Lupus Nephritis

Immunology
22
Pipeline Programs
15
Companies
50
Clinical Trials
8 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
2
9
0
5
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
3100%
+ 16 programs with unclassified modality

On Market (3)

Approved therapies currently available

Roche
CELLCEPTApproved
mycophenolate mofetil
Roche
oral1995
Astellas
PROGRAFApproved
tacrolimus
Astellas
injection1994
AstraZeneca
SAPHNELOApproved
anifrolumab-fnia
AstraZeneca
Type I Interferon Receptor Antagonist [EPC]injection2021

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
2 programs
1
1
tacrolimusPhase 41 trial
tacrolimus capsulePhase 31 trial
Active Trials
NCT01342016Terminated84Est. May 2013
NCT01316133Terminated37Est. Apr 2016
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
1
SAPHNELO(Anifrolumab)Phase 2Monoclonal Antibody5 trials
Active Trials
NCT04750057No Longer Available
NCT07431775Not Yet Recruiting26,000,000Est. Mar 2032
NCT07430306Not Yet Recruiting245Est. Jan 2029
+2 more trials
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
1
Mycophenolate mofetilPhase 35 trials
Active Trials
NCT01672957Completed128Est. Jul 2015
NCT01033864Completed23Est. Jun 2010
NCT02981290Completed32Est. Oct 2008
+2 more trials
Design Therapeutics
1 program
1
RituximabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT01765842TerminatedEst. Dec 2015
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
1
Voclosporin(QL1074)Phase 31 trial
Active Trials
NCT06406205RecruitingEst. Jun 2028
Novartis
NovartisBASEL, Switzerland
1 program
1
ianalumab s.c. q4wPhase 31 trial
Active Trials
NCT05126277Recruiting462Est. Nov 2030
Biogen
BiogenCAMBRIDGE, MA
3 programs
1
2
BIIB023Phase 21 trial
BIIB023Phase 21 trial
FelzartamabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT06064929Active Not Recruiting14Est. Jun 2026
NCT01930890Terminated87Est. Jan 2016
NCT01499355Terminated276Est. Dec 2015
KL
Kezar Life SciencesCA - South SF
2 programs
1
1
zetomipzomibPhase 21 trial
KZR-616Phase 1/21 trial
Active Trials
NCT03393013CompletedEst. Aug 2022
NCT05781750TerminatedEst. Nov 2024
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
2
BI 655064Phase 21 trial
BI 655064 dose 1Phase 21 trial
Active Trials
NCT03385564Completed69Est. Jul 2021
NCT02770170Completed121Est. Aug 2020
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
VIB4920Phase 21 trial
Active Trials
NCT05201469RecruitingEst. Mar 2027
Zai Lab
Zai LabCA - South SF
1 program
1
efgartigimod IVPhase 2
argenx
argenxBelgium - Zwijnaarde
1 program
1
efgartigimod IVPhase 21 trial
Active Trials
NCT05810948Completed73Est. Sep 2025
Nkarta Therapeutics
Nkarta TherapeuticsCA - South SF
1 program
1
NKX019Phase 1/21 trial
Active Trials
NCT06557265RecruitingEst. Apr 2027
Annexon Biosciences
Annexon BiosciencesCA - Brisbane
1 program
1
ANX009Phase 11 trial
Active Trials
NCT05780515CompletedEst. Oct 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
AstraZenecaAnifrolumab
Astellastacrolimus
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
RocheMycophenolate mofetil
AstraZenecaAnifrolumab
AstraZenecaAnifrolumab
AstraZenecaAnifrolumab
Qilu PharmaceuticalVoclosporin(QL1074)

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 8,200 patients across 50 trials

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Start: Jan 2026Est. completion: Aug 202716 patients
Phase 4Recruiting

A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients

Start: Apr 2011Est. completion: Apr 201637 patients
Phase 4Terminated
NCT01033864RocheMycophenolate mofetil

A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

Start: Nov 2009Est. completion: Jun 201023 patients
Phase 4Completed
NCT00206076RocheMycophenolate mofetil

Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation

Start: Aug 2006Est. completion: Jun 200919 patients
Phase 4Completed
NCT00337493RocheMycophenolate mofetil

Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

Start: Dec 2005Est. completion: Jan 2008155 patients
Phase 4Completed
NCT00121784RocheMycophenolate mofetil

Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients

Start: Oct 2005Est. completion: Aug 200612 patients
Phase 4Terminated
NCT00118742RocheMycophenolate mofetil

Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

Start: Aug 2005Est. completion: Dec 2008293 patients
Phase 4Completed
NCT00120419RocheMycophenolate mofetil

Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)

Start: Apr 200590 patients
Phase 4Unknown
NCT00087581RocheMycophenolate mofetil

Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

Start: Jun 2004Est. completion: Sep 2007720 patients
Phase 4Completed
NCT00166244RocheMycophenolate mofetil

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

Start: May 2003Est. completion: Apr 2006901 patients
Phase 4Completed
NCT00199667RocheMycophenolate mofetil

Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

Start: Oct 2002137 patients
Phase 4Unknown

A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus

Start: Apr 2026Est. completion: Jan 2029245 patients
Phase 3Not Yet Recruiting

A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

Start: Jun 2024Est. completion: Aug 2027302 patients
Phase 3Recruiting

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Start: Jun 2024Est. completion: Aug 2028240 patients
Phase 3Recruiting
NCT06406205Qilu PharmaceuticalVoclosporin(QL1074)

A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Start: Dec 2023Est. completion: Jun 2028
Phase 3Recruiting

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

Start: Nov 2023Est. completion: Apr 2028314 patients
Phase 3Active Not Recruiting
NCT05126277Novartisianalumab s.c. q4w

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Start: Jul 2022Est. completion: Nov 2030462 patients
Phase 3Recruiting

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Start: Feb 2022Est. completion: Dec 2028359 patients
Phase 3Active Not Recruiting

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Start: Sep 2021Est. completion: Jun 2025277 patients
Phase 3Completed

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Start: Jun 2021Est. completion: Nov 2026367 patients
Phase 3Active Not Recruiting

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Start: Jul 2015Est. completion: Sep 2018373 patients
Phase 3Completed

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Start: Jun 2015Est. completion: Jul 2018460 patients
Phase 3Completed

Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy

Start: Nov 2012Est. completion: Dec 2015
Phase 3Terminated
NCT01342016Astellastacrolimus capsule

A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients

Start: Apr 2011Est. completion: May 201384 patients
Phase 3Terminated
NCT00377637RocheMycophenolate mofetil

A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.

Start: Jul 2005Est. completion: Mar 2010370 patients
Phase 3Completed
NCT00788567RocheMycophenolate mofetil

CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants

Start: Jun 2005Est. completion: May 2008136 patients
Phase 3Completed
NCT00048152RocheMycophenolate mofetil

A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Start: Dec 2000Est. completion: Mar 2006539 patients
Phase 3Completed

Anifrolumab for Hidradenitis Suppurativa

Start: Jun 2024Est. completion: Apr 202615 patients
Phase 2Active Not Recruiting

Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

Start: Dec 2023Est. completion: May 202648 patients
Phase 2Recruiting

A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

Start: Nov 2023Est. completion: Nov 2024
Phase 2Terminated
NCT05810948argenxefgartigimod IV

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

Start: Feb 2023Est. completion: Sep 202573 patients
Phase 2Completed

Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

Start: Oct 2022Est. completion: Aug 202430 patients
Phase 2Unknown

VIBRANT: VIB4920 for Active Lupus Nephritis

Start: May 2022Est. completion: Mar 2027
Phase 2Recruiting

An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

Start: Jan 2018Est. completion: Jul 202169 patients
Phase 2Completed

A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

Start: Feb 2017Est. completion: Dec 201836 patients
Phase 2Completed

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Start: May 2016Est. completion: Aug 2020121 patients
Phase 2Completed

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

Start: Nov 2015Est. completion: Jan 2021147 patients
Phase 2Completed

BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

Start: Nov 2013Est. completion: Jan 201687 patients
Phase 2Terminated

BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis

Start: Jul 2012Est. completion: Dec 2015276 patients
Phase 2Terminated
NCT00446459RocheMycophenolate mofetil

Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.

Start: Apr 2006Est. completion: Dec 200845 patients
Phase 2Completed
NCT02630563RocheMycophenolate mofetil

Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids

Start: May 2003Est. completion: Jan 20059 patients
Phase 2Terminated
NCT00295425RocheMycophenolate mofetil

CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

Start: May 2000Est. completion: Oct 200650 patients
Phase 2Unknown

A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)

Start: Jun 2024Est. completion: Apr 2027
Phase 1/2Recruiting

A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis

Start: Feb 2018Est. completion: Aug 2022
Phase 1/2Completed

Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants

Start: Oct 2024Est. completion: Jan 202524 patients
Phase 1Completed

A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

Start: Nov 2023Est. completion: Jun 202614 patients
Phase 1Active Not Recruiting

A Study of ANX009 in Adult Participants With Lupus Nephritis

Start: Aug 2022Est. completion: Oct 2023
Phase 1Completed

Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab

Start: Mar 2022Est. completion: Apr 2023180 patients
Phase 1Completed

Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)

Start: Jul 2021Est. completion: Jun 202215 patients
Phase 1Completed

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

Start: Nov 2015Est. completion: May 201630 patients
Phase 1Completed

Related Jobs in Immunology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
8 actively recruiting trials targeting 8,200 patients
15 companies competing in this space