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Report Overview

Lupus Nephritis, a serious renal complication of systemic lupus erythematosus, represents a major cause of morbidity worldwide. It affects around 40% of patients with SLE, predominantly women aged 20-40, with higher prevalence among Black, Hispanic, and Asian populations. Up to 30% may progress to end-stage renal disease within a decade. The lupus nephritis pipeline analysis by Expert Market Research highlights expanding innovation across biologics, targeted immunotherapies, and cell-based approaches aimed at addressing refractory disease and long-term renal preservation for patients globally.

  • Major companies involved in the lupus nephritis pipeline analysis include Novartis Pharmaceuticals, Genentech, Inc., and others.

  • Leading drugs currently in the pipeline include IPG11406, VIB4920 and others.

  • The increasing identification of molecular and immunologic subtypes in lupus nephritis, such as interferon signatures and specific autoantibody profiles, is driving pipeline innovation. Precision-targeted therapies, including novel biologics and cell-based modulators, are accelerating development, enabling personalized treatment options and attracting investment to improve long-term renal outcomes.

Report Coverage

The Lupus Nephritis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into lupus nephritis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for lupus nephritis. The lupus nephritis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The lupus nephritis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with lupus nephritis treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to lupus nephritis.

Lupus Nephritis Pipeline Analysis by Drug Class

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Lupus Nephritis Pipeline Outlook

The lupus nephritis pipeline outlook underscores increasing innovation in a condition traditionally managed with corticosteroids, mycophenolate mofetil, cyclophosphamide, and calcineurin inhibitors, often associated with toxicity and variable long-term renal outcomes.

Lupus Nephritis treatment is significantly shaped by pipeline efforts focused on targeted immunomodulation to enhance efficacy and durability of response. A major milestone was achieved in October 2025, when the US FDA approved Gazyva® (obinutuzumab) for adults with active lupus nephritis. As a type II humanized anti-CD20 monoclonal antibody, Gazyva depletes pathogenic B cells and significantly improves complete renal response when added to standard therapy, marking a meaningful advance in targeted lupus nephritis treatment and reinforcing confidence in biologic-driven pipeline development.

Lupus Nephritis Epidemiology

Lupus nephritis, a severe kidney manifestation of systemic lupus erythematosus (SLE), affects approximately 40% of patients with SLE, making it the most common secondary glomerulonephritis globally. It typically develops 3-5 years after SLE onset and disproportionately affects women, particularly those aged 20-40, with a female-to-male ratio of around 9:1. Ethnic disparities exist, with higher prevalence among Hispanic, Black, and Asian populations. Approximately 10-30% of lupus nephritis cases progress to end-stage renal disease within 10 years, underscoring significant morbidity worldwide.

Lupus Nephritis – Pipeline Therapeutic Assessment

This section of the report covers the analysis of lupus nephritis drug candidates based on several segmentations, including:

By Phase

The pipeline assessment report covers 50+ drug analyses based on phase:

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

The lupus nephritis pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • Peptides
  • Polymers

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration:

  • Oral
  • Parenteral
  • Others

Lupus Nephritis Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase I covers a major share of the total lupus nephritis clinical trials. Phase I represents the largest share at 42%, followed by phase II 35%, early phase I 8%, and phase III 11%, reflecting strong early- to mid-stage pipeline activity.

Lupus Nephritis Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the lupus nephritis pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The lupus nephritis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for lupus nephritis. In June 2025, the FDA approved a subcutaneous autoinjector formulation of Benlysta® (belimumab) for children aged five years and older with active lupus nephritis. Benlysta is a B-lymphocyte stimulator (BlyS)-specific monoclonal antibody that helps reduce immune-mediated kidney damage. The new autoinjector allows at-home administration, improving treatment convenience and adherence in the pediatric population.

Lupus Nephritis Clinical Trials – Key Players

The EMR report for the lupus nephritis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed lupus nephritis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in lupus nephritis clinical trials:

  • Nanjing Immunophage Biotech Co., Ltd
  • Qilu Pharmaceutical Co., Ltd.
  • Guangdong Hengrui Pharmaceutical Co., Ltd
  • AbelZeta Inc.
  • Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
  • Novartis Pharmaceuticals
  • CRISPR Therapeutics
  • Genentech, Inc.
  • Yake Biotechnology Ltd.

Lupus Nephritis – Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for lupus nephritis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of lupus nephritis drug candidates.

Drug: SHR-2173 Injection

SHR-2173 Injection is an investigational therapy belonging to the class of immunomodulatory biologics being evaluated for active lupus nephritis. It is designed to modulate aberrant immune responses and reduce renal inflammation and damage by suppressing pathogenic activity in affected kidneys. The Phase II multicenter, randomized, double-blind trial assesses efficacy and safety versus placebo in reducing proteinuria and improving renal outcomes. This candidate is being advanced by Guangdong Hengrui Pharmaceutical Co., Ltd, a global biopharmaceutical company expanding its pipeline into autoimmune nephritic diseases.

Biological: C-CAR168

C-CAR168 is a novel autologous bi-specific CAR-T cell therapy, classified as a cellular immunotherapy targeting both CD20 and B-cell maturation antigen (BCMA) to eliminate pathogenic B cells implicated in lupus nephritis. By depleting these autoimmune drivers, it aims to reduce immune complex deposition and renal inflammation. Early Phase 1 data indicate promising safety and target engagement. The therapy is being developed by AbelZeta Pharma, Inc., a clinical-stage company focused on innovative cell-based treatments for autoimmune and immunological diseases.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Lupus Nephritis Pipeline Insight Report

  • Which companies/institutions are leading the lupus nephritis drug development?
  • Which company is leading the lupus nephritis pipeline development activities?
  • What is the current lupus nephritis commercial assessment?
  • What are the opportunities and challenges present in the lupus nephritis pipeline landscape?
  • What is the efficacy and safety profile of the lupus nephritis pipeline drugs?
  • Which company is conducting major trials for lupus nephritis drugs?
  • Which companies/institutions are involved in lupus nephritis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in lupus nephritis?

Reasons To Buy This Report

The Lupus Nephritis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for lupus nephritis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into lupus nephritis collaborations, regulatory environments, and potential growth opportunities.

Related Reports

Global Clinical Trials Market

Lupus Nephritis Treatment Market

Lupus Anticoagulant Testing Market

Lupus Nephritis Epidemiology Forecast

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • Peptides
  • Polymers

Leading Sponsors Covered

  • Nanjing Immunophage Biotech Co., Ltd
  • Qilu Pharmaceutical Co., Ltd.
  • Guangdong Hengrui Pharmaceutical Co., Ltd
  • AbelZeta Inc.
  • Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
  • Novartis Pharmaceuticals
  • CRISPR Therapeutics
  • Genentech, Inc.
  • Yake Biotechnology Ltd.

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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