Table 1 The major clinical trials of FXR agonists for cholestatic liver diseases
From: Bile acid-mediated signaling in cholestatic liver diseases
Drug Name | Indication | Clinical Trials No | Start Year | Status | Sponsor |
|---|---|---|---|---|---|
OCA (obeticholic acid), 6-ECDCA (6-ethyl-chenodeoxycholic acid), or INT-747 | PBC | NCT00570765 | 2008 | Phase 2 (Completed) | Intercept Pharmaceuticals |
OCA [100] | PBC | NCT01473524 | 2012 | Phase 3 (Completed) | Intercept Pharmaceuticals |
OCA | PBC | NCT02308111 | 2014 | Phase 4 [Terminated (Due to the lack of feasibility for this post-marketing study as designed)] | Intercept Pharmaceuticals |
OCA [97] | PSC | NCT02177136 | 2015 | Phase 2 (Completed) | Intercept Pharmaceuticals |
OCA | Pediatric Subjects With Biliary Atresia | NCT05321524 | 2015 | Phase 2 (Active, not recruiting) | Intercept Pharmaceuticals |
OCA | PBC | NCT03633227 | 2018 | Phase 4 (Terminated (Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study)) | Intercept Pharmaceuticals |
Tropifexor (LJN452) [103] | PBC | NCT02516605 | 2015 | Phase 2 (Completed) | Novartis Pharmaceuticals |
Cilofexor (GS-9674) | PBC | NCT02943447 | 2016 | Phase 2 (Terminated because of the availability of alternate therapies for PBC) | Gilead Sciences |
Cilofexor (GS-9674) | PSC | NCT02808312 | 2016 | Phase 1 (Completed) | Gilead Sciences |
Cilofexor (GS-9674) [104] | PSC | NCT02943460 | 2016 | Phase 2 (Completed) | Gilead Sciences |
Cilofexor (GS-9674) | PSC | NCT03890120 | 2019 | Phase 3 [Terminated (Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.)] (Updated on January 23, 2023) | Gilead Sciences |
EDP-305 | PBC | NCT03394924 | 2017 | Phase 2 (Completed) | Enanta Pharmaceuticals, Inc |
TQA3526 | PBC | NCT04278820 | 2020 | Phase 2 (Unknown) | Chia Tai Tianqing Pharmaceutical Group Co., Ltd |
ASC42 | PBC | NCT05190523 | 2022 | Phase 2 (Recruiting) | Gannex Pharma Co., Ltd |
Linafexor (CS0159) | PSC | NCT05082779 | 2021 | Phase 1 (Completed) | Cascade Pharmaceuticals, Inc |
Linafexor (CS0159) | PBC | NCT05624294 | 2022 | Phase 1 (Recruiting) | Cascade Pharmaceuticals, Inc |