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 101 indications[4].[1]

Plaquenil is one of 1990 small molecule programs targeting Insulin resistance. It is currently in Approved.

101

Indications

310

Total Trials

Active Trials

1,989

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceApproved

GliomaActive, not recruiting

HIV InfectionActive, not recruiting

Systemic Lupus ErythematosusApproved

Cardiovascular DiseaseActive, not recruiting

Lupus ErythematosusActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Oral Lichen PlanusActive, not recruiting

Sudden Sensorineural Hearing LossActive, not recruiting

Respiratory FailureApproved

Insulin ResistanceApproved

Approved

GliomaPhase 2

Active, not recruiting

HIV InfectionPhase 1

Active, not recruiting

Systemic Lupus ErythematosusApproved

Approved

Cardiovascular DiseasePhase 2

Active, not recruiting

Lupus ErythematosusPhase 2

Active, not recruiting

Endothelial DysfunctionPreclinical

Active, not recruiting

Oral Lichen PlanusPhase 2

Active, not recruiting

Sudden Sensorineural Hearing LossPhase 2

Active, not recruiting

Respiratory FailureApproved

Approved

Showing 10 of 101 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Plaquenil

Alnylam Pharmaceuticals

Approved

7 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 4

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 5

Chirocaine

PPurdue Pharma LP

Preclinical

1 6

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 9

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 10

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Efficacy and Safety

NCT06479291

N/ARecruiting

Efficacy and Safety

NCT06479317

N/ARecruiting

Efficacy and Safety

NCT06479304

Recruiting

Pregnancy

NCT04918524

Phase 1Active, not recruiting

Pancreatic Cancer

NCT04132505

Phase 3Recruiting

Preeclampsia

NCT05287321

Clinical

Trials by Indication[1]

COVID-1966 trials

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

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

A Study of Combination Therapies to Treat COVID-19 Infection

Withdrawn·PProgenaBiome·Phase 2·NCT04459702

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

Show 63 more trials

Trial of Hydroxychloroquine In Covid-19 Kinetics

Terminated·UUniversity of South Alabama·Phase 2/3·NCT04353271·3 enrolled

Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

Completed·HHamad Medical Corporation·N/A·NCT04349592·456 enrolled

Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease

Unknown status·—·Phase 4·NCT04429867·700 enrolled

Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis

Unknown status·RRegional Center for Disease Control and Prevention, Jordan·Phase 2/3·NCT04597775·93 enrolled

Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19

Terminated·UUniversity of Southern California·Phase 2·NCT04373044·6 enrolled

A Study of Quintuple Therapy to Treat COVID-19 Infection

Completed·PProgenaBiome·Phase 2·NCT04334512·118 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

Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers

Completed·—·Phase 2·NCT04333225·221 enrolled

Oxygen-Ozone as Adjuvant Treatment in Early Control of COVID-19 Progression and Modulation of the Gut Microbial Flora

Unknown status·—·Phase 2·NCT04366089·152 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

Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection

Completed·—·Phase 3·NCT04391127·108 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

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

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

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

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

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

Terminated·—·Phase 3·NCT04329611·148 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

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

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

Terminated·UUMC Utrecht·Phase 4·NCT04362332·25 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

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

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

Terminated·—·Phase 3·NCT04328285·118 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

Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19

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

Montelukast - a Treatment Choice for COVID-19

Completed·UUniversity of Sargodha··NCT04714515·150 enrolled

Ivermectin Role in Covid-19 Clinical Trial

Completed·—·Phase 4·NCT04746365·300 enrolled

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

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

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

Unknown status·IIntermountain Health Care, Inc.·Phase 3·NCT04334382·1,550 enrolled

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

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

Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT04858633·1,000 enrolled

Hydroxychloroquine for Treatment of Non-Severe COVID-19

Unknown status·MMakerere University·Phase 2·NCT04860284·105 enrolled

Hydroxychloroquine, Azithromycin in the Treatment of Covid-19

Unknown status·CCentre Hôpital Universitaire Farhat Hached·Phase 3·NCT04405921·200 enrolled

Effectiveness of Hydroxychloroquine in Covid-19 Patients

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

Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04358068·20 enrolled

Treating COVID-19 With Hydroxychloroquine (TEACH)

Terminated·NNYU Langone Health·Phase 2·NCT04369742·128 enrolled

COVID-19 PrEP HCW HCQ Study

Completed·NNYU Langone Health·Phase 2·NCT04354870·130 enrolled

Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19)

Completed·HHospital do Coracao·Phase 3·NCT04322123·667 enrolled

Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients

Terminated·—·Phase 3·NCT04522466·7 enrolled

A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Completed·PProgenaBiome·Phase 2·NCT04335084·254 enrolled

Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

Terminated·IIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS·Phase 2·NCT04363827·155 enrolled

Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

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

Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

Unknown status·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 2·NCT04332094·276 enrolled

Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

Completed·SSt. Francis Hospital, New York·Phase 4·NCT04370782·18 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

#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19

Withdrawn·—·Phase 2/3·NCT04385264

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

Hydroxychloroquine for the Treatment of Mild COVID-19 Disease

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

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

Rheumatoid Arthritis6 trials

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 3·NCT02057250·217 enrolled

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

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

Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis

Completed·—·Phase 3·NCT01132118·30 enrolled

Show 3 more trials

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

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

Pancreatic Cancer5 trials

Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer

Active, not recruiting·UUniversity of Utah·Phase 1·NCT03825289·25 enrolled

Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04132505·39 enrolled

Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

Unknown status·MMassachusetts General Hospital·Phase 2·NCT01494155·50 enrolled

Show 2 more trials

Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

Completed·—·Phase 2·NCT01273805·20 enrolled

A Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane in Pancreatic Cancer

Completed·—·Phase 1/2·NCT01506973·119 enrolled

Pregnancy5 trials

The Clinical Features and Pregnancy Outcomes of CTD Patients

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

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Withdrawn·UUniversity of Utah·Phase 2·NCT02379650

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Unknown status·RRigshospitalet, Denmark·Phase 3·NCT03305263·186 enrolled

Show 2 more trials

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

Breast Cancer5 trials

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

Recruiting·—·Phase 2·NCT04523857·66 enrolled

Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT03774472·15 enrolled

Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")

Withdrawn·—·Phase 1/2·NCT03400254

Show 2 more trials

Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT04316169

Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 1/2·NCT00765765·6 enrolled

81 more indications

Efficacy and Safety5 trials

Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals

Withdrawn·—·Phase 3·NCT04349228

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

Withdrawn·—·Phase 4·NCT04351919

The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP

Recruiting·YYunfeng Cheng·N/A·NCT06479291·126 enrolled

Show 2 more trials

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

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

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

Recruiting·YYunfeng Cheng·N/A·NCT06479304·129 enrolled

Treatment4 trials

a Retrospective Study on the Systemic Treatment of LPP and FFA

Completed·EErasmus Medical Center··NCT06512766·315 enrolled

Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Withdrawn·MMontefiore Medical Center·Phase 2·NCT04350450

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

Show 1 more trial

Treatments Against RA and Effect on FDG-PET/CT

Completed·—·Phase 4·NCT02374021·159 enrolled

Melanoma4 trials

Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 1/2·NCT03754179·63 enrolled

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

Completed·—·Phase 1·NCT01897116·8 enrolled

Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

Completed·—·Phase 1/2·NCT02257424·50 enrolled

Show 1 more trial

Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

Completed·RRutgers, The State University of New Jersey·Phase 1·NCT00962845·20 enrolled

Pneumonia3 trials

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

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

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

Withdrawn·KKootenai Health·Phase 4·NCT04382625

Antiphospholipid Syndrome3 trials

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

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

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

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, 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

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

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

Prophylaxis2 trials

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

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

Pre-exposure Prophylaxis for SARS-Coronavirus-2

Completed·UUniversity of Minnesota·Phase 3·NCT04328467·1,483 enrolled

Telitacicept2 trials

Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients

Unknown status·FFen Li·Phase 4·NCT05666336·30 enrolled

Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

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

HIV infection2 trials

Inducing Immune Quiescence to Prevent HIV Infection in Women

Completed·UUniversity of Manitoba·N/A·NCT02079077·91 enrolled

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

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

Cardiovascular Disease2 trials

Hydroxychloroquine in Cardiovascular Disease in Patients With Chronic Kidney Disease: A Proof of Concept Study

Terminated·UUniversity of Arkansas·Phase 2·NCT01537315·8 enrolled

Management of Cardiovascular Disease in Kidney Disease (MaCK) Study

Completed·VVA Office of Research and Development·Phase 2·NCT03636152·100 enrolled

Primary Sjögren's Syndrome2 trials

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

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

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT06862284·30 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

Thrombocytopenia2 trials

Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

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

Tacrolimus for Thrombocytopenia in SS

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

Efficacy2 trials

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

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

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

Renal Cell Carcinoma2 trials

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

Study of Hydroxychloroquine Before Surgery in Patients With Primary Renal Cell Carcinoma

Terminated·UUniversity of Pittsburgh·Phase 1·NCT01144169·7 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

Solid Tumors2 trials

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

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

HCQ on PAR-4 Levels in Patients With Resectable Solid Tumors

Completed·PPeng Wang, MD PhD·Phase 1·NCT02232243·10 enrolled

Type 2 Diabetes2 trials

Hydroxychloroquine in Type 2 Diabetes During Pregnancy

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

Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes

Completed·UUniversity of Pittsburgh·Phase 4·NCT01326533·32 enrolled

Alopecia1 trial

The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)

Not yet recruiting·EErasmus Medical Center··NCT07190534·50 enrolled

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

Gemcitabine1 trial

Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine

Completed·NNathan Bahary, MD·Phase 2·NCT01978184·104 enrolled

Cardiomyopathy1 trial

The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

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

Methotrexate1 trial

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

Advanced Cancer1 trial

Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer

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

Mortality1 trial

Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients

Unknown status·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT04341207·1,000 enrolled

Dialysis1 trial

The Danish Pre-HCQ COVID Dialysis Study

Withdrawn·NNicholas Carlson·Phase 4·NCT05110651

Coronavirus1 trial

Does Hydroxychloroquine Before & During Patient Exposure Protect Healthcare Workers From Coronavirus?

Terminated·MMegan Landes·Phase 3·NCT04374942·13 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

Preeclampsia1 trial

The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia

Recruiting·YYoo-min Kim·Phase 3·NCT05287321·58 enrolled

ILD1 trial

Hydroxychloroquine in Mild Graves' Orbitopathy

Recruiting·NNational Taiwan University Hospital·Phase 4·NCT05126147·108 enrolled

Immune Thrombocytopenia1 trial

Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia

Completed·—·Phase 4·NCT03229746·40 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

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

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

Hepatitis1 trial

Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

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

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

Prostate Cancer1 trial

Phase I/II Study of Hydroxychloroquine With Itraconazole With Biochemically Recurrent Prostate Cancer

Completed·SSt Vincent's Hospital, Sydney·Phase 1/2·NCT03513211·12 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

Miscarriage1 trial

Hydroxychloroquine and Unexplained Recurrent Miscarriage

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

Drug Repurposing1 trial

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

Completed·—··NCT04691505·133,553 enrolled

Erythema1 trial

Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

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

Kidney Cancer1 trial

Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01480154·62 enrolled

Alopecia Totalis1 trial

Plaquenil for Alopecia Areata, Alopecia Totalis

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

Multiple Myeloma1 trial

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

Completed·—·Phase 1·NCT00568880·25 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

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

Prevention1 trial

Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

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

Colorectal Cancer1 trial

Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer

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

Pulmonary Sarcoidosis1 trial

Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

Recruiting·HHospices Civils de Lyon·Phase 4·NCT05841758·140 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

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

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

Endothelial Dysfunction1 trial

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

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

AIN1 trial

Autophagy Maintenance (AUTOMAIN)

Recruiting·MMedical University of South Carolina·Phase 2·NCT06971744·38 enrolled

Parkinson's Disease1 trial

A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease

Not yet recruiting·OOttawa Hospital Research Institute·Phase 2·NCT06816810·40 enrolled

Pancreatic Adenocarcinoma1 trial

Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Completed·CCancer Insight, LLC·Phase 1·NCT04787991·45 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

Nephropathy1 trial

Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study

Not yet recruiting·—·Phase 2·NCT06350630·334 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

Hepatocellular Cancer1 trial

Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT03037437·64 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

Metastatic Colorectal Cancer1 trial

To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer

Completed·—·Phase 1·NCT03215264·20 enrolled

Urticaria1 trial

Hydroxychloroquine Efficacy in Chronic Urticaria

Withdrawn·VVanderbilt University·N/A·NCT01073852

Sudden Sensorineural Hearing Loss1 trial

Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss

Not yet recruiting·—·Phase 2·NCT06467526·80 enrolled

COVID1 trial

Test and Treat COVID 65plus+

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

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

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

Unspecified3 trials

Double Therapy With IFN-beta 1b and Hydroxychloroquine

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

Metabolic Effects of Hydroxychloroquine

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

Very Early Versus Delayed Etanercept in Patients With RA

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

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PLAQUENIL

NDA NDA009768

Jan 14, 2022

SOVUNA

NDA NDA214581

Sources

References

[1]
ClinicalTrials.gov — 310 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 NDA214581). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alnylam 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: Alnylam Pharmaceuticals