Garg Lupus Lab @ Yale
Therapeutic Pipeline for Lupus

Therapeutic Pipeline for Lupus: FDA-Approved Therapies and Late-Stage Clinical Trials (Phase 2b/3) by Primary Study Completion

Hydroxychloroquine
TLR7-9Ri
Belimumab
BAFFi
Voclosporin
oral calcineurin inhibitor
Anifrolumab
IFN-R-antagonist
Obinutuzumab
Anti-CD20i
Obinutuzumab
Anti-CD20i
Sirolimus
mTOR-inhibitor
Anifrolumab SQ
IFN-R-antagonist
Anifrolumab*
IFN-R-antagonist
Deucravacitinib
TYK2 inhibitor
Litifilimab#
Anti-BDCA2 MAb
Cenerimod
S1P1-R modulator
Enpatoran
TLR7/8 inhibitor
Anifrolumab*
IFN-R-antagonist
Ianalumab#
Anti-BAFF R MAb
Ianalumab
Anti-BAFF R MAb
Upadacitinib
JAK-1inhibitor
Anifrolumab*
IFN-R-antagonist
Dapirolizumab pegol
Anti-CD40L Fab
Nipocalimab
Anti-FcRn MAb
1957
2011-2020
2021
2024
2025
2026
2027
2028
Adult SLE
SLE (2011)
cSLE (2019)
LN (2020)
Adult LN
Adult SLE
(CCLE subgroup)
Adult LN
Adult SLE
Adult SLE
*Adult CLE
#Adult CLE
Adult SLE
*Adult LN
#Adult LN
Adult SLE
*Pediatric SLE

Figure Legend

Green color indicates therapies which are FDA approved/in review; Light Green indicates therapies in Phase 3 trials (ongoing); Yellow indicates therapies in Phase 2/3 trial (ongoing)

*Shows the disease phenotype or condition being studied in the clinical trial if not adult SLE

#Shows additional disease phenotype or condition being studied in the clinical trial along with adult SLE

Abbreviations

TLR=Toll-like receptor; BAFF=B-cell activating factor; IFN-R=Type I interferon receptor; mTOR=Mechanistic target of rapamycin; TYK2=Tyrosine kinase 2; BDCA2=Blood dendritic cell antigen 2; JAK=Janus kinase; FcRn=Neonatal Fc receptor; CD20=Cluster of differentiation 20; CD40L=CD40 ligand; S1P1-R=Sphingosine-1-phosphate receptor 1; SQ=Subcutaneous; i=Inhibitor; R=Receptor; Mab=Monoclonal antibody; Fab=Fragment antigen-binding; SLE=Systemic lupus erythematosus; cSLE=Childhood-onset systemic lupus erythematosus; LN=Lupus nephritis; CLE=Cutaneous lupus erythematosus; CCLE=Chronic cutaneous lupus erythematosus

©Shivani Garg 2026, All Rights Reserved

Disclaimer

Additional agents in the SLE/CLE pipeline, not shown above due to no active US-based trials: Telitacicept (TACI-Ig, dual BAFF/APRIL inhibitor) is approved in China (2021); its two US/global Phase 3 SLE trials (REMESLE-1, REMESLE-2) were terminated and withdrawn by the sponsor (Vor Biopharma) in 2024–2025, so no US data are expected on the current timeline. MIL62 (anti-CD20 Mab) is in Phase 3 at a single site in Beijing, China (primary completion ~Dec 2028). Lenalidomide (cereblon-binding immunomodulator) is in Phase 3 for CLE in France (primary completion ~Feb 2029; not yet recruiting). Rituximab (anti-CD20 Mab) is used off-label for SLE and is not FDA-approved for this indication; its only active Phase 3 study is an investigator-initiated combination trial in the Netherlands (primary completion reported June 2024). CAR-T cell therapy for pediatric refractory lupus nephritis is in Phase 3 at a single site in Guangzhou, China (primary completion ~Apr 2029).