{"disease":{"id":"primary-cholangitis","name":"Primary cholangitis","therapeutic_area":"","data":{},"enrichment_level":0,"last_enriched_at":null,"visit_count":0,"created_at":"2026-04-19T18:31:21.150Z","updated_at":"2026-04-19T18:39:44.960Z","meddra_pt":null,"meddra_code":null,"icd10_codes":null,"synonyms":[],"prevalence_global":null,"prevalence_us":null,"marketed_drug_count":2,"pipeline_drug_count":0,"trial_count":0},"drugs":{"marketed":[{"drug_id":"seladelpar","indication_name":"Primary Biliary Cholangitis (PBC)","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Livdelzi","generic_name":"SELADELPAR","company_name":"Gilead Sciences Inc","drug_phase":"marketed","molecular_target":"","drug_class":"","quality_score":64,"revenue":"200","mechanism":"Livdelzi works by inhibiting the activity of a specific enzyme involved in the progression of liver disease."},{"drug_id":"seladelpar","indication_name":"primary biliary cholangitis (PBC)","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Livdelzi","generic_name":"SELADELPAR","company_name":"Gilead Sciences Inc","drug_phase":"marketed","molecular_target":"","drug_class":"","quality_score":64,"revenue":"200","mechanism":"Livdelzi works by inhibiting the activity of a specific enzyme involved in the progression of liver disease."},{"drug_id":"ocaliva","indication_name":"Primary cholangitis","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":null,"generic_name":"Ocaliva","company_name":"Universitaire Ziekenhuizen KU Leuven","drug_phase":"phase_2","molecular_target":"G-protein coupled bile acid receptor 1, Bile acid receptor","drug_class":"","quality_score":null,"revenue":null,"mechanism":null},{"drug_id":"elafibranor","indication_name":"Primary biliary cholangitis (PBC)","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Iqirvo","generic_name":"ELAFIBRANOR","company_name":"Ipsen","drug_phase":"marketed","molecular_target":"","drug_class":"Peroxisome Proliferator-activated Receptor Agonist [EPC]","quality_score":60,"revenue":null,"mechanism":"Iqirvo works by activating peroxisome proliferator-activated receptors to improve liver function."},{"drug_id":"obeticholic-acid","indication_name":"Primary cholangitis","indication_type":"approved","phase":null,"line_of_therapy":null,"is_primary_indication":false,"pivotal_trial_result":null,"pivotal_trial_p_value":null,"patient_population":null,"brand_name":"Ocaliva","generic_name":"OBETICHOLIC ACID","company_name":"Intercept Pharms Inc","drug_phase":"marketed","molecular_target":"Bile acid receptor","drug_class":"Farnesoid X Receptor Agonist","quality_score":40,"revenue":null,"mechanism":""}],"pipeline":[],"offLabel":[],"totalMarketed":5,"totalPipeline":0},"trials":{"data":[{"nct_id":"NCT05618145","title":"National Database on Primary Sclerosing Cholangitis (PSC)","phase":"","overall_status":"RECRUITING","enrollment_count":6000,"lead_sponsor_name":"University of Milano Bicocca","has_results":false},{"nct_id":"NCT05151809","title":"National Database on Primary Biliary Cholangitis","phase":"","overall_status":"RECRUITING","enrollment_count":6000,"lead_sponsor_name":"University of Milano Bicocca","has_results":false},{"nct_id":"NCT05292872","title":"Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients","phase":"","overall_status":"COMPLETED","enrollment_count":4577,"lead_sponsor_name":"Intercept Pharmaceuticals","has_results":true},{"nct_id":"NCT07149675","title":"PBC Long-term Outcomes Study","phase":"","overall_status":"RECRUITING","enrollment_count":4000,"lead_sponsor_name":"Beijing Friendship Hospital","has_results":false},{"nct_id":"NCT07449793","title":"Biochemical Response and Clinical Outcomes in Patients With PBC","phase":"","overall_status":"RECRUITING","enrollment_count":3000,"lead_sponsor_name":"RenJi Hospital","has_results":false},{"nct_id":"NCT06519162","title":"Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome","phase":"","overall_status":"RECRUITING","enrollment_count":3000,"lead_sponsor_name":"Chungnam National University Hospital","has_results":false},{"nct_id":"NCT05740358","title":"Liver Cirrhosis Network Cohort Study","phase":"","overall_status":"ACTIVE_NOT_RECRUITING","enrollment_count":1222,"lead_sponsor_name":"Northwestern University","has_results":false},{"nct_id":"NCT04181138","title":"Primary Sclerosing Cholangitis in Children","phase":"","overall_status":"RECRUITING","enrollment_count":1000,"lead_sponsor_name":"Arbor Research Collaborative for Health","has_results":false},{"nct_id":"NCT05463445","title":"Multicenter Observational Study of PSC and IgG4-SC in China","phase":"","overall_status":"UNKNOWN","enrollment_count":1000,"lead_sponsor_name":"RenJi Hospital","has_results":false},{"nct_id":"NCT05786482","title":"Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions","phase":"NA","overall_status":"COMPLETED","enrollment_count":825,"lead_sponsor_name":"University of Alberta","has_results":false},{"nct_id":"NCT05750498","title":"A-LiNK: Improving Outcomes in Autoimmune Liver Disease","phase":"","overall_status":"RECRUITING","enrollment_count":800,"lead_sponsor_name":"Children's Hospital Medical Center, Cincinnati","has_results":false},{"nct_id":"NCT03041662","title":"Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)","phase":"","overall_status":"COMPLETED","enrollment_count":620,"lead_sponsor_name":"Karolinska University Hospital","has_results":false},{"nct_id":"NCT04133792","title":"Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)","phase":"PHASE3","overall_status":"ACTIVE_NOT_RECRUITING","enrollment_count":571,"lead_sponsor_name":"Annika Bergquist","has_results":false},{"nct_id":"NCT05919433","title":"Detection Program for Patients With Primary Biliary Cholangitis Lost in the System","phase":"","overall_status":"RECRUITING","enrollment_count":500,"lead_sponsor_name":"Hospital Mutua de Terrassa","has_results":false},{"nct_id":"NCT03146910","title":"Swiss Primary Biliary Cholangitis Cohort Study","phase":"","overall_status":"RECRUITING","enrollment_count":500,"lead_sponsor_name":"Fondazione Epatocentro Ticino","has_results":false},{"nct_id":"NCT06447168","title":"A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment","phase":"","overall_status":"RECRUITING","enrollment_count":424,"lead_sponsor_name":"Ipsen","has_results":false},{"nct_id":"NCT03890120","title":"Study of Cilofexor in Adults With Primary Sclerosing Cholangitis","phase":"PHASE3","overall_status":"TERMINATED","enrollment_count":419,"lead_sponsor_name":"Gilead Sciences","has_results":true},{"nct_id":"NCT05181332","title":"Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis","phase":"","overall_status":"UNKNOWN","enrollment_count":400,"lead_sponsor_name":"West China Hospital","has_results":false},{"nct_id":"NCT07387549","title":"A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis","phase":"PHASE3","overall_status":"NOT_YET_RECRUITING","enrollment_count":350,"lead_sponsor_name":"Ipsen","has_results":false},{"nct_id":"NCT03322943","title":"The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital","phase":"","overall_status":"COMPLETED","enrollment_count":300,"lead_sponsor_name":"West China Hospital","has_results":false},{"nct_id":"NCT04753996","title":"Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients","phase":"","overall_status":"RECRUITING","enrollment_count":300,"lead_sponsor_name":"Mayo Clinic","has_results":false},{"nct_id":"NCT06016842","title":"A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":276,"lead_sponsor_name":"Ipsen","has_results":false},{"nct_id":"NCT03602560","title":"ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":265,"lead_sponsor_name":"Gilead Sciences","has_results":true},{"nct_id":"NCT06591468","title":"A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics","phase":"PHASE2, PHASE3","overall_status":"ENROLLING_BY_INVITATION","enrollment_count":244,"lead_sponsor_name":"Han Ying","has_results":false},{"nct_id":"NCT01672853","title":"Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":235,"lead_sponsor_name":"Gilead Sciences","has_results":true},{"nct_id":"NCT03337074","title":"Paternally Inherited Phenotypes in Cholestasis","phase":"","overall_status":"UNKNOWN","enrollment_count":200,"lead_sponsor_name":"Guy's and St Thomas' NHS Foundation Trust","has_results":false},{"nct_id":"NCT05133336","title":"Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis","phase":"PHASE2, PHASE3","overall_status":"COMPLETED","enrollment_count":196,"lead_sponsor_name":"Zydus Therapeutics Inc.","has_results":false},{"nct_id":"NCT04620733","title":"RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":193,"lead_sponsor_name":"Gilead Sciences","has_results":true},{"nct_id":"NCT05751967","title":"Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":150,"lead_sponsor_name":"Xijing Hospital of Digestive Diseases","has_results":false},{"nct_id":"NCT06427395","title":"Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":150,"lead_sponsor_name":"Zydus Therapeutics Inc.","has_results":false},{"nct_id":"NCT04685200","title":"Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach","phase":"","overall_status":"RECRUITING","enrollment_count":143,"lead_sponsor_name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","has_results":false},{"nct_id":"NCT04618575","title":"Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1","phase":"PHASE4","overall_status":"UNKNOWN","enrollment_count":137,"lead_sponsor_name":"West China Hospital","has_results":false},{"nct_id":"NCT07282353","title":"A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":135,"lead_sponsor_name":"Cascade Pharmaceuticals, Inc","has_results":false},{"nct_id":"NCT07229911","title":"A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)","phase":"PHASE1","overall_status":"RECRUITING","enrollment_count":134,"lead_sponsor_name":"Takeda","has_results":false},{"nct_id":"NCT07296458","title":"FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy","phase":"PHASE3","overall_status":"RECRUITING","enrollment_count":132,"lead_sponsor_name":"Xijing Hospital of Digestive Diseases","has_results":false},{"nct_id":"NCT04480840","title":"Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":121,"lead_sponsor_name":"Pliant Therapeutics, Inc.","has_results":true},{"nct_id":"NCT03146936","title":"Swiss Primary Sclerosing Cholangitis Cohort Study","phase":"","overall_status":"RECRUITING","enrollment_count":120,"lead_sponsor_name":"Fondazione Epatocentro Ticino","has_results":false},{"nct_id":"NCT03545672","title":"Early Identification of Myocardial Impairment in PBC","phase":"","overall_status":"COMPLETED","enrollment_count":119,"lead_sponsor_name":"RenJi Hospital","has_results":true},{"nct_id":"NCT06686810","title":"Endoscopy and Primary Sclerosing Cholangitis","phase":"","overall_status":"COMPLETED","enrollment_count":118,"lead_sponsor_name":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","has_results":false},{"nct_id":"NCT03175471","title":"MRI Based Biomarkers in Pediatric Autoimmune Liver Disease","phase":"","overall_status":"RECRUITING","enrollment_count":115,"lead_sponsor_name":"Children's Hospital Medical Center, Cincinnati","has_results":false},{"nct_id":"NCT05450887","title":"Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis","phase":"PHASE3","overall_status":"COMPLETED","enrollment_count":108,"lead_sponsor_name":"Nanjing Chia-tai Tianqing Pharmaceutical","has_results":false},{"nct_id":"NCT06975150","title":"Efficacy and Safety of HK-660S in the Treatment of Primary Sclerosing Cholangitis","phase":"PHASE2","overall_status":"NOT_YET_RECRUITING","enrollment_count":105,"lead_sponsor_name":"CuromeBiosciences","has_results":false},{"nct_id":"NCT05749822","title":"Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis","phase":"PHASE2, PHASE3","overall_status":"RECRUITING","enrollment_count":104,"lead_sponsor_name":"Xijing Hospital of Digestive Diseases","has_results":false},{"nct_id":"NCT02712736","title":"Quality of Life in Patients With Primary Sclerosing Cholangitis","phase":"NA","overall_status":"COMPLETED","enrollment_count":102,"lead_sponsor_name":"Duke University","has_results":false},{"nct_id":"NCT03710122","title":"Vancomycin for Primary Sclerosing Cholangitis","phase":"PHASE2, PHASE3","overall_status":"COMPLETED","enrollment_count":102,"lead_sponsor_name":"Elizabeth Carey","has_results":false},{"nct_id":"NCT05190523","title":"Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis","phase":"PHASE2","overall_status":"COMPLETED","enrollment_count":98,"lead_sponsor_name":"Gannex Pharma Co., Ltd.","has_results":false},{"nct_id":"NCT04617561","title":"Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II","phase":"PHASE4","overall_status":"UNKNOWN","enrollment_count":90,"lead_sponsor_name":"West China Hospital","has_results":false},{"nct_id":"NCT04376528","title":"Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy","phase":"PHASE4","overall_status":"UNKNOWN","enrollment_count":89,"lead_sponsor_name":"West China Hospital","has_results":false},{"nct_id":"NCT07304843","title":"A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction","phase":"PHASE1, PHASE2","overall_status":"RECRUITING","enrollment_count":84,"lead_sponsor_name":"Umecrine Cognition AB","has_results":false},{"nct_id":"NCT06351696","title":"The Effects of Bromelain Supplement in Patients With Ulcerative Colitis","phase":"NA","overall_status":"RECRUITING","enrollment_count":84,"lead_sponsor_name":"National Nutrition and Food Technology Institute","has_results":false}],"total":50},"guidelines":[],"source":"Drug Landscape verified database"}