ARTESUNATE
PeakNDAINTRAVENOUSPOWDERPriority Review
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
23
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Artesunate is an intravenous artemisinin derivative indicated for severe malaria. It is a fast-acting antimalarial agent that reduces parasite burden rapidly. The drug represents a critical treatment option for life-threatening malaria infections.
Peak17.5 years to LOE
The product is at peak commercial stage with established market presence and limited competitive pressure, suggesting stable mid-sized brand team focused on optimization and market penetration.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (23)
Study Evaluating the Efficacy and Safety of Artesunate
Started Aug 2025
90 enrolled
CMV Infection
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
Started Oct 2024
15 enrolled
Malaria
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Started May 2024
12 enrolled
Cervix CancerCervix Intraepithelial Neoplasia Grade 3Cervix; Intraepithelial Neoplasia, Grade I+1 more
Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya
Started Mar 2024
17 enrolled
Cervix CancerCervix NeoplasmPrecancerous Conditions+1 more
Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria
Started Nov 2023
90 enrolled
Plasmodium Falciparum Infection
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.