COARTEM (artemether)
Coartem is an antimalarial medication used for patients with acute, uncomplicated malaria caused by the Plasmodium falciparum parasite. It helps patients who are at least two months old and weigh at least five kilograms. This combination therapy is particularly useful in geographical regions where the parasite has developed resistance to chloroquine. It is not used for preventing malaria or for managing severe, complicated cases of the infection.
How COARTEM Works
This medication works as an antimalarial agent through a fixed-dose combination of artemether and lumefantrine. These two components are delivered in a 1:6 ratio to help clear the parasite from the patient's system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-04-07
- Routes
- ORAL
- Dosage Forms
- TABLET
COARTEM Approval History
What COARTEM Treats
1 indicationsCOARTEM is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malaria
COARTEM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to COARTEM
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04546633 KALUMI results posted | CKAF156A2203 2021-003583-27 | Ph 2 | completed | Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria |
| NCT04675931 results posted | CKAE609B12201 217692/Z/19/Z, 2020-005035-70 | Ph 2 | completed | To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria |
| NCT05842954 KALUMA | CKLU156A12301 2022-002675-10 | Ph 3 | completed | Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria |
| NCT02942277 results posted | 999917006 17-I-N006 | Ph 1 | completed | Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali |
| NCT03952650 results posted | 999919099 19-I-N099 | Ph 1, Ph 2 | completed | Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa... |
| NCT03167242 results posted | CKAF156A2202 2020-003284-25 | Ph 2 | completed | Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria |
| NCT03334747 results posted | CKAE609A2202 207813/Z/17/Z | Ph 2 | completed | Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria. |
| NCT02627456 | 999916004 16-I-N004 | Ph 1 | completed | Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites in Healthy African Adults in Mali |
| NCT01047436 results posted | ART003 | Ph 2 | completed | Efficacy of ArTiMist™ in Children |
| NCT00699920 SMART-CURE | ARAMF_L_02661 | Ph 4 | completed | Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks |
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.
COARTEM FDA Label Details
Indications & Usage
FDA Label (PDF)COARTEM is indicated for the treatment of Malaria.
Track COARTEM with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment