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Arthemeter-lumefantrine
Arthemeter-lumefantrine is a Antimalarial combination Small molecule drug developed by Research Institute for Tropical Medicine, Philippines. It is currently in Phase 3 development for Uncomplicated malaria caused by Plasmodium falciparum, Malaria caused by other Plasmodium species susceptible to artemether-lumefantrine. Also known as: Coartem, Cofantrine®.
Artemether and lumefantrine work synergistically to kill malaria parasites by disrupting their hemoglobin metabolism and causing oxidative damage.
Artemether and lumefantrine work synergistically to kill malaria parasites by disrupting their hemoglobin metabolism and causing oxidative damage. Used for Uncomplicated malaria caused by Plasmodium falciparum, Malaria caused by other Plasmodium species susceptible to artemether-lumefantrine.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Arthemeter-lumefantrine |
|---|---|
| Also known as | Coartem, Cofantrine® |
| Sponsor | Research Institute for Tropical Medicine, Philippines |
| Drug class | Antimalarial combination |
| Target | Plasmodium falciparum heme detoxification pathway; mitochondrial electron transport |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Artemether, a semi-synthetic artemisinin derivative, rapidly kills malaria parasites by generating reactive oxygen species that damage parasite proteins and membranes. Lumefantrine, a biguanide-like compound, inhibits parasite heme polymerization and disrupts mitochondrial function. Together, they provide rapid parasite clearance and extended post-treatment suppression.
Approved indications
- Uncomplicated malaria caused by Plasmodium falciparum
- Malaria caused by other Plasmodium species susceptible to artemether-lumefantrine
Common side effects
- Headache
- Fever
- Nausea
- Vomiting
- Abdominal pain
- Diarrhea
- Dizziness
Key clinical trials
- TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
- Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy (PHASE4)
- Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy (PHASE3)
- Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients (PHASE3)
- Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites (PHASE4)
- Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa (PHASE3)
- Home Management of Malaria and Pneumonia (PHASE4)
- Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections
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:
- Arthemeter-lumefantrine CI brief — competitive landscape report
- Arthemeter-lumefantrine updates RSS · CI watch RSS
- Research Institute for Tropical Medicine, Philippines portfolio CI
Frequently asked questions about Arthemeter-lumefantrine
What is Arthemeter-lumefantrine?
How does Arthemeter-lumefantrine work?
What is Arthemeter-lumefantrine used for?
Who makes Arthemeter-lumefantrine?
Is Arthemeter-lumefantrine also known as anything else?
What drug class is Arthemeter-lumefantrine in?
What development phase is Arthemeter-lumefantrine in?
What are the side effects of Arthemeter-lumefantrine?
What does Arthemeter-lumefantrine target?
Related
- Drug class: All Antimalarial combination drugs
- Target: All drugs targeting Plasmodium falciparum heme detoxification pathway; mitochondrial electron transport
- Manufacturer: Research Institute for Tropical Medicine, Philippines — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Uncomplicated malaria caused by Plasmodium falciparum
- Indication: Drugs for Malaria caused by other Plasmodium species susceptible to artemether-lumefantrine
- Also known as: Coartem, Cofantrine®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing