Legal status · Australia
Is Everolimus legal in Australia?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Yes. Everolimus is an approved medicine in Australia, classified as "TGA-registered, prescription only". Approval covers its labeled indication and it is supplied on prescription, not over the counter. Products labeled "research use only" fall outside that approval and the label does not make human use lawful. On the evidence, 3 human studies are cited on its profile.
Everolimus in Australia at a glance
| Classification | TGA-registered, prescription only |
|---|---|
| TGA approval status | Approved by TGA for its labeled use |
| Human studies cited | 3 of 3 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Everolimus profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.
What this means
- 01
TGA has approved Everolimus for at least one labeled indication, so a pharmaceutical-grade product exists in Australia and is dispensed on prescription.
- 02
Approval is indication-specific. Uses outside the label are a clinical decision for a prescriber, not something the approval itself authorizes.
- 03
Unlicensed online vials, including those labeled "research use only", are not the approved product and are not covered by the approval.
What Everolimus is
The rapamycin analogue that produced the first credible human geroscience result: improved influenza vaccine response in older adults in a randomised trial.
Everolimus matters to this site for a reason unrelated to its approved uses. It is an approved cancer and transplant drug, and it was also the molecule used for the first randomised trial that took the mTOR longevity hypothesis into humans and got a positive answer.
Mechanism: A rapamycin analogue, or rapalog, that binds FKBP12 and inhibits mechanistic target of rapamycin complex 1. mTORC1 is the central nutrient and growth-factor sensor: when it is active, cells build protein and suppress autophagy, and when it is inhibited, autophagy and stress resistance increase.
Regulatory history: FDA-approved as Afinitor for several cancers and as Zortress for prophylaxis of organ rejection. Not approved for any ageing or immune-ageing indication.
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 Everolimus 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.
Everolimus in other countries
Frequently asked questions
Is Everolimus legal in Australia?
Yes. Everolimus is an approved medicine in Australia, classified as "TGA-registered, prescription only". Approval covers its labeled indication and it is supplied on prescription, not over the counter. Products labeled "research use only" fall outside that approval and the label does not make human use lawful. On the evidence, 3 human studies are cited on its profile.
Can I buy Everolimus in Australia?
Only with a prescription. Everolimus is classified as "TGA-registered, prescription only" in Australia, so it is dispensed by pharmacies against a prescription for its approved indication. Buying it from unlicensed online sellers or as a "research chemical" is outside that system and carries no regulatory protection.
Is Everolimus TGA approved?
Yes, for its labeled indication. In Australia Everolimus is classified as "TGA-registered, prescription only". For comparison, the US FDA status is: FDA-approved as Afinitor for several cancers and as Zortress for prophylaxis of organ rejection. Not approved for any ageing or immune-ageing indication.. On the evidence, 3 human studies are cited on its profile.
Related compounds in Australia
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Everolimus live on its compound profile.
Everolimus profileThis page is general information about the regulatory status of Everolimus 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.