Artesunate

ApprovedSmall molecule

Artesunate is used to treat severe malaria, a serious parasitic infection spread by mosquitoes. It works by killing the malaria parasites in the blood.[2] Artesunate is currently approved and in use across 16 indications[4].[1]

Artesunate is one of 306 small molecule programs targeting Malaria. It is currently in Approved.

Indications

Total Trials

Active Trials

305

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MalariaUnknown status

Cervical Intraepithelial Neoplasia Grade 2/3Approved

Urinary SchistosomiasisApproved

SchistosomiasisApproved

Cytomegalovirus InfectionApproved

CMV InfectionRecruiting

TreatmentRecruiting

Combination TherapyActive, not recruiting

COVID-19Unknown status

Plasmodium Vivax MalariaUnknown status

MalariaApproved

Unknown status

Cervical Intraepithelial Neoplasia Grade 2/3Approved

Approved

Urinary SchistosomiasisApproved

Approved

SchistosomiasisApproved

Approved

Cytomegalovirus InfectionApproved

Approved

CMV InfectionPhase 2

Recruiting

TreatmentPhase 2

Recruiting

Combination TherapyPhase 2

Active, not recruiting

COVID-19Approved

Unknown status

Plasmodium Vivax MalariaApproved

Unknown status

Showing 10 of 15 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Artesunate

AAmivas Inc.

Approved

2 2

Biltricide

Bayer

Preclinical

4 3

Theo-Dur

Pfizer

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Clomid

Ferring

Preclinical

1 8

Aurlumyn

BBTG International Inc.

Preclinical

1 9

Somavert

PPharmacia and Upjohn

Preclinical

1 10

Zoledronate

Mario Negri Institute for Pharmacological Research

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Combination Therapy

NCT07022743

Phase 2Active, not recruiting

Treatment

NCT05555862

Phase 2Recruiting

Treatment

NCT06206564

Q4 2027

Phase 2Recruiting

Vulvar HSIL

NCT06075264

Q2 2028

Phase 2Not yet recruiting

Cervical Cancer

NCT07095478

Phase 2Recruiting

CMV Infection

NCT06853184

Clinical

Trials by Indication[1]

Malaria24 trials

Have Malaria Infections in Kenya Become Less Responsive to Artemisinin Treatment?

Unknown status·KKEMRI-Wellcome Trust Collaborative Research Program·Phase 4·NCT01190371·175 enrolled

Phase II Artesunate Study in Severe Malaria

Completed· Medicines for Malaria Venture logo

Medicines for Malaria Venture·Phase 2·NCT00522132·200 enrolled

Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

Completed·HHeidelberg University·Phase 2·NCT00354380

Show 21 more trials

Relationship Between HIV and Malaria in Ugandan Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00356824·300 enrolled

Artemisone for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia

Withdrawn·UUniversity of Oxford·Phase 2/3·NCT00936767

ACT MALI: Treatment of Malaria Based on Combination Therapies

Completed· Sanofi logo

Sanofi·Phase 4·NCT00452907·780 enrolled

Study on the Treatment of Vivax Malaria

Completed·UUniversity of Oxford·Phase 3·NCT01074905·655 enrolled

A Trial of Four Drug Regimens for the Prevention of Malaria in Senegalese Children

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT00132548·2,200 enrolled

Intravenous Artesunate and Malaria

Unknown status·UUniversity of Khartoum·Phase 4·NCT01805232·80 enrolled

Azithromycin Combination Therapy for Malaria

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00299208·120 enrolled

A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon

Completed·UUniversity of Yaounde 1·Phase 3·NCT02563704·238 enrolled

Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh

Completed·MMedical University of Vienna·Phase 2·NCT00356005·228 enrolled

Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02663700·112 enrolled

Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria

Completed·UUniversity of Oxford·Phase 4·NCT02092766·217 enrolled

Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01955382·70 enrolled

A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06294912·16 enrolled

Azithromycin Combination Therapy for the Treatment of Severe Malaria

Completed·MMedical University of Vienna·Phase 2·NCT01374126·75 enrolled

Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT05750459·90 enrolled

Chloroquine Alone or in Combination for Malaria in Children in Malawi

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00379821·640 enrolled

Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Unknown status·MMakerere University··NCT01122134·20 enrolled

Mass-Drug Administration to Reduce Malaria Transmission

Completed·RRadboud University Medical Center·N/A·NCT00509015·6,000 enrolled

Evaluation of Artesunate in Infants Being Treated for Severe Malaria

Recruiting·AAmivas Inc.··NCT06555809·15 enrolled

Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria

Completed·UUniversity of Oxford·Phase 2·NCT02492178·82 enrolled

Safety and Efficacy Study of IV Artesunate to Treat Malaria

Completed·UU.S. Army Medical Research and Development Command·Phase 2·NCT00298610·30 enrolled

Combination Therapy4 trials

In Vivo and In Vitro Efficacy of Artemisinin Combination Therapy

Completed·GGlobal Emerging Infections Surveillance and Response System·Phase 4·NCT01976780·118 enrolled

Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand

Completed·—·N/A·NCT01659281·13 enrolled

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

Active, not recruiting·OObafemi Awolowo University·Phase 2·NCT07022743·75 enrolled

Show 1 more trial

Trial of Artesunate Combination Therapy in Pakistan

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 2·NCT00959517·588 enrolled

ART3 trials

Assessment of Artesunate/Mefloquine in the Peruvian Amazon

Completed·IInstituto Nacional de Salud. Peru·Phase 4·NCT02084602·45 enrolled

Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00894374·40 enrolled

Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia

Completed·UUniversity of Oxford·N/A·NCT00493363·40 enrolled

Resistance3 trials

Artemisinin Resistance in Bangladesh

Completed·MMedical University of Vienna·N/A·NCT00639873·126 enrolled

Artemisinin Resistance in Cambodia II

Completed·—·N/A·NCT00722150·143 enrolled

Artemisinin Resistance in Cambodia

Completed·MMedical University of Vienna·N/A·NCT00479206

Colorectal Cancer3 trials

Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer (NeoART-V)

Unknown status·—·Phase 2·NCT03093129·200 enrolled

Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/ III Colorectal Cancer

Not yet recruiting·MMetanoic Health Ltd.·Phase 2·NCT07095309·120 enrolled

A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer

Unknown status·SSt George's, University of London·Phase 2·NCT02633098·200 enrolled

20 more indications

COVID-193 trials

Novel Agents for Treatment of High-risk COVID-19 Positive Patients

Terminated·SSusanne Arnold·Phase 2·NCT04374019·13 enrolled

Add-on Study on WHO Solidarity Trial Plus for COVID-19 in Nepal

Unknown status·NNepal Health Research Council·Phase 4·NCT05273242·400 enrolled

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial

Unknown status·SSunnybrook Health Sciences Centre·Phase 3·NCT04330690·2,900 enrolled

Efficacy2 trials

Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia

Completed·CCentro Internacional de Entrenamiento e Investigaciones Médicas·Phase 3·NCT00378625·360 enrolled

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

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT04706130·160 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease

Unknown status·SSanjay Gandhi Postgraduate Institute of Medical Sciences·Phase 2·NCT04713631·40 enrolled

Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02996695·62 enrolled

Treatment2 trials

Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

Active, not recruiting·FFrantz Viral Therapeutics, LLC·Phase 2·NCT05555862·17 enrolled

Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

Recruiting·FFrantz Viral Therapeutics, LLC·Phase 2·NCT06206564·48 enrolled

Intravenous2 trials

Study of the Safety of Intravenous Artesunate

Completed·UU.S. Army Medical Research and Development Command·Phase 1·NCT00292942·26 enrolled

Study of the Safety of Intravenous Artesunate

Completed·UU.S. Army Medical Research and Development Command·Phase 1·NCT00292929·40 enrolled

Plasmodium falciparum malaria1 trial

Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Terminated· Sanofi logo

Sanofi·Phase 2·NCT00988507·440 enrolled

Lupus Nephritis1 trial

Efficacy and Safety of Artesunate Plus Standard of Care in Active Lupus Nephritis

Unknown status·SSun Yat-sen University·Phase 4·NCT03214731·90 enrolled

Cytomegalovirus (CMV)1 trial

Artesunate in Preemptive Treatment of Human Cytomegalovirus (CMV) in Stem Cell Transplant Recipients

Completed·HHadassah Medical Organization·Phase 3·NCT00284687·20 enrolled

Plasmodium vivax malaria1 trial

Comparison of Two Antimalarial Drugs Regimens in Patient With Plasmodium Vivax Malaria in Thailand

Unknown status·MMahidol University·Phase 4·NCT01662700·120 enrolled

Breast Cancer1 trial

Study of Artesunate in Metastatic Breast Cancer

Completed·HHeidelberg University·Phase 1·NCT00764036·23 enrolled

Pulmonary Arterial Hypertension1 trial

A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension

Recruiting·JJoseph C. Wu·Phase 1·NCT06872112·15 enrolled

Cervical Cancer1 trial

Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer

Not yet recruiting·MMetanoic Health Ltd.·Phase 2·NCT07095478·28 enrolled

Hepatocellular Carcinoma1 trial

Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of Artesunate in Patients With Hepatocellular Carcinoma

Terminated·UUniversity Hospital, Ghent·Phase 1·NCT02304289·2 enrolled

Pregnant Women1 trial

Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo

Completed·NNICHD Global Network for Women's and Children's Health·Phase 1·NCT00538382·51 enrolled

Tolerance1 trial

Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

Completed· Sanofi logo

Sanofi·Phase 4·NCT00445796·300 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

Completed·UUniversity of North Carolina·N/A·NCT00287300·141 enrolled

Vulvar HSIL1 trial

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)

Recruiting·FFrantz Viral Therapeutics, LLC·Phase 2·NCT06075264·27 enrolled

Friedreich ataxia1 trial

Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA)

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 1/2·NCT04921930·20 enrolled

Solid Tumors1 trial

Phase I Study of Intravenous Artesunate for Solid Tumors

Completed·GGeorgetown University·Phase 1·NCT02353026·19 enrolled

CMV Infection1 trial

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

Recruiting·AAmivas Inc.·Phase 2·NCT06853184·90 enrolled

Regulatory

FDA Approval Timeline[5]

May 26, 2020

ARTESUNATE

NDA NDA213036

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Artesunate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Artesunate drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Artesunate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Artesunate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213036). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Artesunate. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Amivas Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAmivas Inc.

Patent Landscape[6]

Patent Cliff

Feb 16, 2044

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12121506Feb 16, 2044

12390442Feb 16, 2044

Artesunate

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2028

Trials by Indication[1]

Malaria24 trials

Combination Therapy4 trials

ART3 trials

Resistance3 trials

Colorectal Cancer3 trials

COVID-193 trials

Efficacy2 trials

Safety and Efficacy2 trials

Treatment2 trials

Intravenous2 trials

Plasmodium falciparum malaria1 trial

Lupus Nephritis1 trial

Cytomegalovirus (CMV)1 trial

Plasmodium vivax malaria1 trial

Breast Cancer1 trial

Pulmonary Arterial Hypertension1 trial

Cervical Cancer1 trial

Hepatocellular Carcinoma1 trial

Pregnant Women1 trial

Tolerance1 trial

Efficacy and Safety1 trial

Vulvar HSIL1 trial

Friedreich ataxia1 trial

Solid Tumors1 trial

CMV Infection1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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