Daily weight-loss pill approved in US, experts urge caution
14 Jan 2026
The US Food and Drug Administration (FDA) approved an oral version of semaglutide in December 2025, making it the first prescription pill form of the weight-loss drug Wegovy available in the country. The approval means some adults managing obesity may be able to switch from a weekly injection to a daily tablet.
The medication is produced by Novo Nordisk, which says the pill is cheaper to manufacture than injectable pens and is expected to cost less for consumers. Price competition may also increase, with a similar oral medication from Eli Lilly currently under FDA review.
Unlike injectable GLP-1 medications, which are approved for people aged 12 and over, the pill version is not approved for use in those under 18.
A spokesperson for Australia’s Therapeutic Goods Administration (TGA) confirmed that no application has yet been lodged to register the oral Wegovy pill locally.
In the US, around one in eight people has used injectable GLP-1 medications. In Australia, hundreds of thousands of people access these drugs through private prescriptions, with costs reaching up to $5000 per year.
RACGP Specific Interests Obesity Management Chair Dr Terri-Lynne South said she hopes Australia eventually approves an oral GLP-1 option but warned expectations should be tempered.
She said any approval would need to pass the TGA process and then face a separate assessment if inclusion on the Pharmaceutical Benefits Scheme (PBS) was sought.
Dr South said obesity is a chronic and complex condition requiring long-term management, noting that medications, if used, are typically expected to be ongoing.
Research shows weight regain is common after stopping weight-loss medication. A review of 37 studies found people generally returned to their original weight in less than two years after discontinuation.
Dr South said it is still too early to fully understand the long-term effectiveness and safety of these treatments, particularly beyond four years. While injectable medications have shown sustained benefits when continued, data on longer-term outcomes remain limited.
She also noted concerns about side effects, with oral semaglutide linked to a higher rate of mild gastrointestinal symptoms compared with injectable forms.
In the US, about 42% of adults are classified as obese under traditional body mass index (BMI) definitions. Under new obesity criteria released in 2025 by The Lancet Diabetes and Endocrinology Commission, which incorporate body fat distribution, that figure could rise to around 70%.
Dr South welcomed the shift away from BMI-only definitions, saying it could help reduce stigma and better reflect obesity as a health condition.
While she supports expanding treatment options in Australia, she said affordability and access remain concerns.
https://www1.racgp.org.au/
Source: newsGP / RACGP / US Food and Drug Administration (FDA)