Weight-loss pill launches in US

A daily pill may replace a weekly injection for many American adults managing obesity, with the approval in the United States of a pill version of the weight-loss drug Wegovy.
 
The daily pill has become the country’s first oral semaglutide medication available on prescription, after the pill was approved in December 2025 by the US Food and Drug Administration (FDA).
 
As the pill is cheaper to produce than an injecting pen, its manufacturers, Novo Nordisk, say the medication will also cost less for consumers.
 
Imminent market competition may also play a role in price control, with a second pill, from manufacturer Eli Lilly, also under FDA review and predicted to be available within months.
 
Unlike injectable GLP-1 receptor agonists, which are available to adolescents aged 12 and over, the Wegovy pill is not approved for people aged under 18.
 
A TGA spokesperson told newsGP that, ‘to date’, no application has been received for the registration of the Wegovy weight-loss pill.
 
In the US, one in eight people has used injectable GLP-1 drugs, while in Australia hundreds of thousands of people access the medications under private prescription, paying up to $5000 a year.
 
RACGP Specific Interests Obesity Management Chair Dr Terri-Lynne South hopes Australia follows suit with approving an oral GLP-1, but says GPs and consumers should ‘curb their enthusiasm’ and be prepared for a wait.
 
‘It’s likely to take some time for it to go through the TGA approval process, and then a completely separate consideration if it was requested to be on the PBS,’ she said.
 
Dr South doubts the availability of oral semaglutide would ‘necessarily’ make a big impact on the prevalence of obesity.
 
‘This is a chronic, complex condition which needs ongoing management,’ she said.
 
‘And if a medication is part of that management, then that medication is expected to be long term, if not lifelong.’
 
Much research is already showing ‘significant’ weight regain is common following the cessation of weight-loss medication.
 
A recent review of 37 studies found people who stopped taking their weight loss medication returned to their original weight in less than two years on average.
 
With the medications only becoming available relatively recently for weight loss, Dr South said it is also too early to assess long-term efficacy, or side effects.
 
‘It’s still early days for us to see how well the long-term effects are beyond four years,’ she said.
 
‘We’ve got data of the injectable medication helping patients maintain weight loss if they stay on that maximum tolerance out to four years, but we just don’t know beyond that.
 
‘It’s hopeful, but I still don’t think we’ve got enough long-term data to do future projections on incidences and prevalence rates.’
 
There is also concern around long-term side effects.
 
Dr South said the oral semaglutide medication has been associated with a higher prevalence of mild gastrointestinal symptoms compared to injectable medication.
 
‘It just reinforces that these medications, particularly at higher doses for obesity management, are still relatively new, so we are still working out potential risk-versus-benefit ratios,’ she said.
 
In the US, around 42% of adults, about 100 million people, are considered obese under the traditional body-mass-index definition.
 
However, under a new definition and diagnostic criteria of obesity released in 2025 by the Lancet Diabetes and Endocrinology Commission, which also includes measure of body fat distribution, researchers estimate this figure would skyrocket to 70%.
 
‘That’s actually a very helpful step forward, to get away from using definitions of obesity that are BMI or weight focused,’ Dr South said. ‘That will be helpful in reducing the stigma and separating risk factors from actual health condition definitions.’
 
Dr South said she would welcome Australians having more choices of weight-loss medication, hoping it would make it more accessible and affordable.
 
‘I’m hopeful that a pill version would be less expensive, just because it’s less costly to manufacture [that injectables],’ she said.
 
‘But I have concerns that it still may have health inequities around price point and access.’
 
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