Systemic Sclerosis

17
Pipeline Programs
18
Companies
22
Clinical Trials
4 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
2
10
0
0
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 22 programs with unclassified modality

On Market (1)

Approved therapies currently available

GS
LETAIRISApproved
ambrisentan
Gilead Sciences
Endothelin Receptor Antagonist [EPC]oral2007

Competitive Landscape

17 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
2 programs
1
AmbrisentanPhase 41 trial
AmbrisentanN/A1 trial
Active Trials
NCT01093885Completed15Est. Jul 2016
NCT01051960Completed12Est. Jan 2011
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
Upfront autologous HSCTPhase 41 trial
Active Trials
NCT04464434Recruiting50Est. Oct 2030
United Therapeutics
United TherapeuticsMD - Silver Spring
4 programs
1
3
Oral treprostinilPhase 21 trial
treprostinil diethanolaminePhase 21 trial
treprostinil diethanolaminePhase 21 trial
treprostinil diethanolaminePhase 11 trial
Active Trials
NCT00848939Completed28Est. Apr 2010
NCT02663895Completed12Est. May 2020
NCT00775463Completed148Est. Jul 2011
+1 more trials
CSL Behring
CSL BehringIL - Bradley
2 programs
1
Fibrogammin®P, coagulation factor XIII concentratePhase 21 trial
PrivigenN/A1 trial
Active Trials
NCT01785056Unknown14Est. Jan 2019
NCT02551042Unknown26Est. Sep 2018
Galapagos
Galapagos2800 MECHELEN, Belgium
2 programs
2
GLPG1690Phase 21 trial
GLPG1690Phase 21 trial
Active Trials
NCT03976648Terminated31Est. Apr 2021
NCT03798366Completed33Est. Jun 2020
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
1
AmbrisentanPhase 21 trial
Active Trials
NCT01311362Completed20Est. Dec 2012
Gesynta Pharma
Gesynta PharmaSweden - Stockholm
1 program
1
GS-248Phase 21 trial
Active Trials
NCT04744207CompletedEst. Jun 2022
Novartis
NovartisBASEL, Switzerland
1 program
1
NilotinibPhase 2Small Molecule1 trial
Active Trials
NCT01166139Completed10Est. Jan 2015
AB
Active BiotechSweden - Lund
1 program
1
paquinimodPhase 21 trial
Active Trials
NCT01487551CompletedEst. Feb 2013
Cabaletta Bio
Cabaletta BioPHILADELPHIA, PA
1 program
1
CABA-201Phase 1/21 trial
Active Trials
NCT06328777Recruiting12Est. Jul 2029
Nkarta Therapeutics
Nkarta TherapeuticsCA - South SF
1 program
1
NKX019Phase 1/21 trial
Active Trials
NCT06733935Recruiting144Est. Oct 2028
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
AZD0120Phase 11 trial
Active Trials
NCT07295847Recruiting27Est. Feb 2028
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
ApolloN/A1 trial
Active Trials
NCT04854850CompletedEst. Mar 2023
GSK
GSKLONDON, United Kingdom
1 program
Blood testN/A1 trial
Active Trials
NCT03816189Completed70Est. Apr 2022
Verona Pharma
Verona PharmaUK - London
1 program
Home-care rehabilitation groupN/A1 trial
Active Trials
NCT03614208Completed33Est. Mar 2018
Alder Therapeutics
Alder TherapeuticsSweden - Solna
1 program
Observation - Nailfold capillaroscopyN/A1 trial
Active Trials
NCT06291142Completed112Est. Dec 2024
Alliance Pharmaceuticals
1 program
Observation - Nailfold capillaroscopyN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Boehringer IngelheimUpfront autologous HSCT
Gilead SciencesAmbrisentan
Gesynta PharmaGS-248
GalapagosGLPG1690
GalapagosGLPG1690
United TherapeuticsOral treprostinil
CSL BehringFibrogammin®P, coagulation factor XIII concentrate
Active Biotechpaquinimod
NovartisNilotinib
United Therapeuticstreprostinil diethanolamine
United Therapeuticstreprostinil diethanolamine
Nkarta TherapeuticsNKX019
Cabaletta BioCABA-201
AstraZenecaAZD0120
United Therapeuticstreprostinil diethanolamine

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 912 patients across 22 trials

NCT04464434Boehringer IngelheimUpfront autologous HSCT

Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis

Start: Sep 2020Est. completion: Oct 203050 patients
Phase 4Recruiting
NCT01051960Gilead SciencesAmbrisentan

Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan

Start: Mar 2009Est. completion: Jan 201112 patients
Phase 4Completed
NCT04744207Gesynta PharmaGS-248

A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis

Start: Dec 2020Est. completion: Jun 2022
Phase 2Completed
NCT03976648GalapagosGLPG1690

A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

Start: Jul 2019Est. completion: Apr 202131 patients
Phase 2Terminated
NCT03798366GalapagosGLPG1690

A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis

Start: Jan 2019Est. completion: Jun 202033 patients
Phase 2Completed
NCT02663895United TherapeuticsOral treprostinil

Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

Start: Oct 2016Est. completion: May 202012 patients
Phase 2Completed
NCT02551042CSL BehringFibrogammin®P, coagulation factor XIII concentrate

CSL Behring Sclero XIII

Start: Sep 2015Est. completion: Sep 201826 patients
Phase 2Unknown
NCT01487551Active Biotechpaquinimod

An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

Start: Dec 2011Est. completion: Feb 2013
Phase 2Completed
NCT01166139NovartisNilotinib

Nilotinib in the Treatment of Systemic Sclerosis

Start: Jul 2010Est. completion: Jan 201510 patients
Phase 2Completed
NCT00848107United Therapeuticstreprostinil diethanolamine

Open-Label Study of Oral Treprostinil in Digital Ulcers

Start: Sep 2009Est. completion: Sep 2011115 patients
Phase 2Terminated
NCT00775463United Therapeuticstreprostinil diethanolamine

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Start: May 2009Est. completion: Jul 2011148 patients
Phase 2Completed
NCT06733935Nkarta TherapeuticsNKX019

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)

Start: Nov 2024Est. completion: Oct 2028144 patients
Phase 1/2Recruiting
NCT06328777Cabaletta BioCABA-201

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

Start: Jul 2024Est. completion: Jul 202912 patients
Phase 1/2Recruiting
NCT07295847AstraZenecaAZD0120

A Study of AZD0120 in Autoimmune Diseases

Start: Jan 2026Est. completion: Feb 202827 patients
Phase 1Recruiting
NCT00848939United Therapeuticstreprostinil diethanolamine

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

Start: Dec 2008Est. completion: Apr 201028 patients
Phase 1Completed
NCT06291142Alder TherapeuticsObservation - Nailfold capillaroscopy

Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

Start: Nov 2023Est. completion: Dec 2024112 patients
N/ACompleted
NCT04854850T-TherapeuticsApollo

Apollo Device for Fatigue in Systemic Sclerosis

Start: Jul 2020Est. completion: Mar 2023
N/ACompleted
NCT03816189GSKBlood test

Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

Start: Oct 2018Est. completion: Apr 202270 patients
N/ACompleted
NCT03614208Verona PharmaHome-care rehabilitation group

Individualized Home-based Exercise Program for Patient With Systemic Sclerosis.

Start: Feb 2017Est. completion: Mar 201833 patients
N/ACompleted
NCT01785056CSL BehringPrivigen

IVIG Treatment in Systemic Sclerosis

Start: Apr 2013Est. completion: Jan 201914 patients
N/AUnknown
NCT01311362Heidelberg PharmaAmbrisentan

Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan

Start: Mar 2011Est. completion: Dec 201220 patients
N/ACompleted
NCT01093885Gilead SciencesAmbrisentan

Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis

Start: Feb 2010Est. completion: Jul 201615 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

4 actively recruiting trials targeting 912 patients
18 companies competing in this space