Cytomegalovirus (CMV) Infection Pipeline: 15+ Leading Companies Driving Innovation in Next-Generation Therapies | DelveInsight

The Cytomegalovirus Infection market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Vir Biotechnology, SpyBiotech Limited, Moderna, VBI Vaccines, and Trellis Bioscience. These industry pioneers are transforming treatment strategies and redefining the future of Cytomegalovirus Infection, bringing new hope to patients worldwide.

DelveInsight's "Cytomegalovirus (CMV) Infection - Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Cytomegalovirus Infection market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Cytomegalovirus Infection drugs, the Cytomegalovirus Infection pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Cytomegalovirus Infection Pipeline Report
• DelveInsight's Cytomegalovirus Infection Pipeline analysis depicts a robust space with 15+ active players working to develop 20+ pipeline drugs for Cytomegalovirus Infection treatment.
• The leading Cytomegalovirus Infection companies include Vir Biotechnology, SpyBiotech Limited, Moderna, VBI Vaccines, Trellis Bioscience, GlaxoSmithKline, AlloVir, and others are evaluating their lead assets to improve the Cytomegalovirus Infection treatment landscape.
• Key Cytomegalovirus Infection pipeline therapies in various stages of development include VIR-1388, SPYVAC01, mRNA-1647, VBI-1501, TRL 345, GSK 3993129A, Posoleucel, and others.
• In March 2025, ACTG, a global clinical trials network for HIV and infectious diseases, shared positive results from study A5383 at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco. The study showed that suppressing asymptomatic cytomegalovirus (CMV) with letermovir may enhance immune function and physical health in people living with HIV.
• In June 2023, the FDA approved a new indication for Merck's Prevymis (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. Initially approved in 2017 for CMV prevention in stem cell transplant patients, Prevymis is available as a once-daily oral tablet or IV infusion.
• In November 2022, the European Commission approved LIVTENCITY (maribavir) for the treatment of adults with Post-transplant cytomegalovirus infections or diseases that are refractory (with or without resistance) to one or more prior therapies.
•In February 2022, Cheplapharm Arzneimittel GmbH ("Cheplapharm") signed an agreement with Hoffmann-La Roche to acquire the worldwide rights to VALCYTE (valganciclovir hydrochloride). Under the terms of the agreement, Cheplapharm received product rights for VALCYTE in certain countries worldwide including the US.

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Cytomegalovirus Infection Overview
Cytomegalovirus (CMV), a member of the Herpesviridae family, is a widespread human virus known for its varied clinical impact. While many healthy individuals experience no symptoms or only mild flu-like signs such as fatigue, fever, and muscle aches, CMV poses serious health threats to those with weakened immune systems. This includes people living with HIV/AIDS, organ transplant recipients, and patients on immunosuppressive therapies. In these vulnerable groups, CMV can lead to severe complications such as pneumonia, retinitis, colitis, hepatitis, or encephalitis. Additionally, congenital CMV-passed from an infected mother to her unborn child-can cause significant developmental and neurological issues in newborns.

Diagnosis involves a mix of clinical evaluation and lab tests, such as serological assays for antibodies, PCR for detecting viral DNA, and sometimes biopsies or imaging to assess organ involvement. Treatment focuses on controlling viral replication using antivirals like ganciclovir, valganciclovir, and foscarnet, administered according to the severity of the case. In resistant or intolerant cases, alternative therapies may be used, alongside supportive care like adjusting immunosuppressive drugs or initiating antiretroviral therapy in HIV-positive patients. Despite progress in diagnosis and treatment, managing CMV-especially in high-risk populations-remains challenging. Current research aims to develop more effective antivirals, immune therapies, and preventive measures, including vaccines. Public awareness, hygiene practices, and prenatal screening are also key in reducing the virus's overall impact.

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Cytomegalovirus Infection Treatment Analysis: Drug Profile
mRNA-1647: Moderna
mRNA-1647 is Moderna's investigational vaccine for cytomegalovirus (CMV), composed of six mRNAs that encode two key antigens. Five of these target the CMV pentamer complex, and one targets the glycoprotein B (gB) protein-both critical for viral entry into cells. By inducing immune responses to both antigens, mRNA-1647 aims to block CMV from infecting various cell types and prevent both primary and congenital infections. The vaccine is currently in Phase III clinical trials.

SPYVLP01: SpyBiotech
SPYVLP01 is a CMV vaccine candidate developed using SpyBiotech's virus-like particle platform derived from Hepatitis B. Designed to generate strong antibody responses, SPYVLP01 targets human cytomegalovirus to prevent complications such as congenital abnormalities, including hearing loss and developmental issues. It is currently undergoing Phase I clinical evaluation.

Key Cytomegalovirus Infection Therapies and Companies
• mRNA-1647: Moderna
• SPYVLP01: SpyBiotech
• TRL345: Trellis Bioscience
• Triplex: Helocyte

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Cytomegalovirus Infection Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the Cytomegalovirus Infection Pipeline Report
• Coverage: Global
• Key Cytomegalovirus Infection Companies: Vir Biotechnology, SpyBiotech Limited, Moderna, VBI Vaccines, Trellis Bioscience, GlaxoSmithKline, AlloVir, and others.
• Key Cytomegalovirus Infection Pipeline Therapies: VIR-1388, SPYVAC01, mRNA-1647, VBI-1501, TRL 345, GSK 3993129A, Posoleucel, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Cytomegalovirus Infection Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Cytomegalovirus Infection Pipeline Therapeutics
6. Cytomegalovirus Infection Pipeline: Late-Stage Products (Phase III)
7. Cytomegalovirus Infection Pipeline: Late-Stage Products (Phase III)
8. Cytomegalovirus Infection Pipeline: Mid-Stage Products (Phase II)
9. Cytomegalovirus Infection Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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This release was published on openPR.