NASH - Nonalcoholic Steatohepatitis

Infectious Diseases
17
Pipeline Programs
10
Companies
19
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
10
0
3
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Akero Therapeutics
Akero TherapeuticsCA - South SF
4 programs
3
1
EfruxiferminPhase 31 trial
EFXPhase 21 trial
EFXPhase 21 trial
EfruxiferminPhase 21 trial
Active Trials
NCT03976401CompletedEst. Jan 2022
NCT05039450Active Not RecruitingEst. May 2025
NCT04767529CompletedEst. May 2024
+1 more trials
Inventiva
InventivaDAIX, France
2 programs
1
1
IVA337Phase 31 trial
IVA337Phase 21 trial
Active Trials
NCT05232071CompletedEst. Jun 2024
NCT04849728RecruitingEst. Sep 2026
Madrigal Pharmaceuticals
Madrigal PharmaceuticalsWEST CONSHOHOCKEN, PA
1 program
1
MGL-3196Phase 31 trial
Active Trials
NCT03900429Active Not Recruiting1,759Est. Jan 2028
Rivus Pharmaceuticals
Rivus PharmaceuticalsVA - Charlottesville
3 programs
2
1
HU6Phase 21 trial
HU6Phase 11 trial
HU6Phase 11 trial
Active Trials
NCT04463017CompletedEst. Apr 2021
NCT04709913CompletedEst. Jul 2021
NCT04874233CompletedEst. Dec 2021
Terns Pharmaceuticals
Terns PharmaceuticalsFOSTER CITY, CA
3 programs
1
2
TERN-101Phase 21 trial
TERN-501Phase 21 trial
TERN-201Phase 11 trial
Active Trials
NCT04897594CompletedEst. Sep 2022
NCT04328077CompletedEst. May 2021
NCT05415722CompletedEst. Jul 2023
89bio
89bioCA - San Francisco
2 programs
1
1
BIO89-100Phase 21 trial
BIO89-100Phase 11 trial
Active Trials
NCT05022693Completed8Est. Dec 2021
NCT04929483Completed222Est. Oct 2024
Hepion Pharmaceuticals
1 program
1
CRV431 75mgPhase 21 trial
Active Trials
NCT04480710Completed47Est. Oct 2021
GS
Gilead SciencesFOSTER CITY, CA
1 program
1
SeladelparPhase 21 trial
Active Trials
NCT03551522Terminated181Est. Aug 2020
Fractyl Health
Fractyl HealthMA - Burlington
1 program
DMRN/A1 trial
Active Trials
NCT03536650CompletedEst. Dec 2020
Bristol Myers Squibb
1 program
¹³C-Methacetin Breath TestN/A1 trial
Active Trials
NCT03611101Completed124Est. Nov 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Akero TherapeuticsEfruxifermin
InventivaIVA337
Madrigal PharmaceuticalsMGL-3196
InventivaIVA337
Terns PharmaceuticalsTERN-501
Akero TherapeuticsEFX
89bioBIO89-100
Rivus PharmaceuticalsHU6
Akero TherapeuticsEfruxifermin
Hepion PharmaceuticalsCRV431 75mg
Terns PharmaceuticalsTERN-101
Akero TherapeuticsEFX
Gilead SciencesSeladelpar
89bioBIO89-100
Terns PharmaceuticalsTERN-201

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 2,341 patients across 19 trials

NCT06528314Akero TherapeuticsEfruxifermin

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Start: Sep 2024Est. completion: Oct 2029
Phase 3Recruiting
NCT04849728InventivaIVA337

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

Start: Aug 2021Est. completion: Sep 2026
Phase 3Recruiting
NCT03900429Madrigal PharmaceuticalsMGL-3196

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

Start: Mar 2019Est. completion: Jan 20281,759 patients
Phase 3Active Not Recruiting
NCT05232071InventivaIVA337

Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

Start: Jun 2022Est. completion: Jun 2024
Phase 2Completed
NCT05415722Terns PharmaceuticalsTERN-501

DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

Start: Jun 2022Est. completion: Jul 2023
Phase 2Completed
NCT05039450Akero TherapeuticsEFX

A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

Start: Jul 2021Est. completion: May 2025
Phase 2Active Not Recruiting
NCT0492948389bioBIO89-100

Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

Start: Jun 2021Est. completion: Oct 2024222 patients
Phase 2Completed
NCT04874233Rivus PharmaceuticalsHU6

Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers

Start: Apr 2021Est. completion: Dec 2021
Phase 2Completed
NCT04767529Akero TherapeuticsEfruxifermin

A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Start: Feb 2021Est. completion: May 2024
Phase 2Completed
NCT04480710Hepion PharmaceuticalsCRV431 75mg

A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects

Start: Jun 2020Est. completion: Oct 202147 patients
Phase 2Completed
NCT04328077Terns PharmaceuticalsTERN-101

LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

Start: Jun 2020Est. completion: May 2021
Phase 2Completed
NCT03976401Akero TherapeuticsEFX

A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Start: May 2019Est. completion: Jan 2022
Phase 2Completed
NCT03551522Gilead SciencesSeladelpar

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

Start: Apr 2018Est. completion: Aug 2020181 patients
Phase 2Terminated
NCT0502269389bioBIO89-100

PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

Start: Aug 2021Est. completion: Dec 20218 patients
Phase 1Completed
NCT04897594Terns PharmaceuticalsTERN-201

AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis

Start: May 2021Est. completion: Sep 2022
Phase 1Completed
NCT04709913Rivus PharmaceuticalsHU6

Multiple Ascending Dose Study of HU6 in High BMI Volunteers

Start: Jan 2021Est. completion: Jul 2021
Phase 1Completed
NCT04463017Rivus PharmaceuticalsHU6

Ascending Dose Study of HU6 in Healthy Volunteers

Start: Aug 2020Est. completion: Apr 2021
Phase 1Completed
NCT03611101Bristol Myers Squibb¹³C-Methacetin Breath Test

Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials

Start: May 2018Est. completion: Nov 2021124 patients
N/ACompleted
NCT03536650Fractyl HealthDMR

Effect of DMR in the Treatment of NASH

Start: Nov 2017Est. completion: Dec 2020
N/ACompleted

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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

3 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 2,341 patients
10 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)