Is Ambroxol legal in Australia?

An over-the-counter cough medicine in much of the world that raises glucocerebrosidase levels in the brain at high doses. The one randomised placebo-controlled trial in Parkinson disease dementia, 55 patients over 52 weeks, hit target engagement and missed both primary clinical endpoints.

Ambroxol has been sold as a mucolytic for decades. Its second life began in 2009 when a screen identified it as an enzyme enhancement agent for Gaucher disease, meaning it acts as a pharmacological chaperone that helps the enzyme glucocerebrosidase fold and reach the lysosome.

Mechanism: A pharmacological chaperone for glucocerebrosidase. It binds the enzyme in the endoplasmic reticulum at neutral pH, stabilising the folded form so more of it traffics to the lysosome, and releases it at the acidic lysosomal pH.

Regulatory history: Not approved in the United States for any indication. Widely available over the counter as a mucolytic in Europe, Asia and Latin America. The Parkinson disease work is investigational everywhere and uses doses far above the mucolytic range.

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 Ambroxol 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.