Drug

Artesunate

Approved · EMA

Emerging researchLate-stage development

Also known as AS, Succinyl dihydroartemisinin, Artesunato, Artesunatum+1 more

AS, Succinyl dihydroartemisinin, Artesunato, Artesunatum, dihydroqinghasu hemsuccinate.

RxNorm18346 ChEMBLCHEMBL361497 ATCP01BE03UNII60W3249T9M

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Improving Treatment Outcomes in Chronic Myeloid Leukaemia Patients Using Imatinib and Artesunate Combination Therapy

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Exposure-Response Evaluation of IV Artesunate in Children With Severe Malaria

Clinical trial2026-06-18Results posted · ClinicalTrials.gov

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients

Clinical trial2026-05-19Results expected Q2 2028 · ClinicalTrials.gov

Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension

Clinical trial2026-04-23Results expected Q1 2029 · ClinicalTrials.gov

An Adaptive, Randomized, Active-controlled, Open-label, Sequential Cohort, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Intravenous Cipargamin (KAE609) in Adult and Pediatric Participants With Severe Plasmodium Falciparum Malaria (KARISMA - KAE609's Role In Severe Malaria)

Clinical trial2026-04-09Results posted · ClinicalTrials.gov

Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer

Clinical trial2025-07-31Results expected Q3 2032 · ClinicalTrials.gov

Phase II Single Arm, Open Label Study of Artesunate for the Treatment of Human Papilloma Virus Positive High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

Clinical trial2025-07-31Results expected Q2 2027 · ClinicalTrials.gov

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Suppositories for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)

Clinical trial2025-05-18Results expected Q4 2026 · ClinicalTrials.gov

Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Cameroon

Clinical trial2025-03-05Completed · ClinicalTrials.gov

Approval: Artesunate Amivas (EMA)

Regulatory2021-11-22EMA

Cytokine Storm in COVID-19: The Current Evidence and Treatment Strategies.

Research2020-07-10Frontiers in immunology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Artesunate

Aliases & brands

ASSuccinyl dihydroartemisininArtesunatoArtesunatumdihydroqinghasu hemsuccinate

RxNorm CUI

18346

ChEMBL ID

CHEMBL361497

ATC codes

P01BE03

UNII

60W3249T9M

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2021-11-22

Latest approval

2021-11-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2021-11-22Approval

Approval: Artesunate Amivas (EMA)

Indication: Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children. Consideration should be given to official guidance on the appropriate use of… Show full indication

Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children. Consideration should be given to official guidance on the appropriate use of antimalarial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

61 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 61

Phase 111Phase 220Phase 2 / 31Phase 39Phase 413Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Exposure-Response Evaluation of IV Artesunate in Children With Severe Malaria

CompletedPH IVNational Institute of Allergy and Infectious Diseases (NIAID)n=902025

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

CompletedPH IVUniversity of Maryland, Baltimoren=1602024

WHO Solidarity Trial Plus: An International Randomised Trial of Additional Treatments for COVID-19 in Hospitalised Patients Who Are All Receiving the Local Standard of Care in Nepal

Unknown statusPH IVNepal Health Research Counciln=4002022

A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis: Pilot Study

Unknown statusPH IVSun Yat-sen Universityn=902022

Confirmation of Artemisinin Tolerance in Malaria Parasites Trial in Kilifi

Unknown statusPH IVKEMRI-Wellcome Trust Collaborative Research Programn=1752018

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IINovartis Pharmaceuticalsn=2542025

Exposure-Response Evaluation of IV Artesunate in Children With Severe Malaria

CompletedPH IVNational Institute of Allergy and Infectious Diseases (NIAID)n=902025

Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Zambia

CompletedPH IIILondon School of Hygiene and Tropical Medicinen=6002025

Effect of Single-course Malaria Chemoprevention on Clearance of and Protection From Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Cameroon

CompletedPH IIILondon School of Hygiene and Tropical Medicinen=9022025

A Controlled Human Malaria Infection Study to Evaluate the Antimalarial Activity of MK-7602 Against Plasmodium Falciparum Blood Stage Infection in Healthy Adult Participants

CompletedPH IMerck Sharp & Dohme LLCn=162025

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

CompletedPH IVUniversity of Maryland, Baltimoren=1602024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Cytokine Storm in COVID-19: The Current Evidence and Treatment Strategies.

Frontiers in immunology · 2020 · 756 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Hydroxychloroquine

Studied across 3 of the same disease areas as Artesunate in the shared literature.

3 shared diseases1 shared paper

Tocilizumab

Studied across 3 of the same disease areas as Artesunate in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.