NDAORALTABLET
Approved
Jan 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
SOVUNA (hydroxychloroquine sulfate) by Hikma is 4-aminoquinoline antimalarial [see microbiology (12. Approved for rheumatism. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOVUNA (hydroxychloroquine sulfate) is an oral 4-aminoquinoline small molecule approved in January 2022 by Hikma for treating rheumatoid arthritis, systemic lupus erythematosus, and chronic discoid lupus erythematosus. The drug functions as both an antimalarial and antirheumatic agent, though its exact immunomodulatory mechanisms in autoimmune conditions remain incompletely understood.
Peak
SOVUNA is in peak lifecycle phase with moderate competitive pressure (30/100), indicating a mature but active commercial operation with stable team sizing.
Mechanism of Action
4-aminoquinoline antimalarial [see Microbiology (12.4)] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of SOVUNA in the treatment of rheumatoid…
Indications (1)
Clinical Trials (3)
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy
Started Jun 2016
98 enrolled
Primary IgA Nephropathy
Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion
Started Mar 2012
103 enrolled
Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Started Jul 1993
72 enrolled
ImmunosuppressionRheumatism
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.