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Hydroxychloroquine Sulfate (hydroxychloroquine-pill)
Hydroxychloroquine Sulfate works by interfering with the replication of malaria parasites and modulating the immune system to treat autoimmune diseases.
Hydroxychloroquine Sulfate is a small molecule antimalarial medication developed by SANOFI AVENTIS US, currently owned by the same company. It targets Toll-like receptor 9 and has been FDA-approved since 1955 for various indications including discoid lupus erythematosus and malaria. The medication has a long half-life of 850 hours and high bioavailability of 74%. Hydroxychloroquine Sulfate is used to treat several types of malaria and autoimmune diseases. Its commercial status is owned by SANOFI AVENTIS US, but generic manufacturers are unknown.
At a glance
| Generic name | hydroxychloroquine-pill |
|---|---|
| Sponsor | Sanofi |
| Drug class | Antimalarial |
| Target | Toll-like receptor 9 |
| Therapeutic area | Immunology |
| Phase | discontinued |
| First approval | 1955 |
Mechanism of action
Mechanism of action: The precise mechanism by which hydroxychloroquine exhibits activity against Plasmodium is not known. Hydroxychloroquine, like chloroquine, is weak base and may exert its effect by concentrating in the acid vesicles of the parasite and by inhibiting polymerization of heme. It can also inhibit certain enzymes by its interaction with DNA.
Approved indications
- Discoid lupus erythematosus
- Falciparum malaria
- Malaria Prevention
- Ovale malaria
- Plasmodium Falciparum Malaria Prevention
- Plasmodium Malariae Malaria Prevention
- Plasmodium Ovale Malaria Prevention
- Quartan malaria
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Vivax malaria
Common side effects
- Cardiomyopathy
- Hepatic failure acute
- Bone marrow failure
- Aplastic anemia
- Agranulocytosis
- Leukopenia
- Thrombocytopenia
- Hemolysis
- Ventricular arrhythmias
- Torsade de pointes
- Irreversible retinopathy
- Visual field defects
Key clinical trials
- Study of the Efficiency of Hydroxychloroquine on the Endothelial Dysfunction and Its Vascular Consequences During the Antiphospholipid Syndrome (PHASE2)
- An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis (PHASE2)
- Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (PHASE2)
- Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer (PHASE2)
- Individual Patient Exposure and Response in Pediatric Lupus (NA)
- The Efficacy and Safety of HCQ Plus TPO-RA in ANA Positive ITP (NA)
- TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) (PHASE1)
- Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19 (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydroxychloroquine Sulfate CI brief — competitive landscape report
- Hydroxychloroquine Sulfate updates RSS · CI watch RSS
- Sanofi portfolio CI