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Coartem (LUMEFANTRINE)
Coartem Tablets, a combination of artemether and lumefantrine, act as an antimalarial agent.
Coartem (Lumefantrine) is a small molecule antimalarial medication developed by Novartis, targeting the potassium voltage-gated channel subfamily H member 2. It is FDA-approved for the treatment of falciparum malaria since 2009. As a commercial product, Coartem remains under patent ownership of Novartis. Key safety considerations include potential gastrointestinal side effects and interactions with other medications. Coartem is a combination therapy that works by disrupting the malaria parasite's ability to maintain its internal environment.
At a glance
| Generic name | LUMEFANTRINE |
|---|---|
| Sponsor | Novartis |
| Drug class | Antimalarial [EPC] |
| Target | Potassium voltage-gated channel subfamily H member 2 |
| Modality | Small molecule |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Coartem Tablets contain artemether and lumefantrine in a 1:6 ratio. These components work together to combat malaria, though specific mechanisms are not detailed here.
Approved indications
- Falciparum malaria
Common side effects
- Headache
- Dizziness
- Anorexia
- Asthenia
- Pyrexia
- Cough
- Vomiting
- Arthralgia
- Myalgia
- Nausea
- Abdominal pain
- Diarrhea
Drug interactions
- CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort)
- CYP3A4 Inhibitors (e.g., ketoconazole)
- Antiretrovirals (e.g., protease inhibitors, non-nucleoside reverse transcriptase inhibitors)
- Mefloquine
- Hormonal Contraceptives
- CYP2D6 Substrates
Key clinical trials
- First-in-Human PfSPZ-LARC2 Vaccination/CHMI (PHASE1)
- Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2) (PHASE2)
- Investigating the Pharmacology of Tafenoquine in Papua New Guinean Children With Uncomplicated Malaria (PHASE4)
- OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa (PHASE4)
- CHILD (Child Health and Infection With Low Density) Malaria (NA)
- Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria (PHASE3)
- Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Uncomplicated Malaria in Western Kenya
- Impact of Malaria Mass Drug Administration on Malaria Prevalence in Under 15 Children and Pregnant Women (NA)
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:
- Coartem CI brief — competitive landscape report
- Coartem updates RSS · CI watch RSS
- Novartis portfolio CI