Last reviewed · How we verify
Artesunate (ARTESUNATE)
At a glance
| Generic name | ARTESUNATE |
|---|---|
| Sponsor | Amivas |
| Drug class | artesunate |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2020 |
Approved indications
- Falciparum malaria
- Vivax malaria
Common side effects
Key clinical trials
- Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar (PHASE3)
- Tafenoquine and ACTs (TADORE- Plus) (PHASE4)
- A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults (PHASE1)
- OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa (PHASE4)
- Severe Malaria in Remote Areas- Closing the Evidence Gap
- Health Systems Implementation and Molecular Surveillance of Multiple First-Line Treatments for Uncomplicated Malaria in Western Kenya
- Dose-Escalation Study of Artesunate Patients With IPF (PHASE1)
- A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Artesunate CI brief — competitive landscape report
- Artesunate updates RSS · CI watch RSS
- Amivas portfolio CI