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 |
---|---|---|---|---|---|
2025/06/15 | 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 | |||
2024/08/01 | Phase 3 | Recruiting | |||
2024/07/25 | Phase 2 | 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 |
---|---|---|---|---|---|
Artesunate Tablets | 国药准字H20113075 | 化学药品 | 片剂 | 7/3/2020 | |
Artesunate Tablets | 国药准字H20113074 | 化学药品 | 片剂 | 7/3/2020 | |
Artesunate Tablets | 国药准字H10880057 | 化学药品 | 片剂 | 8/12/2020 | |
Artesunate Tablets | 国药准字H10880055 | 化学药品 | 片剂 | 8/12/2020 | |
Artesunate Tablets | 国药准字H20083378 | 化学药品 | 片剂 | 11/14/2022 | |
Artesunate for Injection | 国药准字H20173021 | 化学药品 | 注射剂 | 9/30/2020 | |
Artesunate for Injection | 国药准字H20133237 | 化学药品 | 注射剂 | 9/30/2020 | |
Artesunate for Injection | 国药准字H10930195 | 化学药品 | 注射剂 | 9/30/2020 |
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. |
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