Hepatitis D Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, NICE Approval, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, United States) As per DelveInsight's assessment, globally, Hepatitis D pipeline constitutes 6+ key companies continuously working towards developing 6+ Hepatitis D treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"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.

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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 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 Virus Infection is a serious liver condition caused by the Hepatitis D virus (HDV), which only occurs in individuals already infected with Hepatitis B virus (HBV). Hepatitis D Virus Infection is considered the most severe form of viral hepatitis due to its rapid progression and high risk of complications. Hepatitis D Virus Infection leads to increased chances of liver cirrhosis, liver failure, and liver cancer compared to HBV infection alone.

Hepatitis D Virus Infection is transmitted through blood and bodily fluids, with common routes including shared needles, unprotected sex, and from mother to child during childbirth. Hepatitis D Virus Infection cannot occur without the presence of HBV, making co-infection or superinfection scenarios critical to understand. Hepatitis D Virus Infection is diagnosed through anti-HDV antibody tests and confirmed with HDV RNA testing.

Hepatitis D Virus Infection currently has limited treatment options, with interferon-based therapies offering modest success. However, newer therapies are emerging. Hepatitis D Virus Infection prevention focuses on HBV vaccination, which indirectly protects against HDV.

Hepatitis D Virus Infection awareness, early detection, and improved treatment access are essential for controlling this aggressive liver disease globally.

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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.
• lonafarnib: Eiger BioPharmaceuticals
• 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 6+ 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 at:
https://www.delveinsight.com/sample-request/hepatitis-d-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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.

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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-
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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

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