Genital Herpes - Pipeline Insight, 2025

This “Genital Herpes - Pipeline Insight, 2025” report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Genital Herpes 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.

Genital Herpes: Understanding

Genital Herpes: Overview

Herpes genitalis is among the most common sexually transmitted infections. It is caused by the herpes simplex virus type 2 (HSV-2) and also, increasingly, the herpes simplex virus type 1 (HSV-1). Both organisms are enveloped DNA viruses that are sensitive to disinfectants and environmental factors 1. Due to marked genetic homology between HSV-1 and HSV-2 numerous biological similarities and antigenic cross-reactions between the viruses exist. Type-specific epitopes include the viral glycoproteins (g) gG (HSV-1 and HSV-2) and gC (HSV-1). The primary mode of transmission of both HSV-1 and HSV-2 is through direct contact. Initial infection with HSV-1 occurs most often during childhood following the disappearance of maternal antibodies during the first year of life. A visible outbreak consists of single or clustered vesicles on the genitalia, perineum, buttocks, upper thighs, or perianal areas that ulcerate before resolving.

Most women with genital herpes do not know they have it. But, if a person get symptoms with the first outbreak of genital herpes, they can be severe. Genital herpes also can be severe and long-lasting in people whose immune systems do not work properly, such as women with HIV. The first signs of genital herpes usually show up two to 12 days after having sexual contact with someone who has herpes. Symptoms can last from two to four weeks.

Genital herpes is diagnosed through a combination of physical examination and laboratory tests. During the physical examination, a healthcare provider will look for characteristic sores or lesions in the genital area. To confirm the diagnosis, a sample from the sore can be taken and tested using polymerase chain reaction (PCR) or viral culture to detect the presence of herpes simplex virus (HSV). Blood tests may also be conducted to identify antibodies against HSV, which indicate a past or current infection. Early and accurate diagnosis is crucial for managing symptoms and reducing the risk of transmission.

Standard first-line drugs include acyclovir, valacyclovir and famciclovir. The specific antiviral action of these acyclic nucleoside analogues is based on their phosphorylation to monophosphate form by thymidine kinase (TK), the key enzyme of HSV-1 and HSV-2, with subsequent phosphorylation via di- to triphosphate form by cellular enzymes. The triphosphate nucleoside analogues inhibit and fixate the viral DNA polymerase by being incorporated into the growing DNA chain as “false” enzyme substrates. In the case of acyclovir/valacyclovir this leads to chain termination, since hydroxyl groups in the 3′ position, which are essential for further linkage, are missing. Famciclovir may be incorporated into the growing DNA chain.

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

Genital Herpes Emerging Drugs Chapters

This segment of the Genital Herpes 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.

Genital Herpes Emerging Drugs

Pritelivir: AiCuris

Pritelivir is a highly potent inhibitor of HSV replication. It belongs to a new chemical class and acts via a novel mechanism of action (inhibition of the viral helicase-primase enzyme complex). In contrast to currently used nucleoside analogues, Pritelivir does not require activation by viral enzymes and can thus protect uninfected cells. Pritelivir is being developed for the treatment of acyclovir-resistant and dual-resistant (resistant to acyclovir and intolerant or resistant to foscarnet) infections in immune-compromised patients. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Genital Herpes.

UB-621: United BioPharma

UB-621 is a new type of anti-herpes simplex virus (HSV) monoclonal antibody being developed for the treatment of recurrent genital HSV-2 infections in adults. It is a first-in-class anti-gD monoclonal antibody that has demonstrated strong viral suppression of transmission and recurrence of both HSV-1 and HSV-2 infections. Currently, the drug is in the Phase II stage of development to treat Genital Herpes.

GSK 3943104: GlaxoSmithKline

GSK-3943104A is a therapeutic herpes simplex virus (HSV) vaccine candidate being developed by GlaxoSmithKline (GSK) for the prevention of recurrent herpes simplex virus type 2 (HSV-2) genital herpes infections. Currently, the drug is in the Phase II stage of development to treat Genital Herpes.

BNT 163: BioNTech

BNT163 is a herpes simplex virus (HSV) vaccine candidate developed by BioNTech in collaboration with the University of Pennsylvania. It is based on the company's messenger RNA (mRNA) platform and encodes three HSV-2 glycoproteins to help prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs. The vaccine was developed through a research collaboration and license agreement between BioNTech and the University of Pennsylvania, with the University receiving sponsored research funding and potential future financial benefits. Currently, the drug is in the Phase I stage of development to treat Genital Herpes.

ABI-5366: Assembly Biosciences

ABI-5366 is an investigational drug candidate being developed by Assembly Biosciences for the treatment of recurrent genital herpes. ABI-5366 is a small molecule helicase-primase inhibitor that has demonstrated nanomolar potency against both HSV-1 and HSV-2 in preclinical studies. Preclinical data has shown that ABI-5366 has a favorable pharmacokinetic profile, with sustained plasma concentrations for over a month after oral or subcutaneous administration, supporting its potential as a long-acting therapeutic. Currently, the drug is in the Phase I stage of development to treat Genital Herpes.

Genital Herpes: Therapeutic Assessment

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

Major Players in Genital Herpes

• There are approx. 18+ key companies which are developing the therapies for Genital Herpes. The companies which have their Genital Herpes drug candidates in the most advanced stage, i.e. Phase III include, Pritelivir.

Phases

The report covers around 20+ 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

Genital Herpes 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.

Genital Herpes: Pipeline Development Activities

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

Genital Herpes Report Insights

• Genital Herpes Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• AiCuris
• United BioPharma
• GlaxoSmithKline
• Assembly Biosciences
• BioNTech
• Innovative Molecules

Key Products

• Pritelivir
• UB-621
• GSK 3943104
• ABI-5366
• BNT 163
• IM-250

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