Plaquenil

(Hydroxychloroquine)

ApprovedSmall molecule

Hydroxychloroquine is used to treat malaria, lupus (an autoimmune disease), and rheumatoid arthritis. It helps reduce inflammation and symptoms like joint pain and skin rashes.[2] Plaquenil is currently approved and in use across 65 indications[4].[1]

Plaquenil is one of 1127 small molecule programs targeting Breast Cancer. It is currently in Approved.

Indications

315

Total Trials

Active Trials

1,126

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Breast CancerWithdrawn

COVID-19Suspended

Osteoarthritis, KneeApproved

Lichen PlanusApproved

Coronavirus Infectious DiseaseApproved

Sjogren SyndromeApproved

Chronic Hepatitis C Virus InfectionApproved

Low Grade GliomaApproved

MastocytosisApproved

Chronic Lymphocytic LeukemiaApproved

Breast CancerPhase 2

Withdrawn

COVID-19Approved

Suspended

Osteoarthritis, KneeApproved

Approved

Lichen PlanusApproved

Approved

Coronavirus Infectious DiseaseApproved

Approved

Sjogren SyndromeApproved

Approved

Chronic Hepatitis C Virus InfectionApproved

Approved

Low Grade GliomaApproved

Approved

MastocytosisApproved

Approved

Chronic Lymphocytic LeukemiaApproved

Approved

Showing 10 of 65 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Plaquenil

Jazz Pharmaceuticals

Approved

7 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Duragesic

CCephalon

Preclinical

1 9

Tricor

JJagotec

Preclinical

1 10

Acupan

YYonsei University

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Preeclampsia

NCT06020378

N/ARecruiting

Efficacy and Safety

NCT06479317

Post-ApprovalRecruiting

Efficacy

NCT05626348

Recruiting

Pregnancy

NCT04918524

Q1 2027

Phase 2Recruiting

COVID-19

NCT05041907

N/ARecruiting

Type 2 Diabetes

NCT06319560

Clinical

Trials by Indication[1]

COVID-1965 trials

Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care

Suspended·PProvidence Health & Services·Phase 4·NCT04334967·13 enrolled

A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients

Terminated·QQueen's Medical Center·Phase 3·NCT04345692·17 enrolled

Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

Unknown status·LLouisiana State University Health Sciences Center in New Orleans·Phase 3·NCT04363450·1,700 enrolled

Show 62 more trials

Favipiravir in Hospitalized COVID-19 Patients

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 4·NCT04359615·40 enrolled

Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic

Completed·BBarcelona Institute for Global Health·Phase 3·NCT04331834·275 enrolled

Azithromycin in Hospitalized COVID-19 Patients

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 4·NCT04359316·40 enrolled

Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Completed·SShehnoor Azhar·Phase 3·NCT04338698·550 enrolled

OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome

Withdrawn·FFondation Hôpital Saint-Joseph·Phase 3·NCT04365582

Hydroxychloroquine in COVID-19 Patients

Unknown status·SSamah Lutfy·Phase 2·NCT04394442·200 enrolled

Favipiravir vs Hydroxychloroquine vs Control in COVID -19

Completed·RRoyal College of Surgeons in Ireland - Medical University of Bahrain·Phase 2·NCT04387760·150 enrolled

EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

Withdrawn·UUniversity Hospital, Strasbourg, France·Phase 3·NCT04347512

Hydroxychloroquine for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection or Death

Withdrawn·RRambam Health Care Campus·Phase 1·NCT04323631

High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19

Completed·UUniversity of Chicago·Phase 1·NCT04351620·12 enrolled

Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic

Completed·—·N/A·NCT04668469·600 enrolled

Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19

Terminated·UUniversity of New Mexico·Phase 1/2·NCT04435808·1 enrolled

Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease

Terminated·UUniversity Hospital, Angers·Phase 3·NCT04325893·259 enrolled

Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO

Suspended·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT04341870·27 enrolled

Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19

Terminated·CChronic Obstructive Pulmonary Disease Trial Network, Denmark·Phase 2·NCT04322396·117 enrolled

Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

Completed·SShanghai Public Health Clinical Center·Phase 3·NCT04261517·30 enrolled

Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.

Unknown status·OOctober 6 University·Phase 4·NCT04779047·150 enrolled

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19

Unknown status·PPerseverance Research Center, LLC·Phase 1/2·NCT04344457·80 enrolled

Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)

Completed·NNational Institute of Respiratory Diseases, Mexico·Phase 3·NCT04318015·289 enrolled

A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04381988·4 enrolled

Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis

Unknown status·NNucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara·N/A·NCT04384458·400 enrolled

ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease

Terminated·—·Phase 3·NCT04329611·148 enrolled

A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04379492

Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to COVID-19

Withdrawn·UUniversidad Nacional de Colombia·Phase 3·NCT04346329

The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial)

Unknown status·CCorpometria Institute·Phase 2/3·NCT04712279·294 enrolled

Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers

Terminated·—·Phase 3·NCT04328285·118 enrolled

Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19

Completed·UUniversidad Peruana Cayetano Heredia·Phase 3·NCT04414241·68 enrolled

Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

Completed·IIntermountain Health Care, Inc.·Phase 2·NCT04329832·85 enrolled

Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts

Completed·—·Phase 4·NCT04652648·54 enrolled

Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients

Unknown status·HHamad Medical Corporation·Phase 2/3·NCT04437693·500 enrolled

Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)

Completed·HHospital Israelita Albert Einstein·Phase 3·NCT04321278·440 enrolled

Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)

Withdrawn·OOregon Health and Science University·Phase 2·NCT04363866

Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19

Completed·—·N/A·NCT04376814·40 enrolled

A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers

Unknown status·MMilitary Hospital of Tunis·Phase 3·NCT04377646·660 enrolled

Hydroxychloroquine for the Treatment of Mild COVID-19 Disease

Terminated·UUniversity Hospital Tuebingen·Phase 2·NCT04340544·17 enrolled

Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19

Unknown status·MMinistry of Health, Turkey·Phase 3·NCT04411433·1,008 enrolled

Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19

Terminated·UUMC Utrecht·Phase 4·NCT04362332·25 enrolled

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Recruiting·UUniversity of Oxford·Phase 2·NCT05041907·3,800 enrolled

Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)

Completed·—·Phase 4·NCT04466540·1,372 enrolled

A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19

Terminated·RRutgers, The State University of New Jersey·Phase 2·NCT04605588·7 enrolled

Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial

Terminated·—·Phase 3·NCT04339816·3 enrolled

International ALLIANCE Study of Therapies to Prevent Progression of COVID-19

Unknown status·NNational Institute of Integrative Medicine, Australia·Phase 2·NCT04395768·200 enrolled

Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)

Completed·NNational Institute of Respiratory Diseases, Mexico·Phase 3·NCT04315896·320 enrolled

Completed·MMassachusetts General Hospital·Phase 3·NCT04332991·479 enrolled

An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial

Completed·SShahid Beheshti University of Medical Sciences·Phase 2·NCT04343768·60 enrolled

Preventing COVID-19 in Healthcare Workers With HCQ: A RCT

Withdrawn·SStony Brook University·Phase 2·NCT04347889

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease

Terminated·LLCMC Health·Phase 3·NCT04344444·22 enrolled

Montelukast - a Treatment Choice for COVID-19

Completed·UUniversity of Sargodha··NCT04714515·150 enrolled

Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19

Terminated·UUniversity Hospital, Strasbourg, France·Phase 3·NCT04359953·16 enrolled

Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment

Completed·HHealth Institutes of Turkey·Phase 3·NCT04981379·1,120 enrolled

Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19

Terminated·HHugo Mendieta Zeron·Phase 4·NCT04341493·44 enrolled

Bacteriotherapy in the Treatment of COVID-19

Unknown status·UUniversity of Roma La Sapienza··NCT04368351·70 enrolled

Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19

Withdrawn·HHeinrich-Heine University, Duesseldorf·Phase 4·NCT04338906

Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers

Unknown status·RRambam Health Care Campus·N/A·NCT04438837·582 enrolled

Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel

Completed·PPlan Nacional sobre el Sida (PNS)·Phase 3·NCT04334928·1,002 enrolled

Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)

Terminated·—·Phase 2/3·NCT04318444·10 enrolled

VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

Suspended·—·Phase 3·NCT04363203·300 enrolled

Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic

Unknown status·QQassim University··NCT04460547·200 enrolled

Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19

Withdrawn·—·N/A·NCT04466280

Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

Suspended·FFundacion GenesisCare·N/A·NCT04394182·15 enrolled

Effectiveness of Hydroxychloroquine in Covid-19 Patients

Unknown status·PProf. Dr. Umar Farooq·Phase 3·NCT04328272·75 enrolled

Rheumatoid Arthritis8 trials

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00259610·755 enrolled

Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

Completed·UUS Department of Veterans Affairs·N/A·NCT00405275·353 enrolled

Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis

Suspended·IIncannex Healthcare Ltd·Phase 2·NCT05942911·20 enrolled

Show 5 more 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

Antimalarial and Covid 19 in Rheumatoid Arthritis

Completed·—··NCT04389320·60 enrolled

Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis

Completed·—·Phase 3·NCT01132118·30 enrolled

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Completed·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 4·NCT02644499·186 enrolled

Treatment4 trials

Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Withdrawn·MMontefiore Medical Center·Phase 2·NCT04350450

a Retrospective Study on the Systemic Treatment of LPP and FFA

Completed·EErasmus Medical Center··NCT06512766·315 enrolled

Treatments Against RA and Effect on FDG-PET/CT

Completed·—·Phase 4·NCT02374021·159 enrolled

Show 1 more trial

Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

Terminated·UUniversity of New Mexico·Phase 2·NCT04458948·28 enrolled

Pregnancy4 trials

The Clinical Features and Pregnancy Outcomes of CTD Patients

Recruiting·QQilu Hospital of Shandong University··NCT04918524·126 enrolled

Hydroxychloroquine in Unexplained Recurrent Pregnancy Loss

Unknown status·—·Phase 1·NCT05237843·70 enrolled

The Clinical Features and Pregnancy Outcomes of RA Patients

Unknown status·QQilu Hospital of Shandong University··NCT05651373·100 enrolled

Show 1 more trial

Treatment of Pregnancy RA

Unknown status·RRenJi Hospital·N/A·NCT04569890·100 enrolled

Efficacy3 trials

The Clinical Efficacy of Immunomodulators in RA Patients

Recruiting·QQilu Hospital of Shandong University·Phase 4·NCT05626348·400 enrolled

The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients

Unknown status·OOslo University Hospital·Phase 2/3·NCT04321616·700 enrolled

Evaluation of the Efficacy of Hydroxychloroquine in Decreasing Immune Activation in Asymptomatic HIV-infected Patients

Unknown status·MMedical Research Council·Phase 2·NCT01067417·83 enrolled

88 more indications

Non-Small Cell Lung Cancer3 trials

Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT01649947·32 enrolled

Hydroxychloroquine With or Without Erlotinib in Advanced Non-small Cell Lung Cancer (NSCLC)

Terminated·MMassachusetts General Hospital·Phase 1·NCT01026844·27 enrolled

Hydroxychloroquine, Carboplatin, Paclitaxel, and Bevacizumab in Recurrent Advanced Non-Small Cell Lung Cancer

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 1/2·NCT00728845·8 enrolled

Antiphospholipid Syndrome3 trials

Hydroxychloroquine for Thrombosis Prevention and Antiphospholipid Antibody Reduction in Primary Antiphospholipid Syndrome

Completed·NNational and Kapodistrian University of Athens·N/A·NCT04153201·50 enrolled

Study of the Efficiency of Hydroxychloroquine on the Endothelial Dysfunction and Its Vascular Consequences During the Antiphospholipid Syndrome

Completed·UUniversity Hospital, Rouen·Phase 2·NCT02595346·25 enrolled

Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome

Unknown status·UUniversity Hospital, Angers·Phase 3·NCT03540810·300 enrolled

Breast Cancer3 trials

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

Recruiting·—·Phase 2·NCT04523857·66 enrolled

HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 1/2·NCT06328387·120 enrolled

Hydroxychloroquine in Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Hormonal Therapy

Terminated·WWestern Regional Medical Center·Phase 1·NCT02414776·3 enrolled

Efficacy and Safety3 trials

Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+)

Withdrawn·—·Phase 4·NCT04351919

The Efficacy and Safety of HCQ Plus DEX in ANA Positive ITP

Recruiting·YYunfeng Cheng·N/A·NCT06479317·129 enrolled

Efficacy and Safety of Baricitinib in Sjogren's Syndrome

Completed·PPeking Union Medical College Hospital·Phase 2·NCT05016297·87 enrolled

Pancreatic Cancer2 trials

Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

Completed·—·Phase 2·NCT01273805·20 enrolled

PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer

Recruiting·CCancer Trials Ireland·Phase 2·NCT05518110·22 enrolled

Prostate Cancer2 trials

Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer

Terminated·RRutgers, The State University of New Jersey·Phase 2·NCT01828476·13 enrolled

Hydroxychloroquine in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT00726596·64 enrolled

Prophylaxis2 trials

Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2

Completed·UUniversity of Minnesota·Phase 3·NCT04308668·1,312 enrolled

HCQ for Primary Prophylaxis Against COVID19 in Health-care Workers

Withdrawn·MMedical University of Vienna·Phase 3·NCT04336748

Methotrexate2 trials

Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

Unknown status·UUniversity of Leeds·Phase 4·NCT03813771·106 enrolled

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Terminated·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 3·NCT02930343·136 enrolled

Lupus Nephritis2 trials

Multicenter Registry of Pediatric Lupus Nephritis in China

Unknown status·XXiqiang Dang··NCT03791827·1,200 enrolled

Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine

Unknown status·TTanta University··NCT03687905·60 enrolled

Thrombocytopenia2 trials

Tacrolimus for Thrombocytopenia in SS

Unknown status·PPeking Union Medical College Hospital·Phase 2/3·NCT05678335·54 enrolled

Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Terminated·CChinese SLE Treatment And Research Group·Phase 3·NCT02444728·50 enrolled

Preeclampsia2 trials

Hydroxychloroquine May be Beneficial for Preeclampsia

Active, not recruiting·RRenJi Hospital··NCT06020378·462 enrolled

Hydroxychloroquine in Prevention of Preeclampsia

Completed·—·N/A·NCT04755322·50 enrolled

Outcome2 trials

Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

Completed·AAdrian Hernandez·Phase 3·NCT04334148·1,360 enrolled

Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT

Completed·TThe Cleveland Clinic·Phase 2·NCT03283566·9 enrolled

Renal Cell Carcinoma2 trials

Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)

Completed·LLeonard Appleman·Phase 1/2·NCT01550367·30 enrolled

Autophagy Inhibition to Augment Mammilian Target of Rapamycin (mTOR) Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine (HCQ) in Patients With Previously Treated Renal Cell Carcinoma

Completed·—·Phase 1/2·NCT01510119·40 enrolled

ESS2 trials

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02451748·32 enrolled

Immunosuppressant Regimens for Living Fetuses Study

Unknown status·RRenJi Hospital·N/A·NCT03671174·420 enrolled

Multiple Myeloma2 trials

Combined Carfilzomib and Hydroxychloroquine in Patients With Relapsed/Refractory Multiple Myeloma

Completed·NNorwegian University of Science and Technology·Phase 1·NCT04163107·19 enrolled

Hydroxychloroquine and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·—·Phase 1·NCT00568880·25 enrolled

Miscarriage2 trials

Hydroxychloroquine and Unexplained Recurrent Miscarriage

Completed·—·N/A·NCT04228263·156 enrolled

Hydroxychloroquine for Prevention of Recurrent Miscarriage.

Unknown status·UUniversity Hospital, Brest·Phase 3·NCT03165136·300 enrolled

Erythema2 trials

Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

Completed·—·Phase 1/2·NCT02756546·100 enrolled

The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea

Recruiting·TThe Fourth Affiliated Hospital of Zhejiang University School of Medicine·N/A·NCT07343635·186 enrolled

Thyroiditis2 trials

The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis

Unknown status·NNational Taiwan University Hospital·N/A·NCT02126683·60 enrolled

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Completed·NNational Taiwan University Hospital·N/A·NCT01760421·40 enrolled

Prevention2 trials

Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Terminated·HHospital for Special Surgery, New York·Phase 3·NCT01784523·11 enrolled

Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04344379·122 enrolled

Colorectal Cancer2 trials

Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT02316340·42 enrolled

FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer

Completed·—·Phase 1/2·NCT01206530·50 enrolled

Heart1 trial

Preventive Approach to Congenital Heart Block With Hydroxychloroquine

Completed·NNYU Langone Health·Phase 2·NCT01379573·74 enrolled

Systemic Mastocytosis1 trial

Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients

Unknown status·UUniversity Hospital, Toulouse·Phase 2/3·NCT05084872·30 enrolled

Oral Lichen Planus1 trial

Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00102557·74 enrolled

Hepatitis1 trial

Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

Unknown status·NNational Taiwan University Hospital··NCT05733897·150 enrolled

Metastatic Colorectal Cancer1 trial

Hydroxychloroquine, Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT01006369·38 enrolled

Ankylosing Spondylitis1 trial

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT04077957·100 enrolled

Porphyria Cutanea Tarda1 trial

Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda

Completed·TThe University of Texas Medical Branch, Galveston·Phase 2·NCT01573754·48 enrolled

COVID1 trial

Test and Treat COVID 65plus+

Withdrawn·UUniversity Hospital Tuebingen·Phase 2/3·NCT04351516

Drug1 trial

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01709578·546 enrolled

Insulin Secretion1 trial

The Influence of Plaquenil/Hydroxychloroquine (HCQ) on Insulin Secretion

Unknown status·HHadassah Medical Organization·Phase 1/2·NCT02910076·40 enrolled

Cardiomyopathy1 trial

The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

Recruiting·TTongji Hospital·Phase 2/3·NCT05961202·200 enrolled

Advanced Cancer1 trial

Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01266057·143 enrolled

Dialysis1 trial

The Danish Pre-HCQ COVID Dialysis Study

Withdrawn·NNicholas Carlson·Phase 4·NCT05110651

Telitacicept1 trial

Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

Unknown status·QQilu Hospital of Shandong University··NCT05644210·80 enrolled

Glioblastoma Multiforme1 trial

Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT00486603·92 enrolled

Hepatocellular Carcinoma1 trial

Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma

Not yet recruiting·VVA Office of Research and Development·Phase 1/2·NCT05842174·93 enrolled

Hepatitis C1 trial

Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C

Terminated·BBioLineRx, Ltd.·Phase 1/2·NCT01833845·4 enrolled

Effectiveness1 trial

A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19

Completed·BBurnasyan Federal Medical Biophysical Center·Phase 2/3·NCT04347031·320 enrolled

Urticaria1 trial

Hydroxychloroquine Efficacy in Chronic Urticaria

Withdrawn·VVanderbilt University·N/A·NCT01073852

Primary Sjögren's Syndrome1 trial

Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome

Completed·SSeoul National University Hospital·Phase 3·NCT01601028·39 enrolled

Chronic Graft Versus Host Disease1 trial

Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

Completed·CChildren's Oncology Group·Phase 3·NCT00031824·82 enrolled

Adenocarcinoma1 trial

Study of Pre-surgery Gemcitabine + Hydroxychloroquine (GcHc) in Stage IIb or III Adenocarcinoma of the Pancreas

Completed·AAmer Zureikat·Phase 1/2·NCT01128296·35 enrolled

Lichen Planopilaris1 trial

The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial

Recruiting·EErasmus Medical Center··NCT06512753·56 enrolled

Behcet's Disease1 trial

Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

Unknown status·—·N/A·NCT04022421·50 enrolled

Metastatic Solid Tumors1 trial

Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment

Completed·—·Phase 1·NCT00909831·40 enrolled

Patients With Solid Tumors1 trial

Hydroxychloroquine in Treating Patients With Solid Tumors Undergoing Radiation Therapy for Bone Metastases

Terminated·VVirginia Commonwealth University·Phase 1·NCT01417403·10 enrolled

SARS CoV 2 Infection1 trial

Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

Terminated·—·Phase 2·NCT04335552·11 enrolled

ART1 trial

A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04973566·48 enrolled

Immune Checkpoint Blockade1 trial

Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies

Terminated·—·Phase 1/2·NCT04214418·27 enrolled

Myeloid Leukemia1 trial

Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia

Unknown status·LLynn McMahon·Phase 2·NCT01227135·66 enrolled

Pericarditis1 trial

Hydroxychloroquine in Colchicine-Resistant Glucocorticoid-Dependent Idiopathic Recurrent Pericarditis

Unknown status·HHippocration General Hospital·Phase 3·NCT05737680·30 enrolled

Myelodysplastic Syndrome1 trial

CPI-613 and Hydroxychloroquine for Patients With High Risk Myelodysplastic Syndrome

Withdrawn·WWake Forest University Health Sciences·Phase 1/2·NCT03929211

Pneumonia1 trial

Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial

Withdrawn·KKootenai Health·Phase 4·NCT04382625

HIV infection1 trial

Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Completed·SSEARCH Research Foundation·Phase 1/2·NCT02475915·15 enrolled

Myocardial Infarction1 trial

Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial

Completed·HHelsinki University Central Hospital·Phase 4·NCT02648464·125 enrolled

Small Cell Lung Cancer1 trial

STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)

Terminated·UUniversity College, London·Phase 2·NCT02722369·72 enrolled

Drug Repurposing1 trial

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Methotrexate vs Hydroxychloroquine

Completed·—··NCT04691505·133,553 enrolled

Trial1 trial

Public Health Emergency: SOLIDARITY TRIAL Philippines

Completed·UUniversity of the Philippines·N/A·NCT05024006·1,314 enrolled

Interstitial Lung Disease1 trial

Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes

Recruiting·—·Phase 1·NCT04532346·60 enrolled

Muscle Cramp1 trial

Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Completed·MMayo Clinic·Phase 1·NCT01495403·3 enrolled

Tocilizumab1 trial

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01768572·202 enrolled

Refractory Solid Tumors1 trial

CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors

Recruiting·NNorthwestern University·Phase 2·NCT05733000·94 enrolled

Osteosarcoma1 trial

Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03598595·31 enrolled

Type 2 Diabetes Mellitus1 trial

Hydroxychloroquine Versus Pioglitazone in Combination Treatment for Type 2 Diabetes Mellitus

Terminated·—·Phase 2·NCT02303405·22 enrolled

Type 1 Diabetes Mellitus1 trial

Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

Terminated·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT03428945·273 enrolled

Solid Tumors1 trial

Biological Effects of Agent on PAR-4 Levels With Resected Solid Tumors

Completed·PPeng Wang, MD PhD·Phase 1·NCT03015324·38 enrolled

Alopecia Totalis1 trial

Plaquenil for Alopecia Areata, Alopecia Totalis

Completed·HHordinsky, Maria K., MD·Phase 4·NCT00176982·16 enrolled

Advanced NSCLC1 trial

Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT00977470·76 enrolled

Endothelial Function1 trial

Anti-Inflammatory Drug and Endothelial Function

Unknown status·IInstituto de Cardiologia do Rio Grande do Sul·Phase 4·NCT04161339·50 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

Oral1 trial

Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

Completed·—··NCT00873496·30 enrolled

Advanced Solid Tumors1 trial

Hydroxychloroquine + Vorinostat in Advanced Solid Tumors

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT01023737·72 enrolled

Patients With Advanced Solid Tumors1 trial

Sunitinib Malate and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Chemotherapy

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00813423·40 enrolled

Hidradenitis Suppurativa1 trial

Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa

Completed·—·Phase 1/2·NCT03275870·17 enrolled

Glioma1 trial

A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)

Completed·UUniversity College, London·Phase 2·NCT01602588·54 enrolled

Vasculitis1 trial

Hydroxychloroquine in ANCA Vasculitis Evaluation

Unknown status·GGuy's and St Thomas' NHS Foundation Trust·Phase 4·NCT04316494·43 enrolled

Ulcerative Colitis1 trial

Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis

Active, not recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT05119140·3 enrolled

Unresectable Solid Tumor1 trial

Hydroxychloroquine and Temozolomide in Treating Patients With Metastatic or Unresectable Solid Tumors

Completed·—·Phase 1·NCT00714181·38 enrolled

Ovarian Cancer1 trial

A Study of the Safety, Tolerability and Effectiveness of Hydroxychloroquine and Itraconazole in Platinum-resistant Epithelial Ovarian Cancer

Completed·UUniversity Health Network, Toronto·Phase 1/2·NCT03081702·13 enrolled

Acute Respiratory Distress Syndrome1 trial

Dexamethasone Treatment for Severe Acute Respiratory Distress Syndrome Induced by COVID-19

Terminated·CCentre Chirurgical Marie Lannelongue·Phase 3·NCT04347980·5 enrolled

Lupus Erythematosus1 trial

Study of Anti-Malarials in Incomplete Lupus Erythematosus

Completed·MMilton S. Hershey Medical Center·Phase 2·NCT03030118·187 enrolled

Endothelial Dysfunction1 trial

Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Completed·IIndonesia University·N/A·NCT03085940·37 enrolled

Type 2 Diabetes1 trial

Hydroxychloroquine in Type 2 Diabetes During Pregnancy

Recruiting·NNational University of Malaysia·N/A·NCT06319560·56 enrolled

Melanoma1 trial

A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

Completed·—·Phase 1·NCT01897116·8 enrolled

Baricitinib1 trial

Baricitinib in CPPD - the BAPTIST Study

Not yet recruiting·II.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio·Phase 2·NCT06768294·32 enrolled

TIA1 trial

Genetic Variants in Egyptian Patients Receiving HCQ(Hydroxychloroquine)

Unknown status·—··NCT03180190·50 enrolled

Cutaneous Lupus Erythematosus1 trial

Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

Completed· Sanofi logo

Sanofi·Phase 3·NCT01551069·103 enrolled

Unspecified5 trials

Double Therapy With IFN-beta 1b and Hydroxychloroquine

Completed·TThe University of Hong Kong·Phase 2·NCT04350281·60 enrolled

Evaluation of Hydroxychloroquine to Prevent CIPN

Withdrawn·UUniversity of Arizona·Phase 2·NCT05689359

Very Early Versus Delayed Etanercept in Patients With RA

Completed·UUniversity of Leeds·Phase 4·NCT02433184·120 enrolled

Show 2 more trials

Metabolic Effects of Hydroxychloroquine

Terminated·WWashington University School of Medicine·N/A·NCT02026232·21 enrolled

Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

Completed·UUniversity of Pittsburgh·Phase 1·NCT02124681·34 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 18, 1955

PLAQUENIL

NDA NDA009768

Apr 29, 1976

PLAQUENIL

NDA NDA009768

Feb 19, 1980

PLAQUENIL

NDA NDA009768

May 15, 1981

PLAQUENIL

NDA NDA009768

Jan 1, 1982

PLAQUENIL

NDA NDA009768

May 14, 1982

PLAQUENIL

NDA NDA009768

Jun 30, 1982

PLAQUENIL

NDA NDA009768

Sep 15, 1982

PLAQUENIL

NDA NDA009768

Jun 17, 1983

PLAQUENIL

NDA NDA009768

Nov 1, 1984

PLAQUENIL

NDA NDA009768

Jul 5, 1985

PLAQUENIL

NDA NDA009768

Jul 22, 1985

PLAQUENIL

NDA NDA009768

Dec 12, 1986

PLAQUENIL

NDA NDA009768

Jan 2, 1987

PLAQUENIL

NDA NDA009768

Mar 3, 1987

PLAQUENIL

NDA NDA009768

Aug 4, 1988

PLAQUENIL

NDA NDA009768

Sep 30, 1988

PLAQUENIL

NDA NDA009768

Apr 4, 1989

PLAQUENIL

NDA NDA009768

Nov 19, 1990

PLAQUENIL

NDA NDA009768

Feb 14, 1991

PLAQUENIL

NDA NDA009768

Feb 14, 1991

PLAQUENIL

NDA NDA009768

May 26, 1994

PLAQUENIL

NDA NDA009768

Oct 2, 1996

PLAQUENIL

NDA NDA009768

Oct 5, 2000

PLAQUENIL

NDA NDA009768

Feb 7, 2002

PLAQUENIL

NDA NDA009768

May 2, 2002

PLAQUENIL

NDA NDA009768

Jun 20, 2007

PLAQUENIL

NDA NDA009768

Jan 27, 2017

PLAQUENIL

NDA NDA009768

Jan 27, 2017

PLAQUENIL

NDA NDA009768

Jan 27, 2017

PLAQUENIL

NDA NDA009768

Jan 5, 2019

PLAQUENIL

NDA NDA009768

May 3, 2021

PLAQUENIL

NDA NDA009768

Jan 14, 2022

SOVUNA

NDA NDA214581

May 3, 2022

PLAQUENIL

NDA NDA009768

Jul 24, 2023

PLAQUENIL

NDA NDA009768

Dec 12, 2023

PLAQUENIL

NDA NDA009768

Sources

References

[1]
ClinicalTrials.gov — 315 trial records for Hydroxychloroquine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Plaquenil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Hydroxychloroquine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Hydroxychloroquine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA009768). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Toll-Like Receptor 7 Antagonist; Toll-Like Receptor 9 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals