First GLP-1 weight loss pill approved in Australia
Australia’s medicines regulator has approved Novo Nordisk’s Wegovy tablet for eligible adults, marking the country’s first GLP-1 weight-loss pill. The oral medicine is expected later this year, after a review of its packaging and production processes. Doctors say wider access could help patients, but warn that prescribing must include careful screening and ongoing support.
Australia’s Therapeutic Goods Administration approved Novo Nordisk’s first GLP-1 weight loss pill, Wegovy, on Tuesday evening, opening a tablet option for eligible adults after years of access through weekly injections. The company expects availability later this year, once the regulator reviews packaging and production processes.
The approval covers weight management and reducing the risk of major adverse cardiovascular events. But wider access also raises questions about safe prescribing as demand for these medicines has climbed.
What changes with the first GLP-1 weight loss pill?
Patients will take the tablet every morning on an empty stomach. Unlike injectable Wegovy, the pill stays stable at room temperature and does not require refrigeration.
A Novo Nordisk spokesperson said the company 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”. The TGA approved the oral formulation in 1.5mg, 4mg, 9mg and 25mg strengths.
The medicine is not yet on the market. The TGA still needs to review packaging and production processes before it can be supplied in Australia. The approval follows similar endorsements in the UK and the US, where the oral Wegovy pill is also cheaper than injectable versions.
Rising demand brings prescribing concerns
GLP-1 use has already grown sharply in Australia. A University of NSW study found peptide sales increased almost 10-fold in five years, from about 58,000 units in May 2020 to about 500,000 sales in April 2025. The study said those figures underestimate overall GLP-1 use because treatments marketed purely for weight loss were omitted.
The new tablet could widen access further. For patients, that may mean a medicine that is easier to store and take than a weekly injection. Yet easier access does not remove the need to assess whether treatment is suitable or to provide continuing care.
Dr Karen Spielman, chair of the RACGP’s Specific Interests Psychological Medicine group, said the approval could improve accessibility and affordability for Australians seeking medical weight loss. She also warned that a broad rise in prescribing could expose patients to harm, including reports of people with an eating disorder being hospitalised after accessing the drug. The TGA has also warned of links between GLP-1 medicines, including Wegovy, and suicidal thoughts.
“[GLP-1s] do a lot of good for a lot of people, but there are some people that they’re really dangerous for,” Spielman said. “It’s really incumbent on us as prescribers to screen, manage and support our patients ongoing.”
Spielman said higher Medicare patient rebates were needed so patients could have complex, longer consultations. “There’s a risk of inappropriate prescribing if people aren’t able to have complex, longer consultations,” she said.
For confidential and free eating-disorder support, the Butterfly National Helpline can be reached on 1800 ED HOPE (1800 33 4673); the service also offers online chat and email through butterfly.org.au.
