Table 2 The major clinical trials of FGF19 analogs and ASBT Inhibitors for cholestatic liver diseases
From: Bile acid-mediated signaling in cholestatic liver diseases
Drug Name | Indication | Targets and Mechanism | Clinical Trials No | Start Year | Status | Sponsor |
|---|---|---|---|---|---|---|
Aldafermin (NGM282) | PBC | FGFR4 (FGF19 analogue) | NCT02026401 | 2014 | Phase 2 (Completed) | NGM Biopharmaceuticals, Inc |
Aldafermin (NGM282) [107] | PSC | FGFR4 (FGF19 analogue) | NCT02704364 | 2016 | Phase 2 (Completed) | NGM Biopharmaceuticals, Inc |
Odevixibat (A4250) | PBC Pruritus | ASBT (Inhibitor) | NCT02360852 | 2015 | Phase 2 [Terminated ((Expected) side effects)] | Sahlgrenska University Hospital, Sweden |
Odevixibat (A4250) | Pediatric Cholestasis | ASBT (Inhibitor) | NCT02630875 | 2015 | Phase 2 (Completed) | Albireo |
Odevixibat (A4250) [108] | Children With PFIC1/2 | ASBT (Inhibitor) | NCT03566238 | 2018 | Phase 3 (Completed) | Albireo |
Linerixibat (GSK2330672) [109] | PBC Pruritus | ASBT (Inhibitor) | NCT01899703 | 2014 | Phase 2a (Completed) | GlaxoSmithKline |
Linerixibat (GSK2330672) | PBC Pruritus | ASBT (Inhibitor) | NCT02801981 | 2016 | Phase 1 (Completed) | GlaxoSmithKline |
Linerixibat (GSK2330672) [110] | PBC Pruritus | ASBT (Inhibitor) | NCT02966834 | 2017 | Phase 2b (Completed) | GlaxoSmithKline |
Linerixibat (GSK2330672) | PBC Pruritus | ASBT (Inhibitor) | NCT04950127 | 2021 | Phase 3 (Recruiting) | GlaxoSmithKline |
Maralixibat (LUM001) [111] | PFIC | ASBT (Inhibitor) | NCT02057718 | 2014 | Phase 2 (Completed) | Mirum Pharmaceuticals, Inc |
Maralixibat (LUM001) | PSC | ASBT (Inhibitor) | NCT02061540 | 2014 | Phase 2 (Completed) | Mirum Pharmaceuticals, Inc |
Maralixibat (LUM001) | PFIC | ASBT (Inhibitor) | NCT03905330 | 2019 | Phase 3 (Completed) | Mirum Pharmaceuticals, Inc |
Maralixibat (LUM001) [112] | ALGS | ASBT (Inhibitor) | NCT02160782 | 2014 | Phase 2 (Completed) | Mirum Pharmaceuticals, Inc |
Maralixibat (LUM001) | PFIC; ALGS; CLD | ASBT (Inhibitor) | NCT04729751 | 2021 | Phase 2 (Recruiting) | Mirum Pharmaceuticals, Inc |
Volixibat | PSC | ASBT (Inhibitor) | NCT04663308 | 2020 | Phase 2 (Recruiting) | Mirum Pharmaceuticals, Inc |
Volixibat | ICP | ASBT (Inhibitor) | NCT04718961 | 2021 | Phase 2 (Active, not recruiting) | Mirum Pharmaceuticals, Inc |
A3907 | PSC | ASBT (Inhibitor) | NCT05642468 | 2023 | Phase 2 (Recruiting) | Albireo |
Maralixibat chloride (TAK-625) | PFIC | ASBT (Inhibitor) | NCT05543187 | 2023 | Phase 3 (Recruiting) | Takeda |
Maralixibat chloride (TAK-625) | ALGS | ASBT (Inhibitor) | NCT05543174 | 2023 | Phase 3 (Recruiting) | Takeda |