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Aralen

(Chloroquine)

ApprovedSmall molecule

Chloroquine is used to treat and prevent malaria, a serious infection spread by mosquitoes. It is also used to treat certain autoimmune diseases like lupus and rheumatoid arthritis.[2] Aralen is currently approved and in use across 17 indications[4].[1]

Aralen is one of 390 small molecule programs targeting Women. It is currently in Approved.

17

Indications

94

Total Trials

3

Active Trials

389

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

WomenCompleted

AIDSApproved

Plasmodium Falciparum MalariaApproved

Brain DiseaseApproved

Dengue Hemorrhagic FeverApproved

Breast Ductal Carcinoma in SituApproved

HIV InfectionApproved

Bacterial DiseaseApproved

Lupus NephritisActive, not recruiting

Metabolic SyndromeActive, not recruiting

WomenPreclinical

Completed

AIDSApproved

Approved

Plasmodium Falciparum MalariaApproved

Approved

Brain DiseaseApproved

Approved

Dengue Hemorrhagic FeverApproved

Approved

Breast Ductal Carcinoma in SituApproved

Approved

HIV InfectionApproved

Approved

Bacterial DiseaseApproved

Approved

Lupus NephritisPreclinical

Active, not recruiting

Metabolic SyndromePreclinical

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Aralen

Blood Taken

HHospices Civils de Lyon

Hymecromone

SStanford University

Immunosuppressive

Chiesi Farmaceutici S.p.A.

Serology

UUniversity Hospital Center of Martinique

Pfizer-Biontech COVID-19 MRNA Vaccine

Administration of Almitrine

CCentre Hospitalier Universitaire de Nice

Tpa

UUniversity of Florida

Thrombolytic

FFaculty Hospital Kralovske Vinohrady

Stools

VVersailles Hospital

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

Timeline

Expected Milestones

Q1 2028

ApprovedRecruiting

Plasmodium Vivax Malaria

NCT04704999

Q2 2030

Post-ApprovalNot yet recruiting

Atopic Dermatitis

NCT07352566

Clinical

Trials by Indication[1]

Malaria27 trials

Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component

Completed·IInstitute of Tropical Medicine, Belgium·Phase 4·NCT00680732·1,370 enrolled

A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria

Completed· GSK logo

GSK·Phase 2·NCT02563496·60 enrolled

Ethiopia Antimalarial in Vivo Efficacy Study 2012

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT01680406·398 enrolled

Show 24 more trials

Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.

Completed·SState University of New York - Upstate Medical University·Phase 4·NCT02564471·103 enrolled

Comparing Chemoprevention Drugs for School-based Malaria Control

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT05980156·646 enrolled

PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02773979·28 enrolled

Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 4·NCT01019408·163 enrolled

An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older

Recruiting· GSK logo

GSK·Phase 3·NCT06666491·300 enrolled

Chloroquine and Amodiaquine for Treatment of Malaria in Children

Completed·BBandim Health Project·Phase 4·NCT00137514·720 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

Malaria Challenge in Healthy Volunteers

Completed·SSeattle Children's Hospital·Phase 1·NCT01500980·36 enrolled

Evaluating the Role of Chloroquine for Malaria Elimination

Completed·CCentro de Investigacao em Saude de Manhica·Phase 2/3·NCT02698748·75 enrolled

Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 2·NCT00486694·190 enrolled

Chloroquine (CQ) and Azithromycin (AZ) Combination for Malaria Prophylaxis

Withdrawn·UU.S. Army Medical Research and Development Command·Phase 2·NCT03278808

Chloroquine and Post Malaria Anaemia Study

Completed·MMedical Research Council Unit, The Gambia·N/A·NCT00473837·96 enrolled

Impact of Insecticide-treated Curtains on Antimalarial Drug Resistance

Completed·LLondon School of Hygiene and Tropical Medicine·N/A·NCT00169078·1,035 enrolled

Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria

Suspended·UUniversité Victor Segalen Bordeaux 2·Phase 3·NCT00442403·200 enrolled

Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam

Completed·OOxford University Clinical Research Unit, Vietnam·Phase 4·NCT01887821·330 enrolled

Comparing Chemoprevention Approaches for School-based Malaria Control

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT05244954·746 enrolled

Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

Completed·MMenzies School of Health Research··NCT01716260·24 enrolled

New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa

Completed·IInstitute of Tropical Medicine, Belgium·Phase 3·NCT00730366·2,766 enrolled

Study on the Treatment of Vivax Malaria

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

Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria

Terminated· Medicines for Malaria Venture logo

Medicines for Malaria Venture·Phase 3·NCT04368910·30 enrolled

G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria

Completed·UUniversity of Oxford·Phase 4·NCT02876549·1,000 enrolled

Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients

Completed·FFundação de Medicina Tropical Dr. Heitor Vieira Dourado·Phase 2·NCT03529396·106 enrolled

Antimalarial Drug Resistance in Mali

Completed·CCenters for Disease Control and Prevention·N/A·NCT00127998·1,011 enrolled

A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh

Completed·MMenzies School of Health Research·Phase 4·NCT02389374·181 enrolled

COVID-196 trials

Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID

Terminated·—·Phase 2·NCT04349371·5 enrolled

Prevention With Chloroquine in Health Personnel Exposed to Infection With Coronavirus Disease 2019 (COVID-19) (TS-COVID)

Completed·FFundacion Clinica Valle del Lili·Phase 2·NCT04627467·3,217 enrolled

Chloroquine for Mild Symptomatic and Asymptomatic COVID-19

Terminated·HHaEmek Medical Center, Israel·Phase 2/3·NCT04333628·5 enrolled

Show 3 more trials

Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds

Terminated·GGovernment of Punjab, Specialized Healthcare and Medical Education Department·Phase 4·NCT04346667·125 enrolled

Efficacy of Faviprevir in COVID-19 Treatment

Completed·TTanta University·Phase 2/3·NCT04351295·92 enrolled

PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds

Terminated·GGovernment of Punjab, Specialized Healthcare and Medical Education Department·Phase 4·NCT04351191·137 enrolled

Plasmodium vivax malaria5 trials

Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

Completed· Sanofi logo

Sanofi·Phase 3·NCT01378286·380 enrolled

Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

Completed· GSK logo

GSK·Phase 3·NCT02216123·251 enrolled

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

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

Show 2 more trials

Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria

Completed· Medicines for Malaria Venture logo

Medicines for Malaria Venture·Phase 3·NCT00440999·456 enrolled

Optimizing the Dose of Tafenoquine for the Radical Cure of Plasmodium Vivax Malaria in Southeast Asia

Recruiting·UUniversity of Oxford·Approved·NCT04704999·820 enrolled

Glioblastoma3 trials

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

Terminated·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT04397679·2 enrolled

The Addition of Chloroquine to Chemoradiation for Glioblastoma,

Withdrawn·MMaastricht Radiation Oncology·Phase 2·NCT02432417

The Addition of Chloroquine to Chemoradiation for Glioblastoma

Completed·MMaastricht Radiation Oncology·Phase 1·NCT02378532·13 enrolled

Treatment3 trials

The Effect of Chloroquine in the Treatment of Patients With Dengue

Unknown status·UUniversity of Sao Paulo·Phase 1/2·NCT00849602·132 enrolled

Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax

Completed·DDinka Dugassa·Phase 4·NCT06044805·100 enrolled

Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity

Completed·PPapua New Guinea Institute of Medical Research·Phase 4·NCT02143934·524 enrolled

40 more indications

Plasmodium Falciparum3 trials

Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis

Completed·RRadboud University Medical Center·N/A·NCT02080026·15 enrolled

Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau

Completed·BBandim Health Project·Phase 4·NCT00426439·300 enrolled

Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00082563·14 enrolled

Pregnancy3 trials

Chloroquine for Malaria in Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT01443130·900 enrolled

Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)

Terminated·CCenters for Disease Control and Prevention·Phase 4·NCT01107145·16 enrolled

Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance

Completed·LLondon School of Hygiene and Tropical Medicine·N/A·NCT00140517·700 enrolled

Plasmodium Vivax Infection2 trials

Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

Completed·OOswaldo Cruz Foundation·Phase 2/3·NCT02691910·204 enrolled

Evaluating the Efficacy of Chloroquine for the Treatment of Plasmodium Vivax Infections in Central Vietnam

Unknown status·NNational Institute of Malariology, Parasitology and Entomology, Vietnam·Phase 4·NCT02610686·100 enrolled

Efficacy and Safety2 trials

CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease

Terminated·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT00391313

Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT00131703·900 enrolled

ART2 trials

TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014

Completed·RResearch Institute for Tropical Medicine, Philippines··NCT04222088·159 enrolled

Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD)

Completed·UUniversity of Oxford·Phase 3·NCT01640574·680 enrolled

Efficacy2 trials

Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax

Completed·WWalter Reed Army Institute of Research (WRAIR)·Phase 2·NCT00811096·20 enrolled

Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil

Completed·CCenters for Disease Control and Prevention·N/A·NCT02043652·119 enrolled

Trial2 trials

P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine

Completed·MMenzies School of Health Research·Phase 3·NCT01708876·250 enrolled

P. Knowlesi Trial of Artemether-lumefantrine vs Chloroquine

Completed·MMenzies School of Health Research·Phase 3·NCT02001012·123 enrolled

Rheumatoid Arthritis2 trials

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Completed· Roche logo

Roche·Phase 3·NCT01941095·100 enrolled

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT03449758·84 enrolled

Advanced Solid Tumors1 trial

Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

Completed·UUniversity of Cincinnati·Phase 1·NCT02071537·24 enrolled

Glioblastoma Multiforme1 trial

Chloroquine for Treatment of Glioblastoma Multiforme

Completed·NNational Institute of Neurology and Neurosurgery, Mexico·Phase 3·NCT00224978

Multiple Myeloma1 trial

Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma

Terminated·NNYU Langone Health·Phase 2·NCT01438177·11 enrolled

Safety and Efficacy1 trial

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

Vaccine1 trial

Sanaria™ PfSPZ Challenge Vaccine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01546389·30 enrolled

Sickle Cell Disease1 trial

Vascular Function Intervention Trial in Sickle Cell Disease

Unknown status·LLondon School of Hygiene and Tropical Medicine·Phase 2/3·NCT01718054·120 enrolled

Breast Cancer1 trial

A Phase 2 Randomized, Double-blind Trial Evaluating the Effects of Chloroquine in Breast Cancer

Unknown status·OOttawa Hospital Research Institute·Phase 2·NCT02333890·60 enrolled

Brain Metastases1 trial

Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Terminated·IInstituto Nacional de Cancerologia de Mexico·Phase 2·NCT01894633·73 enrolled

Pregnant Women1 trial

Influence of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda

Completed·LLondon School of Hygiene and Tropical Medicine·N/A·NCT00132535·2,548 enrolled

Metabolic Syndrome1 trial

Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)

Completed·WWashington University School of Medicine·N/A·NCT00455403·357 enrolled

Splenomegaly1 trial

Prednisone Plus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly

Withdrawn·LLihir Medical Centre·Phase 3·NCT01785979

Adult Subject1 trial

A Phase 1 Study To Estimate The Relative Bioavailability Of Co-Administered Formulations Of Azithromycin Microsphere And Chloroquine Test Formulation Compared With Co-Administered Immediate Release Individual Azithromycin And Chloroquine Tablets In Healthy Adult Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01100060·40 enrolled

Prevention1 trial

Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse

Completed· GSK logo

GSK·Phase 2·NCT01376167·851 enrolled

Combination Therapy1 trial

Trial of Artesunate Combination Therapy in Pakistan

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

Prophylaxis1 trial

Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Trial to Determine Safety and Protective Efficacy of Sanaria PfSPZ Challenge With Concurrent Pyrimethamine Treatment That Inhibits Development of Asexual B...

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02511054·57 enrolled

Pneumonia1 trial

Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

Completed·CCentro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva·Phase 3·NCT04420247·142 enrolled

Relapse1 trial

Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan

Completed·UUniversity of Oxford·Phase 4·NCT01178021·593 enrolled

Biomarker1 trial

CiPA Phase 1 ECG Biomarker Validation Study

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT03070470·60 enrolled

Lip1 trial

TES of Chloroquine for Pv in the Philippines in 2016

Completed·RResearch Institute for Tropical Medicine, Philippines··NCT05958797·74 enrolled

Lupus Nephritis1 trial

Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Unknown status·TTanta University··NCT03687905·60 enrolled

Influenza1 trial

The Chloroquine for Influenza Prevention Trial

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT01078779·1,516 enrolled

Immune Response1 trial

Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose

Completed· GSK logo

GSK·Phase 2·NCT00972725·28 enrolled

Small Cell Lung Cancer1 trial

Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer

Terminated·MMaastricht Radiation Oncology·Phase 1·NCT01575782·5 enrolled

Immune1 trial

Chloroquine for Reducing Immune Activation in HIV- Infected Individuals

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT00819390·70 enrolled

Women1 trial

Chloroquine Population Pharmacokinetics in Pre and Post-partum Women

Completed·UUniversity of Oxford·N/A·NCT01546961·49 enrolled

Pilot Study1 trial

"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"

Completed·SShiraz University of Medical Sciences·Phase 4·NCT02058173·10 enrolled

Hemolysis1 trial

G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)

Completed· GSK logo

GSK·Phase 1·NCT01205178·192 enrolled

TED1 trial

Comparison of the ECG Effects Related to Pharmacokinetic Profile of Chloroquine and Piperaquine

Completed·UUniversity of Oxford·Phase 4·NCT02192944·16 enrolled

Gemcitabine1 trial

Adjuvant Effect of Chloroquine on Gemcitabine

Completed·UUniversity of Zurich·Phase 1·NCT01777477·9 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

T Cell1 trial

Chloroquine as a Modulator of T Cell Immune Activation

Completed·CCIHR Canadian HIV Trials Network·N/A·NCT02004314·19 enrolled

Malaria, Falciparum1 trial

Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

Completed·LLiverpool School of Tropical Medicine·Approved·NCT06083688·788 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ARALEN HYDROCHLORIDE

NDA NDA006002

Sources

References

[1]
ClinicalTrials.gov — 94 trial records for Chloroquine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aralen drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Chloroquine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Chloroquine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA006002). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

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