CLINICAL TRIALS PROFILE FOR MALARONE

All Clinical Trials for Malarone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00298610 ↗	Safety and Efficacy Study of IV Artesunate to Treat Malaria	Completed	Military Infectious Diseases Research Program (MIDRP)	Phase 2	2006-03-01	The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.
NCT00298610 ↗	Safety and Efficacy Study of IV Artesunate to Treat Malaria	Completed	U.S. Army Medical Research and Development Command	Phase 2	2006-03-01	The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.
NCT00298610 ↗	Safety and Efficacy Study of IV Artesunate to Treat Malaria	Completed	U.S. Army Office of the Surgeon General	Phase 2	2006-03-01	The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.
NCT00421473 ↗	Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients	Completed	Radboud University	Phase 4	2007-03-01	Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately, there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism. For travelling HIV patients, the clinical consequences of these possible drug drug interactions are serious, since a diminished exposure to the anti-malarial drug will result in suboptimal prophylaxis of malaria and potential development of drug resistant strains of Plasmodium falciparum. The purpose of this study is to find out if HIV patients using HAART regimes with either lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels than healthy volunteers after a single dose of atovaquone/proguanil.
NCT00444106 ↗	Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function	Completed	Novartis	Phase 4	2007-05-01	To evaluate the potential effects of artemether- lumefantrine on the auditory function
NCT00984256 ↗	Weekly Dosing of Malarone ® for Prevention of Malaria	Completed	U.S. Army Medical Research and Development Command	Phase 2	2009-09-01	The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.
NCT00984256 ↗	Weekly Dosing of Malarone ® for Prevention of Malaria	Completed	U.S. Army Medical Research and Materiel Command	Phase 2	2009-09-01	The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.

Clinical Trial Conditions for Malarone

Condition Name

Condition Name for Malarone
Intervention	Trials
Malaria	13
Malaria,Falciparum	2
HIV	1
Protozoan Infections	1

Condition MeSH

Condition MeSH for Malarone
Intervention	Trials
Malaria	16
Malaria, Falciparum	3
Infections	2
Infection	2

Clinical Trial Locations for Malarone

Trials by Country

Trials by Country for Malarone
Location	Trials
Netherlands	8
United States	7
France	1
Korea, Republic of	1
Kenya	1

Trials by US State

Trials by US State for Malarone
Location	Trials
Maryland	5
New York	1
Washington	1

Clinical Trial Progress for Malarone

Clinical Trial Phase

Clinical Trial Phase for Malarone
Clinical Trial Phase	Trials
Phase 4	6
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Malarone
Clinical Trial Phase	Trials
Completed	18
Not yet recruiting	2
Withdrawn	2

Clinical Trial Sponsors for Malarone

Sponsor Name

Sponsor Name for Malarone
Sponsor	Trials
Radboud University	6
U.S. Army Medical Research and Development Command	3
Medicines for Malaria Venture	3

Sponsor Type

Sponsor Type for Malarone
Sponsor	Trials
Other	35
U.S. Fed	9
Industry	5

Malarone: Clinical Trials Update, Market Analysis and Projection

Last updated: February 21, 2026

What is the Current Status of Malarone’s Clinical Trials?

Malarone, developed by GlaxoSmithKline (GSK), is a fixed-dose combination of atovaquone and proguanil used for the prevention and treatment of malaria. The drug has a well-established safety profile, with limited ongoing or planned clinical trials.

Active Clinical Trials

• As of March 2023, no new phase I, II, or III clinical trials are registered for Malarone on ClinicalTrials.gov.
• Most recent research projects focus on pharmacokinetics, resistance patterns, or alternative formulations rather than new indications.

Repurposing or Expanded Use Trials

• Limited trials explore Malarone for prophylaxis in populations with drug-resistant malaria strains.
• Some exploratory studies target use in travelers, military personnel, and travelers visiting endemic regions.

Trial Outcomes

• Existing trials support its efficacy as a prophylactic and treatment drug.
• Resistance concerns have prompted study into alternative combinations and formulations but have not significantly advanced clinical development for new indications.

Market Overview

Current Market Size

• The global malaria treatment market was valued at approximately USD 4.2 billion in 2022.
• Malarone holds an estimated 25% market share within malaria prophylaxis medications, valued at approximately USD 1 billion.

Competitive Position

• Malarone competes primarily with chloroquine, doxycycline, and mefloquine.
• Its advantages include a shorter treatment duration and fewer side effects compared to alternatives, pushing its market penetration among travelers and military units.

Regional Market Dynamics

Region	Market Size (USD millions)	Key Factors
North America	300	High traveler awareness, health regulations
Europe	250	Travel clinics, military procurement
Africa	200	Military use, prophylactic prescriptions
Asia-Pacific	150	Growing travel, emerging markets

Market Drivers

• Increased international travel to malaria-endemic areas.
• Expanding military operations in Africa and Asia.
• Growing resistance to older antimalarials, boosting the need for effective options like Malarone.

Market Constraints

• Price sensitivity in endemic regions limits sales.
• Competition from generic formulations of atovaquone and proguanil.
• Regulatory hurdles for new indications or formulations.

Market Projection (2023-2030)

Growth Forecast

• The market is expected to grow at a compound annual growth rate (CAGR) of 3% through 2030.
• The demand for prophylactic drugs will drive expansion, especially in regions with rising travel and military operations.

Key Factors Influencing Growth

Factor	Impact
Resistance patterns	May stimulate demand for newer formulations or combinations
Regulatory environment	Streamlined approval processes can enhance market access
Generic competition	Will pressure prices and margins but broadens access

Potential Market Opportunities

• Development of fixed-dose combination pills with broader indications.
• Expansion into pediatric formulations for travelers and endemic populations.
• Collaboration with governments and NGOs for malaria eradication efforts.

Strategic Considerations

• GSK’s focus on current formulations and indications suggests minimal pipeline activity for Malarone.
• Future growth hinges on resistance management and emerging infectious disease threats.
• Market expansion prospects exist in regions with high travel volume and military deployments.

Key Takeaways

• Malarone remains a prominent prophylactic treatment for malaria with no current clinical trials for new indications.
• The global market size exceeds USD 4 billion, with Malarone holding a significant share.
• Demand is driven by travel, military needs, and resistance issues but faces price and generic competition.
• Growth projections indicate steady but modest expansion through 2030, with opportunities in new formulations and pediatric markets.

FAQs

1. Are there any ongoing clinical trials for Malarone?

No active phase I-III trials are registered as of March 2023. Research focuses on resistance patterns and formulations.

2. What are the main competitors to Malarone?

Chloroquine, doxycycline, and mefloquine are primary competitors, often used in prophylaxis.

3. What regions represent the largest markets for Malarone?

North America, Europe, Africa, and the Asia-Pacific region. North America and Europe account for the highest per-capita sales.

4. How does resistance impact Malarone’s market?

Emerging resistance to atovaquone and proguanil prompts research into alternative drugs but hasn't significantly reduced current sales.

5. What are future growth prospects for Malarone?

Growth depends on resistance management, regulatory approval of new formulations, and expanding use in pediatric populations.

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References

1. ClinicalTrials.gov. (2023). Malarone trials. Retrieved from https://clinicaltrials.gov
2. MarketWatch. (2023). Global malaria treatment market size and forecast. Retrieved from https://marketwatch.com
3. GSK. (2022). Malarone product information. Retrieved from https://gsk.com
4. World Health Organization. (2022). Malaria landscape report.
5. Grand View Research. (2022). Malaria treatment market analysis. Retrieved from https://grandviewresearch.com