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AA(FDC)
AA(FDC) is a fixed-dose combination antimalarial therapy containing artesunate and amodiaquine that works by disrupting parasite metabolism and preventing malaria infection.
AA(FDC) is a fixed-dose combination antimalarial therapy containing artesunate and amodiaquine. Used for Uncomplicated malaria caused by Plasmodium falciparum, Malaria treatment in endemic regions.
At a glance
| Generic name | AA(FDC) |
|---|---|
| Also known as | Artesunate Amodiaquine Winthrop® Sanofi Aventis |
| Sponsor | Medecins Sans Frontieres, Netherlands |
| Drug class | Antimalarial combination |
| Target | Plasmodium falciparum (multiple mechanisms: artemisinin-based ROS generation and quinoline-based heme polymerization inhibition) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Artesunate is an artemisinin derivative that generates reactive oxygen species to damage Plasmodium parasites, while amodiaquine is a 4-aminoquinoline that inhibits heme polymerization and parasite protein synthesis. Together in fixed-dose combination, they provide synergistic antimalarial activity with reduced risk of resistance development compared to monotherapy.
Approved indications
- Uncomplicated malaria caused by Plasmodium falciparum
- Malaria treatment in endemic regions, particularly in sub-Saharan Africa
Common side effects
- Nausea
- Vomiting
- Abdominal pain
- Headache
- Pruritus
Key clinical trials
- An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2) (PHASE3)
- An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1) (PHASE3)
- Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations (PHASE1)
- Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria (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:
- AA(FDC) CI brief — competitive landscape report
- AA(FDC) updates RSS · CI watch RSS
- Medecins Sans Frontieres, Netherlands portfolio CI