ATOVAQUONE AND PROGUANIL HYDROCHLORIDE (atovaquone)
Atovaquone and proguanil hydrochloride is an antimalarial medication used to prevent Plasmodium falciparum malaria, even in geographic regions where chloroquine resistance is common. It also treats patients with acute, uncomplicated cases of the infection. This combination is particularly useful in areas where other standard treatments, such as mefloquine or halofantrine, may fail due to drug resistance.
How ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Works
This medication works by combining atovaquone and proguanil hydrochloride into a single fixed-dose tablet. Together, these components function as an antiprotozoal agent to target and eliminate the Plasmodium falciparum parasite.
Details
- Status
- Prescription
- First Approved
- 2011-01-12
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Approval History
What ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Treats
1 indicationsATOVAQUONE AND PROGUANIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malaria
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07357103 SPIRIT-ALT | 2026-12268 527077 | Ph 4 | not yet recruiting | Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives) |
| NCT05998135 | STUDY00005363 NCI-2023-03479, STUDY00005363 | Ph 2 | recruiting | Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer |
| NCT06624371 AflacBT2303 | STUDY00007693 | Ph 1 | recruiting | Atovaquone Combined With Radiation in Children With Malignant Brain Tumors |
| NCT01858831 | 116441 | Ph 1 | completed | Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE FDA Label Details
Indications & Usage
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE is indicated for the treatment of Malaria.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.