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artesunate

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

May 26, 2020

Artesunate (AS) is a medication used to treat malaria. The intravenous form is preferred to quinine for severe malaria. Often it is used as part of combination therapy, such as artesunate plus mefloquine. It is not used for the prevention of malaria. Artesunate can be given by injection into a vein, injection into a muscle, by mouth, and by rectum. — Wikipedia

Clinical trial activity

213 trials · 208 clinical orgs · 1 marketing orgs

Phase 1
27
Phase 2
93
Phase 3
59
Phase 4
63

Earliest trial started Jan 1, 2000 (NCT00140361)

Timeline

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  4. Mar 28, 2006

    Orphan Drug Designation

2020s

  1. May 26, 2020

    Amivas — Earliest FDA Approval

  2. May 26, 2020

    Amivas — Marketing Organization

  3. May 26, 2020

    Amivas — NDA Secondary Org

  4. May 26, 2020

    Amivas — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedPriority reviewFast trackBreakthroughMay 26, 2020

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1[C@H](OC(=O)CCC(=O)O)O[C@@H]2O[C@@]3(C)CC[C@H]4[C@H](C)CC[C@@H]1[C@@]24OO3
Mol. weight
384.43 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Prodrug

Sources

Also known as

  • arinate
  • arsuamoon
  • arsumax
  • arsumax
  • arsumax
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunate
  • artesunato
  • artesunato
  • artesunatum
  • artesunatum
  • artesunic acid
  • artesunic acid
  • artesunic acid
  • as
  • as
  • butanedioic acid, 1-[(3r,5as,6r,8as,9r,10s,12r,12ar)-decahydro-3,6,9-trimethyl-3,12-epoxy-12h-pyrano[4,3-j]-1,2-benzodioxepin-10-yl] ester
  • butanedioic acid, 1-[(3r,5as,6r,8as,9r,10s,12r,12ar)-decahydro-3,6,9-trimethyl-3,12-epoxy-12h-pyrano[4,3-j]-1,2-benzodioxepin-10-yl] ester
  • cosunate
  • dihydroartemisinine-12-alpha-succinate
  • dihydroqinghasu hemsuccinate
  • dihydroqinghasu hemsuccinate
  • dihydroqinghasu hemsuccinate
  • malacef
  • malartin
  • sm 804
  • sm-804
  • sodium artesunate
  • succinyl dihydroartemisinin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06872112Phase 1Jan 1, 2026Stanford University
NCT06967519Phase 4Dec 31, 2025National Institutes of Health (NIH), Yale University
NCT06962319Phase 3Sep 30, 2025Medicines for Malaria Venture, University of Liverpool
NCT07095309Phase 2Aug 15, 2025Clinical Research Centre, Malaysia, Metanoic Health Ltd.
NCT07095478Phase 2Aug 1, 2025Clinical Research Centre, Malaysia, Metanoic Health Ltd.
NCT07022743Phase 2Jul 1, 2025Obafemi Awolowo University
NCT06853184Phase 2May 1, 2025Amivas
NCT06519994Phase 2Jul 4, 2024Kenya Medical Research Institute, National Cancer Institute (NCI), University of North Carolina at Chapel Hill
NCT06263582Phase 1May 29, 2024University of North Carolina at Chapel Hill
NCT06294912Phase 1Apr 18, 2024Merck
NCT05988463Phase 1Feb 1, 2024Stanford University
NCT05951595Phase 3Jan 1, 2024Mahidol University, University of Oxford
NCT06165614Phase 1Dec 31, 2023Gilead Sciences, University of North Carolina at Chapel Hill
NCT05750459Phase 4Nov 29, 2023National Institute of Allergy and Infectious Diseases (NIAID)
NCT05929157Phase 1/Phase 2 (Phase 2)Sep 1, 2023Centre de Recherche Médicale de Lambaréné, University of Tuebingen
NCT06076213Phase 4May 1, 2023Centers for Disease Control and Prevention (CDC), Global Health Innovative Technology Fund, Government of the Democratic Republic of the Congo
NCT05764746Phase 2/Phase 3 (Phase 3)Apr 1, 2023Muhimbili University, The Swedish Research Council, Uppsala University
NCT05689047Phase 2Mar 29, 2023Merck KGaA
NCT06472258N/AMar 1, 2023RESnTEC, Institute of Research
NCT05555862Phase 2Nov 15, 2022Amarex Clinical Research, Anal Dysplasia Clinic MidWest, Frantz Medical, University of California, San Francisco
Showing 20 of 213 trials
Page 1 / 11

Organizations

Research & Development (208)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of LondonAcademic/Hospital241942001
University of OxfordAcademic/Hospital211852007
Shin Poong PharmaceuticalsFor profit19742005
Medicines for Malaria VentureAcademic/Hospital181242005
Centers for Disease Control and Prevention (CDC)Government151232000
World Health OrganizationGovernment15042000
Institute of Tropical Medicine, BelgiumAcademic/Hospital12532003
Mahidol UniversityAcademic/Hospital12152005
Government of ThailandGovernment9632006
SanofiFor profit9942005
Centre MurazAcademic/Hospital8422007
United States ArmyGovernment8442006
University of KinshasaAcademic/Hospital8142007
University of AntwerpAcademic/Hospital7132003
Bill and Melinda Gates FoundationAcademic/Hospital6132004
Kenya Medical Research InstituteAcademic/Hospital6142004
National Institute for Medical Research, TanzaniaGovernment6232004
National Institute of Allergy and Infectious Diseases (NIAID)Government6542004
University of LiverpoolAcademic/Hospital6322007
University of TuebingenAcademic/Hospital6122006
208 organizations
Page 1 / 11

Marketing (3)

OrganizationOrg typeRelationshipDate
AmivasFor profitMKTGMay 26, 2020
AmivasFor profitNDA2May 26, 2020
AmivasFor profitNDAMay 26, 2020