Clasado Biosciences’ prebiotic galactooligosaccharide gains Australian TGA approval

Clasado Biosciences has reached a regulatory milestone for its prebiotic galactooligosaccharide ingredient, Bimuno GOS, which is now approved for use in Therapeutic Goods Administration-listed (TGA) products in Australia. This includes dietary supplements intended for therapeutic purposes, a development set to expand options for Australian consumers seeking gut-focused health solutions.

The TGA approval means dietary supplements incorporating Bimuno GOS can now be marketed under the TGA framework and can refer to a range of permitted health effects.

This builds upon Bimuno GOS’ existing success within the FSANZ (Food Standards Australia New Zealand) category, where 29 self-substantiated food-health relationship claims are already available.

“This is a major step forward for Bimuno GOS in Australia. Formulators now have the opportunity to include the most studied GOS on the market in therapeutic products that align with consumer demand for credible, gut-focused health solutions,” says David Mharakurwa, regional director APAC at Clasado Biosciences.

“With permitted claims available under TGA regulation for products containing Bimuno GOS, it makes it easier to communicate those benefits clearly and confidently to consumers.”

Australian supplement market surges

Australia’s supplement market is one of the world’s most progressive, valued at US$13.74 billion in 2023, highlights Clasado Biosciences. In particular, it notes the prebiotic category is experiencing strong growth, with projections forecasting its value to triple to US$708 million by 2030 at a 17.6% CAGR.

Bimuno GOS is backed by its strong scientific profile, supported by more than 125 publications and over 20 clinical trials, and a clinically proven low dose starting from 1.37 g daily. This offers formulators flexibility in product development.

The ingredient also delivers synergies with other ingredients, as one previous study highlighted the benefits of combining Bimuno GOS with the probiotic Probi Defendum, which is designed to support immune health formulations.

“Entering the TGA category is a key milestone for Bimuno GOS in the APAC region. This reinforces the trusted safety and quality of Bimuno GOS while creating new opportunities for our partners to innovate in the growing therapeutic product space,” says Lucie Nagy, general counsel at Clasado Biosciences.

Mharakurwa adds: “This development supports our broader ambition — to make better gut health accessible to more people, in more markets, through scientifically validated ingredients that are easy to formulate and trusted by the industry.”

“With Bimuno now available for use within TGA-listed products now, we’re proud to be giving Australian formulators the tools to deliver next-generation prebiotic gut health products that meet the highest consumer and regulatory expectations.”