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Malarone (PROGUANIL)
Malarone works by inhibiting the parasite's ability to synthesize nucleic acids, ultimately preventing its replication and spread within the body.
Malarone, also known as Proguanil, is an antimalarial small molecule developed by GlaxoSmithKline. It is used to treat and prevent malaria caused by Plasmodium falciparum, particularly in cases resistant to chloroquine. Malarone was FDA-approved in 2000 for its indications and is still owned by GlaxoSmithKline. Key safety considerations include its half-life of 12-21 hours and bioavailability of 60%. The commercial status of Malarone is patented.
At a glance
| Generic name | PROGUANIL |
|---|---|
| Sponsor | GSK |
| Drug class | Antimalarial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2000 |
Mechanism of action
Atovaquone and Proguanil Hydrochloride tablets, fixed-dose combination of atovaquone and proguanil hydrochloride, is an antimalarial agent [see Microbiology (12.4)].
Approved indications
- Chloroquine-Resistant Plasmodium Falciparum Malaria Prevention
- Falciparum malaria
- Plasmodium Falciparum Malaria Prevention
Common side effects
- Abdominal pain
- Headache
- Cough
- Vomiting
- Nausea
- Diarrhea
- Dizziness
- Pruritus
- Fever
- Oral ulcers
- Visual difficulties
- Depression
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)
- Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE) (PHASE4)
- Safety and Efficacy of NF135 CPS Immunization (NA)
- Atoguanil BA Study (PHASE1)
- 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)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Malarone CI brief — competitive landscape report
- Malarone updates RSS · CI watch RSS
- GSK portfolio CI