Last reviewed 2026-05-31 · How we verify

arthemeter-lumefantrin

University of Oxford · Phase 3 active Small molecule Under review Quality 0/100

arthemeter-lumefantrin is a Antimalarial Small molecule drug developed by University of Oxford. It is currently in Phase 3 development for Treatment of uncomplicated malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae. Also known as: Coartem.

Artemether-lumefantrin is a combination antimalarial drug that works by inhibiting the growth and replication of Plasmodium parasites.

Arthemeter-lumefantrin is a small molecule that inhibits Ferriprotoporphyrin IX, a mechanism consistent with its classification as an inhibitor. It has been studied as a treatment for malaria in clinical trials.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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-lumefantrin
Also known as	Coartem
Sponsor	University of Oxford
Drug class	Antimalarial
Target	Plasmodium parasites
Modality	Small molecule
Therapeutic area	Infectious Diseases
Phase	Phase 3

Mechanism of action

Artemether is a fast-acting antimalarial agent that targets the parasite's 80S ribosome, while lumefantrin is a slow-acting agent that targets the parasite's heme detoxification pathway. The combination of these two drugs provides a synergistic effect, making it effective against a wide range of Plasmodium species.

Approved indications

Treatment of uncomplicated malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae

Common side effects

Nausea
Vomiting
Diarrhea
Headache
Dizziness

Key clinical trials

Randomised Trial of 3 Artemisinin Combination Therapy for Malaria in Pregnancy (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:

arthemeter-lumefantrin CI brief — competitive landscape report
arthemeter-lumefantrin updates RSS · CI watch RSS
University of Oxford portfolio CI

Frequently asked questions about arthemeter-lumefantrin

What is arthemeter-lumefantrin?

arthemeter-lumefantrin is a Antimalarial drug developed by University of Oxford, indicated for Treatment of uncomplicated malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae.

How does arthemeter-lumefantrin work?

Artemether-lumefantrin is a combination antimalarial drug that works by inhibiting the growth and replication of Plasmodium parasites.

What is arthemeter-lumefantrin used for?

arthemeter-lumefantrin is indicated for Treatment of uncomplicated malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae.

Who makes arthemeter-lumefantrin?

arthemeter-lumefantrin is developed by University of Oxford (see full University of Oxford pipeline at /company/university-of-oxford).

Is arthemeter-lumefantrin also known as anything else?

arthemeter-lumefantrin is also known as Coartem.

What drug class is arthemeter-lumefantrin in?

arthemeter-lumefantrin belongs to the Antimalarial class. See all Antimalarial drugs at /class/antimalarial.

What development phase is arthemeter-lumefantrin in?

arthemeter-lumefantrin is in Phase 3.

What are the side effects of arthemeter-lumefantrin?

Common side effects of arthemeter-lumefantrin include Nausea, Vomiting, Diarrhea, Headache, Dizziness.

What does arthemeter-lumefantrin target?

arthemeter-lumefantrin targets Plasmodium parasites and is a Antimalarial.

Drug class: All Antimalarial drugs
Target: All drugs targeting Plasmodium parasites
Manufacturer: University of Oxford — full pipeline
Therapeutic area: All drugs in Infectious Diseases
Indication: Drugs for Treatment of uncomplicated malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae
Also known as: Coartem

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing