Therapeutic Goods Administration approves Australia’s first oral weight-loss medication


The Therapeutic Goods Administration has approved Australia’s first oral weight-loss medication.

The TGA greenlit Novo Nordisk’s Wegovy tablets, which contain semaglutide, the same active ingredient used in the popular jabs.

The approval covers four strengths: 1.5mg, 4mg, 9mg and 25mg.

The tablets were approved for weight management and to help reduce the risk of major cardiovascular events in at-risk patients.

“The indications are consistent with those approved for the injectable formulation of Wegovy,” a Department of Health spokesman told news.com.au.

The oral medication is taken once daily and a precise routine must be followed for the tablet to work.

It is understood the drug will be available in Australia sometime in 2027.

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The pills work by mimicking the GLP-1 hormone, which helps regulate appetite, increase feelings of fullness and reduce food intake.

However, patients will need a prescription, and the treatment is not suitable for everyone.

In Australia, weight loss drugs are currently approved under the Pharmaceutical Benefits Scheme only for people with type 2 diabetes who meet specific criteria.

CEO of pharmaceutical giant Novo Nordisk, Mike Doustdar, previously told News24 the firm was having “very good” dialogue with the Pharmaceutical Benefits Advisory Committee (PBAC) about access to its medicines.

Novo Nordisk produces Ozempic and Wegovy, while United States company Eli Lilly makes Mounjaro.

“Think about your vaccine. You cannot drink your vaccine, the gut enzymes and acids destroy it before it gets to your bloodstream,” he said.

“We’ve been able to create a pill and encapsulate it in very special technologies that allow for that to happen.

“Our product in the pill format has the exact same efficacy as the injectable one.

“So patients have the choice of going for a weekly injection or a daily pill with the same efficacy and the same tolerability, which is fantastic.

“We have introduced that in the US and hope to expand from there into other markets, hopefully also one day here.”

In December 2025, the Therapeutic Goods Administration warned patients taking GLP-1 weight loss and diabetes jabs should be monitored for suicidal behaviour.

Product warnings across medicines were updated to ensure “consistent information regarding the potential risk of suicidal thoughts or behaviours”.

However, the Advisory Committee on Medicines found insufficient evidence the drugs actually caused suicidal ideation – although it still advised information for the drugs should be updated to add awareness of potential risks.

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