6 completed, 2 recruiting, 2 terminated, 1 active not recruiting. 5 Phase 2, 5 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Terminated 2, Completed 1, Not yet recruiting 1, Recruiting 1 |
| Phase 3 | 5 | Completed 3, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 2 | Completed 2 |
Follow seladelpar: new trials by email Literature Review of seladelpar trials Research Report on seladelpar
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 Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis Seladelpar, PTM Seladelpar, Cilofexor Dose B - Primary Biliary Cholangitis | Phase 2 | Recruiting | Gilead Sciences | 132 | 2026-10-01 | 2026-10-27 |
| Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC). Seladelpar - Liver Transplant; Complications, Ischemic Cholangiopathy | Phase 2 | Not yet recruiting | University of California, San Diego | 10 | 2026-05-01 | 2026-04-09 |
| 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 | 2026-10-06 |
| 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 |
| An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Seladelpar - Primary Biliary Cholangitis, Compensated Cirrhosis | Phase 1 | Completed | Gilead Sciences | 24 | 2021-11-16 | 2026-05-04 |
| 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 |
| A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC Seladelpar, Placebo to match Seladelpar - Primary Sclerosing Cholangitis | Phase 2 | Terminated | Gilead Sciences | 1 | 2019-11-12 | 2025-01-16 |
| 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 |
| A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH) Seladelpar, Placebos - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Terminated | Gilead Sciences | 181 | 2018-04-30 | 2022-09-15 |
| Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule - Primary Biliary Cirrhosis | Phase 3 | Active not recruiting | Gilead Sciences | 340 | 2017-12-12 | 2026-05-04 |
| Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects seladelpar - Hepatic Impairment | Phase 1 | Completed | Gilead Sciences | 32 | 2017-11-27 | 2018-05-18 |
| Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule - Primary Biliary Cirrhosis | Phase 2 | Completed | Gilead Sciences | 119 | 2016-11-28 | 2022-07-14 |
Liver Cirrhosis, Biliary (8) · Bile Duct Diseases (1) · Biliary Tract Diseases (1) · Cholangitis (1) · Cholangitis, Sclerosing (1) · Digestive System Diseases (1) · Non-alcoholic Fatty Liver Disease (1)
Gilead Sciences (11) · University of California, San Diego (1)
United States (11) · Canada (7) · United Kingdom (6) · Germany (5) · Poland (5) · South Korea (5) · Spain (5) · Argentina (4) · Australia (4) · Austria (4) · Belgium (4) · Chile (4) · France (4) · Greece (4) · Hungary (4)
PMID 33793651, PMID 35367282, PMID 37904314, PMID 38381664, PMID 39326675, PMID 40553148, PMID 41933275, PMID 42798953
2019 (1)