Legal status · Australia
Is Urolithin B legal in Australia?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Urolithin B can be sold in Australia as a supplement or cosmetic ingredient, classified as "Available as a supplement / complementary medicine". That is not drug approval: TGA has not evaluated any health claim, and injectable or "research use only" versions fall outside supplement rules, so that label does not make human use lawful. On the evidence, 1 human study is cited on its profile.
Urolithin B in Australia at a glance
| Classification | Available as a supplement / complementary medicine |
|---|---|
| Note | Available in complementary medicine products. |
| TGA approval status | Not a TGA drug approval; sold as a supplement or cosmetic |
| Human studies cited | 1 of 4 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Urolithin B profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.
What this means
- 01
Urolithin B can be sold in Australia as a supplement, food or cosmetic ingredient under the classification above, without drug approval.
- 02
Supplement status means TGA has not evaluated any health claim; manufacturers are responsible for safety and labeling, and quality varies by product.
- 03
Injectable or "research use only" versions are not supplements. That label does not make human use lawful, and injectables fall under medicines rules.
What Urolithin B is
Sold on the reputation of urolithin A, which has human trials. Urolithin B has none: the muscle result is C2C12 cells and mice given 10 micrograms a day through an implanted osmotic pump for 28 days.
Urolithin B is one of the compounds gut bacteria make from the ellagitannins in pomegranate, walnuts and berries. It is structurally simpler than urolithin A and has a different reported action: rather than mitophagy, the 2017 paper that put it on the map described it as a regulator of muscle protein balance acting through the androgen receptor.
Mechanism: In muscle cells and mice, an increase in protein synthesis with repression of the ubiquitin-proteasome degradation pathway, with the androgen receptor implicated genetically and pharmacologically and crosstalk to mTORC1 signalling, possibly through AMPK. This is a different proposed mechanism from urolithin A, which is sold and studied as a mitophagy activator.
Regulatory history: Not an approved drug. Sold as a supplement ingredient and as a research chemical. No registered human trial has administered it.
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 Urolithin B 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.
Urolithin B in other countries
Frequently asked questions
Is Urolithin B legal in Australia?
Urolithin B can be sold in Australia as a supplement or cosmetic ingredient, classified as "Available as a supplement / complementary medicine". That is not drug approval: TGA has not evaluated any health claim, and injectable or "research use only" versions fall outside supplement rules, so that label does not make human use lawful. On the evidence, 1 human study is cited on its profile. Note: Available in complementary medicine products.
Can I buy Urolithin B in Australia?
Yes, in supplement or cosmetic form. In Australia Urolithin B is classified as "Available as a supplement / complementary medicine", so oral, topical or cosmetic products can be sold under supplement rules. Injectable versions and products labeled "research use only" are not supplements and are not approved for human use. Note: Available in complementary medicine products.
Is Urolithin B TGA approved?
No. In Australia Urolithin B is classified as "Available as a supplement / complementary medicine", which is not a TGA marketing approval. For comparison, the US FDA status is: Not an approved drug. Sold as a supplement ingredient and as a research chemical. No registered human trial has administered it.. On the evidence, 1 human study is cited on its profile.
Related compounds in Australia
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Urolithin B live on its compound profile.
Urolithin B profileThis page is general information about the regulatory status of Urolithin B 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.