Overview
Artesunate is indicated for the initial treatment of severe malaria. The World Health Organization recommends artesunate as first line treatment for severe malaria. Artesunate was developed out of a need for a more hydrophilic derivative of artemisinin. Artesunate was granted FDA approval on 26 May 2020.
Indication
Artesunate is indicated for the initial treatment of severe malaria in adult and pediatric patients.
Associated Conditions
- Acute Uncomplicated Plasmodium Falciparum Malaria
- Malaria, Cerebral
- Severe Malaria
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/31 | Not Applicable | Not yet recruiting | Metanoic Health Ltd. | ||
2025/07/31 | Not Applicable | Not yet recruiting | Metanoic Health Ltd. | ||
2025/06/15 | Phase 2 | Active, not recruiting | |||
2025/05/25 | Not Applicable | Not yet recruiting | |||
2025/03/26 | Not Applicable | Completed | |||
2025/03/12 | Phase 1 | Not yet recruiting | Joseph C. Wu | ||
2025/02/28 | Phase 2 | Not yet recruiting | |||
2025/01/20 | Phase 4 | Not yet recruiting | |||
2024/12/16 | Phase 1 | Completed | Procter and Gamble | ||
2024/08/15 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Amivas Ireland Ltd,Suite 5, Second Floor,Station House,Railway Square,Waterford,X91 P381,IRELAND | Authorised | 11/22/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Artesunate Amivas Powder and Solvent for Solution for Injection 110mg/vial | SIN17135P | INJECTION, POWDER, FOR SOLUTION | 110mg/vial | 11/11/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ARTESUNATO AMIVAS 110 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | Amivas Ireland Limited | 1211582001 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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