Table 1. Promising pharmacological agents for hepatic antifibrosis in clinical trials.
Mechanism of antihepatic fibrosis | Drug | Pharmaceutical company | Indication disease | Current phase | Trial name | Participants | Patient | Major AEs |
FXR agonist | OCA | Intercept | NASH | III | REGENERATE | Fibrosis | 2370 | Pruritus; Drug toxicity |
REVERSE | Compensated cirrhosis | 540 | ||||||
CCR2/CCR5 inhibitor | Cenriviroc | Allergan | NASH | III | AURORA | Fibrosis | 2000 | Fatigue; Diarrhea |
CENTAUR | Fibrosis (S 1-3) | 289 | ||||||
ASK-1 inhibitor | Selonsertib | Gilead | NASH | III | STELLAR- 3 | Advanced fibrosis | 800 | Nausea, Headache, Nasopharyngitis, Upper abdominal pain, Sinusitis, Back pain, Fatigue |
STELLAR- 4 | Compensated cirrhosis | 883 | ||||||
Pyridinone derivative | Pirfenidone | Shionogi | HCV | II | - | Chronic hepatitis C | 34 | Gastrointestinal, Skin-related AEs |
FGF‑21 analog | Pegbelfermin | Bristol Myers Squibb | NASH | IIa | - | Fibrosis stage 1-3 | 75 | Diarrhea, Nausea |
FGF19 analog | Aldafermin (NGM282) | NGM Biopharmaceuticals | NASH | IIb | - | Fibrosis (S 1-3) | 82 | Injection site reactions, Gastrointestinal symptoms |
PSC | II | - | Fibrosis | 62 | ||||
PPAR α/δ agonist | Elafibranor | Genfit | NASH | III | RESOLVE-IT | F2-3 | 2000 | Renal impairment/failure |
PBC | II | - | 45 | |||||
siRNA against HSP47 | BMS-986263 | Bristol Myers Squibb | HCV | II | - | METAVIR Stage 3- 4 | 62 | Mild to moderate infusion related reactions |
Abbreviations: AEs, adverse events; ASK1, apoptosis signal-regulating kinase 1; CCR2/5, C-C chemokine receptor type 2; FGF, fibroblast growth factor; FXR, farnesoid X receptor; HSP, heat shock protein; NASH, non-alcoholic fatty liver disease; OCA, obeticholic acid; PBC, primary biliary cholangitis; PPAR, peroxisome proliferator-activated receptor; PSC, primary sclerosing cholangitis; siRNA, small interfering RNA.