Pegozafermin

Phase 3Protein / enzyme

Pegozafermin is a protein / enzyme that works as a FGF21 Analog.[2] It is being investigated across 8 indications, with its most advanced program in Phase 3.[1]

Pegozafermin is one of 161 fusion protein programs targeting Alcoholic Fatty Liver Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

160

Competitors

Pipeline

Status by Indication[3][1]

Indication

Alcoholic Fatty Liver DiseaseActive, not recruiting

FibrosisActive, not recruiting

NASH/MASHRecruiting

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisRecruiting

Severe HypertriglyceridemiaCompleted

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated CirrhosisRecruiting

CirrhosisActive, not recruiting

HypertriglyceridemiaActive, not recruiting

Alcoholic Fatty Liver DiseasePhase 1/Phase 2

Active, not recruiting

FibrosisPhase 3

Active, not recruiting

NASH/MASHPhase 3

Recruiting

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisPhase 3

Recruiting

Severe HypertriglyceridemiaPhase 3

Completed

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated CirrhosisPhase 3

Recruiting

CirrhosisPhase 3

Active, not recruiting

HypertriglyceridemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

252 competitors in Cirrhosis

#DrugCompanyPhaseTrials

Pegozafermin

89bio

Phase 3

5 2

Proamatine

Takeda

Preclinical

9 3

Crestor

AstraZeneca

Preclinical

2 4

Farxiga

AstraZeneca

Preclinical

1 5

Thalomid

Bristol-Myers Squibb

Preclinical

1 6

Dobutrex

Eli Lilly

Preclinical

1 7

Azulfidine

Pfizer

Preclinical

1 8

HEPCLUDEX

Gilead

Preclinical

1 9

Coreg

Akero Therapeutics

Preclinical

6 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2029

Phase 3Recruiting

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

NCT06318169

Q3 2031

Phase 3Recruiting

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

NCT06419374

Clinical

Trials by Indication[1]

Hypertriglyceridemia1 trial

Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia

Completed· 89bio logo

89bio·Phase 2·NCT04541186·86 enrolled

Alcoholic Fatty Liver Disease1 trial

A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

Completed· 89bio logo

89bio·Phase 1/2·NCT04048135·101 enrolled

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis1 trial

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)

Recruiting· 89bio logo

89bio·Phase 3·NCT06419374·762 enrolled

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis1 trial

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Recruiting· 89bio logo

89bio·Phase 3·NCT06318169·1,350 enrolled

Severe Hypertriglyceridemia1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study

Completed· 89bio logo

89bio·Phase 3·NCT05852431·369 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Pegozafermin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pegozafermin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pegozafermin. EMBL-EBI & Wellcome Sanger Institute.
[4]
PubMed — 2 publications indexed for Pegozafermin. U.S. National Library of Medicine.
[5]
SEC EDGAR — 89bio company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FGF21 Analog[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: 89bio

Key Publications[4]

Pegozafermin in NASH: ENLIVEN Phase 2b Results

Lancet Gastroenterol HepatolNov 9, 2023DOI: 10.1016/S2468-1253(23)00329-6

Pegozafermin in Severe Hypertriglyceridemia: Phase 2

JAMASep 14, 2023DOI: 10.1001/jama.2023.14954

Pegozafermin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Q3 2031

Trials by Indication[1]

Hypertriglyceridemia1 trial

Alcoholic Fatty Liver Disease1 trial

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis1 trial

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis1 trial

Severe Hypertriglyceridemia1 trial

References

Drug Info

Quick Facts

Key Publications[4]

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