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Hydroxychloroquine Sulfate (HYDROXYCHLOROQUINE)
Hydroxychloroquine Sulfate works by interfering with the replication of malaria parasites and reducing inflammation in the body.
Hydroxychloroquine Sulfate, marketed by Advanz, is an established antimalarial and anti-inflammatory agent with a key composition patent expiring in 2028. Its primary strength lies in its well-documented efficacy for treating uncomplicated malaria, supported by a long history of use. The primary risk is the presence of multiple off-patent competitors, including chloroquine and primaquine, which may erode market share.
At a glance
| Generic name | HYDROXYCHLOROQUINE |
|---|---|
| Sponsor | Advanz |
| Drug class | Antimalarial |
| Target | Toll-like receptor 9 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| 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
- Uncomplicated malaria treatment
- Malaria prophylaxis
- Rheumatoid arthritis treatment
- Systemic lupus erythematosus treatment
- Chronic discoid lupus erythematosus treatment
Common side effects
- Drug intolerance
- Contraindicated product administered
- Joint swelling
- Rheumatoid arthritis
- Synovitis
- Treatment failure
- Arthropathy
- Systemic lupus erythematosus
- Therapeutic product effect decreased
- Pemphigus
- Alopecia
- Hand deformity
Key clinical trials
- Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer (PHASE1)
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- Genotype-Phenotype Study of Patients With Plaquenil -Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene
- Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (PHASE2)
- The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea (NA)
- Hydroxychloroquin (HCQ) in chILD of Genetic Defect (NA)
- A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies (PHASE1)
- Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes (EARLY_PHASE1)
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
- Advanz portfolio CI