Dengue Clinical Trials Assessment 2025: Drug Pipeline, Regulatory Approvals, and Market Growth Analysis by DelveInsight

(Albany, USA) - DelveInsight, a leading market research and consulting firm, has released its latest publication, "Dengue Pipeline Insight 2025", delivering an extensive analysis of the global dengue research and development landscape. The report provides an in-depth understanding of clinical and non-clinical products, therapeutic assessments by drug class, route of administration, and mechanism of action, as well as updates on regulatory approvals from the FDA, EMA, and PDMA.

With 20+ companies actively engaged and 20+ pipeline drugs under development, the dengue treatment market is witnessing unprecedented momentum, driven by breakthrough therapies and innovative vaccine platforms.

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Recent Clinical Developments in Dengue Pipeline (2025)
DelveInsight's report captures key highlights from ongoing clinical trials and research initiatives, reflecting the rapid progress in the field:
• On 3 September 2025, Takeda announced study is to learn about TDV's ability to create an immune response in adults, adolescents, and children administered. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times. Participants will be in this study for approximately 270 days (9 months).
• In June 2025, MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK), announced the initiation of the MOBILIZE-1 Phase 3 clinical trial evaluating the safety, immunogenicity and efficacy of a single dose of V181, an investigational quadrivalent vaccine, for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4), regardless of prior dengue exposure. Recruitment for the trial has begun, and the first participants are now enrolling in Singapore.
• AbViro LLC (March 2025): Initiated a Phase II, randomized, double-blind, placebo-controlled study evaluating three dose levels of AV-1 in healthy adults challenged with a controlled human infection strain of DENV-3.
• Takeda (March 2025): Advanced a pivotal study on its tetravalent dengue vaccine (TDV), assessing immune responses in adults, adolescents, and children across multiple dosing schedules.
• Novartis Pharmaceuticals (March 2025): Launched a study to evaluate EYU688 for its impact on viral load, fever clearance, and clinical symptom reduction compared to placebo in dengue-infected patients.
These advancements underscore a robust clinical pipeline, positioning the dengue treatment market for transformative growth over the coming decade.

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Dengue Overview: A Global Health Burden
Dengue is a mosquito-borne viral infection that continues to threaten billions worldwide, particularly in tropical and subtropical regions. Severe cases can lead to hemorrhagic fever, organ failure, and death, making the demand for effective therapies and vaccines more urgent than ever. Despite decades of research, treatment has largely remained supportive, and no universally accepted therapeutic has yet emerged. The rising global burden has accelerated the pace of clinical trials and investment in next-generation therapies.

Dengue Competitive Landscape
Leading Players in the Dengue Pipeline:
Visterra, Takeda, Codagenix, Atea Pharmaceuticals, Abivax, Janssen Research & Development, Plex Pharmaceuticals, and several emerging players.
These companies are leveraging a diverse range of modalities-vaccines, monoclonal antibodies, antivirals, and synthetic constructs-each designed to address unmet needs in prevention, treatment, and disease management.

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Promising Dengue Therapies in Development
The Dengue Pipeline Insight 2025 profiles several high-potential candidates:
• VIS513 (Visterra): A monoclonal antibody demonstrating activity against all four dengue virus serotypes, with potential to treat severe dengue cases characterized by bleeding and multi-organ complications.
• TAK-003 (Takeda): A tetravalent vaccine based on a live-attenuated DENV-2 virus backbone. Phase II trials showed strong and persistent immune responses in children and adolescents for up to 48 months post-vaccination.
• CDX DENV (Codagenix): A synthetic tetravalent vaccine in preclinical development, re-designed from contemporary dengue strains to ensure safety and immunogenicity.
• AT-752 (Atea Pharmaceuticals): A purine nucleotide prodrug with potent antiviral activity across dengue serotypes, showing favorable safety profiles and efficacy in predictive animal models.
Collectively, these therapies reflect the innovation pipeline transitioning from preclinical research to late-stage clinical validation, supported by strong safety and efficacy data.

Comprehensive Dengue Market and Therapeutic Assessment
DelveInsight's report categorizes dengue pipeline products based on:
• Stage of Development: Discovery, Pre-clinical, Phase I, II, and III.
• Route of Administration: Intravenous, oral, subcutaneous, transdermal, topical, ophthalmic, parenteral, intraocular, intrathecal, and intra-articular.
• Molecule Type: Oligonucleotides, peptides, small molecules, and other advanced constructs.
• Therapeutic Approach: Monotherapy, combination therapy, and hybrid approaches.
This segmentation provides stakeholders with a granular understanding of therapeutic diversity and the future roadmap of dengue R&D.

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Inactive and Dormant Dengue Projects
The analysis also includes insights into inactive or discontinued projects, reflecting the challenges in dengue drug development. Understanding these barriers offers valuable lessons for ongoing programs and highlights the complexities of balancing efficacy, safety, and cost-effectiveness in vaccine and antiviral design.

Dengue Market Dynamics and Trends
Key drivers of the dengue pipeline include:
• Growing global incidence of dengue infections.
• Increased funding for infectious disease R&D post-COVID-19.
• Technological advances in vaccine platforms, monoclonal antibodies, and small-molecule antivirals.
• Regulatory momentum with multiple FDA, EMA, and PDMA designations accelerating clinical progress.

Major Dengue market barriers include:
• Complex viral biology with four distinct serotypes.
• Risk of antibody-dependent enhancement (ADE).
• High R&D costs and regulatory hurdles across geographies.
• Challenges in ensuring equitable vaccine distribution in resource-limited regions.

For a detailed overview of our latest research findings and future plans, read the full details of Dengue Pipeline on our website @ Dengue Drugs and Companies - https://www.delveinsight.com/sample-request/dengue-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Key Takeaways from the Dengue Pipeline Report
• Over 20 companies are actively developing dengue therapies.
• More than 20 pipeline products are currently in discovery through late clinical stages.
• Late-stage candidates such as TAK-003 and EYU688 are showing promising clinical efficacy.
• Dengue therapeutics are expanding across multiple routes of administration and molecule types.
• Industry collaboration, licensing agreements, and strategic financing are accelerating R&D.

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.