Hepatitis D Pipeline 2025: Detailed Clinical Trials and FDA-Approved Therapies Review by DelveInsight | Eiger BioPharma, Gilead Sciences, Shanghai HEP Pharma, Hepatera Ltd. Vir Biotech, Ribocure Pharm

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Hepatitis D pipeline constitutes 8+ key companies continuously working towards developing 10+ Hepatitis D treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Hepatitis D Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/hepatitis-d-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" 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:

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Companies across the globe are diligently working toward developing novel Hepatitis D treatment therapies with a considerable amount of success over the years.

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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

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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.

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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.

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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.

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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.

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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).

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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.

Get a Free Sample PDF Report to know more about Hepatitis D Pipeline Therapeutic Assessment-

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Emerging Hepatitis D Drugs Under Different Phases of Clinical Development Include:

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lonafarnib: Eiger BioPharmaceuticals

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Bulevirtide: Gilead Sciences

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Hepalatide: Shanghai HEP Pharmaceutical

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PEG IFN alfa-2a: Hepatera Ltd.

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lonafarnib: Eiger BioPharmaceuticals

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VIR-2218: Vir Biotechnology, Inc.

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Lonafarnib: Soroka University Medical Center

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RBD1016: Ribocure Pharmaceuticals AB

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JNJ-73763989: Janssen Research & Development

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peginterferon alfa-2a [Pegasys]: Hoffmann-La Roche

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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

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Oral

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Parenteral

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Intravenous

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Subcutaneous

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Topical

Hepatitis D Molecule Type

Hepatitis D Products have been categorized under various Molecule types, such as

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Monoclonal Antibody

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Peptides

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Polymer

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Small molecule

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Gene therapy

Hepatitis D Pipeline Therapeutics Assessment

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Hepatitis D Assessment by Product Type

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Hepatitis D By Stage and Product Type

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Hepatitis D Assessment by Route of Administration

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Hepatitis D By Stage and Route of Administration

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Hepatitis D Assessment by Molecule Type

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Hepatitis D by Stage and Molecule Type

DelveInsight's Hepatitis D Report covers around 10+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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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 [https://www.delveinsight.com/sample-request/hepatitis-d-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

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

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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.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hepatitis D Treatment.

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Hepatitis D key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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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.

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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 [https://www.delveinsight.com/sample-request/hepatitis-d-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Hepatitis D Pipeline Market Drivers

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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

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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

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Coverage: Global

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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

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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

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Hepatitis D Therapeutic Assessment: Hepatitis D current marketed and Hepatitis D emerging therapies

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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 [https://www.delveinsight.com/sample-request/hepatitis-d-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

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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