Garg Lupus Lab @ Yale
Therapeutic Pipeline for Lupus

Therapeutic Pipeline for Lupus

HCQ
TLR7-9R inhibitor
Belimumab
BAFF inhibitor
Voclosporinc
Oral calcineurin inhibitor
Anifrolumab
IFNAR1 antagonist
Obinutuzumabc
Anti-CD20 antibody
Obinutuzumab+
Anti-CD20 antibody
Anifrolumab SQ
IFNAR1 antagonist
Litifilimab
Anti-BDCA2
Anifrolumaba
IFNAR1 antagonist
Deucravacitinib
TYK2 inhibitor
Litifilimabb
Anti-BDCA2
Cenerimod
S1P1-R modulator
Anifrolumabc
IFNAR1 antagonist
Ianalumabc
Anti-BAFF receptor
Ianalumab
Anti-BAFF receptor
Upadacitinib
JAK-1 inhibitor
Enpatoranb
TLR7/8 inhibitor
Anifrolumabd
IFNAR1 antagonist
Dapirolizumab pegole
Anti-CD40 ligand Fab
1956
2011-2020*
2021
2024
2025
2026
2027
2028

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). FDA approved therapies are listed by their year of FDA approval; all other therapies are listed by primary study completion date reported on clinicaltrials.gov.

Primary disease phenotype or condition being evaluated is adult SLE unless otherwise indicated.

a Adult CLE; b Adult CLE with or without systemic disease; c Adult LN; d Pediatric SLE; e In patients ≥16 years of age, or ≥18 years of age in China

*SLE (2011); Pediatric SLE (2019); LN (2020)

+Indicates FDA approval pending

Abbreviations

APRIL, A proliferation-inducing ligand; BAFF, B-cell activating factor; BDCA2, blood dendritic cell antigen 2; CAR-T, chimeric antigen receptor T-cell; CD20, Cluster of Differentiation 20; CD40, Cluster of Differentiation 40; CLE, cutaneous lupus erythematosus; Fab, fragment antigen-binding; FcRn, neonatal Fc (fragment crystallizable) receptor; FDA, Food and Drug Administration; i, inhibitor; IFNAR1, interferon-α/β receptor 1; JAK-1, Janus kinase 1; LN, lupus nephritis; mTOR, mechanistic target of rapamycin; R, receptor; S1P1-R, sphingosine-1-phosphate receptor 1; SLE, systemic lupus erythematosus; SQ, subcutaneous; TLR, toll-like receptor; TYK2, tyrosine kinase 2; US, United States.

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inhibitor) is approved in China (2021); its two US/global Phase 3 SLE trials (REMESLE-1, REMESLE-2) were terminated and withdrawn by the sponsor (Vor Biopharma) in 2024–2025, so no US data are expected on the current timeline.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). Sirolimus (mTORi) is not shown: its Phase 3 study in proteinuric lupus nephritis flares (NCT04892212) was estimated to complete in 2023 and has not been updated on clinicaltrials.gov since 2021. Phase 1 or 2 studies were not included.

©Shivani Garg 2026, All Rights Reserved

Figure Attribution: Data visualization and pipeline analysis depicted in this figure were executed via Pipeline ©, owned by Shivani Garg (Garglabs LLC). ©Shivani Garg 2026 (garglabs LLC). All rights reserved.