CLINICAL TRIALS PROFILE FOR ATOVAQUONE

505(b)(2) Clinical Trials for atovaquone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00000773 ↗	Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.

All Clinical Trials for atovaquone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
NCT00000773 ↗	Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
NCT00000794 ↗	Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis. AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.
NCT00000802 ↗	A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides. Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.
NCT00000811 ↗	A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1969-12-31	This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.
NCT00000811 ↗	A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children	Completed	Glaxo Wellcome	Phase 2	1969-12-31	This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.

Clinical Trial Conditions for atovaquone

Condition Name

Condition Name for atovaquone
Intervention	Trials
Malaria	12
HIV Infections	11
Pneumonia, Pneumocystis Carinii	8
Toxoplasmosis, Cerebral	2

Condition MeSH

Condition MeSH for atovaquone
Intervention	Trials
Malaria	21
HIV Infections	11
Pneumonia, Pneumocystis	9
Pneumonia	9

Clinical Trial Locations for atovaquone

Trials by Country

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−

Trials by Country for atovaquone
Location	Trials
United States	104
Netherlands	7
Canada	7
United Kingdom	4
Thailand	3

Trials by US State

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−

Trials by US State for atovaquone
Location	Trials
Maryland	9
California	7
North Carolina	7
New York	7
Texas	6

Clinical Trial Progress for atovaquone

Clinical Trial Phase

Clinical Trial Phase for atovaquone
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for atovaquone
Clinical Trial Phase	Trials
Completed	29
Terminated	4
Recruiting	3

Clinical Trial Sponsors for atovaquone

Sponsor Name

Sponsor Name for atovaquone
Sponsor	Trials
Glaxo Wellcome	7
National Institute of Allergy and Infectious Diseases (NIAID)	6
Radboud University	4

Sponsor Type

Sponsor Type for atovaquone
Sponsor	Trials
Other	49
Industry	17
NIH	8

Atovaquone: Clinical Trials, Market Analysis, and Projections

Introduction to Atovaquone

Atovaquone, often used in combination with proguanil, is a widely recognized antimalarial medication. It has been a cornerstone in the prevention and treatment of malaria, particularly for travelers to malaria-endemic areas. Here, we will delve into the latest clinical trials, market analysis, and projections for atovaquone.

Clinical Trials Update

Long-Acting Injectable Malaria Prevention

A significant development in the field of malaria prevention is the first-ever long-acting injectable form of atovaquone, known as MMV371. This derivative of atovaquone is being tested in a first-in-human clinical trial to evaluate its safety, tolerability, and pharmacokinetics. The injectable form is designed to provide up to 3 months of protection against malaria with a single intramuscular dose. This innovation is crucial given the high burden of malaria, with 249 million cases and 608,000 deaths globally in 2022, predominantly in sub-Saharan Africa[1].

Atovaquone in Cancer Treatment

Atovaquone is also being explored for its potential in treating certain cancers. Clinical trials are underway to investigate its efficacy in combination with radiation therapy for pediatric brain tumors, such as high-grade gliomas and medulloblastomas. Atovaquone's ability to inhibit the STAT3 protein, which is involved in cancer cell survival and immune response suppression, makes it a promising candidate. Early trials have shown promise in reducing tumor size and improving survival rates[4].

Atovaquone in Babesiosis Treatment

Another area of clinical research involves the use of atovaquone in treating babesiosis, an emerging tick-borne illness. A planned clinical trial by 60 Degrees Pharmaceuticals will evaluate the safety and efficacy of a combination therapy including tafenoquine, atovaquone, and azithromycin in hospitalized babesiosis patients. This trial is set to begin in summer 2024 and will be the first of its kind[3].

Market Analysis

Current Market Size and Growth

The global Atovaquone and Proguanil market was valued at USD 185.6 million in 2024. This market is expected to expand at a compound annual growth rate (CAGR) of 11.50% from 2024 to 2031, reaching USD 397.65 million by 2031. The growth is driven by the ongoing need for effective malaria prevention and treatment, particularly in endemic areas[2].

Regional Market Dynamics

• North America: This region dominated the market in 2024, driven by increased travel to malaria-endemic areas and a strong healthcare infrastructure. High disposable incomes also contribute to the demand for antimalarial medications like Atovaquone/Proguanil[2].
• Europe: Europe is the fastest-growing region, fueled by growing global travel and a heightened focus on malaria prevention. The region's robust 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. It 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 significant growth potential, with Latin America expected to grow at a CAGR of 10.9% and the Middle East & Africa at 11.2% from 2024 to 2031[2].

Dosage Forms and Market Impact

The 250 mg/100 mg formulation of Atovaquone and Proguanil is the dominant category, offering a convenient and effective dosage option. The 62.5 mg/25 mg formulation is the fastest-growing category, catering to pediatric and smaller adult populations, thereby enhancing broader accessibility and adherence[2].

Market Projections

Future Growth Drivers

The market for Atovaquone and Proguanil is expected to rebound strongly as vaccination efforts progress and travel resumes post-COVID-19. The ongoing need for reliable antimalarial solutions, coupled with the expansion of global travel to malaria-endemic regions, will drive market growth. Strong healthcare infrastructures in regions like North America and Europe will continue to support this growth[2].

Emerging Opportunities

The development of new formulations, such as the long-acting injectable form, and the potential use of Atovaquone in treating other diseases like cancer and babesiosis, present significant opportunities for market expansion. These innovations could lead to increased demand and broader applications for Atovaquone, further driving market growth[1][3][4].

Key Takeaways

• Clinical Trials: Atovaquone is being tested in new forms, including a long-acting injectable for malaria prevention and in combination with other treatments for cancer and babesiosis.
• Market Size and Growth: The global Atovaquone and Proguanil market is valued at USD 185.6 million in 2024 and is projected to grow at a CAGR of 11.50% to USD 397.65 million by 2031.
• Regional Dynamics: North America, Europe, and Asia Pacific are key regions driving market growth due to increased travel and robust healthcare infrastructures.
• Dosage Forms: The 250 mg/100 mg and 62.5 mg/25 mg formulations are significant contributors to market growth, catering to different patient demographics.

FAQs

What is the current market size of Atovaquone and Proguanil?

The global Atovaquone and Proguanil market was valued 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 CAGR of 11.50% from 2024 to 2031[2].

What are the key regions driving the growth of the Atovaquone and Proguanil market?

North America, Europe, and Asia Pacific are the key regions driving market growth[2].

What new clinical trials are underway for Atovaquone?

Clinical trials are ongoing for a long-acting injectable form of Atovaquone for malaria prevention, its use in treating pediatric brain tumors, and its potential in treating babesiosis[1][3][4].

How does Atovaquone work in cancer treatment?

Atovaquone inhibits the STAT3 protein, which is involved in cancer cell survival and immune response suppression, making it a promising candidate when combined with radiation therapy for certain cancers[4].

Sources

1. MMV Newsroom: "First-ever long-acting injectable for malaria prevention administered..."
2. Cognitive Market Research: "Atovaquone and Proguanil Market Report 2024 (Global Edition)"
3. Biospace: "60 Degrees Pharmaceuticals Outlines Upcoming Clinical Trial of Tafenoquine in Babesiosis..."
4. CenterWatch: "Atovaquone Combined with Radiation in Children with Malignant Brain Tumors"
5. OpenPR: "Atovaquone and Proguanil Market to Witness Astonishing Growth by 2028"