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tablets artemether/lumefantrine
tablets artemether/lumefantrine is a Antimalarial Small molecule drug developed by University of Khartoum. It is currently in Phase 3 development for Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae. Also known as: Quartem.
Artemether/lumefantrine works by targeting the malaria parasite's cell membrane and disrupting its function, ultimately leading to the parasite's death.
Tablets of artemether/lumefantrine are used to treat malaria, specifically uncomplicated Plasmodium falciparum and Plasmodium vivax malaria. The exact mechanism of action of artemether/lumefantrine is unknown.
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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 | tablets artemether/lumefantrine |
|---|---|
| Also known as | Quartem |
| Sponsor | University of Khartoum |
| Drug class | Antimalarial |
| Target | Malaria parasite cell membrane |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
Artemether is a fast-acting antimalarial agent that rapidly kills the parasite, while lumefantrine is a slower-acting agent that helps to eliminate any remaining parasites. Together, they provide a synergistic effect in treating malaria.
Approved indications
- Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
Key clinical trials
- 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)
- Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics (PHASE4)
- Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (PHASE2, PHASE3)
- Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials (PHASE2, PHASE3)
- Safety of Antimalarials in the FIRst trimEster (PHASE3)
- A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines (PHASE3)
- A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs. (PHASE3)
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:
- tablets artemether/lumefantrine CI brief — competitive landscape report
- tablets artemether/lumefantrine updates RSS · CI watch RSS
- University of Khartoum portfolio CI
Frequently asked questions about tablets artemether/lumefantrine
What is tablets artemether/lumefantrine?
How does tablets artemether/lumefantrine work?
What is tablets artemether/lumefantrine used for?
Who makes tablets artemether/lumefantrine?
Is tablets artemether/lumefantrine also known as anything else?
What drug class is tablets artemether/lumefantrine in?
What development phase is tablets artemether/lumefantrine in?
What are the side effects of tablets artemether/lumefantrine?
What does tablets artemether/lumefantrine target?
Related
- Drug class: All Antimalarial drugs
- Target: All drugs targeting Malaria parasite cell membrane
- Manufacturer: University of Khartoum — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae
- Also known as: Quartem
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing