Systemic Sclerosis

Pipeline Programs

Companies

Clinical Trials

3 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody

556%

Small Molecule

444%

+ 42 programs with unclassified modality

On Market (1)

Approved therapies currently available

LETAIRISApproved

ambrisentan

Gilead Sciences

Endothelin Receptor Antagonist [EPC]oral2007

89M Part D

Competitive Landscape

33 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

UNION therapeuticsDenmark - Hellerup

6 programs

BaricitinibPhase 4Small Molecule

Development and Prevention of Pulmonary Hypertension in Systemic SclerosisN/A1 trial

Development and Prevention of Severe Heart Disease in Systemic SclerosisN/A1 trial

Improvement of Hand Dysfunction by Arthritis in Systemic SclerosisN/A1 trial

Prevention and Treatment of Digital Ulcers in Systemic SclerosisN/A1 trial

+1 more programs

Active Trials

NCT01840748Unknown960Est. Jun 2017

NCT01829126Unknown765Est. Aug 2016

NCT01834157Unknown160Est. Nov 2017

+2 more trials

Angeles Therapeutics

3 programs

AmbrisentanPhase 41 trial

RelaxinPhase 31 trial

rapamycinPhase 1/21 trial

Active Trials

NCT00241189Completed17Est. Jun 2006

NCT00704665Completed231Est. Dec 2001

NCT01051960Completed12Est. Jan 2011

Gilead SciencesFOSTER CITY, CA

2 programs

AmbrisentanN/A

AmbrisentanPHASE_4

Kite PharmaCA - El Segundo

2 programs

AmbrisentanPhase 4

AmbrisentanN/A1 trial

Active Trials

NCT01093885Completed15Est. Jul 2016

Prevail TherapeuticsNY - New York

1 program

BaricitinibPhase 4Small Molecule1 trial

Active Trials

NCT05300932Active Not Recruiting60Est. Nov 2026

Colorado TherapeuticsCO - Louisville

1 program

RelaxinPhase 3

ViiV HealthcareNC - Durham

3 programs

AmbrisentanPhase 2

BelimumabPhase 2Monoclonal Antibody

Blood testN/A

CSL SeqirusUK - Maidenhead

2 programs

Fibrogammin®P, coagulation factor XIII concentratePhase 2

PrivigenN/A

SandozAustria - Kundl

2 programs

Imatinib MesylatePhase 21 trial

NilotinibPhase 2Small Molecule1 trial

Active Trials

NCT00555581Completed30Est. Dec 2011

NCT01166139Completed10Est. Jan 2015

Chemomab TherapeuticsIsrael - Tel Aviv

1 program

10 mg/kg CM-101Phase 21 trial

Active Trials

NCT06210945Suspended45Est. Dec 2028

Human BioSciencesWV - Martinsburg

1 program

BelimumabPhase 2Monoclonal Antibody1 trial

Active Trials

NCT01670565Completed20Est. Feb 2016

Genome & CompanyKorea - Suwon

1 program

BelimumabPhase 2Monoclonal Antibody

Ergomed

1 program

GS-248Phase 2

GaldermaTX - Dallas

1 program

NemolizumabPhase 2Monoclonal Antibody1 trial

Active Trials

NCT07047690Recruiting162Est. Jul 2028

Maruho

1 program

nemolizumabPhase 2Monoclonal Antibody1 trial

Active Trials

NCT05214794Completed6Est. Jul 2024

BiocorpFrance - Issoire

1 program

CABA-201Phase 1/21 trial

Active Trials

NCT06328777Recruiting12Est. Jul 2029

Kyverna TherapeuticsCA - Emeryville

1 program

KYV-101Phase 1/21 trial

Active Trials

NCT06400303Active Not Recruiting3Est. Mar 2027

Sharp TherapeuticsPA - Pittsburgh

1 program

MK-2225Phase 1

MSDIreland - Ballydine

1 program

MK-2225Phase 11 trial

Active Trials

NCT06643390Completed32Est. Jul 2025

United TherapeuticsMD - Silver Spring

4 programs

treprostinil diethanolaminePHASE_11 trial

Oral treprostinilPHASE_21 trial

treprostinil diethanolaminePHASE_21 trial

Active Trials

NCT00848939Completed28Est. Apr 2010

NCT02663895Completed12Est. May 2020

NCT00848107Terminated115Est. Sep 2011

+1 more trials

CSL BehringIL - Bradley

2 programs

PrivigenN/A1 trial

Fibrogammin®P, coagulation factor XIII concentratePHASE_21 trial

Active Trials

NCT01785056Unknown14Est. Jan 2019

NCT02551042Unknown26Est. Sep 2018

Galapagos2800 MECHELEN, Belgium

2 programs

GLPG1690PHASE_21 trial

Active Trials

NCT03976648Terminated31Est. Apr 2021

NCT03798366Completed33Est. Jun 2020

T-TherapeuticsUK - Cambridge

1 program

ApolloN/A

GSKLONDON, United Kingdom

1 program

Blood testN/A1 trial

Active Trials

NCT03816189Completed70Est. Apr 2022

Verona PharmaUK - London

1 program

Home-care rehabilitation groupN/A1 trial

Active Trials

NCT03614208Completed33Est. Mar 2018

Alder TherapeuticsSweden - Solna

1 program

Observation - Nailfold capillaroscopyN/A1 trial

Active Trials

NCT06291142Completed112Est. Dec 2024

Alliance PharmaceuticalsUK - Wiltshire

1 program

Observation - Nailfold capillaroscopyN/A

Cabaletta BioPHILADELPHIA, PA

1 program

CABA-201PHASE_1_2

Nkarta TherapeuticsCA - South SF

1 program

NKX019PHASE_1_21 trial

Active Trials

NCT06733935Recruiting144Est. Oct 2028

Heidelberg PharmaGermany - Ladenburg

1 program

AmbrisentanPHASE_2

+3 more companies

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

Prevail TherapeuticsBaricitinib

Boehringer IngelheimUpfront autologous HSCT

Angeles TherapeuticsAmbrisentan

Angeles TherapeuticsRelaxin

Chemomab Therapeutics10 mg/kg CM-101

GaldermaNemolizumab

Maruhonemolizumab

Gesynta PharmaGS-248

GalapagosGLPG1690

United TherapeuticsOral treprostinil

CSL BehringFibrogammin®P, coagulation factor XIII concentrate

Human BioSciencesBelimumab

SandozNilotinib

United Therapeuticstreprostinil diethanolamine

Showing 15 of 33 trials with date data

Clinical Trials (33)

Total enrollment: 5,252 patients across 33 trials

NCT05300932 Prevail TherapeuticsBaricitinib

A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis

Start: Mar 2022Est. completion: Nov 202660 patients

Phase 4Active Not Recruiting

NCT04464434 Boehringer IngelheimUpfront autologous HSCT

Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis

Start: Sep 2020Est. completion: Mar 202660 patients

Phase 4Completed

NCT01051960 Angeles TherapeuticsAmbrisentan

Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan

Start: Mar 2009Est. completion: Jan 201112 patients

Phase 4Completed

NCT00704665 Angeles TherapeuticsRelaxin

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Start: Dec 1998Est. completion: Dec 2001231 patients

Phase 3Completed

NCT06210945 Chemomab Therapeutics10 mg/kg CM-101

Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis

Start: Sep 2026Est. completion: Dec 202845 patients

Phase 2Suspended

NCT07047690 GaldermaNemolizumab

A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis

Start: Feb 2026Est. completion: Jul 2028162 patients

Phase 2Recruiting

NCT05214794 Maruhonemolizumab

An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

Start: Apr 2022Est. completion: Jul 20246 patients

Phase 2Completed

NCT04744207 Gesynta PharmaGS-248

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

Start: Dec 2020Est. completion: Jun 202294 patients

Phase 2Completed

NCT03976648 GalapagosGLPG1690

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

Start: Jul 2019Est. completion: Apr 202131 patients

Phase 2Terminated

NCT03798366 GalapagosGLPG1690

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

NCT02663895 United 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

NCT02551042 CSL BehringFibrogammin®P, coagulation factor XIII concentrate

CSL Behring Sclero XIII

Start: Sep 2015Est. completion: Sep 201826 patients

Phase 2Unknown

NCT01670565 Human BioSciencesBelimumab

Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Start: Aug 2012Est. completion: Feb 201620 patients

Phase 2Completed

NCT01166139 SandozNilotinib

Nilotinib in the Treatment of Systemic Sclerosis

Start: Jul 2010Est. completion: Jan 201510 patients

Phase 2Completed

NCT00848107 United Therapeuticstreprostinil diethanolamine

Open-Label Study of Oral Treprostinil in Digital Ulcers

Start: Sep 2009Est. completion: Sep 2011115 patients

Phase 2Terminated

NCT00775463 United Therapeuticstreprostinil diethanolamine

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Start: May 2009Est. completion: Jul 2011148 patients

Phase 2Completed

NCT00555581 SandozImatinib Mesylate

Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis

Start: Aug 2007Est. completion: Dec 201130 patients

Phase 2Completed

NCT06733935 Nkarta 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

NCT06400303 Kyverna TherapeuticsKYV-101

KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis

Start: Aug 2024Est. completion: Mar 20273 patients

Phase 1/2Active Not Recruiting

NCT06328777 BiocorpCABA-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

NCT00241189 Angeles Therapeuticsrapamycin

Rapamycin vs Methotrexate in Diffuse SSc

Start: Aug 2002Est. completion: Jun 200617 patients

Phase 1/2Completed

NCT06643390 MSDMK-2225

A Study of MK-2225 in Healthy Participants (MK-2225-003)

Start: Nov 2023Est. completion: Jul 202532 patients

Phase 1Completed

NCT00848939 United Therapeuticstreprostinil diethanolamine

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

Start: Dec 2008Est. completion: Apr 201028 patients

Phase 1Completed

NCT06291142 Alder TherapeuticsObservation - Nailfold capillaroscopy

Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

Start: Nov 2023Est. completion: Dec 2024112 patients

N/ACompleted

NCT03816189 GSKBlood test

Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

Start: Oct 2018Est. completion: Apr 202270 patients

N/ACompleted

NCT03614208 Verona PharmaHome-care rehabilitation group

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

Start: Feb 2017Est. completion: Mar 201833 patients

N/ACompleted

NCT01858259 UNION therapeuticsTreatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis

Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis

Start: May 2013Est. completion: Jun 20161,372 patients

N/AUnknown

NCT01785056 CSL BehringPrivigen

IVIG Treatment in Systemic Sclerosis

Start: Apr 2013Est. completion: Jan 201914 patients

N/AUnknown

NCT01836263 UNION therapeuticsPrevention and Treatment of Digital Ulcers in Systemic Sclerosis

Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

Start: Apr 2013Est. completion: Jun 2017420 patients

N/AUnknown

NCT01829126 UNION therapeuticsDevelopment and Prevention of Severe Heart Disease in Systemic Sclerosis

Development and Prevention of Severe Heart Disease in Systemic Sclerosis

Start: Apr 2013Est. completion: Aug 2016765 patients

N/AUnknown

NCT01840748 UNION therapeuticsDevelopment and Prevention of Pulmonary Hypertension in Systemic Sclerosis

Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis

Start: Apr 2013Est. completion: Jun 2017960 patients

N/AUnknown

NCT01834157 UNION therapeuticsImprovement of Hand Dysfunction by Arthritis in Systemic Sclerosis

Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

Start: Apr 2013Est. completion: Nov 2017160 patients

N/AUnknown

NCT01093885 Kite PharmaAmbrisentan

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

2 late-stage (Phase 3) programs, potential near-term approvals

3 actively recruiting trials targeting 5,252 patients

30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.