37 completed, 12 recruiting, 9 unknown, 7 active not recruiting. 73 Phase 3, 13 Phase 2.
Follow Cholestasis: new trials by email Literature Review of Cholestasis trials Research Report on Cholestasis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| J-LINX: Japan LINerixibat eXtension Study Linerixibat - Pruritus | Phase 3 | Not yet recruiting | GlaxoSmithKline | 40 | 2026-10-09 | 2026-10-06 |
| Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy Saroglitazar Magnesium 1 mg, Placebo - Primary Biliary Cholangitis | Phase 3 | Recruiting | Zydus Therapeutics Inc. | 90 | 2026-08-11 | 2026-09-15 |
| Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes Saroglitazar magnesium 1 mg, Placebo - Primary Biliary Cholangitis | Phase 3 | Recruiting | Zydus Therapeutics Inc. | 386 | 2026-03-24 | 2026-08-04 |
| FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy Fenofibrate, UDCA (Ursodeoxycholic acid) - Primary Biliary Cholangitis (PBC) | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 132 | 2025-12-15 | 2026-11-02 |
| A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA 2mg CS0159, Placebo - Primary Biliary Cholangitis | Phase 3 | Recruiting | Cascade Pharmaceuticals, Inc | 135 | 2025-12-01 | 2026-11-12 |
| A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) Elafibranor - Primary Biliary Cholangitis | Phase 3 | Active not recruiting | Ipsen | 18 | 2025-01-16 | 2026-10-23 |
| 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 Prednisone, UDCA (Ursodeoxycholic acid) - Primary Biliary Cholangitis (PBC) | Phase 2 / Phase 3 | Enrolling by invitation | Han Ying | 244 | 2024-10-30 | 2026-10-29 |
| Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis Saroglitazar Magnesium 1 mg - Primary Biliary Cholangitis | Phase 3 | Active not recruiting | Zydus Therapeutics Inc. | 102 | 2024-07-16 | 2026-05-12 |
| A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. Elafibranor, Placebo - Primary Biliary Cholangitis | Phase 3 | Completed | Ipsen | 92 | 2024-07-09 | 2026-07-09 |
| To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate FDC tablet (OCA 5 mg + BZF 400 mg SR) - Primary Biliary Cholangitis | Phase 3 | Terminated | Intercept Pharmaceuticals | 62 | 2024-07-01 | 2026-06-08 |
| Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study Fenofibrate in Combination With Ursodeoxycholic Acid - Primary Biliary Cholangitis (PBC) | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 150 | 2024-01-30 | 2026-01-08 |
| Fenofibrate in Primary Biliary Cholangitis: a Real World Study Fenofibrate - Primary Biliary Cholangitis (PBC) | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 300 | 2024-01-17 | 2026-01-08 |
| Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Seladelpar, Placebo - Primary Biliary Cholangitis | Phase 3 | Recruiting | Gilead Sciences | 402 | 2023-09-07 | 2026-11-02 |
| Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) Seladelpar 10 mg, Placebo - Primary Biliary Cholangitis | Phase 3 | Completed | Gilead Sciences | 96 | 2023-09-05 | 2026-06-04 |
| A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis Elafibranor, Matched 80 mg placebo - Primary Biliary Cholangitis (PBC) | Phase 3 | Recruiting | Ipsen | 276 | 2023-08-31 | 2026-10-23 |
| Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis Fenofibrate, Placebo, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Active not recruiting | Han Ying | 184 | 2023-08-21 | 2026-10-29 |
| Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis Remaxa, enteric-coated tablets, Remaxol, Placebo - Cholestasis, Intrahepatic | Phase 2 / Phase 3 | Completed | POLYSAN Scientific & Technological Pharmaceutical Company | 328 | 2023-05-27 | 2025-04-29 |
| Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis Placebo Combined With Ursodeoxycholic Acid, Fenofibrate Combined With Ursodeoxycholic Acid - Primary Biliary Cholangitis | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 150 | 2023-02-22 | 2026-01-08 |
| Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis Fenofibrate 200mg, Placebo, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 104 | 2023-02-17 | 2026-01-08 |
| BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases 4-Phenylbutyrate - Hereditary Diseases, Cholestasis, Intrahepatic | Phase 2 / Phase 3 | Withdrawn | Children's Hospital of Fudan University | 2023-02-08 | 2023-02-09 |
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Liver Cirrhosis, Biliary (44) · Cholestasis, Intrahepatic (5) · Cholestasis, progressive familial intrahepatic 1 (4) · Fibrosis (4) · Liver Diseases (4) · Pruritus (4) · Alagille Syndrome (3) · Gastrointestinal Diseases (3) · Hyperphagia (3) · Short Bowel Syndrome (3) · Bile Duct Diseases (2) · Biliary Tract Diseases (2) · Cholangitis, Sclerosing (2) · Cholestasis, Extrahepatic (2)
Bile Duct Diseases (71) · Biliary Tract Diseases (71) · Digestive System Diseases (71) · Liver Diseases (53) · Pathological Conditions, Signs and Symptoms (51) · Pathologic Processes (48) · Cholestasis, Intrahepatic (47) · Liver Cirrhosis (44) · Fibrosis (41) · Signs and Symptoms (7) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (6) · Congenital Abnormalities (5) · Abnormalities, Multiple (4) · Cardiovascular Diseases (4)
Ursodeoxycholic Acid (14) · Fenofibrate (8) · fish oil triglycerides (5) · seladelpar (5) · 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (4) · Bezafibrate (4) · odevixibat (4) · saroglitazar (4) · Methotrexate (3) · maralixibat (3) · obeticholic acid (2) · soybean oil, phospholipid emulsion (2) · (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid (1) · 4-phenylbutyric acid (1) · Atorvastatin (1)
Xijing Hospital of Digestive Diseases (10) · Gilead Sciences (5) · Ipsen (4) · Mirum Pharmaceuticals, Inc. (4) · Zydus Therapeutics Inc. (4) · GlaxoSmithKline (3) · Albireo (2) · Albireo, an Ipsen Company (2) · Asan Medical Center (2) · Han Ying (2) · Intercept Pharmaceuticals (2) · National Center for Research Resources (NCRR) (2) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (2) · Abbott (1) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1)
United States (32) · Canada (18) · China (18) · France (18) · Germany (17) · Italy (17) · United Kingdom (17) · Belgium (14) · Poland (14) · Spain (13) · Turkey (Türkiye) (13) · Argentina (12) · Mexico (11) · Israel (10) · Australia (9)
Andrew L Mason, MBBS MRCPI (1) · Avash J Singh, MD (1) · Bret Petersen, MD (1) · Bruce Bacon, MD (1) · Burton Combes (1) · Catherine Vincent, MD FRCPC (1) · Christian Weyer, MD (1) · Deven Parmar (1) · Deven V Parmar, MD (1) · Do Hyun Park, MD, PhD (1)
PMID 25543678, PMID 32716060, PMID 10051462, PMID 10343514, PMID 10347106, PMID 12360466, PMID 15017671, PMID 15128074, PMID 15468571, PMID 16299032, PMID 16530513, PMID 16848809, PMID 16863557, PMID 17058231, PMID 17399846, PMID 18752324, PMID 19554543, PMID 19661785, PMID 19782361, PMID 20531018, PMID 22237883, PMID 22245904, PMID 22259000, PMID 22271046, PMID 22911624, PMID 23141888, PMID 23978872, PMID 24625898, PMID 24671010, PMID 27532829, PMID 27824743, PMID 2803071, PMID 28535810, PMID 28644367, PMID 30922873, PMID 31606455, PMID 32059815, PMID 32950590, PMID 33006765, PMID 33031833, PMID 33038344, PMID 33319187, PMID 34695449, PMID 35780807, PMID 36066745, PMID 36892506, PMID 37456676, PMID 37904314, PMID 37953500, PMID 37962077
2019 (3), 2017 (2), 2023 (2), R01DK046602 (1), R03DK055618 (1)