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Artesunate for Injection
Artesunate for Injection is a Antimalarial Small molecule drug developed by U.S. Army Office of the Surgeon General. It is currently in Phase 2 development for Treatment of severe malaria, Treatment of uncomplicated malaria.
Artesunate for Injection works by inhibiting the growth of malaria parasites in the blood.
Artesunate for Injection works by inhibiting the growth of malaria parasites in the blood. Used for Treatment of severe malaria, Treatment of uncomplicated malaria.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Artesunate for Injection |
|---|---|
| Sponsor | U.S. Army Office of the Surgeon General |
| Drug class | Antimalarial |
| Target | Plasmodial protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Artesunate is a derivative of artemisinin, a compound found in the herb Artemisia annua. It targets the malaria parasite's plasmodial protein, disrupting its ability to synthesize ATP and ultimately leading to the parasite's death.
Approved indications
- Treatment of severe malaria
- Treatment of uncomplicated malaria
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
Key clinical trials
- Severe Malaria in Remote Areas- Closing the Evidence Gap
- Study Evaluating the Efficacy and Safety of Artesunate (PHASE2)
- Evaluation of Artesunate in Infants Being Treated for Severe Malaria
- Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults (PHASE1, PHASE2)
- Study to Compare Feasibility of 1-step Injectable Artesunate vs. Conventional 2-step Injectable Artesunate (PHASE2)
- Plasmodium Immunotherapy for Lung Cancer (PHASE1, PHASE2)
- Add-on Study on WHO Solidarity Trial Plus for COVID-19 in Nepal (PHASE4)
- Dose Escalation PfSPZ-CVac (PHASE1)
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:
- Artesunate for Injection CI brief — competitive landscape report
- Artesunate for Injection updates RSS · CI watch RSS
- U.S. Army Office of the Surgeon General portfolio CI
Frequently asked questions about Artesunate for Injection
What is Artesunate for Injection?
How does Artesunate for Injection work?
What is Artesunate for Injection used for?
Who makes Artesunate for Injection?
What drug class is Artesunate for Injection in?
What development phase is Artesunate for Injection in?
What are the side effects of Artesunate for Injection?
What does Artesunate for Injection target?
Related
- Drug class: All Antimalarial drugs
- Target: All drugs targeting Plasmodial protein
- Manufacturer: U.S. Army Office of the Surgeon General — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Treatment of severe malaria
- Indication: Drugs for Treatment of uncomplicated malaria
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing