MedPath

Artesunate

Generic Name
Artesunate
Brand Names
Artesunate Amivas
Drug Type
Small Molecule
Chemical Formula
C19H28O8
CAS Number
88495-63-0
Unique Ingredient Identifier
60W3249T9M

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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