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The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020.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

Associated Therapies: -

Clinical Trials

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

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Abiraterone
Drug: ABT-263
Drug: Hydroxychloroquine

First Posted Date: 2013-04-10

Last Posted Date: 2017-05-04

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 13

Registration Number: NCT01828476

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Phase 3

Terminated

Conditions: Antiphospholipid Syndrome

Interventions: Drug: Hydroxychloroquine

First Posted Date: 2013-02-06

Last Posted Date: 2021-09-14

Lead Sponsor: Hospital for Special Surgery, New York

Target Recruit Count: 11

Registration Number: NCT01784523

Locations: 🇺🇸
Hospital for Special Surgery, New York, New York, United States

Antibiotics and Hydroxychloroquine in Crohn's

Phase 2

Completed

Conditions: Crohn's Disease

Interventions: Drug: Budesonide
Drug: Ciprofloxacin
Drug: Doxycycline
Drug: Hydroxychloroquine

First Posted Date: 2013-02-04

Last Posted Date: 2019-10-31

Lead Sponsor: Royal Liverpool University Hospital

Target Recruit Count: 59

Registration Number: NCT01783106

Locations: 🇬🇧
Royal Liverpool and Broadgreen Unversity Hospitals Trust, Liverpool, Merseyside, United Kingdom

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)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: sarilumab SAR153191 (REGN88)
Drug: tocilizumab
Drug: hydroxychloroquine
Drug: methotrexate
Drug: sulfasalazine
Drug: leflunomide
Drug: intravenous placebo
Drug: subcutaneous placebo

First Posted Date: 2013-01-15

Last Posted Date: 2017-06-26

Lead Sponsor: Sanofi

Target Recruit Count: 202

Registration Number: NCT01768572

Locations: 🇺🇸
Investigational Site Number 840033, Fort Lauderdale, Florida, United States
🇺🇸
Investigational Site Number 840150, Lansing, Michigan, United States
🇺🇸
Investigational Site Number 840022, Dallas, Texas, United States

and more 75 locations

The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis

Not Applicable

Completed

Conditions: Hashimoto Thyroiditis

Interventions: Drug: Hydroxychloroquine

First Posted Date: 2013-01-04

Last Posted Date: 2014-04-23

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 40

Registration Number: NCT01760421

Locations: 🇨🇳
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

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)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: placebo
Drug: Sarilumab
Drug: hydroxychloroquine
Drug: methotrexate
Drug: sulfasalazine
Drug: leflunomide

First Posted Date: 2012-10-18

Last Posted Date: 2017-08-08

Lead Sponsor: Sanofi

Target Recruit Count: 546

Registration Number: NCT01709578

Locations: 🇺🇸
Investigational Site Number 840018, Idaho Falls, Idaho, United States
🇺🇸
Investigational Site Number 840058, Columbia, South Carolina, United States
🇺🇸
Investigational Site Number 840124, Clarksburg, West Virginia, United States

and more 193 locations

Hydroxychloroquine, Cyclophosphamide, Dexamethasone, and Sirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Hydroxychloroquine
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Sirolimus

First Posted Date: 2012-09-21

Last Posted Date: 2017-09-07

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 18

Registration Number: NCT01689987

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

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

Phase 2

Completed

Conditions: Non-small Cell Lung Cancer
Advanced Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer

Interventions: Drug: Paclitaxel
Drug: Carboplatin
Drug: Hydroxychloroquine
Drug: Bevacizumab

First Posted Date: 2012-07-25

Last Posted Date: 2022-11-21

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 32

Registration Number: NCT01649947

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Robert Wood Johnson University Hospital at Hamilton, Hamilton, New Jersey, United States

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)

Phase 2

Completed

Conditions: Glioblastoma

Interventions: Radiation: Radiotherapy
Drug: Hydroxychloroquine

First Posted Date: 2012-05-21

Last Posted Date: 2018-05-03

Lead Sponsor: University College, London

Target Recruit Count: 54

Registration Number: NCT01602588

Locations: 🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
🇬🇧
St James's University Hospital, Leeds, West Yorkshire, United Kingdom
🇬🇧
Ninewells Hospital, Dundee, United Kingdom

and more 12 locations

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

Phase 3

Completed

Conditions: Dry Eye
Sjogren's Syndrome
Autoimmune Diseases

Interventions: Drug: Hydroxychloroquine
Drug: Placebo

First Posted Date: 2012-05-17

Last Posted Date: 2013-10-17

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 39

Registration Number: NCT01601028

Locations: 🇰🇷
Seoul National Unversity Hospital, Seoul, Korea, Republic of

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