Efficacy and safety of anti-hepatic fibrosis drugs

doi:10.3748/wjg.v26.i41.6304

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World Journal of Gastroenterology

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World J Gastroenterol. Nov 7, 2020; 26(41): 6304-6321
Published online Nov 7, 2020. doi: 10.3748/wjg.v26.i41.6304

Table 1 Drugs currently in phase 3 investigation trials for the treatment of nonalcoholic steatohepatitis according to ClinicalTrials.gov

Drug name	Mechanism of action	Estimated completion	Study/identifier
Resmetirom (MGL-3196)	Thyroid hormone receptor agonist	March 2024	[MAESTRO-NASH] NCT03900429
Dapaglifozin	SGLT-2 inhibitor	November 2021	[DEAN] NCT03723252
Aramchol	SCD1 inhibitor	December 2024	[ARMOR] NCT04104321
Cenicriviroc	CCR2-CCR5 antagonist	October 2028	[AURORA] NCT03028740
Elafibranor	PPAR agonist	December 2021	[RESOLVE-IT] NCT02704403
Obeticholic acid	FXR agonist	October 2022	[REGENERATE] NCT02548351

CCR: Chemokine receptor; FXR: Farnesoid X receptor; PPAR: Peroxisome proliferator-activated receptor; SCD1: Stearoyl coenzyme A desaturase 1; SGLT-2: Sodium-glucose transport protein.

Table 2 Drugs currently in clinical trials for the treatment of various etiologies of hepatic fibrosis according to ClinicalTrials.gov

Drug name	Mechanism of action	Condition(s)	Clinical phase	Study/Identifier
Candesartan + Ramipril	Angiotensin II receptor Antagonist, ACE inhibitor	HCV	3	NCT03770936
Pirfenidone	Anti-inflammatory + Antifibrotic	Multiple	2	[PROMETEO] NCT04099407
BMS-986036, Pegbelfermin	PEG-FGF21Analog	NASH F3	2	[FALCON 1] NCT03486899
		NASH + Compensated, Cirrhosis	2	[FALCON 2] NCT03486912
Aldafermin (NGM282)	FGF19 Analog	NASH	2	NCT02443116
CC-90001	JNK inhibitor	NASH F3/F4	2	NCT04048876
Entecavir	Reverse transcriptase inhibitor	HBV	4	NCT02849132
Entecavir + Fuzheng Huaya + TCM granule	Reverse transcriptase inhibitor + Traditional Chinese medicine	HBV	4	NCT02241616
Tropifexor + Licoglifozin	FXR agonist + SGLT 1 and 2 inhibitor	NASH F2/F3	2	[ELIVATE] NCT04065841
Tropifexor + Cenicriviroc	FXR agonist + CCR2-CCR5 antagonist	NASH F2/F3	2	[TANDEM] NCT03517540
Nitazoxanide	Anti-protazoal	NASH F2/F3	2	NCT03656068
Mesenchymal stem cells	Umbilical cord mesenchymal stem cells	HBV + Decompensated cirrhosis	2	NCT03945487
GXHPC1	Adipose-derived stem cells	Cirrhosis of multiple etiologies	2	NCT04088058
G-CSF	Granulocyte colony stimulating factor	Decompensated cirrhosis of multiple etiologies	2/3	NCT03911037
Mesenchymal stem cells	Autologous bone marrow mesenchymal SCs	Cirrhosis of multiple etiologies	2	NCT03626090
ADR-001	Adipose-derived stem cells	HCV or NASH Cirrhosis	2	NCT03254758
CD 34 + MSCs	Autologous hematopoietic and mesenchymal SCs	Cirrhosis of multiple etiologies	4	NCT04243681
Simvastatin	HMG-CoA Reductase Inhibitor	Cirrhosis of multiple etiologies	2	NCT02968810
ORMD-0801	Oral insulin formulation	NASH + Type 2 Diabetes	2	NCT02653300
Atorvastatin	HMG-CoA reductase inhibitor	Cirrhosis of multiple etiologies	4	[STATLiver] NCT04072601
Aldafermin (NGM282)	FGF19 analog	NASH F2/F3; NASH + Compensated cirrhosis	2; 2	[ALPINE 2/3] NCT03912532; [ALPINE 4] NCT04210245
Obeticholic acid	FXR agonist	PBC + Hepatic impairment	4	NCT03633227
Stem cell	Autologous bone marrow mononuclear stem cells	Liver cirrhosis + Biliary atresia	2	NCT03468699
VK2809	Thyroid receptor agonist	NASH	2	[VOYAGE] NCT04173065
Spironolactone + Carvedilol	Aldosterone antagonist + Beta receptor blocker	Compensated cirrhosis	4	NCT02907749
Cenicriviroc	CCR2-CCR5 antagonist	NASH + Completion of CENTAUR and AURORA Study	2	NCT03059446
Selonsertib + Firsocostat + Cilofexor + Fenofibrate + Vascepa^®	ASK 1 inhibitor + ACC inhibitor + FXR agonist + Anti-lipid + Anti-lipid	NAFLD, NASH	2	NCT02781584
Erlotinib	Tyrosine kinase inhibitor	Fibrosis, Cirrhosis	1/2	NCT02273362
Saroglitizar	PPAR agonist	NAFLD, NASH	2	NCT03061721

ACC: Acetyl-CoA carboxylase; ASK: Apoptosis signal-regulating kinase 1; CCR: Chemokine receptor; FXR: Farnesoid X receptor; HBV: Hepatitis B virus; HCV: Hepatitis C virus; HMG-CoA: Hydroxymethylglutaryl coenzyme A; JNK: C-Jun N-terminal kinase; NAFLD: Nonalcoholic fatty liver disease; NASH: Nonalcoholic steatohepatitis; PBC: Primary biliary cirrhosis; PEG-FGF21: PEGylated human fibroblast growth factor 21; PPAR: Peroxisome proliferator-activated receptor; SGLT-1: Sodium-glucose transport protein 1; SGLT-2: Sodium-glucose transport protein 2; TCM: Traditional Chinese Medicine.

Citation: Damiris K, Tafesh ZH, Pyrsopoulos N. Efficacy and safety of anti-hepatic fibrosis drugs. World J Gastroenterol 2020; 26(41): 6304-6321
URL: https://www.wjgnet.com/1007-9327/full/v26/i41/6304.htm
DOI: https://dx.doi.org/10.3748/wjg.v26.i41.6304