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Artemef (ARTEMISININ)

Phase 3 active Small molecule Quality 31/100

Artemef (generic name: ARTEMISININ) is a artemisinin drug. It is currently in Phase 3 development for Falciparum malaria.

Artemef works by generating reactive oxygen species that rapidly kill malaria parasites.

Artemisinin, also known as Artemef, is a small molecule drug in the artemisinin class that targets Cytochrome P450 1A2. It is used to treat Falciparum malaria, a severe and potentially life-threatening disease caused by the Plasmodium falciparum parasite. The commercial status of Artemef is unclear, as it is not listed as a patented or generic medication. Artemef works by rapidly killing malaria parasites, but its exact mechanism of action is complex and involves the generation of reactive oxygen species. Further research is needed to fully understand its pharmacokinetics and safety profile.

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 nameARTEMISININ
Drug classartemisinin
TargetCytochrome P450 1A2
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 3

Mechanism of action

Imagine your body's cells as a city under attack by a group of invaders. Artemef is like a special kind of bomb that targets and destroys these invaders, but it's designed to only affect the bad guys and not harm the good cells.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Artemef

What is Artemef?

Artemef (ARTEMISININ) is a artemisinin drug, indicated for Falciparum malaria.

How does Artemef work?

Artemef works by generating reactive oxygen species that rapidly kill malaria parasites.

What is Artemef used for?

Artemef is indicated for Falciparum malaria.

What is the generic name of Artemef?

ARTEMISININ is the generic (nonproprietary) name of Artemef.

What drug class is Artemef in?

Artemef belongs to the artemisinin class. See all artemisinin drugs at /class/artemisinin.

What development phase is Artemef in?

Artemef is in Phase 3.

What does Artemef target?

Artemef targets Cytochrome P450 1A2 and is a artemisinin.

Related

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