Hepatitis D - Pipeline Insight, 2025

Published Date : 2025
Pages : 60
Region : Global,

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hepatitis d pipeline insight

DelveInsight’s, “Hepatitis D - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Hepatitis D 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

  • Global coverage

Hepatitis D: Understanding

Hepatitis D: Overview

Hepatitis D virus (HDV), first identified in 1977 in patients with chronic hepatitis B virus (HBV) infection, is a unique, defective RNA virus that depends entirely on HBV for its replication and transmission. Known as the delta agent, HDV uses the hepatitis B surface antigen (HBsAg) from HBV to form its outer envelope, making it capable of infecting only individuals who are also infected with HBV. Structurally simple, HDV carries a small, circular RNA genome and encodes only the hepatitis D antigen (HDAg), relying heavily on host cellular machinery for replication. Interestingly, HDV infection often suppresses HBV replication through mechanisms that are not yet fully understood. HDV can manifest either as a co-infection with HBV, which usually results in an acute and self-limiting disease, or as a superinfection in individuals with chronic HBV, which typically leads to more severe outcomes. Co-infection with HDV is associated with accelerated liver damage, a higher likelihood of cirrhosis, and an increased risk of liver failure and hepatocellular carcinoma compared to HBV infection alone, making it the most severe form of viral hepatitis.

Hepatitis D infection can present with a broad spectrum of symptoms, many of which overlap with those seen in other forms of viral hepatitis. Early signs often include non-specific symptoms such as fever, fatigue, loss of appetite, nausea, and vomiting, which can be mistaken for a general viral illness. As the infection progresses, more liver-specific signs may appear, such as dark urine, pale-colored stools, and jaundice—the yellowing of the skin and eyes—indicative of impaired liver function and elevated bilirubin levels. Some patients may also report abdominal discomfort or pain, particularly in the upper right quadrant, along with joint pain. In severe or advanced cases, complications like confusion, spontaneous bruising, or bleeding may emerge, signaling worsening liver function or potential liver failure. The severity of symptoms can vary greatly depending on whether the infection is acute or chronic and whether it occurs as a co-infection or superinfection with hepatitis B.

Hepatitis D virus (HDV) is a defective RNA virus that relies on hepatitis B virus (HBV) for replication and uses HBV surface proteins to form its outer envelope. It encodes only the hepatitis D antigen (HDAg), with two forms: a short one that supports replication and a long one that facilitates viral assembly. HDV infects only individuals already carrying HBV and can present as either an acute coinfection or a more severe superinfection, the latter often leading to chronic liver disease. Liver damage is mainly driven by the host immune response, with disease severity influenced by HDV genotype—genotype 1 being the most common and aggressive.

Treatment options for hepatitis D virus (HDV) remain limited, particularly for acute infection, for which no approved therapies exist. For chronic HDV, pegylated interferon alpha is the preferred option, though it is not FDA-approved, and its effectiveness varies. It is usually given once weekly for a year or more, with the goal of suppressing viral replication and reducing liver inflammation. Success is measured by the clearance of HDV RNA from the blood and improvement in liver enzyme levels. In advanced cases progressing to cirrhosis, liver transplantation becomes the only viable treatment.

"Hepatitis D- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hepatitis D pipeline landscape is provided which includes the disease overview and Hepatitis D treatment guidelines. The assessment part of the report embraces, in depth Hepatitis D 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, Hepatitis D 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 Hepatitis D R&D. The therapies under development are focused on novel approaches to treat/improve Hepatitis D.

Hepatitis D Emerging Drugs Chapters

This segment of the Hepatitis D 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.

Hepatitis D Emerging Drugs

  • Tobevibart + Elebsiran: Vir Biotechnology/ Alnylam Pharmaceuticals

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. It is the first asset in Vir Biotechnology’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. Currently, this combination drug product is in Phase III stage of its development for the treatment of Hepatitis D.

  • Brelovitug: Bluejay Therapeutics

Brelovitug is an investigational, highly potent, pan-genotypic, fully human IgG1 mAb that targets the anti-HBsAg on both the HDV and the HBV. Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which gives brelovitug a potentially advantageous safety profile and makes it a potentially efficacious treatment for CHD, a condition with urgent unmet medical need. In addition, brelovitug has shown immunomodulatory functions in CHB patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. Currently, the drug is in the Phase II/III stage of its development for the treatment of Hepatitis D.

  • RBD1016: Ribocure Pharmaceuticals AB

RBD1016 is a GalNAc-siRNA drug independently developed by Ribo based on its proprietary GalNAc-siRNA platform, targeting the X gene of hepatitis B virus. It inhibits all four HBV transcripts through the RNA interference mechanism, and can simultaneously inhibit HBV DNA replication, reduce cccDNA and integrate DNA derived HBsAg and other antigens. RBD1016 demonstrates well-tolerated safety profile in Phase I study including both healthy subjects and patients with CHB infection. RBD1016 shows a highly efficient long-acting effect of reducing the HBsAg in patients. Currently, the drug is in Phase II stage of its development for the treatment of Hepatitis D.

Further product details are provided in the report……..

Hepatitis D: Therapeutic Assessment

This segment of the report provides insights about the different Hepatitis D drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hepatitis D

There are approx. 8+ key companies which are developing the therapies for Hepatitis D. The companies which have their Hepatitis D drug candidates in the most advanced stage, i.e. Phase II include, Vir Biotechnology/ Alnylam Pharmaceuticals.

Phases

DelveInsight’s 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) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates

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
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Molecule Type

Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hepatitis D: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Hepatitis D 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 Hepatitis D drugs.

Hepatitis D Report Insights

  • Hepatitis D Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Hepatitis D Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Hepatitis D drugs?
  • How many Hepatitis D drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hepatitis D?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Hepatitis D 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 Hepatitis D and their status?
  • What are the key designations that have been granted to the emerging drugs?

Tags:

  • Hepatitis D Pipeline
  • Hepatitis D clinical trials
  • Hepatitis D companies
  • Hepatitis D drugs