SOVUNA (hydroxychloroquine sulfate) · NOVITIUM PHARMA
Sovuna is an antimalarial and antirheumatic medication. It is indicated for the treatment of uncomplicated malaria (caused by *P. falciparum, P. malariae, P. ovale,* and *P. vivax*) and the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in both adult and pediatric patients. Additionally, it is indicated for the treatment of rheumatoid arthritis, systemic lupus erythematosus, and chronic discoid lupus erythematosus in adults. It is not recommended for complicated malaria or for the prevention of relapses of *P. vivax* or *P. ovale*, as it is inactive against the hypnozoite liver stage.
How SOVUNA Works
Hydroxychloroquine is a 4-aminoquinoline agent that exerts both antimalarial and antirheumatic effects. While its antimalarial activity is well-characterized, the exact mechanisms underlying its immunomodulatory and anti-inflammatory actions in the treatment of rheumatoid arthritis and lupus erythematosus are not fully known.
Details
- Status
- Prescription
- First Approved
- 2022-01-14
- Routes
- ORAL
- Dosage Forms
- TABLET
SOVUNA Approval History
What SOVUNA Treats
4 indicationsSOVUNA is approved for 4 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malaria
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Chronic Discoid Lupus Erythematosus
SOVUNA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SOVUNA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SOVUNA treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04911816 | 2103260669 | Ph 1, Ph 2 | recruiting | Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma |
| NCT02615938 HCQ-chILD-EU results posted | EudratCT:2013-003714-40 | Ph 2 | terminated | Hydroxychloroquine (HCQ) in Pediatric Interstitial Lung Disease (ILD) |
| NCT04386057 results posted | 19-529 | Ph 2 | completed | LY3214996 +/- HCQ in Pancreatic Cancer |
| NCT06519617 | 2024-KY-173 | Ph 2 | enrolling by invitation | Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage |
| NCT04341727 WU352 results posted | 202003188 | Ph 3 | terminated | Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection |
| NCT04336332 results posted | 002011 Pro2020000712, Pro2020000712 | Ph 2 | terminated | Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19 |
| NCT04354428 results posted | STUDY00009878 INV-017062 | Ph 2, Ph 3 | terminated | Treatment for COVID-19 in High-Risk Adult Outpatients |
| NCT04328961 results posted | STUDY00009750 INV-016204 | Ph 2, Ph 3 | completed | Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP) |
| NCT04342221 COV-HCQ | COV-HCQ 2020-001224-33 | Ph 3 | terminated | Hydroxychloroquine for COVID-19 |
| NCT04361461 | APS000/2020 | Ph 3 | withdrawn | Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19) |
| NCT04307693 | S2020-0472-0001 | Ph 2 | terminated | Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19) |
| NCT02942381 | 2016(1057) | Ph 2 | completed | A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy |
| NCT02351752 | 2014【851】 | Ph 4 | completed | Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOVUNA FDA Label Details
Indications & Usage
FDA Label (PDF)1 INDICATIONS & USAGE SOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. Treatment of rheumatoid arthritis in adults. Treatment of systemic lupus erythematosus in adults. Treatment of chronic discoid lupus erythematosus in adults. Limitations of Use : SOVUNA is not recommended for the: Treatment of complicat...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.