Data updated: May 26, 2026
ARTESUNATE
Trial Activity: Stable 6 active trials
Orphan Drug Breakthrough Therapy Priority Review Fast Track
Infectious Disease
Approved 2020-05-26
Development Insights
National Institute of Allergy and Infectious Diseases (NIAID) conducting 4 trials (17%)
25 indications explored (Broad Platform)
→ plasmodium falciparum infection (4 trials)
→ malaria (4 trials)
→ vivax malaria (2 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2020-05-26
- Patent Cliff
- 2044
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ARTESUNATE Approval History
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2020 to 2026
What ARTESUNATE Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- Other (1)
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Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06872112 (STOP-PAH) | 80578 | Ph 1 | recruiting | A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension |
| NCT05750459 | 19-0007 5UM1AI148689-03 | Ph 4 | completed | Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria |
| NCT06853184 | IVAS-CMV-01 | Ph 2 | recruiting | Study Evaluating the Efficacy and Safety of Artesunate |
| NCT07022743 | IMART Trial IRB/IEC/Z0004553 | Ph 2 | active not recruiting | Improving Treatment Outcomes in Chronic Myeloid Leukaemia Patients Using Imatinib and Artesunate Combination Therapy |
| NCT07095309 NeoART-M | 2023-MHL-001 NMRR ID-24-01879-TSI | Ph 2 | not yet recruiting | Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer |
| NCT07095478 NeoART-CIN | 2023-MHL-002 NMRR ID-24-01779-UWV | Ph 2 | not yet recruiting | Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer |
| NCT05555862 anal HSIL HIV- | ART-AIN IIB | Ph 2 | active not recruiting | Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL |
| NCT04706130 | 20-0010 | Ph 4 | completed | Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure |
| NCT06294912 | 7602-003 MK-7602-003 | Ph 1 | completed | A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003) |
| NCT04374019 results posted | MCC-20-COVID-01-PMC | Ph 2 | terminated | Novel Agents for Treatment of High-risk COVID-19 Positive Patients |
| NCT02304289 DESPARTH | AGO/2014/003 2014-002503-16 | Ph 1 | terminated | Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of Artesunate in Patients With Hepatocellular Carcinoma |
| NCT02084602 Artesunate | U.2012.0008 | Ph 4 | completed | Assessment of Artesunate/Mefloquine in the Peruvian Amazon |
| NCT02996695 | 15-0052 HHSN272201300022I | Ph 1 | completed | Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults |
| NCT02663700 | 15-0001 | Ph 1 | completed | Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso |
| NCT00936767 AMOS | BAKMAL0901 | Ph 2, Ph 3 | withdrawn | Artemisone for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia |
| NCT01955382 results posted | 999913209 13-I-N209, NCT01955382 | Ph 2 | completed | Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria |
| NCT00764036 ARTIC-M33/2 | M33/2 | Ph 1 | completed | Study of Artesunate in Metastatic Breast Cancer |
| NCT01976780 | WRAIR1935 | Ph 4 | completed | In Vivo and In Vitro Efficacy of Artemisinin Combination Therapy |
| NCT02563704 | UYaounde1 | Ph 3 | completed | A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon |
| NCT02092766 DHART | KIMORU005 | Ph 4 | completed | Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria |
| NCT01074905 VHX | SMRU0908 | Ph 3 | completed | Study on the Treatment of Vivax Malaria |
| NCT01374126 | PR-11019 | Ph 2 | completed | Azithromycin Combination Therapy for the Treatment of Severe Malaria |
| NCT00988507 FARM | DRI10382 | Ph 2 | terminated | Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARTESUNATE FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
4 international docs across 1 countries
ARTESUNATE Patents & Exclusivity
Latest Patent: Feb 2044
Exclusivity: May 2027
Patents (2 active)
US12390442
Expires Feb 16, 2044
US12121506
Expires Feb 16, 2044
Exclusivity
ODE-290
Until May 2027
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for ARTESUNATE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2044
- • 2 active patents
Trial Analysis
- • 23 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment