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Artemef (ARTEMISININ)
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.
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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 | ARTEMISININ |
|---|---|
| Drug class | artemisinin |
| Target | Cytochrome P450 1A2 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 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
- Falciparum malaria
Common side effects
Key clinical trials
- A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults (PHASE1)
- Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2) (PHASE2)
- 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)
- Severe Malaria in Remote Areas- Closing the Evidence Gap
- Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria (PHASE3)
- Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Uncomplicated Malaria in Western Kenya
- Impact of Malaria Mass Drug Administration on Malaria Prevalence in Under 15 Children and Pregnant Women (NA)
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:
- Artemef CI brief — competitive landscape report
- Artemef updates RSS · CI watch RSS
Frequently asked questions about Artemef
What is Artemef?
How does Artemef work?
What is Artemef used for?
What is the generic name of Artemef?
What drug class is Artemef in?
What development phase is Artemef in?
What does Artemef target?
Related
- Drug class: All artemisinin drugs
- Target: All drugs targeting Cytochrome P450 1A2
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Falciparum malaria
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing