis D 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)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Further Hepatitis D product details are provided in the report. Download the Hepatitis D pipeline report to learn more about the emerging Hepatitis D therapies
Some of the key companies in the Hepatitis D Therapeutics Market include:
Key companies developing therapies for Hepatitis D are – Pharma Essentia, REPLICor, SomaGenics, Eiger Biopharmaceuticals, Arrowhead Pharmaceuticals, Antios Therapeutics, Vir Biotechnology, VLP Biotech, and others.
Hepatitis D Pipeline Analysis:
The Hepatitis D pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Hepatitis D with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hepatitis D Treatment.
Hepatitis D key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Hepatitis D Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hepatitis D market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Download Sample PDF Report to know more about Hepatitis D drugs and therapies
Hepatitis D Pipeline Market Drivers
Rising Prevalence of Hepatitis D, Advancements in Antiviral Therapies, Growing Awareness and Screening Programs, Government and Non-Profit Support, Emerging Targeted Therapies, Strategic Collaborations and Investments, are some of the important factors that are fueling the Hepatitis D Market.
Hepatitis D Pipeline Market Barriers
However, Limited Treatment Options, High Cost of Therapies, Low Awareness and Diagnosis Rates, Regulatory Challenges, Co-infection with HBV Challenges, Limited Access to Healthcare in Developing Regions, and other factors are creating obstacles in the Hepatitis D Market growth.
Scope of Hepatitis D Pipeline Drug Insight
Coverage: Global
Key Hepatitis D Companies: Eiger BioPharmaceuticals, Gilead Sciences, Shanghai HEP Pharmaceutical, Hepatera Ltd. Vir Biotechnology, Inc., Soroka University Medical Center, Ribocure Pharmaceuticals AB, Janssen Research & Development, Hoffmann-La Roche, Hepatera Ltd, and others
Key Hepatitis D Therapies: lonafarnib, Bulevirtide, Hepalatide, PEG IFN alfa-2a, VIR-2218, Lonafarnib, RBD1016, JNJ-73763989, peginterferon alfa-2a [Pegasys], Myrcludex B, and others
Hepatitis D Therapeutic Assessment: Hepatitis D current marketed and Hepatitis D emerging therapies
Hepatitis D Market Dynamics: Hepatitis D market drivers and Hepatitis D market barriers
Request for Sample PDF Report for Hepatitis D Pipeline Assessment and clinical trials
Table of Contents
1. Hepatitis D Report Introduction
2. Hepatitis D Executive Summary
3. Hepatitis D Overview
4. Hepatitis D- Analytical Perspective In-depth Commercial Assessment
5. Hepatitis D Pipeline Therapeutics
6. Hepatitis D Late Stage Products (Phase II/III)
7. Hepatitis D Mid Stage Products (Phase II)
8. Hepatitis D Early Stage Products (Phase I)
9. Hepatitis D Preclinical Stage Products
10. Hepatitis D Therapeutics Assessment
11. Hepatitis D Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Hepatitis D Key Companies
14. Hepatitis D Key Products
15. Hepatitis D Unmet Needs
16 . Hepatitis D Market Drivers and Barriers
17. Hepatitis D Future Perspectives and Conclusion
18. Hepatitis D Analyst Views
19. Appendix
20. About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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