Non-alcoholic Steatohepatitis

Infectious Diseases
17
Pipeline Programs
8
Companies
14
Clinical Trials
1 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
1
7
0
1
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
2100%
+ 12 programs with unclassified modality

On Market (3)

Approved therapies currently available

Novo Nordisk
OZEMPICApproved
semaglutide
Novo Nordisk
GLP-1 Receptor Agonist [EPC]subcutaneous2017
Novo Nordisk
RYBELSUSApproved
semaglutide
Novo Nordisk
oral2020
Novo Nordisk
WEGOVYApproved
semaglutide
Novo Nordisk
GLP-1 Receptor Agonist [EPC]oral2025

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
5 programs
2
2
1
1
SemaglutidePhase 3Peptide1 trial
NNC0194 0499 50 mg/mLPhase 21 trial
SemaglutidePhase 2Peptide1 trial
NNC0194-0499Phase 11 trial
NNC0194-0499Phase 11 trial
Active Trials
NCT04722653Completed42Est. Apr 2021
NCT05766709Completed53Est. Feb 2024
NCT05016882Completed698Est. Mar 2025
+2 more trials
Mirum Pharmaceuticals
Mirum PharmaceuticalsFOSTER CITY, CA
3 programs
2
1
SHP626Phase 21 trial
SHP626Phase 11 trial
SHP626Phase 11 trial
Active Trials
NCT02287779Completed84Est. Jun 2015
NCT02571192Completed8Est. Oct 2015
NCT02787304Terminated197Est. Jul 2018
Astellas
AstellasChina - Shenyang
1 program
1
ASP9831Phase 21 trial
Active Trials
NCT00668070Completed114Est. Oct 2010
Madrigal Pharmaceuticals
Madrigal PharmaceuticalsWEST CONSHOHOCKEN, PA
1 program
1
MGL-3196Phase 21 trial
Active Trials
NCT02912260Completed125Est. Nov 2021
MediciNova
MediciNovaLA JOLLA, CA
1 program
1
MN-001Phase 21 trial
Active Trials
NCT02681055Completed19Est. Oct 2019
CT
1 program
1
TQA2225/AP025 or TQA2225/AP025 Placebo 25mgPhase 21 trial
Active Trials
NCT06569524RecruitingEst. Dec 2027
Arrowhead Pharmaceuticals
1 program
1
ARO-HSD InjectionPhase 1/21 trial
Active Trials
NCT04202354Completed50Est. Sep 2021
Sagimet Biosciences
Sagimet BiosciencesCA - San Mateo
1 program
1
TVB-2640 - 50 mgPhase 11 trial
Active Trials
NCT05835180CompletedEst. Dec 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Novo NordiskSemaglutide
Chia Tai TianQing Pharmaceutical GroupTQA2225/AP025 or TQA2225/AP025 Placebo 25mg
Novo NordiskNNC0194 0499 50 mg/mL
Novo NordiskSemaglutide
Mirum PharmaceuticalsSHP626
Madrigal PharmaceuticalsMGL-3196
MediciNovaMN-001
AstellasASP9831
Arrowhead PharmaceuticalsARO-HSD Injection
Sagimet BiosciencesTVB-2640 - 50 mg
Novo NordiskNNC0194-0499
Novo NordiskNNC0194-0499
Mirum PharmaceuticalsSHP626
Mirum PharmaceuticalsSHP626

Clinical Trials (14)

Total enrollment: 2,666 patients across 14 trials

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

Start: Apr 2021Est. completion: Apr 20291,205 patients
Phase 3Active Not Recruiting
NCT06569524Chia Tai TianQing Pharmaceutical GroupTQA2225/AP025 or TQA2225/AP025 Placebo 25mg

Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)

Start: Sep 2023Est. completion: Dec 2027
Phase 2Recruiting
NCT05016882Novo NordiskNNC0194 0499 50 mg/mL

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

Start: Aug 2021Est. completion: Mar 2025698 patients
Phase 2Completed

A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

Start: Jun 2019Est. completion: Jun 202171 patients
Phase 2Completed

Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)

Start: Oct 2016Est. completion: Jul 2018197 patients
Phase 2Terminated

Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Start: Oct 2016Est. completion: Nov 2021125 patients
Phase 2Completed

Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects

Start: Mar 2016Est. completion: Oct 201919 patients
Phase 2Completed

A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831

Start: Apr 2008Est. completion: Oct 2010114 patients
Phase 2Completed

Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH

Start: Mar 2020Est. completion: Sep 202150 patients
Phase 1/2Completed

A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Start: May 2023Est. completion: Dec 2023
Phase 1Completed

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations

Start: Mar 2023Est. completion: Feb 202453 patients
Phase 1Completed

A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

Start: Feb 2021Est. completion: Apr 202142 patients
Phase 1Completed

A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose

Start: Oct 2015Est. completion: Oct 20158 patients
Phase 1Completed

Safety and Tolerability Study of SHP626 in Overweight and Obese Adults

Start: Jan 2015Est. completion: Jun 201584 patients
Phase 1Completed

Related Jobs in Infectious Diseases

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 2,666 patients
8 companies competing in this space