Legal status · Canada
Is Pegozafermin legal in Canada?
No. Pegozafermin is not approved for any medical use in Canada; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. Human evidence to date: Moderate.
Pegozafermin in Canada at a glance
| Classification | Investigational, not approved |
|---|---|
| Health Canada approval status | Not approved by Health Canada; investigational |
| Evidence level | Moderate (research strength: Moderate) |
| Reviewed | Sep 2026 |
Classification and note come from the Pegozafermin profile, checked against Health Canada, Health Products and Food Branch (Health Canada) listings at the reviewed date.
What this means
- 01
Pegozafermin is being studied in registered clinical trials but has not received Health Canada marketing approval in Canada.
- 02
Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.
- 03
Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.
What Pegozafermin is
A glycoPEGylated FGF21 analog dosed weekly or every two weeks, now owned by Roche and in two Phase 3 MASH trials.
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: Long-acting FGF21 analog acting on FGFR1c/beta-klotho to reduce liver fat and fibrosis and improve lipids.
Regulatory history: Investigational; Phase 3
How Health Canada treats this kind of product
Authorises drugs for sale through a Notice of Compliance and Drug Identification Number. A compound that is not authorised for sale cannot lawfully be sold for human use, and personal importation of prescription drugs is limited.
The classification above is the The Longevity Archive reading of Health Canada, Health Products and Food Branch listings for Pegozafermin at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
Pegozafermin in other countries
Frequently asked questions
Is Pegozafermin legal in Canada?
No. Pegozafermin is not approved for any medical use in Canada; its classification is "Investigational, not approved". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. Human evidence to date: Moderate.
Can I buy Pegozafermin in Canada?
No approved product exists to buy. In Canada Pegozafermin is classified as "Investigational, not approved", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors.
Is Pegozafermin Health Canada approved?
No. In Canada Pegozafermin is classified as "Investigational, not approved", which is not a Health Canada marketing approval. For comparison, the US FDA status is: Investigational; Phase 3. Evidence level: Moderate.
Related compounds in Canada
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Pegozafermin live on its compound profile.
Pegozafermin profileThis page is general information about the regulatory status of Pegozafermin in Canada, current as of Sep 2026. It is not legal advice, and classifications change; check Health Canada, Health Products and Food Branch directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.