Chronic hepatitis delta virus (HDV) Infection is a severe form of viral hepatitis driven by an RNA virus that requires hepatitis B virus (HBV) to replicate. According to Jiyoon Park et al. (2025), HDV has a global prevalence of approximately 4.5% among HBV-infected patients, roughly 12 million people worldwide. Clinically, interferon-alpha (including pegylated forms) remains the only treatment option, though its benefits are limited. The pipeline landscape, per chronic hepatitis delta virus infection pipeline analysis by Expert Market Research, features over eight companies and more than ten drug candidates in various stages. These include RNA-targeted agents, monoclonal antibodies, entry inhibitors and combination therapies, offering hope for better disease management and functional cures soon. Emerging innovation and intensified R&D signal significant growth ahead in HDV therapeutic development.
Major companies involved in the chronic hepatitis delta virus (HDV) infection pipeline analysis include Gilead Sciences, Vir Biotechnology, Inc., and others.
Leading drugs currently in the pipeline include HH-003, VIR-2218, RBD1016, and others.
The growth of chronic hepatitis delta virus (HDV) infection pipeline is driven by rising clinical trials, novel antiviral mechanisms, and increasing regulatory support for targeted therapies and combination treatments.
The Chronic Hepatitis Delta Virus (HDV) Infection Pipeline Analysis Report by Expert Market Research gives comprehensive insights into chronic hepatitis delta virus (HDV) infection therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for chronic hepatitis delta virus (HDV) infection. The chronic hepatitis delta virus (HDV) infection report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The chronic hepatitis delta virus (HDV) infection pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with chronic hepatitis delta virus (HDV) infection treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to chronic hepatitis delta virus (HDV) infection.
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Chronic hepatitis delta virus (HDV) infection is a severe liver disease caused by the hepatitis D virus, which requires Hepatitis B surface antigen for replication. It spreads through blood contact, unsafe injections, and unprotected sexual activity.
Chronic hepatitis delta virus (HDV) infection treatments include antiviral therapies, interferon-based regimens, and entry inhibitors such as bulevirtide, which aim to suppress viral replication and improve long-term liver function. In May 2025, Bulevirtide (Hepcludex®) entered Ireland’s chronic hepatitis delta virus (HDV) infection pipeline under the High Tech Arrangement with a Managed Access Protocol, enabling reimbursement for eligible plasma HDV-RNA positive adult patients with compensated liver disease.
Chronic hepatitis delta virus (HDV) infection continues to represent a significant global health concern. According to Jiyoon Park et al., 2025, it affects an estimated 12 million individuals worldwide, with a prevalence of 4.5% among hepatitis B virus (HBV) patients. The United States shows a prevalence of 4.6%, compared to 3% in Europe and 6% in Africa among HBV surface antigen-positive individuals, reflecting notable regional variations in disease burden.
This section of the report covers the analysis of chronic hepatitis delta virus (HDV) infection drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The chronic hepatitis delta virus (HDV) infection pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II accounted for 61% covers a major share of the total chronic hepatitis delta virus (HDV) infection clinical trials. Phase III represented 31%, highlighting promising late-stage developments. Together, these segments drive growth and future opportunities in the HDV Infection market.
The drug molecule categories covered under the chronic hepatitis delta virus (HDV) infection pipeline analysis include small molecules, monoclonal antibodies, gene therapies, polymers, and peptides. The chronic hepatitis delta virus (HDV) infection report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for chronic hepatitis delta virus (HDV) infection. Monoclonal antibodies and small interfering ribonucleic acid (siRNA) therapies are emerging in the chronic hepatitis delta virus (HDV) infection pipeline. For instance, Tobevibart, a monoclonal antibody targeting both hepatitis B and HDV, is being investigated alone and in combination with Elebsiran, an HBV-targeting siRNA. This combination has shown encouraging virologic responses and received Fast Track designation from the United States Food and Drug Administration.
The EMR report for the chronic hepatitis delta virus (HDV) infection pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed chronic hepatitis delta virus (HDV) infection therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in chronic hepatitis delta virus (HDV) infection clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for chronic hepatitis delta virus (HDV) infection. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of chronic hepatitis delta virus (HDV) infection drug candidates.
HH-003 injection, developed by Huahui Health, is a human monoclonal antibody targeting the preS1 domain of the large envelope protein of HBV and HDV. By blocking the binding of preS1 to NTCP, it is preventing viral infection and re-infection of hepatocytes. This Phase IIb multicenter, randomized, open-label study is assessing the efficacy and safety of HH-003 in chronic HDV patients, intending to evaluate antiviral activity and liver function improvement.
SOLSTICE, sponsored by Vir Biotechnology, Inc., is a Phase 2 trial evaluating the combination therapy of VIR-2218 and VIR-3434 for chronic hepatitis D virus (HDV) infection. VIR-2218, a subcutaneously administered siRNA developed with Alnylam Pharmaceuticals, is designed to target HBV while reducing HDV replication through its enhanced stabilization chemistry plus (ESC+) technology. This study is examining safety, tolerability, and efficacy, with participants transitioning from monotherapy to combination therapy for improved outcomes.
RBD1016, developed by Ribocure Pharmaceuticals AB, is under evaluation in a Phase 2a multicentre trial for chronic hepatitis D virus (HDV) infection. The study is examining its efficacy, safety, and pharmacokinetics compared with placebo. Administered via subcutaneous injection, RBD1016 is a novel antiviral candidate designed to target both hepatitis B and hepatitis D. Participants are receiving either active treatment or deferred dosing, aiming to assess reductions in HDV RNA levels and overall clinical outcomes.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Chronic Hepatitis Delta Virus (HDV) Infection Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for chronic hepatitis delta virus (HDV) infection. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into chronic hepatitis delta virus (HDV) infection collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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