Hydroxychloroquine

Generic Name: Hydroxychloroquine

Brand Names: Plaquenil, Sovuna

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₆ClN_₃O

CAS Number: 118-42-3

Unique Ingredient Identifier: 4QWG6N8QKH

Background: Hydroxychloroquine is a racemic mixture consisting of an R and S enantiomer. Hydroxychloroquine is an aminoquinoline like chloroquine. It is a commonly prescribed medication in the treatment of uncomplicated malaria, rheumatoid arthritis, chronic discoid lupus erythematosus, and systemic lupus erythematosus. Hydroxychloroquine is also used for the prophylaxis of malaria in regions where chloroquine resistance is unlikely. It was developed during World War II as a derivative of quinacrine with less severe side effects. Chloroquine and hydroxychloroquine are both being investigated for the treatment of SARS-CoV-2.

The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020.

Hydroxychloroquine was granted FDA approval on 18 April 1955.

A recent study reported a fatality in the group being treated with hydroxychloroquine for COVID-19.

Indication: Hydroxychloroquine is indicated for the prophylaxis of malaria where chloroquine resistance is not reported, treatment of uncomplicated malaria (caused by P. falciparum, P. malariae, P. ovale, or P. vivax), chronic discoid lupus erythematosus, systemic lupus erythematosus, acute rheumatoid arthritis, and chronic rheumatoid arthritis.

Associated Conditions: Acute Rheumatoid Arthritis, Malaria, Porphyria Cutanea Tarda, Q Fever, Sjogren's Syndrome (SS), Systemic Lupus Erythematosus, Uncomplicated Malaria caused by Plasmodium Vivax, Uncomplicated Malaria caused by Plasmodium malariae, Uncomplicated Malaria caused by Plasmodium ovale, Chronic Discoid Lupus Erythematosus (DLE), Chronic Rheumatoid Arthritis, Uncomplicated Malaria caused by Plasmodium falciparum

Clinical Trials

Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

Phase 3

Completed

Conditions: Primary Sjögren's Syndrome

Interventions: Drug: Hydroxychloroquine
Drug: Placebo

First Posted Date: 2008-03-11

Last Posted Date: 2012-07-03

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 120

Registration Number: NCT00632866

Locations: 🇫🇷
Hopital Bicëtre, Le Kremlin Bicetre, France

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

Phase 1

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: bortezomib
Drug: hydroxychloroquine

First Posted Date: 2007-12-06

Last Posted Date: 2020-02-07

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 25

Registration Number: NCT00568880

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

Interventions: Drug: hydroxychloroquine
Drug: temozolomide
Other: pharmacological study
Radiation: Radiation

First Posted Date: 2007-06-14

Last Posted Date: 2019-07-10

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 92

Registration Number: NCT00486603

Locations: 🇺🇸
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 6 locations

The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS

Phase 4

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: versus hydroxychloroquine

First Posted Date: 2006-12-19

Last Posted Date: 2011-01-27

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 543

Registration Number: NCT00413361

Locations: 🇫🇷
Chu Pitie Salpetriere, Paris, France
🇫🇷
Hopital la Pitié Salpétrière Assistance Publique, Paris, France

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

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Etanercept
Drug: methotrexate
Drug: Sulfasalazine
Drug: Placebo, triple
Drug: Hydroxychloroquine
Drug: Placebo, etanercept

First Posted Date: 2006-11-30

Last Posted Date: 2013-12-03

Lead Sponsor: US Department of Veterans Affairs

Target Recruit Count: 353

Registration Number: NCT00405275

Locations: 🇺🇸
VA Medical Center, Loma Linda, Loma Linda, California, United States
🇺🇸
VA Pittsburgh Health Care System, Pittsburgh, Pennsylvania, United States
🇺🇸
Geisinger Medical Group - State College, State College, Pennsylvania, United States

and more 34 locations

Hydroxychloroquine in Cystic Fibrosis

Phase 1

Completed

Conditions: Cystic Fibrosis

First Posted Date: 2006-04-06

Last Posted Date: 2008-01-30

Lead Sponsor: Vanderbilt University

Target Recruit Count: 20

Registration Number: NCT00311883

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: methotrexate
Drug: sulfasalazine
Drug: etanercept
Drug: hydroxychloroquine

First Posted Date: 2005-11-29

Last Posted Date: 2014-07-17

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 755

Registration Number: NCT00259610

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Plaquenil for Alopecia Areata, Alopecia Totalis

Phase 4

Completed

Conditions: Alopecia Areata

First Posted Date: 2005-09-15

Last Posted Date: 2009-08-13

Lead Sponsor: Hordinsky, Maria K., MD

Target Recruit Count: 16

Registration Number: NCT00176982

Locations: 🇺🇸
State University of New York at Stony Brook, Stonybrook, New York, United States
🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States

Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus

Phase 2

Completed

Conditions: Lichen Planus, Oral

First Posted Date: 2005-01-31

Last Posted Date: 2008-03-04

Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Target Recruit Count: 74

Registration Number: NCT00102557

Locations: 🇺🇸
National Institute of Dental And Craniofacial Research (NIDCR), Bethesda, Maryland, United States

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

Phase 3

Completed

Conditions: Graft Versus Host Disease

First Posted Date: 2003-01-27

Last Posted Date: 2014-02-14

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 82

Registration Number: NCT00031824

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
All Children's Hospital, St. Petersburg, Florida, United States
🇺🇸
Maine Children's Cancer Program, Scarborough, Maine, United States

and more 100 locations

Drug Development Updates

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