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Primary Sclerosing Cholangitis (PSC)

3
Pipeline Programs
5
Companies
5
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 4 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

HighTide Therapeutics
HighTide TherapeuticsChina - Shenzhen
1 program
1
HTD1801Phase 21 trial
Active Trials
NCT03333928Completed59Est. Aug 2020
LISCure Biosciences
LISCure BiosciencesKorea - Seongnam
1 program
1
LB-P8 low-dosePhase 21 trial
Active Trials
NCT06699121Recruiting87Est. Feb 2029
Kite Pharma
Kite PharmaCA - El Segundo
1 program
1
SimtuzumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01672853Completed235Est. Aug 2016
Boston Scientific
Boston ScientificCA - Valencia
1 program
SpyGlass DS I - IIN/A1 trial
Active Trials
NCT03766035Completed43Est. Dec 2022
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
1 program
LUM001PHASE_21 trial
Active Trials
NCT02061540Completed27Est. Feb 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
LISCure BiosciencesLB-P8 low-dose
HighTide TherapeuticsHTD1801
Mirum PharmaceuticalsLUM001
Kite PharmaSimtuzumab
Boston ScientificSpyGlass DS I - II

Clinical Trials (5)

Total enrollment: 451 patients across 5 trials

NCT06699121LISCure BiosciencesLB-P8 low-dose

A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC

Start: Nov 2025Est. completion: Feb 202987 patients
Phase 2Recruiting
NCT03333928HighTide TherapeuticsHTD1801

A POC and Dose-Ranging Study of HTD1801 in PSC Patients

Start: Feb 2018Est. completion: Aug 202059 patients
Phase 2Completed
NCT02061540Mirum PharmaceuticalsLUM001

Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis

Start: Mar 2014Est. completion: Feb 201627 patients
Phase 2Completed
NCT01672853Kite PharmaSimtuzumab

Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)

Start: Mar 2013Est. completion: Aug 2016235 patients
Phase 2Completed
NCT03766035Boston ScientificSpyGlass DS I - II

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Start: Dec 2018Est. completion: Dec 202243 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

1 actively recruiting trials targeting 451 patients
5 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.