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Primary Sclerosing Cholangitis

15
Pipeline Programs
15
Companies
22
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
7
1
3
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 27 programs with unclassified modality

Competitive Landscape

15 companies ranked by most advanced pipeline stage

Kite Pharma
Kite PharmaCA - El Segundo
4 programs
1
2
1
CilofexorPhase 31 trial
CilofexorPhase 21 trial
SeladelparPhase 21 trial
CilofexorPhase 11 trial
Active Trials
NCT04060147Terminated11Est. Sep 2021
NCT02943460Completed52Est. May 2020
NCT04024813Terminated1Est. Jan 2020
+1 more trials
Dr. Falk Pharma
Dr. Falk PharmaGermany - Freiburg
3 programs
1
2
norUrsodeoxycholic AcidPhase 31 trial
norucholic acidPhase 31 trial
norUDCAPhase 21 trial
Active Trials
NCT01755507Completed159Est. Dec 2015
NCT03872921Active Not Recruiting303Est. Jun 2026
NCT06886360Not Yet Recruiting120Est. Sep 2027
NGM Biopharmaceuticals
2 programs
1
1
aldaferminPhase 2/31 trial
NGM282Phase 21 trial
Active Trials
NCT02704364Completed62Est. Jun 2017
NCT06654726Withdrawn0Est. Mar 2025
HighTide Therapeutics
HighTide TherapeuticsChina - Shenzhen
2 programs
1
1
HTD1801Phase 21 trial
HTD1801Phase 11 trial
Active Trials
NCT03099603Completed32Est. Oct 2017
NCT03678480Withdrawn0Est. Nov 2021
Chemomab Therapeutics
Chemomab TherapeuticsIsrael - Tel Aviv
1 program
1
Anti-human CCL24 monoclonal antibodyPhase 21 trial
Active Trials
NCT04595825Active Not Recruiting68Est. Sep 2025
Galmed Pharmaceuticals
Galmed PharmaceuticalsIsrael - Tel Aviv
1 program
1
Aramchol megluminePhase 21 trial
Active Trials
NCT06095986Withdrawn0Est. Dec 2027
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
2 programs
1
ursodeoxycholic acidPhase 1
probe based confocal laser endomicroscopyN/A1 trial
Active Trials
NCT02736708Completed65Est. May 2020
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
ursodeoxycholic acidPhase 11 trial
Active Trials
NCT01088607Completed27Est. Jun 2017
Gilead Sciences
Gilead SciencesFOSTER CITY, CA
4 programs
SeladelparPHASE_2
SeladelparPHASE_2
CilofexorPHASE_3
CilofexorPHASE_3
Ipsen
IpsenChina - Tianjin
3 programs
Elafibranor 80 mgPHASE_21 trial
RitivixibatPHASE_21 trial
ElafibranorPHASE_31 trial
Active Trials
NCT05627362Active Not Recruiting68Est. Aug 2026
NCT05642468Completed18Est. Jul 2025
NCT07387549Not Yet Recruiting350Est. May 2031
Mauna Kea Technologies
1 program
probe based confocal laser endomicroscopyN/A
Genentech
GenentechCA - Oceanside
1 program
ErlotinibPHASE_1Small Molecule1 trial
Active Trials
NCT00955149Completed6Est. Apr 2013
Pliant Therapeutics
Pliant TherapeuticsCA - South SF
1 program
PLN-74809PHASE_21 trial
Active Trials
NCT04480840Completed121Est. Mar 2024
Bristol Myers Squibb
1 program
ThalidomidePHASE_21 trial
Active Trials
NCT00953615Terminated1Est. May 2009
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
1 program
VolixibatPHASE_21 trial
Active Trials
NCT04663308Active Not Recruiting182Est. Apr 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
IpsenElafibranor
Dr. Falk Pharmanorucholic acid
Kite PharmaCilofexor
Dr. Falk PharmanorUrsodeoxycholic Acid
NGM Biopharmaceuticalsaldafermin
Galmed PharmaceuticalsAramchol meglumine
IpsenRitivixibat
IpsenElafibranor 80 mg
HighTide TherapeuticsHTD1801
Mirum PharmaceuticalsVolixibat
Chemomab TherapeuticsAnti-human CCL24 monoclonal antibody
Pliant TherapeuticsPLN-74809
Kite PharmaSeladelpar
Kite PharmaCilofexor
NGM BiopharmaceuticalsNGM282

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 2,065 patients across 22 trials

NCT07387549IpsenElafibranor

A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis

Start: Apr 2026Est. completion: May 2031350 patients
Phase 3Not Yet Recruiting
NCT06886360Dr. Falk Pharmanorucholic acid

Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Start: Mar 2025Est. completion: Sep 2027120 patients
Phase 3Not Yet Recruiting
NCT03890120Kite PharmaCilofexor

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

Start: Mar 2019Est. completion: Dec 2022419 patients
Phase 3Terminated
NCT03872921Dr. Falk PharmanorUrsodeoxycholic Acid

norUrsodeoxycholic Acid vs Placebo in PSC

Start: Feb 2018Est. completion: Jun 2026303 patients
Phase 3Active Not Recruiting
NCT06654726NGM Biopharmaceuticalsaldafermin

A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis.

Start: Oct 2024Est. completion: Mar 20250
Phase 2/3Withdrawn
NCT06095986Galmed PharmaceuticalsAramchol meglumine

A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis

Start: Jun 2025Est. completion: Dec 20270
Phase 2Withdrawn
NCT05642468IpsenRitivixibat

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis

Start: Jan 2023Est. completion: Jul 202518 patients
Phase 2Completed
NCT05627362IpsenElafibranor 80 mg

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

Start: Dec 2022Est. completion: Aug 202668 patients
Phase 2Active Not Recruiting
NCT03678480HighTide TherapeuticsHTD1801

A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

Start: Mar 2021Est. completion: Nov 20210
Phase 2Withdrawn
NCT04663308Mirum PharmaceuticalsVolixibat

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

Start: Dec 2020Est. completion: Apr 2027182 patients
Phase 2Active Not Recruiting
NCT04595825Chemomab TherapeuticsAnti-human CCL24 monoclonal antibody

CM-101 in PSC Patients -The SPRING Study

Start: Oct 2020Est. completion: Sep 202568 patients
Phase 2Active Not Recruiting
NCT04480840Pliant TherapeuticsPLN-74809

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

Start: Jul 2020Est. completion: Mar 2024121 patients
Phase 2Completed
NCT04024813Kite PharmaSeladelpar

A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

Start: Nov 2019Est. completion: Jan 20201 patients
Phase 2Terminated
NCT02943460Kite PharmaCilofexor

Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis

Start: Nov 2016Est. completion: May 202052 patients
Phase 2Completed
NCT02704364NGM BiopharmaceuticalsNGM282

A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

Start: Mar 2016Est. completion: Jun 201762 patients
Phase 2Completed
NCT01755507Dr. Falk PharmanorUDCA

Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Start: Dec 2012Est. completion: Dec 2015159 patients
Phase 2Completed
NCT00953615Bristol Myers SquibbThalidomide

Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)

Start: Apr 2006Est. completion: May 20091 patients
Phase 2Terminated
NCT04060147Kite PharmaCilofexor

Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

Start: Oct 2019Est. completion: Sep 202111 patients
Phase 1Terminated
NCT03099603HighTide TherapeuticsHTD1801

A Study of HTD1801 in Healthy Subjects

Start: Mar 2017Est. completion: Oct 201732 patients
Phase 1Completed
NCT01088607Angeles Therapeuticsursodeoxycholic acid

Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis

Start: Oct 2010Est. completion: Jun 201727 patients
Phase 1Completed
NCT00955149GenentechErlotinib

Erlotinib for Chemoprevention in Trisomy 7 Positive Primary Sclerosing Cholangitis (PSC)

Start: Aug 2009Est. completion: Apr 20136 patients
Phase 1Completed
NCT02736708Colorado Therapeuticsprobe based confocal laser endomicroscopy

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures

Start: Jan 2013Est. completion: May 202065 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

3 late-stage (Phase 3) programs, potential near-term approvals
15 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.