Sold as Artesunate. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Artesunate (sold as Artesunate), first approved May 26, 2020, with 0 new uses approved and 0 published complete response letters.
| AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRPCoronary Heart Disease, Inflammation · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not applicable | Not yet recruiting | Nov 12, 2026 |
| A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy AdultsMalaria · University of Oxford | Phase 1 | Not yet recruiting | Mar 13, 2026 |
| Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal CancerStage II/III Colon Cancer, Bowel Cancer · Metanoic Health Ltd. | Phase 2 | Not yet recruiting | Jul 31, 2025 |
| Safety and Efficacy of Oral Artesunate for Pre-cervical CancerCIN 2/3 · Metanoic Health Ltd. | Phase 2 | Not yet recruiting | Jul 31, 2025 |
| Tafenoquine and ACTs (TADORE- Plus)Vivax Malaria · Menzies School of Health Research | Phase 4 | Not yet recruiting | Jul 11, 2025 |
| Improving Treatment Outcomes in Chronic Myeloid Leukaemia Patients Using Imatinib and Artesunate Combination TherapyChronic Myeloid Leukemia (CML) · Obafemi Awolowo University | Phase 2 | Active, not recruiting | Jun 15, 2025 |
| OPTImizing Malaria And HIV Treatment in a Shifting Landscape in AfricaMalaria, Hiv · Yale University | Phase 4 | Recruiting | May 13, 2025 |
| Safety of Antimalarials in the FIRst trimEsterMalaria, Pregnancy, Malaria, Antepartum · Liverpool School of Tropical Medicine | Phase 3 | Recruiting | May 8, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| May 26, 2020 | ArtesunateNDA 213036 · New molecular entity | Amivas | 5 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
