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Drugs in development · updated 30 October 2026

Systemic scleroderma: drugs in development

Rare diseasePrevalence 1-5 / 10 000 according to Orphanet · ORPHA:90291

As of 30 October 2026 there are 71 active clinical trials (recruiting or ongoing, phases I–III) on 77 drugs for systemic scleroderma. 50 are experimental, that is not yet approved in the United States.

71Active trials
50Experimental drugs
3Experimental, 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
BMS-986353III1NCT07335562
CABA-201II–III1NCT06328777
DivozilimabIII1NCT05726630
CD19II2NCT05029336
AmlitelimabII1NCT06195072
CRT-402I–II1NCT07778446
EfzofitimodII1NCT05892614
FT839I–II1NCT07800871
GM-CSFGranulocyte-Macrophage Colony-Stimulating FactorII1NCT03630211
ItacitinibII1NCT04789850
NKX019I–II1NCT06733935
Oral IfetrobanII1NCT02682511
PF-08154225I–II1NCT07782450
PRO-203I–II1NCT07641634
QEL-005I–II1NCT07473154
TibulizumabII1NCT06843239
TollB-001II1NCT07745725
TOP-N53II1NCT06954597
CD20I2NCT07676266
ADI-001I1NCT06375993
ALLO-329I1NCT07085104
ATG-201I1NCT07732309
AZD0120I1NCT07295847
BMS-986515I1NCT07115745
BMS-986553I1NCT07873931
C-CAR168I1NCT07854483
CC-97540I1NCT05869955
CNTY-101I1NCT06255028
CTX112I1NCT06925542
FluoropyrimidineI1NCT03816345
FT819I1NCT06308978
HBM7020I1NCT07649265
HN2302I1NCT07523282
KITE-363I1NCT07038447
LMY-922I1NCT07729995
OL-108I1NCT06980597
OL-CD19-GDTI1NCT07167537
QLS2416I1NCT07906145
Relmacabtagene autoleucelRelma-celI1NCT06414135
STK-009I1NCT06544330

Sorted by most advanced phase and number of active trials. Showing 40 of 50 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
CyclophosphamideCyclophosphamid, CytoxanIII12NCT07335562
FludarabineFludara, FLUDARABINIII10NCT07335562
RituximabRuxience, RituxanIII4NCT07335562
TocilizumabTociluzumab, AvtozmaIII4NCT07335562
BelimumabBenlysta®II–III2NCT05878717
NerandomilastBI 1015550, Jascayd®III2NCT07497087
NintedanibNintedanib Accord®, Vargatef®III2NCT07335562
CannabidiolEpidiolex, Epidyolex®III1NCT07245238
ClopidogrelClopidgrel, Clopidogrel Zentiva (previously Clopidogrel Winthrop)®II–III1NCT05098704
InebilizumabUplizna®III1NCT05198557
UreaSterile Urea®, Ureaphil®III1NCT07245238
Mycophenolate MofetilMycophenolate, CellceptII2NCT07734012
AlemtuzumabCampath, Lemtrada®II1NCT03630211
Anti-Thymocyte GlobulinII1NCT03630211
MesnaUromitexan, Mesnex®II1NCT03630211

Sorted by most advanced phase and number of active trials. Showing 15 of 27 drugs.

All 77 drugs, with the details

In Phuturdex every drug has all its trials, sponsors and countries, FDA and EMA approvals, orphan designations and safety alerts. Free until 31 March 2027.

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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: D012595 “Scleroderma, Systemic”. Prevalence: Orphanet.

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