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The FDA emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19 was revoked on 15 June 2020.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

A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i

Phase 1

Recruiting

Conditions: Inhibition of Autophagy Synergizes Anti-tumor Effect

Interventions: Drug: 600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib
Drug: RP2D dose of 600mg bid of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial.

First Posted Date: 2023-07-20

Last Posted Date: 2024-12-03

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 29

Registration Number: NCT05953350

Locations: 🇨🇳
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

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

Phase 2

Suspended

Conditions: Rheumatoid Arthritis

Interventions: Drug: IHL-675A
Drug: Cannabidiol
Drug: Hydroxychloroquine
Drug: Placebo

First Posted Date: 2023-07-12

Last Posted Date: 2025-01-15

Lead Sponsor: Incannex Healthcare Ltd

Target Recruit Count: 20

Registration Number: NCT05942911

Locations: 🇦🇺
Paratus Clinical (Woden Dermatology), Phillip, Australian Capital Territory, Australia
🇦🇺
Genesis Research Services, Broadmeadow, New South Wales, Australia
🇦🇺
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

and more 7 locations

Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Hydroxychloroquine
Drug: Irinotecan
Drug: Fluorouracil
Drug: Leucovorin
Drug: Bevacizumab

First Posted Date: 2023-05-06

Last Posted Date: 2025-02-03

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 155

Registration Number: NCT05843188

Locations: 🇨🇦
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis

Phase 4

Recruiting

Conditions: Sarcoidosis, Pulmonary

Interventions: Drug: Hydroxychloroquine
Drug: Placebo

First Posted Date: 2023-05-03

Last Posted Date: 2025-03-30

Lead Sponsor: Hospices Civils de Lyon

Target Recruit Count: 140

Registration Number: NCT05841758

Locations: 🇫🇷
Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud, Avignon, France
🇫🇷
Service de Pneumologie - Hôpital Avicenne, Bobigny, France
🇫🇷
Service de medecine interne - Hôpital Henri Mondor, Créteil, France

and more 16 locations

Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma

Phase 1

Not yet recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Lipiodol
Drug: Hydroxychloroquine
Drug: Placebo

First Posted Date: 2023-05-03

Last Posted Date: 2025-01-20

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 93

Registration Number: NCT05842174

Locations: 🇺🇸
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Phase 3

Recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Placebo
Drug: Hydroxychloroquine

First Posted Date: 2023-04-05

Last Posted Date: 2025-04-23

Lead Sponsor: NYU Langone Health

Target Recruit Count: 330

Registration Number: NCT05799378

Locations: 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, United States
🇺🇸
VA NY Harbor Healthcare System, New York, New York, United States

and more 7 locations

Hydroxychloroquine in Colchicine-Resistant Glucocorticoid-Dependent Idiopathic Recurrent Pericarditis

Phase 3

Not yet recruiting

Conditions: Pericarditis Idiopathic Recurrent

Interventions: Drug: Colchicine
Drug: Hydroxychloroquine

First Posted Date: 2023-02-21

Last Posted Date: 2023-02-22

Lead Sponsor: Hippocration General Hospital

Target Recruit Count: 30

Registration Number: NCT05737680

Locations: 🇬🇷
"Hippokration" General Hospital of Athens, Athens, Attiki, Greece

Using Hydroxychloroquine to Treat Nonalcoholic Steatohepatitis

Recruiting

Conditions: Nonalcoholic Steatohepatitis

First Posted Date: 2023-02-17

Last Posted Date: 2023-03-02

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 150

Registration Number: NCT05733897

Locations: 🇨🇳
Graduate Institute of Pharmacology, College of Medicine, National Taiwan University, Taipei, Taiwan
🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

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

Phase 2

Recruiting

Conditions: Advanced Pancreatic Carcinoma
Metastatic Ovarian Carcinoma
Refractory Lung Adenocarcinoma
Refractory Urothelial Carcinoma
Stage II Pancreatic Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Advanced Biliary Tract Carcinoma
Advanced Lung Adenocarcinoma
Advanced Malignant Solid Neoplasm
Advanced Urothelial Carcinoma