The approval covers four strengths of the oral tablet: 1.5 mg, 4 mg, 9 mg, and 25 mg. The TGA has authorized the medication as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management, including both weight loss and maintenance. Additionally, the pill is approved to reduce the risk of major adverse cardiovascular events, such as heart attack or stroke, in eligible adults. These indications align with those already approved for the injectable version of Wegovy.
For many patients, the shift from injection to oral medication represents a significant improvement in convenience. The injectable form of semaglutide requires weekly administration into the abdomen, thigh, or upper arm, necessitating refrigeration and additional equipment such as swabs and sharps containers. In contrast, the oral tablet is taken daily. However, the convenience is tempered by strict administration protocols. Patients must take the pill on an empty stomach with a sip of water upon waking. They are required to fast for eight hours prior to taking the dose and must wait 30 minutes before eating, drinking, or taking any other oral medications. This regimen is designed to ensure the drug is absorbed effectively, as food and other liquids can interfere with its bioavailability.
Eligibility for the treatment remains tied to specific clinical criteria. Adults with obesity, defined as a body mass index (BMI) of 30 or higher, are eligible. Those with overweight, defined as a BMI between 27 and 30, are also eligible if they have at least one weight-related comorbidity. Dr. Brendan Hanrahan, an obesity medicine expert at Brisbane’s Wesley Hospital, noted that the range of qualifying conditions is broad, including knee osteoarthritis and fatty liver disease. He described the drugs as having “lived up to and exceeded the hype,” welcoming the improved access. However, he also raised questions about the reliance on BMI cutoffs, suggesting that waist circumference might be a more accurate measure of risk for some individuals, though he acknowledged that outliers exist in both metrics.
The TGA has issued clear warnings regarding the safety profile of the medication. As with other GLP-1 receptor agonists, gastrointestinal side effects are common and can include nausea, diarrhea, vomiting, and constipation. The TGA specifically warns that stomach issues can lead to dehydration, which in turn may cause renal failure. Other potential risks include acute pancreatitis and diabetic retinopathy. Novo Nordisk also lists headache, fatigue, and dizziness as possible adverse effects. The TGA explicitly advises against combining the oral Wegovy tablets with Wegovy injections or any other semaglutide-containing products or GLP-1 receptor agonists.
While the approval is a significant milestone, practical barriers remain. The price of the drug in Australia has not yet been determined, raising concerns about affordability and accessibility. In the United States, where the oral formulation was released in January, Wegovy tablets surpassed three million prescriptions in just over five months. Novo Nordisk noted that the majority of these new prescriptions were for patients new to GLP-1 therapy, indicating a strong demand for non-injectable options. The rapid uptake in the US, where one script was filled every five seconds, suggests that Australian demand may be similarly high once the product is available.
RACGP President Dr. Michael Wright described the approval as “a step forward” for patients, highlighting that the injection requirement has been a key limitation of GLP-1 therapy in recent years. The approval brings Australia in line with other major markets and offers a new pathway for individuals who may have been hesitant to start treatment due to the barrier of injections. Yet, the strict fasting requirements and the need for daily dosing mean that patient adherence will be a critical factor in the drug’s real-world effectiveness. As the medication approaches the market, healthcare providers and patients will be watching closely for pricing details and any further guidance on long-term management and side-effect monitoring.
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