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Drugs in development · updated 30 October 2026

Systemic lupus erythematosus: drugs in development

Rare diseasePrevalence 1-5 / 10 000 according to Orphanet · ORPHA:536

As of 30 October 2026 there are 178 active clinical trials (recruiting or ongoing, phases I–III) on 178 drugs for systemic lupus erythematosus. 120 are experimental, that is not yet approved in the United States.

178Active trials
120Experimental drugs
7Experimental, in phase III

Summary updated every week · data as of 30 October 2026. In Phuturdex you get the full detail of every drug and an email when an alert is published on the ones you follow.

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Experimental drugs

Not yet approved by the US FDA for any indication.

DrugMost advanced phaseActive trialsReference trial
CenerimodIII5NCT05648500
IanalumabVAY736III5NCT05126277
EnpatoranM5049III4NCT07355218
LitifilimabBIIB059II–III4NCT05531565
MIL62III2NCT07405970
Dapirolizumab pegolIII1NCT04976322
MelatoninSlenyto®, Circadin®II–III1NCT07721324
CD19I–II6NCT06106893
CC-97540II2NCT07015983
FT819II2NCT07570862
YK012I–II2NCT07010835
2-hydroxybenzylamine2-HOBA acetateII1NCT07225543
AfimetoranII1NCT04895696
AZD0120I–II1NCT06897930
BI 3000202II1NCT07409181
C-CAR168II1NCT07729826
CABA-201I–II1NCT06121297
CART19I–II1NCT06839976
CM313 injectionII1NCT06791772
CRC01I–II1NCT07364396
CRT-402I–II1NCT07778446
DB-2304I–II1NCT06625671
Descartes-08II1NCT06038474
E6742II1NCT07515014
EnvudeucitinibII1NCT05966480
ESG206II1NCT07760155
FrexalimabSAR441344 IVII1NCT05039840
FT839I–II1NCT07800871
GC012FI–II1NCT06530849
GR1803I–II1NCT07348055
ICG318II1NCT07328581
IL-15II1NCT07328581
IMC-002I–II1NCT06535412
IMM0306SI–II1NCT06535412
JY231I–II1NCT06675422
KP104II1NCT05504187
MB-CART19.1I–II1NCT06189157
ObexelimabII1NCT06559163
PF-08154225I–II1NCT07782450
SCTB35I–II1NCT06841042

Sorted by most advanced phase and number of active trials. Showing 40 of 120 drugs.

Approved drugs in new trials

Approved by the US FDA for at least one indication, not necessarily this disease, and now in active trials on it.

DrugMost advanced phaseActive trialsReference trial
AnifrolumabMedi-546, Saphnelo®III6NCT05138133
ObinutuzumabGazyva®, Gazyvaro®III4NCT04963296
DeucravacitinibBMS-986165, Sotyktu®III3NCT07791199
Mycophenolate MofetilMycophenolate, CellceptIII3NCT04702256
SirolimusRapamycin, Scomara®II–III3NCT07657793
AcetaminophenParacetamol, APAPIII2NCT04963296
HydroxychloroquineSovuna®, Plaquenil®III2NCT05799378
MethotrexateJylamvo®, Reditrex®III2NCT06965244
MethylprednisoloneMethylprednisolon, MethylprenisoloneIII2NCT04963296
PrednisonePredinisone, CortancylIII2NCT04702256
UpadacitinibRinvoq Lq®, Rinvoq®III2NCT05843643
DexchlorpheniramineIII1NCT04702256
DiphenhydramineBenadryl, Benadryl Preservative Free®III1NCT04963296
LenalidomideRevlimid, lenalinomideIII1NCT06965244
NipocalimabM281, Imaavy®III1NCT07438496

Sorted by most advanced phase and number of active trials. Showing 15 of 58 drugs.

All 178 drugs, with the details

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Specific forms

Broader categories

Source: Phuturdex analysis of ClinicalTrials.gov data (U.S. National Library of Medicine), updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III, with at least one identified drug; phase and sites refer to the trials on this disease. Disease name: Wikidata; NLM MeSH term: D008180 “Lupus Erythematosus, Systemic”. Prevalence: Orphanet.

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