Nonalcoholic Steatohepatitis

Infectious Diseases
15
Pipeline Programs
7
Companies
11
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
12
0
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
7100%
+ 8 programs with unclassified modality

Competitive Landscape

6 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
8 programs
6
2
SELPhase 31 trial
SELPhase 31 trial
GS-9450Phase 21 trial
SELPhase 21 trial
SemaglutidePhase 2Peptide
+3 more programs
Active Trials
NCT00740610Completed124Est. Sep 2009
NCT03449446Completed395Est. Nov 2019
NCT03987074Completed109Est. Jul 2020
+3 more trials
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
3 programs
3
LiraglutidePhase 2Peptide1 trial
SemaglutidePhase 2Peptide
SemaglutidePhase 2Peptide
Active Trials
NCT01237119Completed52Est. Jul 2014
Galectin Therapeutics
1 program
1
GR-MD-02Phase 21 trial
Active Trials
NCT02421094CompletedEst. Sep 2016
Teva
TevaIsrael - Petach Tikva
1 program
1
TEV-45478Phase 21 trial
Active Trials
NCT02769091Withdrawn0Est. Feb 2018
Bayer
BayerLEVERKUSEN, Germany
1 program
1
testosterone undecanoatePhase 21 trial
Active Trials
NCT01919294Completed3Est. Jan 2017
Alnylam Pharmaceuticals
1 program
1
ALN-HSDPhase 11 trial
Active Trials
NCT04565717Terminated6Est. Dec 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Gilead SciencesSEL
Gilead SciencesSEL
Gilead SciencesSemaglutide
Gilead SciencesSemaglutide
Gilead SciencesSEL
TevaTEV-45478
Galectin TherapeuticsGR-MD-02
Bayertestosterone undecanoate
Novo NordiskLiraglutide
Gilead SciencesGS-9450
Alnylam PharmaceuticalsALN-HSD

Clinical Trials (11)

Total enrollment: 2,837 patients across 11 trials

NCT03053050Gilead SciencesSEL

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Start: Feb 2017Est. completion: Jun 2019808 patients
Phase 3Terminated
NCT03053063Gilead SciencesSEL

Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Start: Jan 2017Est. completion: May 2019883 patients
Phase 3Terminated
NCT04971785Gilead SciencesSemaglutide

Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Start: Aug 2021Est. completion: Dec 2024457 patients
Phase 2Completed
NCT03987074Gilead SciencesSemaglutide

Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

Start: Jul 2019Est. completion: Jul 2020109 patients
Phase 2Completed
NCT03449446Gilead SciencesSEL

Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Start: Mar 2018Est. completion: Nov 2019395 patients
Phase 2Completed
NCT02769091TevaTEV-45478

A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes

Start: Sep 2016Est. completion: Feb 20180
Phase 2Withdrawn
NCT02421094Galectin TherapeuticsGR-MD-02

Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis

Start: Sep 2015Est. completion: Sep 2016
Phase 2Completed
NCT01919294Bayertestosterone undecanoate

Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)

Start: Jul 2013Est. completion: Jan 20173 patients
Phase 2Completed
NCT01237119Novo NordiskLiraglutide

Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

Start: Aug 2010Est. completion: Jul 201452 patients
Phase 2Completed
NCT00740610Gilead SciencesGS-9450

Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

Start: Aug 2008Est. completion: Sep 2009124 patients
Phase 2Completed
NCT04565717Alnylam PharmaceuticalsALN-HSD

A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)

Start: Oct 2020Est. completion: Dec 20236 patients
Phase 1Terminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
7 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)