You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR ATOVAQUONE; PROGUANIL HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for atovaquone; proguanil hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for atovaquone; proguanil hydrochloride

Condition Name

12220024681012MalariaMalaria, FalciparumMalaria,Falciparum[disabled in preview]
Condition Name for atovaquone; proguanil hydrochloride
Intervention Trials
Malaria 12
Malaria, Falciparum 2
Malaria,Falciparum 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

21720-20246810121416182022MalariaMalaria, FalciparumInfections[disabled in preview]
Condition MeSH for atovaquone; proguanil hydrochloride
Intervention Trials
Malaria 21
Malaria, Falciparum 7
Infections 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
France 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for atovaquone; proguanil hydrochloride
Location Trials
Maryland 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for atovaquone; proguanil hydrochloride

Clinical Trial Phase

75.0%16.7%8.3%00123456789Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for atovaquone; proguanil hydrochloride
Clinical Trial Phase Trials
Phase 4 9
Phase 3 2
Phase 2/Phase 3 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

77.3%13.6%9.1%0024681012141618CompletedTerminatedNot yet recruiting[disabled in preview]
Clinical Trial Status for atovaquone; proguanil hydrochloride
Clinical Trial Phase Trials
Completed 17
Terminated 3
Not yet recruiting 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for atovaquone; proguanil hydrochloride

Sponsor Name

trials011223344Radboud UniversityMedicines for Malaria VentureThe PATH Malaria Vaccine Initiative (MVI)[disabled in preview]
Sponsor Name for atovaquone; proguanil hydrochloride
Sponsor Trials
Radboud University 4
Medicines for Malaria Venture 3
The PATH Malaria Vaccine Initiative (MVI) 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

71.4%18.4%10.2%005101520253035OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for atovaquone; proguanil hydrochloride
Sponsor Trials
Other 35
Industry 9
U.S. Fed 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.