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Atovaquone and Proguanil
Atovaquone and Proguanil, marketed by the State University of New York - Upstate Medical University, is a leading prophylactic treatment for P. falciparum malaria. The drug's key strength lies in its well-established mechanism and market presence, with a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent expiration approaches.
At a glance
| Generic name | Atovaquone and Proguanil |
|---|---|
| Also known as | Malarone |
| Sponsor | State University of New York - Upstate Medical University |
| Drug class | Antimalarial [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
- Prophylaxis of P. falciparum malaria
- Treatment of acute, uncomplicated P. falciparum malaria
Common side effects
- diarrhea
- dreams
- oral ulcers
- headache
- abdominal pain
- nausea
- vomiting
- asthenia
- anorexia
- dizziness
- vomiting
- pruritus
Drug interactions
- rifampin/rifabutin
- warfarin and other coumarin-based anticoagulants
- tetracycline
- metoclopramide
- indinavir
Key clinical trials
- First-in-Human PfSPZ-LARC2 Vaccination/CHMI (PHASE1)
- Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2) (PHASE2)
- A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003) (PHASE1)
- Safety and Efficacy of NF135 CPS Immunization (NA)
- Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers (PHASE1)
- Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis. (PHASE4)
- The ASAP Study - Therapeutic Efficacy of Atovaquone-proguanil vs. Artesunate-atovaquone-proguanil in Cambodia (PHASE4)
- Drug Combinations of Atovaquone-Proguanil (AP) With ACT (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: