Malaria Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, NICE Approval, IND, ROA, MOA, NDA Approval and Companies involved by DelveInsight

(Albany, USA) DelveInsight's "Malaria Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the malaria 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 malaria drugs, the malaria pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

The malaria therapeutics and vaccine market is undergoing a critical transformation, led by innovators such as Sanaria, GlaxoSmithKline, Novartis, Bharat Biotech, and GeoVax. With the emergence of genetically attenuated sporozoite vaccines, transmission-blocking candidates, and novel antimalarial compounds, these companies are redefining prevention and treatment paradigms. The pipeline is especially focused on overcoming drug resistance and improving efficacy in endemic regions, with new-age platforms offering hope for long-term malaria control and eventual eradication.

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Key Takeaways from the Malaria Pipeline Report
• DelveInsight's malaria pipeline analysis depicts a strong space with 15+ active players working to develop 20+ pipeline drugs for malaria treatment.
• The leading malaria companies include Sanaria, Novartis, GlaxoSmithKline, Lyndra Therapeutics, Tarsus Pharmaceuticals, GeoVax, Bharat Biotech, Sumitomo Pharma, Zymergen, and others are evaluating their lead assets to improve the malaria treatment landscape.
• Key malaria pipeline therapies in various stages of development include Research programme: Malaria therapeutics, Pneumococcal vaccine, PF 06842433, V 116, EuPCV15, V 114, ASP3772, 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine, Pneumococcal vaccine conjugate 10-valent, VAX 24, VAX XP, and others.
• In March 2025, the FDA placed a clinical hold on BioNTech's early-to-mid stage trial of its experimental malaria vaccine, BNT165e. The trial aimed to evaluate the safety and efficacy of the RNA-based vaccine for preventing malaria caused by the P. falciparum parasite in healthy adults who had never had malaria. Following the announcement, BioNTech's U.S.-listed shares fell by 1.5%.
• In January 2025, Ocean Biomedical announced that its Scientific Co-founder, Dr. Jonathan Kurtis, received additional NIH funding to advance malaria vaccine research. Recent FDA guidance on lipid-encapsulated vaccines may further accelerate its development.
• In March 2024, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced FDA approval of the cobas® Malaria test for its 6800/8800 Systems, offering a highly sensitive tool to help prevent transfusion-related malaria by detecting and removing infected blood units.

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Malaria Overview
Malaria is a life-threatening disease caused by Plasmodium parasites, transmitted through bites from infected female Anopheles mosquitoes. It is preventable and curable, with an estimated 229 million cases worldwide in 2019. The most dangerous species are P. falciparum and P. vivax. Symptoms typically appear 10-15 days after infection and include fever, headache, and chills, which can worsen without treatment, especially in P. falciparum cases. Early diagnosis and treatment are crucial to prevent severe illness or death. Malaria can also be prevented with chemoprophylaxis for travelers. Common antimalarial drugs, such as chloroquine, are used to treat and prevent the disease.

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Malaria Treatment Analysis: Drug Profile
Cipargamin: Novartis
Cipargamin is a groundbreaking antimalarial drug candidate, marking the first novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years. As the first compound in the spiroindolone class, Cipargamin works by inhibiting the P-type cation-transporter ATPase4 (PfATP4), which regulates sodium concentration within the parasite. This mechanism not only helps combat the parasite but may also be effective against its sexual forms, potentially preventing disease transmission. In clinical trials, Cipargamin demonstrated a median parasite clearance time of just 12 hours, including in patients with resistant malaria infections. The drug is currently in Phase II development for the treatment of malaria.

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Malaria 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
• Intranasal
• Intrathecal
• Intravenous
• Oral
• Oral/Intravenous
• Parenteral
• Subcutaneous
• Subcutaneous/Intramuscular
• Transdermal

By Molecule Type
• Antisense oligonucleotide
• Gene therapy
• Hormones
• Neuropeptides
• Oligonucleotides
• Small Molecule
• Triglyceride

Scope of the Malaria Pipeline Report
• Coverage: Global
• Key Malaria Companies: Sanaria, Novartis, GlaxoSmithKline, Lyndra Therapeutics, Tarsus Pharmaceuticals, GeoVax, Bharat Biotech, Sumitomo Pharma, Zymergen, and others.
• Key Malaria Pipeline Therapies: Research programme: Malaria therapeutics, Pneumococcal vaccine, PF 06842433, V 116, EuPCV15, V 114, ASP3772, 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine, Pneumococcal vaccine conjugate 10-valent, VAX 24, VAX XP, and others.

Dive deep into rich insights for drugs used for Malaria treatment; visit @ https://www.delveinsight.com/sample-request/malaria-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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

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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.

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