New Weight Management Option Approved in Australia

The Therapeutic Goods Administration (TGA) has recently approved semaglutide tablets (Wegovy®), the first oral glucagon-like peptide-1 (GLP-1) receptor agonist to be approved for weight management in Australia. Semaglutide tablets provide an alternative to weekly injectable GLP-1 therapies and may improve access for patients who are unable or unwilling to use injections.

Wegovy® tablets are registered as an adjunct to diet and exercise for chronic weight management in adults with obesity, and for those who are overweight with at least one weight-related comorbidity. They are also indicated to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease who are overweight or obese. Four tablet strengths have been approved (1.5 mg, 4 mg, 9 mg, and 25 mg) to support gradual dose escalation, similar to the titration approach used with injectable semaglutide.

Semaglutide is poorly absorbed from the gastrointestinal tract. To overcome this limitation, the tablets are formulated with the absorption enhancer, salcaprozate sodium. This molecule improves semaglutide absorption through several mechanisms, including:

• Local buffering of gastric contents, reducing proteolytic degradation;
• Stabilisation of the monomeric form of semaglutide, preventing the formation of large complexes that are less readily absorbed; and
• Facilitation of semaglutide absorption across the gastric mucosa.

To maximise absorption, semaglutide tablets should be taken on an empty stomach with a small amount of water. Patients should then wait 30 minutes before eating, drinking, or taking other oral medicines.

A recently published clinical trial compared the efficacy of oral semaglutide (25 mg daily) with placebo. Participants receiving semaglutide achieved a mean body weight reduction of 13.6%, compared with 2.2% in the placebo group. Gastrointestinal adverse effects, including nausea, vomiting and diarrhoea, were the most frequently reported adverse events. These were generally mild to moderate in severity and typically improved with continuing therapy.

Although Wegovy® tablets have received regulatory approval, they are not yet available in Australia. The sponsor has indicated that the product is expected to be available in late 2026 and will be accessed by private prescription.