7 recruiting, 6 completed, 3 active not recruiting, 1 terminated. 18 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 18 | Recruiting 7, Completed 6, Active not recruiting 3, Terminated 1, Unknown 1 |
| Phase 2 | 4 | Recruiting 2, Active not recruiting 1, Completed 1 |
Follow Primary Biliary Cholangitis: new trials by email Literature Review of Primary Biliary Cholangitis trials Research Report on Primary Biliary Cholangitis
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 | 2026-07-08 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Placebo - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Completed | Zydus Therapeutics Inc. | 196 | 2022-04-01 | 2026-09-17 |
| Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis Obeticholic Acid Tablets（OCA）, UDCA, Placebo - Primary Biliary Cholangitis | Phase 3 | Completed | Nanjing Chia-tai Tianqing Pharmaceutical | 108 | 2021-09-23 | 2024-07-11 |
| RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) Seladelpar 10 mg, Placebo, Seladelpar 5 mg - Primary Biliary Cholangitis | Phase 3 | Completed | Gilead Sciences | 193 | 2021-04-21 | 2024-09-05 |
| ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) seladelpar 5-10 mg, seladelpar 10 mg, Placebo - Primary Biliary Cholangitis | Phase 3 | Completed | Gilead Sciences | 265 | 2018-10-01 | 2022-08-02 |
| Fenofibrate in Patients With Primary Biliary Cholangitis (PBC) Fenofibrate, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 117 | 2017-04-08 | 2026-10-30 |
| The Effect of Bezafibrate on Cholestatic Itch Bezafibrate, Placebo - Primary Biliary Cholangitis, Primary Sclerosing Cholangitis | Phase 3 | Unknown | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 84 | 2016-02-01 | 2016-03-08 |
Liver Cirrhosis, Biliary (18) · Cholangitis, Sclerosing (1) · Cholestasis (1) · Pruritus (1)
Bile Duct Diseases (18) · Biliary Tract Diseases (18) · Cholestasis, Intrahepatic (18) · Digestive System Diseases (18) · Fibrosis (18) · Liver Cirrhosis (18) · Liver Diseases (18) · Pathologic Processes (18) · Pathological Conditions, Signs and Symptoms (18) · Cholestasis (17) · Cholangitis (1) · Signs and Symptoms (1) · Skin Diseases (1) · Skin Manifestations (1) · Skin and Connective Tissue Diseases (1)
saroglitazar (4) · seladelpar (4) · Fenofibrate (3) · 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (2) · Bezafibrate (1) · Ursodeoxycholic Acid (1)
Gilead Sciences (4) · Zydus Therapeutics Inc. (4) · Xijing Hospital of Digestive Diseases (3) · Ipsen (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · Cascade Pharmaceuticals, Inc (1) · Han Ying (1) · Intercept Pharmaceuticals (1) · Nanjing Chia-tai Tianqing Pharmaceutical (1)
United States (10) · China (7) · Argentina (6) · Spain (6) · Canada (5) · France (5) · Germany (5) · Italy (5) · South Korea (5) · Turkey (Türkiye) (5) · United Kingdom (5) · Australia (4) · Belgium (4) · Czechia (4) · Greece (4)
Deven Parmar (1) · Deven V Parmar, MD (1) · Lynda Szczech, PhD (1) · Ma Xiong, MD (1) · Ying Han (1) · Ying Han, Doctor (1)
PMID 28535810, PMID 33031833, PMID 38381664, PMID 41933275, PMID 42798953