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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Artesunate is an intravenous antimalarial powder approved in 2020 with a remarkably broad indication portfolio spanning infectious diseases (malaria, HIV, CMV) and oncology (cervical and breast cancer) plus rare disease (Friedreich Ataxia). The mechanism of action remains undisclosed in available data, suggesting either proprietary formulation advantages or ongoing characterization across diverse disease states. This multi-indication profile is highly unusual for a single NDA and signals potential off-label development or repurposing strategy.
Peak17.8 years to LOE
Drug is at peak commercial maturity with zero reported competitive pressure, suggesting either niche positioning or weak market penetration despite broad indications; team likely lean and focused on specific therapeutic pockets.
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.