First GLP-1 weight loss pill in Australia to hit market by end of the year

A GLP-1 weight-loss tablet has been approved in Australia for the first time, expected to lead to a surge in demand for the sought-after peptide that could hit the market by the end of this year.

The Therapeutic Goods Administration (TGA) approved Novo Nordisk’s Wegovy (semaglutide) pill on Tuesday evening, following similar endorsements in the UK and the US.

Until now, Australians could only access GLP-1s in the form of weekly injections, with the new pill the first accreditation of its kind in Australia.

The pill was approved for use in eligible adults for the purposes of weight management and for reduction in the risk of major adverse cardiovascular events.

Peptide sales increased almost 10-fold in five years across the country, a University of NSW study found, from about 58,000 units in May 2020 to about 500,000 sales in April 2025, driven by private access for purposes including weight loss. These numbers underestimate Australia’s overall use of GLP-1s, with treatments marketed purely for weight loss omitted.

The accessibility of oral peptides is expected to lead to another marked boost in sales.

The new pill is taken every morning on an empty stomach and stays stable at room temperature, unlike the injectable Wegovy, which requires refrigeration. In the UK and US, Wegovy’s oral pill is also cheaper than its injectables.

The TGA will still need to review packaging and production processes before the pill hits the market in Australia, with oral formulation approved in 1.5mg, 4mg, 9mg and 25mg strengths.

A spokesperson for Novo Nordisk said the pharmaceutical giant was “working towards bringing this new treatment option to eligible Australians, with anticipated availability later this year. We will share confirmed availability timing as soon as we can”.

Chair of the RACGP’s Specific Interests Psychological Medicine group, Dr Karen Spielman, said the approval would improve accessibility and affordability for Australians seeking medical weight loss.

However, she warned that a widespread increase in prescribing came with patient risks, including reports of patients with an eating disorder being hospitalised after accessing the drug, and a warning from the TGA about links between GLP-1s including Wegovy and suicidal thoughts.

Spielman said if the approval led to another rapid surge in demand, it was essential to ensure appropriate guidelines were in place for both patients and prescribers.

“[GLP-1s] do a lot of good for a lot of people, but there are some people that they’re really dangerous for,” she said. “It’s really incumbent on us as prescribers to screen, manage and support our patients ongoing.”

Spielman said an increase to Medicare patient rebates was needed to prevent harm: “There’s a risk of inappropriate prescribing if people aren’t able to have complex, longer consultations.”

For confidential & free support for eating disorders call the Butterfly National Helpline on 1800 ED HOPE (1800 33 4673) or visit www.butterfly.org.au to chat online or email.

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