Legal status · Australia
Is Pegozafermin legal in Australia?
No. Pegozafermin is not approved for any medical use in Australia; its classification is "Investigational, not registered". 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 Australia at a glance
| Classification | Investigational, not registered |
|---|---|
| TGA approval status | Not approved by TGA; investigational |
| Evidence level | Moderate (research strength: Moderate) |
| Reviewed | Sep 2026 |
Classification and note come from the Pegozafermin profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.
What this means
- 01
Pegozafermin is being studied in registered clinical trials but has not received TGA marketing approval in Australia.
- 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 TGA treats this kind of product
Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.
The classification above is the The Longevity Archive reading of Therapeutic Goods Administration 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 Australia?
No. Pegozafermin is not approved for any medical use in Australia; its classification is "Investigational, not registered". 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 Australia?
No approved product exists to buy. In Australia Pegozafermin is classified as "Investigational, not registered", 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 TGA approved?
No. In Australia Pegozafermin is classified as "Investigational, not registered", which is not a TGA marketing approval. For comparison, the US FDA status is: Investigational; Phase 3. Evidence level: Moderate.
Related compounds in Australia
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 Australia, current as of Sep 2026. It is not legal advice, and classifications change; check Therapeutic Goods Administration 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.