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Disease

Lupus Nephritis

Late-stage therapeutic developmentEmerging researchRising momentum
MeSHLupus Nephritis
3
Publications
24
Clinical trials
1
Related conditions
2024
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 5 clinical trials expected to report results, the earliest in Q2 2027.
Upcoming Milestones
Clinical Milestones11View all 11
Results posted 4
Results expected 5
Other updates 2
+3 more in the activity timeline below
Activity timeline11

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Voclosporinapproved

Approval — Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adul… (2022)

Obinutuzumabapproved

Approval — Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is ind… (2014)

Belimumabapproved

Approval — Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, a… (2011)

Clinical trials

15 sponsors · 4 new · 0 completed in the last 12 months (net +3)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Phase 3 · Recruiting · Janssen Research & Development, LLC

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy

Phase 3 · Recruiting · Viatris Innovation GmbH

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

Phase 3 · Active, not recruiting · Hoffmann-La Roche

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia

Phase 2/3 · Recruiting · Chinese SLE Treatment And Research Group

A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)

Phase 3 · Recruiting · EMD Serono Research & Development Institute, Inc.

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).

Phase 3 · Active, not recruiting · Novartis Pharmaceuticals
Recruiting

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Phase 3 · Recruiting · Janssen Research & Development, LLC

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy

Phase 3 · Recruiting · Viatris Innovation GmbH

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial and Open-Label Extension Study of Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia

Phase 2/3 · Recruiting · Chinese SLE Treatment And Research Group

A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)

Phase 3 · Recruiting · EMD Serono Research & Development Institute, Inc.
Recently completed

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus

Phase 3 · Completed · AstraZeneca

A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV±V Lupus Nephritis

Phase 3 · Completed · The University of Hong Kong

A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous

Phase 3 · Completed · Swedish Orphan Biovitrum

A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)

Phase 4 · Completed · GlaxoSmithKline

SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients

Phase 4 · Completed · Mansoura University

Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients

Phase 4 · Completed · Mansoura University

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2022emaApproval — Voclosporin· Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN). source ↗
2014emaApproval — Obinutuzumab· Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.  Follicular Lymphoma (FL)  Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.   Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.  Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).  source ↗
2011emaApproval — Belimumab· Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

3 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20112024
Major themes3
  • Lupus Nephritis2
  • Lupus Erythematosus, Systemic1
  • Podocytes1
Leading journals3
  • Journal of immunology (Baltimore, Md. : 1950)1
  • Kidney international1
  • Molecular medicine reports1
Leading researchers8
  • Berthier CC1
  • Bruce AT1
  • Chaperot L1
  • Denny MF1
  • Hodgin JB1
  • Kaplan MJ1
  • Khandpur R1
  • Klinker M1
Affiliations (unnormalised)5
  • Basic Medical College1
  • School of Public Health1
  • Shanxi Bethune Hospital1
  • Third Hospital of Shanxi Medical University1
  • University of Michigan Medical School1

Related conditions

1 match

Diseases frequently studied alongside this one. Number shows shared papers.

Lupus Erythematosus, Systemic2

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Glomerulonephritis associated with autoimmune disease SYSTEMIC LUPUS ERYTHEMATOSUS. Lupus nephritis is histologically classified into 6 classes: class I - normal glomeruli, class II - pure mesangial alterations, class III - focal segmental glomerulonephritis, class IV - diffuse glomerulonephritis, class V - diffuse membranous glomerulonephritis, and class VI - advanced sclerosing glomerulonephritis (The World Health Organization classification 1982).

Identifiers
MeSHLupus Nephritis
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.