TheraRadar
Landscape / Immunology
Page updated Jul 4, 2026 · using data updated on Jun 28, 2026

Lupus Clinical Trial Landscape

Systemic lupus erythematosus is a chronic, multi-organ autoimmune disease driven by autoantibodies, type-I interferon signaling, and B-cell dysregulation, with a relapsing-remitting course that has long been managed with corticosteroids, antimalarials such as hydroxychloroquine, and broad immunosuppression. For decades the field saw little targeted innovation, and clinical development was notorious for trial failures against a heterogeneous disease and a high placebo response.

That changed with the arrival of the anti-BLyS antibody belimumab (Benlysta) and, more recently, the type-I interferon receptor blocker anifrolumab (Saphnelo) — the first mechanism-specific biologics in the indication. The field has since shifted from broad immunosuppression toward selectively resetting the B-cell and interferon axes that underlie the disease.

Trial activity

238 active / 543 total since 2008
Active by phase 34 Ph3 / 79 83 Ph2 / 228 108 Ph1 / 197 13 Ph4 / 39

Competitive Intelligence

This Lupus competitive landscape maps 18 companies against 14 mechanisms of action (MOA) across 24 active drug-development programs. Each cell is the lead program for a company–mechanism pair — its trial phase, modality, combination, and nearest readout. Read down a column to see who is competing on the same mechanism in Lupus, across a row to see one company's mechanistic spread, and click any cell for the full program list and trial links.

Beta 18 companies 14 mechanisms 24 programs mapped 4 lowTrust (17%) ⏰ 6 due ≤6 mo click any cell → asset tearsheet
The competitive read

Lupus has finally moved past a long approval drought: belimumab and anifrolumab established the BLyS and type-I interferon franchises, and the action has now swung decisively toward cell therapy, with autologous CD19 CAR-T emerging as the single most-contested approach in the pipeline. The field is broadening rather than consolidating — a wave of T-cell engagers and BAFF/APRIL agents is crowding in behind the cell therapies, while a separate cohort led by Biogen and Viatris is betting on fewer but more advanced lead assets. Where the approved drugs damp down immune signaling, the frontier is increasingly about depleting or re-engaging the B cells driving the disease.

Key findings
  • 155 total programs (125 mapped to a mechanism) across 8 companies; the 3 leading sponsors hold a combined 31% share.
  • CD19 CAR-T leads the pipeline with 26 programs, far ahead of the next mechanisms: BAFF/APRIL inhibitors (7), and anti-BDCA2, anti-IFNAR1 and CD19×CD3 T-cell engagers (6 each).
  • 18 are new molecular entities; mechanism breadth spans 9 approved-class and 11 pre-approval mechanisms, with a 24-program long tail.
  • Top sponsors by program count: Novartis (9), Bristol-Myers Squibb (7), AstraZeneca (6); most novel asset is Zenas BioPharma's anti-CD19 × FcγRIIb (Phase 2).

Forward catalysts next 18 months⏰ 6 due ≤6 mo

Nearest first. ⚖ Confirmed FDA PDUFA dates (curated calendar, primary sources) and 📅 estimated readouts (ClinicalTrials.gov primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.

Company × Mechanism

Each cell = a company’s most-advanced program in that mechanism. Click for the asset tearsheet.
Unverified (lowTrust) cells:
Ph1 Ph2 Ph3 Ph4 ⚠ lowTrust +combo
Select & Focus Pro 🔒 Transpose, filtering, selection & export are Pro (search & sort are free) — start a free trial, or try them free on our showcase →
CD19 CAR-T (autoimmune)
Anti-BDCA2 (mAb)
BAFF/APRIL inhibitor
CD19 CAR-T (MS)
TYK2
Anti-IFNAR1 (type-I IFN)
S1P modulator
TLR7/8 antagonist
Anti-CD38 (mAb)
CD19 × CD3 T-cell engager
CD19 ADC (GRM payload)
Anti-CD20 (mAb)
Anti-CD19 (mAb)
BCMA CAR-T (autoimmune)
Novartis
Bristol-Myers Squibb
🇨🇳China Immunotech (Beijing)
Biogen
AstraZeneca
Chongqing Precision
Viatris Innovation
AbbVie
Autolus Limited
🇨🇳Beijing Mabworks
Climb Bio
EMD Serono Research & Develop…
Fate
🇨🇳Hangzhou Sumgen
🇨🇳Shenzhen MagicRNA
🇨🇳Beijing InnoCare Pharma Tech
🇨🇳Genrix (Shanghai) Biopharmace…
🇨🇳Sinocelltech

Phase 3 leaders · most advanced

  1. recruiting EMD Serono Research & Development Institute, Inc. NCT07355218
  2. recruiting EMD Serono Research & Development Institute, Inc. NCT07332481
  3. recruiting Janssen Research & Development, LLC NCT07438496
  4. active Viatris Innovation GmbH NCT05648500
  5. recruiting AstraZeneca NCT05835310

Beyond the grid Beta

What the matrix leaves out — rare mechanisms with only one player, small & emerging sponsors, and programs we haven’t classified yet.

Single-company mechanisms — BD white space 7 found

Mechanisms only ONE company is pursuing in this indication — the uncrowded / first-in-class bets the matrix cap hides. ⚡ first-in-class · ⚠ unverified mechanism. ⚡ first-in-class is computed across 61 mapped landscapes — scope-limited, not a global claim.
⚡ first-in-class · 🌱 first-in-indication · 🆕 NME candidate · ✅ AI-classified + verified · ⚙️ AI-classified, unverified · first-in-class computed across 61 mapped landscapes
Single-program mechanisms (32) — one program each — earliest-stage, sorted by phase
PhaseMechanismCompanyModalityReadoutTrial
Ph3 Anti-CD40L ⚡ 🌱 🆕 UCB 3Q30 NCT04976322
Ph3 CD40LG ⚡ 🌱 🆕 UCB 2Q28 NCT06617325
Ph3 IFNAR1 ⚡ 🌱 AstraZeneca SC 3Q25 NCT04877691
Ph3 JAK1 selective 🌱 AbbVie Oral 1Q27 NCT05843643
Ph2 Anti-BAFF-R (mAb) ⚡ 🌱 🆕 Novartis SC 1Q26 NCT06293365
Ph2 Anti-CD19 × FcγRIIb 🌱 🆕 Zenas BioPharma (USA) ⏰ 2Q26 NCT06559163
Ph2 Anti-CD19 mAb (NMOSD/MS) 🌱 Amgen IV 3Q28 NCT06570798
Ph2 Anti-CD40L (Sanofi) 🌱 🆕 Sanofi ⏰ 3Q26 NCT05039840
Ph1+Ph2 BCL-2 inhibitor 🌱 🆕 Ascentage Pharma Group 2Q26 NCT06182969
Ph1+Ph2 BCMA × CD3 bispecific 🌱 🆕 Genrix (Shanghai) Biophar… 2Q27 NCT07348055
Ph2 BTK inhibitor 🌱 🆕 Beijing InnoCare Pharma T… 3Q25 NCT05688696
Ph1+Ph2 CD20 × CD3 bispecific ⚡ 🌱 🆕 Sinocelltech 2Q27 NCT06841042
Ph1+Ph2 CD20/BCMA CAR-T (autoimmune) 🌱 🆕 AbelZeta Cell therapy 2Q29 NCT06935474
Ph2 cGAS inhibitor ⚡ 🌱 🆕 Ventus Therapeutics U.S. ⏰ 3Q26 NCT07260877
Ph2 Complement C5 / Factor H inhibitor 🌱 🆕 Kira Pharmacenticals (US)… 1Q26 NCT05504187
Ph2 Complement Factor B/D inhibitor 🌱 🆕 Novartis 1Q26 NCT05268289
Ph1+Ph2 Glucocorticoid receptor agonist 🌱 DualityBio 2Q27 NCT06625671
Ph1+Ph2 Opioid receptors 🌱 Truway Health 4Q34 NCT07221565
Ph2 T cell surface glycoprotein CD3 🌱 Roche / Genentech IV 1Q28 NCT07598396
Ph1 Anti-BDCA2 / TACI bispecific ⚡ 🌱 🆕 Nanjing Leads Biolabs 4Q27 NCT07323173
Ph1 Anti-ILT7 (pDC depletion) ⚡ 🌱 🆕 Kyowa Kirin 4Q24 NCT05411016
Ph1 BCMA × CD3 (TCE) 🌱 🆕 Candid 4Q27 NCT07215663
Ph1 BCMA/GPRC5D T-cell engager 🌱 🆕 Qilu ⏰ 4Q26 NCT07001839
Ph1 CAR-T ⚡ 🌱 🆕 Hangzhou Qihan Cell therapy 4Q28 NCT07444307
Ph1 CAR-T (autoimmune) ⚡ 🌱 🆕 Nanjing Legend 1Q28 NCT07331272
Ph1 CD19 CAR-NK (autoimmune) 🌱 🆕 Ruitherapeutics 3Q27 NCT07358988
Ph1 CD19/CD20 bispecific (mAb) 🌱 🆕 Hinge Bio 4Q27 NCT07491900
Ph1 Engineered IL-2 ⚡ 🌱 🆕 Otsuka Pharmaceutical Dev… ⏰ 4Q26 NCT06799520
Ph1 FCGRH3 🌱 🆕 Roche / Genentech IV 1Q30 NCT07629583
Ph1 IL-2 🌱 Century 3Q28 NCT06255028
Ph1 Mesenchymal stem cell 🌱 🆕 LiveKidney.Bio Cell therapy ⏰ 2Q26 NCT06737380
Ph1 Undisclosed target 🌱 🆕 Eli Lilly 1Q28 NCT07276958
Emerging & small-cap sponsors (31) — few programs here — partnering / M&A radar
PhaseMechanismCompanyModalityReadoutTrial
Ph2 TYK2 Alumis ⏰ 3Q26 NCT05966480
Ph1+Ph2 🇨🇳 CD19 CAR-T Beijing IV 1Q27 NCT07523542
Ph1 🇨🇳 CD19 CAR-T (autoimmune) Beijing Immunochina Medic… 1Q26 NCT06852573
Ph1+Ph2 CD19 CAR-T (autoimmune) Cabaletta Bio 4Q29 NCT06121297
Ph1 CD19 CAR-T (autoimmune) Capstan IV 4Q27 NCT06917742
Ph2 BCMA CAR-T (autoimmune) Cartesian ⏰ 4Q26 NCT06038474
Ph1 CD19 CAR-T (autoimmune) CRISPR 4Q31 NCT06925542
Ph1 BCMA CAR-T (autoimmune) CSPC ZhongQi Pharmaceutic… 1Q29 NCT06694298
Ph1 CD19 × CD3 T-cell engager Cullinan SC ⏰ 4Q26 NCT06613360
Ph1+Ph2 CD19 CAR-T (autoimmune) Curocell 2Q30 NCT07364396
Ph1 CD19 × CD3 T-cell engager CytoCares 3Q27 NCT07177911
Ph2 TLR7/8 antagonist Eisai 3Q28 NCT07515014
Ph1+Ph2 CD19 × CD3 T-cell engager Excyte Biopharma 2Q27 NCT07010835
Ph1 BAFF/APRIL inhibitor GSK 1Q28 NCT06576271
Ph1 🇨🇳 CD19 CAR-T (autoimmune) Guangdong Ruishun ⏰ 4Q26 NCT06340490
Ph1 Anti-CD38 (mAb) HI-Bio, A Biogen Company ⏰ 2Q26 NCT06064929
Ph2 FcRn inhibitor Immunovant Sciences ⏰ 4Q26 NCT06980805
Ph3 FcRn inhibitor Johnson & Johnson 4Q28 NCT07438496
Ph2 Anti-CD38 (mAb) Keymed ⏰ 4Q26 NCT06791772
Ph1+Ph2 CD19 CAR-T Kyverna Cell therapy 4Q28 NCT06342960
Ph1 BAFF/APRIL inhibitor Luminary Cell therapy ⏰ 2Q26 NCT06340750
Ph1 CD19 × CD3 T-cell engager Merck & Co. 3Q29 NCT07363590
Ph2 TLR7/8 antagonist Merck Healthcare KGaA, Da… 3Q28 NCT05540327
Ph1+Ph2 CD19 CAR-T Miltenyi Biomedicine Cell therapy ⏰ 2Q26 NCT06347718
Ph1 🇨🇳 CD19 CAR-T (autoimmune) Nanjing IASO 2Q28 NCT07109986
Ph1 CD19 CAR-T (autoimmune) Sana Biotechnology 4Q27 NCT06294236
Ph1 🇨🇳 Anti-CD19 (mAb) Shanghai IASO 3Q27 NCT07483346
Ph1 🇨🇳 CD19 × CD3 T-cell engager Sichuan Baili 4Q27 NCT06857214
Ph1+Ph2 🇨🇳 Anti-BDCA2 (mAb) Sunshine Guojian Pharmace… 3Q28 NCT07185269
Ph1 CD19 CAR-T (autoimmune) Therorna ⏰ 2Q26 NCT07413341
Ph2 S1P modulator Viatris 4Q27 NCT07266090
Unclassified programs (39) — mechanism not captured yet
PhaseMechanismCompanyModalityReadoutTrial
Ph3 A Phase III Study to Investigate the Efficacy and Safety of Ani…unclassified AstraZeneca NCT06015737
Ph3 Obinutuzumab, Placebo, Acetaminophen/Paracetamolunclassified Hoffmann-La Roche NCT04963296
Ph1+Ph2 AZD0120, Cyclophosphamide, Fludarabineunclassified AstraZeneca NCT06897930
Ph2 TQH3906 capsule, TQH3906 placebounclassified Chia Tai Tianqing Pharmac… NCT07509892
Ph2 SHR-2173 Injection, SHR-2173 Injection Placebounclassified Guangdong Hengrui Pharmac… NCT07299422
Ph2 Dihydroartemisinin tablets, Dihydroartemisinin tablets, Hydroxy…unclassified Kunming Pharmaceuticals, … NCT07557927
Ph2 BI 3000202, Placebounclassified Boehringer Ingelheim NCT07409181
Ph2 D-2570, D-2570 Placebounclassified InventisBio Co., Ltd NCT07311200
Ph1+Ph2 GC012F Injectionunclassified Gracell Biotechnologies (… NCT06530849
Ph1+Ph2 ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following cy…unclassified iCell Gene Therapeutics NCT07328581
Ph1+Ph2 MB-CART19.1unclassified Miltenyi Biomedicine GmbH NCT06189157
Ph2 Mesenchymal stem cells (MSC), Placebounclassified Red de Terapia Celular NCT03673748
Ph1+Ph2 hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose)…unclassified Shenzhen Beike Bio-Techno… NCT07041801
Ph2 TQB3702 Tablets, TQB3702 Tablets+TQB3702 Placebo, TQB3702 Place…unclassified Chia Tai Tianqing Pharmac… NCT06859931
Ph2 A Study to Investigate Pharmacokinetics, Pharmacodynamics, and …unclassified AstraZeneca NCT07630714
Ph1 RO7507062, Tocilizumabunclassified Hoffmann-La Roche NCT05835986
Ph1 Fludarabine, Cyclophosphamide, Tocilizumabunclassified Juno Therapeutics, Inc., … NCT07115745
Ph1 AZD5492unclassified AstraZeneca NCT06916806
Ph1 P-CD19CD20-ALLO1 Cells, Cyclophosphamide, Fludarabineunclassified Genentech, Inc. NCT06984341
Ph1 Vonsetamig, Odronextamabunclassified Regeneron Pharmaceuticals NCT06975787
Ph1 ISH0613 for injection, Placebounclassified SUNHO(China)BioPharmaceut… NCT07516639
Ph1 Cyclophosphamide, Fludarabineunclassified Allogene Therapeutics NCT07085104
Ph1 KITE-363, Fludarabine, Cyclophosphamideunclassified Kite, A Gilead Company NCT07038447
Ph1 SAR448501unclassified Sanofi NCT06647069
Ph1 ADI-001, Fludarabine, Cyclophosphamideunclassified Adicet Therapeutics NCT06375993
Ph1 GSK5926371unclassified GlaxoSmithKline NCT07371468
Ph1 ACT100 Injection, Placebo for ACT100, ACT100 Injectionunclassified Xiamen Amoytop Biotech Co… NCT07408908
Ph1 PTOC1unclassified Chongqing Precision Biote… NCT07403097
Ph1 HC022, Placebounclassified HC Biopharma Inc. NCT07306585
Ph1 AB-101, Cyclophosphamide, Fludarabineunclassified Artiva Biotherapeutics, I… NCT06265220
Ph1 SYNCAR-001, STK-009unclassified Synthekine NCT06544330
Ph1 BCD-256, BCD-256, BCD-256unclassified Biocad NCT07136389
Ph1 Inaticabtagene autoleucel Injectionunclassified Juventas Cell Therapy Ltd. NCT06826430
Ph1 HC022, Placebounclassified HC Biopharma Inc. NCT06657703
Ph1 zamtocabtagene autoleucel, Cyclophosphamide, Fludarabineunclassified Miltenyi Biomedicine GmbH NCT06708845
Ph1 After preconditioning with chemotherapy, F01 will be evaluated.unclassified Shanghai Simnova Biotechn… NCT06468683
Ph1 ATHENA CAR-T, Fludarabine, Cyclophosphamideunclassified EdiGene Inc. NCT06373991
Ph1 Relma-celunclassified Shanghai Ming Ju Biotechn… NCT06297408
Ph1 HBM7020unclassified Otsuka Pharmaceutical Dev… NCT07649265
Drugs in this landscape: Deucravacitinib · Anifrolumab · Obecabtagene autoleucel

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
AstraZeneca 9 8 0
Novartis 7 2 2
Bristol-Myers Squibb 5 13 1
Roche 5 3 2
Biogen 5 3 0
China Immunotech (Beijing) Biotechnology Co., Ltd. 5 0 0
Chongqing Precision Biotech Co., Ltd 5 0 0
GSK 4 17 2
Viatris Innovation GmbH 4 2 0
AbbVie 3 2 0
Miltenyi Biomedicine GmbH 3 0 0
Sanofi 2 3 1
EMD Serono Research & Development Institute, Inc. 2 2 1
UCB Biopharma SRL 2 1 0
Beijing InnoCare Pharma Tech Co., Ltd. 2 1 0

All 15 active Lupus sponsors

Unlock the remaining 7 sponsors with active / completed / failed counts — sortable and exportable.

Unlock with Pro

How the field has grown

New-trial starts peaked in 2025 (74 registered). The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (49 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
20
2017
23
2018
24
2019
21
2020
12
2021
30
2022
27
2023
34
2024
63
2025
74
2026
63

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (2)
281
2017 (0)
0
2018 (6)
404
2019 (2)
741
2020 (1)
321
2021 (11)
277
2022 (6)
271
2023 (7)
451
2024 (6)
390
2025 (1)
122
2026 (7)
245

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT07355218 RECRUITING
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
EMD Serono Research & Development Institute, Inc. n=202
NCT07332481 RECRUITING
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
EMD Serono Research & Development Institute, Inc. n=202
NCT05352919 ENROLLING BY INVITATION
An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Biogen n=864
NCT07438496 RECRUITING
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Janssen Research & Development, LLC n=600
NCT06475742 ENROLLING BY INVITATION
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
Viatris Innovation GmbH n=680
NCT05648500 ACTIVE NOT RECRUITING
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Viatris Innovation GmbH n=470
NCT05835310 RECRUITING
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
AstraZeneca n=100
NCT06044337 ENROLLING BY INVITATION
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Biogen n=322
NCT07430306 RECRUITING
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
AstraZeneca n=245
NCT07405970 RECRUITING
A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Beijing Mabworks Biotech Co., Ltd. n=316
NCT06015737 ACTIVE NOT RECRUITING
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
AstraZeneca n=306
NCT06617325 RECRUITING
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
UCB Biopharma SRL n=450
NCT04976322 ENROLLING BY INVITATION
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
UCB Biopharma SRL n=760
NCT07201129 RECRUITING
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Viatris Innovation GmbH n=300
NCT05843643 ACTIVE NOT RECRUITING
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
AbbVie n=1,014
NCT05531565 ACTIVE NOT RECRUITING
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Biogen n=450
NCT04877691 ACTIVE NOT RECRUITING
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
AstraZeneca n=367
NCT04963296 ACTIVE NOT RECRUITING
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Hoffmann-La Roche n=303
NCT05672576 ACTIVE NOT RECRUITING
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Viatris Innovation GmbH n=451
NCT06133972 RECRUITING
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Novartis Pharmaceuticals n=550
NCT05624749 ACTIVE NOT RECRUITING
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
Novartis Pharmaceuticals n=288
NCT05639114 ACTIVE NOT RECRUITING
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
Novartis Pharmaceuticals n=436
NCT05799378 RECRUITING
Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
NYU Langone Health n=330
NCT04895241 ACTIVE NOT RECRUITING
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Biogen n=548
NCT04961567 ACTIVE NOT RECRUITING
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Biogen n=562
NCT05617677 ACTIVE NOT RECRUITING
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Bristol-Myers Squibb n=516
NCT05620407 ACTIVE NOT RECRUITING
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Bristol-Myers Squibb n=513
NCT04702256 RECRUITING
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
Assistance Publique - Hôpitaux de Paris n=196
NCT04582136 ACTIVE NOT RECRUITING
Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus
Chinese SLE Treatment And Research Group n=146
NCT06965244 NOT YET RECRUITING
Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus
Assistance Publique - Hôpitaux de Paris n=122
NCT05458622 ACTIVE NOT RECRUITING
3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol
University Hospital, Brest n=25
NCT03747159 ACTIVE NOT RECRUITING
Synergetic B-cell Immunomodulation in SLE - 2nd Study.
Leiden University Medical Center n=70
NCT06618573 RECRUITING
Safety of Administering Isoniazid to SLE Patients to Prevent TB
Universitas Padjadjaran n=60
NCT07657793 RECRUITING
Sirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia
Chinese SLE Treatment And Research Group n=164
NCT05001737 COMPLETED
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
Swedish Orphan Biovitrum n=33
NCT05306574 TERMINATED
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
Vor Biopharma n=91
NCT06456567 WITHDRAWN
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
Vor Biopharma
NCT04931563 COMPLETED
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
AstraZeneca n=277
NCT01284725 COMPLETED
Weaning of Immunosuppression in Nephritis of Lupus
Assistance Publique Hopitaux De Marseille n=100
NCT00611663 COMPLETED
Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus
Assistance Publique - Hôpitaux de Paris n=47
NCT04294667 COMPLETED
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
UCB Biopharma SRL n=321
NCT03517722 TERMINATED
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Janssen Research & Development, LLC n=516
NCT03312907 COMPLETED
A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE
GlaxoSmithKline n=292
NCT04060888 WITHDRAWN
A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus
Janssen Research & Development, LLC
NCT05063513 WITHDRAWN
Autologous Stem Cell Transplantation: International Lupus Trial
European Society for Blood and Marrow Transplantation
NCT03843125 TERMINATED
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
Eli Lilly and Company n=1,147
NCT04082416 COMPLETED
Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
RemeGen Co., Ltd. n=335
NCT04806113 COMPLETED
COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases
McGill University Health Centre/Research Institute of the McGill University Health Centre n=220
NCT03616912 TERMINATED
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Eli Lilly and Company n=830
NCT02794285 COMPLETED
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
AstraZeneca n=559
NCT02446912 COMPLETED
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
AstraZeneca n=460
NCT02446899 COMPLETED
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
AstraZeneca n=373
NCT01240694 TERMINATED
A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
Cephalon, Inc. n=136
NCT03616964 COMPLETED
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
Eli Lilly and Company n=778
NCT05326841 COMPLETED
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
Dr Cipto Mangunkusumo General Hospital n=60
NCT00626197 TERMINATED
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
Genentech, Inc. n=381
NCT01261793 COMPLETED
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
UCB Pharma n=791
NCT01597622 COMPLETED
BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115
GlaxoSmithKline n=142
NCT02119156 COMPLETED
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
GlaxoSmithKline n=80
NCT00712933 COMPLETED
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Human Genome Sciences Inc., a GSK Company n=738
NCT01345253 COMPLETED
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
GlaxoSmithKline n=709
NCT03979976 COMPLETED
Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Federal University of São Paulo n=37
NCT02504645 COMPLETED
A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
ImmuPharma n=202
NCT03427151 COMPLETED
Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
ImmuPharma n=62
NCT01408576 COMPLETED
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
UCB Pharma n=1,250
NCT01262365 COMPLETED
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
UCB Pharma n=793
NCT01205438 COMPLETED
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Eli Lilly and Company n=1,124
NCT02041091 TERMINATED
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Eli Lilly and Company n=226
NCT01196091 COMPLETED
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Eli Lilly and Company n=1,164
NCT01484496 COMPLETED
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Human Genome Sciences Inc., a GSK Company n=839
NCT01488708 TERMINATED
On Open-Label Study in Participants With Systemic Lupus Erythematosus
Eli Lilly and Company n=1,518
NCT01773616 TERMINATED
Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis
Imperial College London n=24
NCT01257802 TERMINATED
GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
Joseph Mccune n=14
NCT02514967 TERMINATED
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
Anthera Pharmaceuticals n=3
NCT01395745 COMPLETED
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
Anthera Pharmaceuticals n=442
NCT00724867 COMPLETED
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
Human Genome Sciences Inc., a GSK Company n=268
NCT00624338 COMPLETED
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
EMD Serono n=461
NCT02074020 WITHDRAWN
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
Anthera Pharmaceuticals
NCT01551069 COMPLETED
Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion
Sanofi n=103

Full Lupus Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

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Frequently asked

Common questions about the Lupus landscape

How many companies are developing Systemic Lupus Erythematosus treatments?
18 companies have active or registered Systemic Lupus Erythematosus programs in TheraRadar's competitive landscape (118 classified trials). The most active are Novartis, Bristol-Myers Squibb, and China Immunotech (Beijing).
What mechanisms of action are being developed for Systemic Lupus Erythematosus?
14 distinct mechanisms of action appear across the Systemic Lupus Erythematosus pipeline, including CD19 CAR-T (autoimmune), Anti-BDCA2 (mAb), BAFF/APRIL inhibitor, CD19 CAR-T (MS), and TYK2.
What is the most crowded mechanism in Systemic Lupus Erythematosus?
CD19 CAR-T (autoimmune) is the most contested mechanism in Systemic Lupus Erythematosus, with 15 programs mapped to it.
Are there upcoming Systemic Lupus Erythematosus clinical readouts or FDA decisions?
Near-term Systemic Lupus Erythematosus catalysts include Afimetoran (data readout, Jun '26); CD19 CAR-T cells (data readout, Jul '26); BCMA/CD70 CAR-T cells (data readout, Jul '26). Dates combine estimated trial primary-completion readouts and confirmed FDA decision dates.
Where does TheraRadar's Systemic Lupus Erythematosus landscape data come from?
Programs are derived from industry-sponsored ClinicalTrials.gov registrations (2008–present) and classified by mechanism of action using a curated rule set plus an LLM pipeline. Every cell links to its underlying trials, so each program is verifiable.
Is the Systemic Lupus Erythematosus heatmap free to use?
Yes — viewing and searching the Systemic Lupus Erythematosus heatmap is free. A TheraRadar Pro subscription adds advanced filters, row/column selection, and one-click export to PowerPoint, PDF, and CSV.
How this is built — methodology & limits

These grids are only as good as the data and the classification behind them — so here is exactly what goes in, what stays out, how every assignment is made, and where the limits are.

Where the data comes from

Every heatmap is built from the public ClinicalTrials.gov registry, via its official API — interventional drug and biologic trials with a start date of 2008 or later. The master index holds over 145,000 trials and is refreshed weekly (see the “updated” date on this page). A disease landscape draws only from the active, Phase 1–3, industry-sponsored slice of that index.

  • In scope: industry-sponsored trials in Phase 1, 2, or 3, with an active status (recruiting, active-not-recruiting, not-yet-recruiting, or enrolling by invitation). Phase 4 sits in the index but is left out of the landscapes.
  • Filtered out: deeply stale programs (a primary completion date more than two years past with no update to completed or terminated); basket trials and incidental mentions (a trial counts toward a disease only when that disease is genuinely the subject of study — not a secondary cohort, an organ-of-origin overlap, or a passing mention); and healthy-volunteer studies.

We do not exclude trials by sponsor geography. Where a sponsor is based in China, the program is flagged on the page rather than hidden, so you can weigh it yourself. An automated test fails the weekly refresh if the underlying index is more than 14 days old, so a published grid is never built on a stale index.

How a trial is matched to a disease

Matching uses a structured medical ontology, not keyword guessing, and is designed so that no trial is ever silently dropped — every trial that clears the filters gets a classification, even if that is just “Other.” It runs as an ordered sequence of steps, stopping at the first that applies:

  1. Healthy-volunteer studies are set aside as non-disease trials.
  2. Ontology match — each tracked disease is linked to its official identifiers in the standard medical taxonomy (MeSH), so a trial can be matched even when its text uses a synonym.
  3. Curated disease patterns — a hand-maintained library of over 150 disease-name patterns covers the more granular indications across oncology, hematology, infectious disease, cardiometabolic, immunology, and neuropsychiatry.
  4. Basket guard — a trial matching four or more distinct diseases, or carrying explicit basket language (“tumor-agnostic,” “all solid tumors,” “pan-cancer”), is grouped into a single advanced-solid-tumor category rather than over-counted across every cancer it touches.
  5. Therapeutic-area roll-up — a trial with no specific match, but which the taxonomy still places under a broad area, is assigned to that area (“Oncology — other,” “Immunology — other,” …), checking cancers first so a site-specific tumor isn’t filed under its anatomical system.

A “drop-if-parent-present” rule keeps a generic name from drowning out a subtype: a trial matching both lupus and lupus nephritis is reported only as lupus nephritis. Internal abbreviations are translated to the plain disease names used across the site (for example, “CRC” becomes “Colorectal Cancer”), and the same classifier is shared by every heatmap, so the same trial always maps to the same disease wherever it appears.

How a drug is matched to its mechanism

Mechanism of action is the hardest part to get right, so it is assigned in layers — leaning on curated and public data first, with AI as a last resort:

  1. Curated rulebook (first). A rulebook we maintain — over 600 drug-to-mechanism rules — is checked first, matching on drug names, trial acronyms, sponsor trial identifiers, and intervention lists. First match wins, which stops a combination trial from being counted several times.
  2. Public molecular-target data. Where no rule applies, each intervention’s target is looked up in a public target database, with verbose or gene-symbol labels normalized into consistent short forms so one target isn’t split across several columns.
  3. Standard-of-care backbones. A small set of rules recognizes common combination scaffolds (checkpoint-inhibitor monotherapy, standard chemotherapy regimens, established standard-of-care agents) so they aren’t mistaken for the experimental arm.
  4. AI as a last resort, then cross-checked. Only for genuinely opaque sponsor code-names that none of the first three steps can resolve do we ask an AI model to propose a mechanism — applied only above a fixed confidence bar, then automatically cross-checked against the sponsor’s own pipeline page. Where AI and the sponsor agree, the program is marked sponsor-verified. Where they contradict, the label is discarded entirely — not shown, not counted.

New mechanism rules are independently double-verified before they’re trusted — a second, adversarial pass set up to disprove the first — and each is checked so it can’t mislabel an unrelated trial. Drugs whose mechanism isn’t publicly disclosed are shown openly as “Emerging — not yet disclosed” rather than guessed at: for a tool meant to support real decisions, “we don’t yet know” is a more trustworthy answer than a confident guess.

Where AI is used — and where it isn’t

The disease and mechanism matching above is driven first by deterministic rules and public ontologies, not AI. AI plays three bounded, disclosed roles: (1) an optional extra check that a trial genuinely studies the disease, on top of the ontology match; (2) inferring a trial’s treatment setting on the competitive grids when the rules don’t cover it, only above a fixed confidence bar; and (3) the last-resort mechanism step above, always cross-checked against the sponsor’s disclosures. Wherever an AI label reaches a cell, the page marks it (⚙️ or ✅) — AI is never the silent, sole source of what you see.

What the on-page markers mean

  • ✅ Sponsor-verified — AI proposed the mechanism and it matched the sponsor’s own pipeline page. High-trust.
  • ⚙️ AI-classified — AI proposed it above the confidence bar but it has not yet been cross-checked against the sponsor. Useful; verify before citing. It never means a person reviewed it.
  • ⚡ First-in-class — the mechanism hasn’t appeared in any other disease landscape we’ve built. This reflects the scope of landscapes published so far (the tooltip lists exactly which were scanned), not an absolute claim about the whole market.
  • 🌱 First-in-indication — the only program competing on that mechanism within this disease.
  • 🆕 NME candidate — the interventions match no drug in our approved-drug index, suggesting a new molecular entity. The index is incomplete — a signal, not a regulatory fact.
  • 🔗 Combination · 👶 Pediatric · 🔥 Hot (readout within six months) · ⏳ Stale (completion date passed but still marked active — often a stalled program).

Sponsor names are resolved through a curated parent/subsidiary map; unrecognized sponsors appear under their raw registry name. The registry records the sponsor at a trial’s inception, so names are as originally filed and may not reflect later acquisitions. To keep large grids legible, mechanisms with a single program are listed separately rather than crowding the main grid, and very small players are listed below it — presentation choices only; nothing is removed from the underlying counts.

How we score programs — “what’s about to move”

Each program carries a 0–100 score that deliberately ranks imminence over raw stage — the most decision-relevant signal on a competitive grid. It is the sum of:

  • Clinical phase — up to 40 points (Phase 3 = 40, Phase 2 = 25, Phase 1 = 10).
  • Readout proximity — up to 60 points (next readout <6 months = 60, 6–12 months = 45, 1–2 years = 30, distant = 5).
  • Stale penalty — the score is halved if a trial is past its expected readout but still listed as active.

Cell colour on the grid is driven by this score, so a Phase 2 program about to read out can — correctly — outrank a dormant Phase 3 one. It answers “what’s about to move,” not just “what’s furthest along.”

What each grid plots

  • Indication landscape (this page) — one disease — companies (rows) × mechanism of action (columns): who is competing, and on what mechanism.
  • Company portfolio — one company — diseases (rows) × mechanism (columns): where it is active, and what it is betting on.
  • MOA platform — one mechanism family — drugs (rows) × diseases (columns): who is working on this class, and where.
  • Competitive landscape — one disease — mechanism (rows) × clinical setting (columns), aggregated across companies; setting columns are tailored per disease (e.g. lines of therapy in oncology; biologic-naïve vs. biologic-experienced in IBD).

What we don’t claim

  • First-in-class is editorial, not absolute — “not seen in the landscapes we’ve built,” not “novel across the industry.”
  • NME candidate is a signal, not a filing — absent from our (incomplete) approved-drug index.
  • Disease matching is automated and not exhaustively validated per disease — ontology and pattern matching can occasionally include or miss a trial.
  • AI-classified mechanisms are machine-proposed — unconfirmed unless they also carry ✅.
  • Sponsor names are as-filed and may lag current ownership.
  • Grids are as fresh as their last rebuild from the weekly index — no faster continuous refresh is claimed.

Data: ClinicalTrials.gov v2 API + FDA Drugs@FDA (approved-drug index). Spot an error? [email protected].

Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only