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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ATOVAQUONE; PROGUANIL HYDROCHLORIDE


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All Clinical Trials for Atovaquone; Proguanil Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00084227 ↗ Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America Completed Pfizer Phase 2/Phase 3 2004-07-01 The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00149383 ↗ Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria Completed McLaughlin-Rotman Center for Global Health, University of Toronto Phase 1/Phase 2 2004-12-01 The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.
NCT00149383 ↗ Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria Completed Mahidol University Phase 1/Phase 2 2004-12-01 The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.
NCT00379821 ↗ Chloroquine Alone or in Combination for Malaria in Children in Malawi Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2007-02-01 Malaria is a sickness caused by a germ that can get into a person's body when a mosquito bites them. It can cause fever, headache, body aches and weakness. It can even cause death, especially in children. When malaria is treated with the appropriate medicine(s), it can be cured completely. The purpose of this study is to find out if it is better to use chloroquine alone or in combination with another drug to most effectively treat malaria. About 640 children with malaria, aged 6 months to 5 years of age, from the Blantyre Malaria Project Research Clinic at the Ndirande Health Center in Malawi will be in the study. They will be treated with either chloroquine alone or a combination of chloroquine plus another medication (azithromycin or artesunate or atovaquone-proguanil) every time they get malaria for a year. Blood samples will be collected and tested at least every 4 weeks. Participants will be involved in the study for 1 year.
NCT00386750 ↗ Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function Terminated Novartis Pharmaceuticals Phase 4 2005-06-01 THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.
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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Atovaquone; Proguanil Hydrochloride

Condition Name

Condition Name for Atovaquone; Proguanil Hydrochloride
Intervention Trials
Malaria 12
Malaria, Falciparum 2
Malaria,Falciparum 2
Controlled Human Malaria Infection 2
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Condition MeSH

Condition MeSH for Atovaquone; Proguanil Hydrochloride
Intervention Trials
Malaria 21
Malaria, Falciparum 7
Communicable Diseases 2
Infections 2
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Clinical Trial Locations for Atovaquone; Proguanil Hydrochloride

Trials by Country

Trials by Country for Atovaquone; Proguanil Hydrochloride
Location Trials
Netherlands 6
United States 3
Thailand 3
Cambodia 2
United Kingdom 1
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Trials by US State

Trials by US State for Atovaquone; Proguanil Hydrochloride
Location Trials
Maryland 3
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Clinical Trial Progress for Atovaquone; Proguanil Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Atovaquone; Proguanil Hydrochloride
Clinical Trial Phase Trials
Phase 4 9
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Atovaquone; Proguanil Hydrochloride
Clinical Trial Phase Trials
Completed 17
Terminated 3
Not yet recruiting 2
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Clinical Trial Sponsors for Atovaquone; Proguanil Hydrochloride

Sponsor Name

Sponsor Name for Atovaquone; Proguanil Hydrochloride
Sponsor Trials
Radboud University 4
Medicines for Malaria Venture 3
The PATH Malaria Vaccine Initiative (MVI) 3
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Sponsor Type

Sponsor Type for Atovaquone; Proguanil Hydrochloride
Sponsor Trials
Other 35
Industry 9
U.S. Fed 5
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Atovaquone and Proguanil Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Atovaquone and proguanil hydrochloride, commonly known by the brand name Malarone, is a potent antimalarial drug combination used for both the treatment and prophylaxis of malaria. This article delves into the clinical trials, market analysis, and future projections for this essential medication.

Clinical Trials and Efficacy

Clinical trials have consistently demonstrated the efficacy and safety of atovaquone and proguanil hydrochloride. A randomized, double-blinded study involving 297 individuals migrating to malaria-endemic areas in Papua, Indonesia, showed that the drug was highly effective. The protective efficacy was 84% for Plasmodium vivax malaria, 96% for Plasmodium falciparum malaria, and 93% overall[1].

This study highlighted that atovaquone/proguanil is well tolerated, safe, and effective for preventing drug-resistant P. vivax and P. falciparum malaria in individuals without prior malaria exposure. The drug did not significantly alter hematologic and clinical chemistry values, further underscoring its safety profile.

Pharmacokinetics and Clinical Pharmacology

The pharmacokinetics of atovaquone and proguanil are crucial for understanding their effectiveness. Atovaquone is a highly lipophilic compound with low aqueous solubility, and its absorption is significantly enhanced by dietary fat. Proguanil, on the other hand, is rapidly and extensively absorbed regardless of food intake[4].

Atovaquone is predominantly eliminated unchanged in feces, while proguanil is partially metabolized and excreted in urine. The principal metabolite of proguanil, cycloguanil, is also excreted in urine. The elimination half-life of atovaquone is 2 to 3 days in adults and 1 to 2 days in children, while the elimination half-lives of proguanil and cycloguanil are 12 to 15 hours in both adults and children[4].

Market Analysis

The global market for atovaquone and proguanil is experiencing significant growth driven by several factors. As of 2024, the global market size is estimated at USD 185.6 million and is projected to expand at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031, reaching USD 397.65 million by 2031[2].

Regional Market Dynamics

  • North America: This region dominated the market in 2024, driven by increased travel to malaria-endemic areas and a strong focus on malaria prevention. The robust healthcare infrastructure and high disposable incomes in North America contribute to the demand for effective antimalarial medications like atovaquone/proguanil[2].
  • Europe: Europe is the fastest-growing region, driven by growing global travel to malaria-prone regions and a heightened focus on malaria prevention measures. Europe's strong healthcare systems and emphasis on travel medicine are key factors[2].
  • Asia Pacific: This region held around 23% of the global revenue in 2024, with a market size of USD 42.6 million, and is expected to grow at a CAGR of 13.5% from 2024 to 2031[2].
  • Latin America and Middle East & Africa: These regions also show promising growth, with Latin America expected to grow at a CAGR of 10.9% and the Middle East & Africa at a CAGR of 11.2% from 2024 to 2031[2].

Dosage and Formulations

The 250 mg/100 mg formulation of atovaquone and proguanil is the dominating category, offering a convenient and effective dosage option for malaria prevention and treatment. The 62.5 mg/25 mg formulation is emerging as the fastest-growing category, providing a lower-dose option suitable for pediatric and smaller adult populations, thereby enhancing broader accessibility and adherence[2].

Impact of COVID-19

The COVID-19 pandemic had a multifaceted impact on the atovaquone/proguanil market. Initial travel restrictions reduced demand from travelers, but the ongoing need for effective malaria prevention and treatment in endemic areas persisted. Supply chain disruptions and logistical challenges affected availability and distribution, while healthcare resources were diverted to handle COVID-19 cases. However, the pandemic underscored the importance of robust healthcare systems capable of addressing infectious diseases, including malaria. As vaccination efforts progress and travel resumes, the market for atovaquone/proguanil is expected to rebound[2].

Future Projections

The market for atovaquone and proguanil is poised for significant growth. Here are some key projections:

  • Market Size: Expected to reach USD 397.65 million by 2031, growing at a CAGR of 11.50% from 2024 to 2031[2].
  • Regional Growth: Europe is expected to be the fastest-growing region, driven by increased global travel and a strong focus on malaria prevention[2].
  • Dosage Trends: The 62.5 mg/25 mg formulation is expected to continue growing, catering to pediatric and smaller adult populations[2].

Key Takeaways

  • Efficacy and Safety: Atovaquone and proguanil hydrochloride have been proven to be highly effective and safe in clinical trials.
  • Market Growth: The global market is expected to grow significantly, driven by increased travel to malaria-endemic areas and a strong focus on malaria prevention.
  • Regional Dynamics: North America, Europe, and Asia Pacific are key regions driving market growth.
  • Dosage Formulations: The 250 mg/100 mg and 62.5 mg/25 mg formulations are crucial for market growth, catering to different patient demographics.

FAQs

What is the current market size of atovaquone and proguanil?

The global market size for atovaquone and proguanil was estimated at USD 185.6 million in 2024[2].

What is the projected growth rate of the atovaquone and proguanil market?

The market is expected to grow at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031[2].

Which regions are driving the growth of the atovaquone and proguanil market?

North America, Europe, and Asia Pacific are the key regions driving market growth, with Europe being the fastest-growing region[2].

What are the dominant dosage formulations of atovaquone and proguanil?

The 250 mg/100 mg formulation is the dominant category, while the 62.5 mg/25 mg formulation is the fastest-growing category, particularly for pediatric and smaller adult populations[2].

How did the COVID-19 pandemic impact the atovaquone and proguanil market?

The pandemic initially reduced demand due to travel restrictions but underscored the importance of robust healthcare systems. As travel resumes, the market is expected to rebound[2].

Sources

  1. Randomized, placebo-controlled trial of atovaquone/proguanil for malaria prophylaxis in nonimmune travelers to Papua, Indonesia. PubMed.
  2. Atovaquone and Proguanil Market Report 2024 (Global Edition). Cognitive Market Research.
  3. MALARONE (atovaquone and proguanil hydrochloride) Label. FDA.
  4. Clinical Pharmacology of Atovaquone and Proguanil Hydrochloride. Journal of Travel Medicine.

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