Pegozafermin by Roche: status and timeline

Pegozafermin

Reverse liver scarring in MASH, including in cirrhosis where no drug is approved, by restoring the hormone signal FGF21 that tells the liver to burn fat and stop laying down scar tissue.

PilotStage 3 of 5

Phase 3 in MASH fibrosis (data H1 2027) and cirrhosis (2028); Roche bought 89bio for up to $3.5B.

Updated 30 Oct 2025Checked 11 Oct0 updates this week

Milestones

Next · ENLIGHTEN-Fibrosis (F2–F3) first topline results

Phase 2b ENLIVEN (219 patients): fibrosis and MASH gains at 24 weeksDoneComplete.
EMA PRIME priority designation2024Complete.
Roche agrees to buy 89bio (up to $3.5B)18 Sep 2025Complete.
Roche completes tender offer29 Oct 2025Complete.
ENLIGHTEN-Fibrosis (F2–F3) first topline resultsTarget 2027Current milestone.
ENLIGHTEN-Cirrhosis (F4) first resultsTarget 2028Not yet reached.

Most important updates

Upcoming

2027ENLIGHTEN-Fibrosis (F2–F3) first topline results (next)
2028ENLIGHTEN-Cirrhosis (F4) first results

Current obstacles

Cirrhosis is the hard targetMost MASH drugs fail in F4 cirrhosis; one deal milestone requires a cirrhosis launch by March 2030.
Same-class rival aheadNovo Nordisk's efruxifermin (from Akero) is another FGF21 drug in phase 3 for MASH and cirrhosis.

Physics limits

Proteins need injectionsFGF21 is a protein digested in the gut, so it must be injected; even with shielding, dosing stays weekly or twice-monthly rather than a pill.
Scar reversal is slowCollagen scars remodel over years, so trials of a year or two catch only early regression, and proof of fewer liver failures needs long outcome trials.

How it works

4 parts

Hormone

FGF21 copy

FGF21 is a hormone the liver makes under stress; it boosts fat burning, insulin sensitivity and calms scar-forming cells.

Glyco-PEG

Lasts days, not hours

Natural FGF21 is cleared in hours; a sugar-linked polymer chain shields it, allowing weekly or twice-monthly shots.

Two effects

Less fat, less scarring

Lowers liver fat and triglycerides and directly dampens inflammation and fibrosis, not just weight.

Combination

Pairs with incretins

Roche plans combinations with GLP-1-type obesity drugs, which cut weight but act on scarring less directly.

Spec sheet

Spec	Pegozafermin
ENLIGHTEN-Fibrosis enrollment	~1,050 adults (F2–F3)^R (reported)
ENLIGHTEN-Cirrhosis enrollment	~760 adults (F4)^R (reported)
Doses in phase 3	30 mg weekly or 44 mg every two weeks^R (reported)
Acquisition value	Up to $3.5B ($2.4B upfront)^R (reported)
Phase 2b ENLIVEN	219 patients^R (reported)

^R reported by the company

Update log

2 updates

Thu 30 Oct 2025

Minor: Roche completes tender offer for 89bio, taking control of pegozaferminPressPartnership

Thu 18 Sep 2025

Major: Roche agrees to buy 89bio for up to $3.5B to gain pegozafermin, a phase 3 MASH drugPressPartnership

About Roche

The team behind Pegozafermin

Roche

Diagnostics, pharmaceuticals, obesity, sequencing

Swiss pharma giant (Basel, 1896) developing obesity drugs and sequencing systems. Acquired Carmot Therapeutics (2024) and partnered with Zealand Pharma for obesity treatments. Launched Axelios 1 (June 2026), a next-gen sequencing platform with same-day whole-genome analysis.

Obesity portfolio: CT-388 (once-weekly), CT-996 (daily oral), and petrelintide combo (Phase 3 by 2026).
Axelios 1 (June 2026): same-day whole genomes via SBX chemistry; first pharma sequencer vs Illumina.
SIX-listed, ~112,000 employees, established diagnostics and medicines across pharma.

roche.com (opens roche.com)Company profile →

Founded: 1896130 yrs
Headquarters: Switzerland
Status: Public
Valuation: public
Staff: ~112,000
Works in: BiotechGenomics & sequencing
Coverage: 3 programs · 6 updateslatest 29 Jun 2026checked 11 Oct
Partners: Zealand Pharma (opens zealandpharma.com)10x Genomics (opens 10xgenomics.com)
People: Thomas Schinecker (opens roche.com)Chief Executive Officer

Spec

Pegozafermin

ENLIGHTEN-Fibrosis enrollment

~1,050 adults (F2–F3)^R (reported)

ENLIGHTEN-Cirrhosis enrollment

~760 adults (F4)^R (reported)

Doses in phase 3

30 mg weekly or 44 mg every two weeks^R (reported)

Acquisition value

Up to $3.5B ($2.4B upfront)^R (reported)

Phase 2b ENLIVEN

219 patients^R (reported)