Pegozafermin
Pegozafermin (BIO89-100)
Also known as: BIO89-100
A glycoPEGylated FGF21 analog dosed weekly or every two weeks, now owned by Roche and in two Phase 3 MASH trials.
Overview
Pegozafermin (from 89bio, acquired by Roche in 2025) showed fibrosis improvement in the ENLIVEN Phase 2b and is being tested in ENLIGHTEN-Fibrosis (F2/F3) and ENLIGHTEN-Cirrhosis (F4) with 52-week histology endpoints. Roche now holds an FGF21, a GLP-1/GIP dual agonist (enicepatide) and an amylin partnership, one of the broadest metabolic portfolios outside Lilly and Novo.
Mechanism of action
Long-acting FGF21 analog acting on FGFR1c/beta-klotho to reduce liver fat and fibrosis and improve lipids.
Key studies & citations
- Human2023
Pegozafermin in MASH with fibrosis (ENLIVEN)
Fibrosis improvement without worsening of MASH at 24 weeks.
New England Journal of Medicine - Human2024
89bio initiates Phase 3 ENLIGHTEN-Fibrosis
52-week histology co-primary endpoints.
89bio press release
Frequently asked questions
How does pegozafermin differ from efruxifermin?
Both are FGF21 analogs; they use different half-life technologies (PEGylation versus Fc fusion) and different dosing schedules. Neither has Phase 3 results yet.