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Systemic Lupus Erythematosus (SLE) — Treatment Landscape & Competitive Intelligence

Systemic Lupus Erythematosus (SLE) (Immunology & Inflammation) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

Immunology & Inflammation 10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Systemic Lupus Erythematosus (SLE), deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Lymphostat B BELIMUMAB Human Genome Sciences Inc. B Lymphocyte Stimulator-specific Inhibitor [EPC] Tumor necrosis factor ligand superfamily member 13B 2011-01-01
Imuran AZATHIOPRINE Legacy Pharma Purine Antimetabolite [EPC] ATP-binding cassette sub-family G member 2 1968-01-01
Decadron dexamethasone Generic (originally Merck) Corticosteroid [EPC] Annexin A1, Interleukin-4, Androgen receptor 1958-10-30
Medrol methylprednisolone Generic (originally Upjohn/Pfizer) Glucocorticoid (corticosteroid) Annexin A1, Short transient receptor potential channel 5, Glucocorticoid receptor 1957-10-01
Prelone prednisolone Generic (originally Schering) Glucocorticoid (corticosteroid) Annexin A1, Corticosteroid-binding globulin, G-protein coupled bile acid receptor 1 1955-01-01
Deltasone prednisone Generic (originally Schering) Corticosteroid [EPC] Annexin A1, Sodium/nucleoside cotransporter 1, Glucocorticoid receptor 1955-01-01
Hydroxychloroquine Sulfate HYDROXYCHLOROQUINE Advanz Antimalarial Toll-like receptor 9 1955-01-01
Solu-Cortef hydrocortisone succinate Pfizer Corticosteroid Glucocorticoid receptor 1955-01-01
Cortef hydrocortisone Generic (originally Merck/Upjohn) Corticosteroid [EPC] Annexin A1, Corticosteroid-binding globulin, Nitric oxide synthase, inducible 1952-01-01
Cortifoam HYDROCORTISONE ACETATE Pfizer Corticosteroid Corticosteroid-binding globulin 1951-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

  1. · 5 drugs in Systemic Lupus Erythematosus (SLE)
  2. Pfizer · 3 drugs in Systemic Lupus Erythematosus (SLE)
  3. Sanofi · 2 drugs in Systemic Lupus Erythematosus (SLE)
  4. Generic (originally Schering) · 2 drugs in Systemic Lupus Erythematosus (SLE)
  5. Generic (originally Merck) · 1 drug in Systemic Lupus Erythematosus (SLE)
  6. Generic (originally Merck/Upjohn) · 1 drug in Systemic Lupus Erythematosus (SLE)
  7. Generic (originally Upjohn/Pfizer) · 1 drug in Systemic Lupus Erythematosus (SLE)
  8. GlaxoSmithKline · 1 drug in Systemic Lupus Erythematosus (SLE)
  9. Hannover Medical School · 1 drug in Systemic Lupus Erythematosus (SLE)
  10. Human Genome Sciences Inc. · 1 drug in Systemic Lupus Erythematosus (SLE)
  11. Legacy Pharma · 1 drug in Systemic Lupus Erythematosus (SLE)
  12. Leiden University Medical Center · 1 drug in Systemic Lupus Erythematosus (SLE)

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Every new regulatory action, PDUFA date, or trial completion in Systemic Lupus Erythematosus (SLE):

Cite this brief

Drug Landscape (2026). Systemic Lupus Erythematosus (SLE) — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/systemic-lupus-erythematosus. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing