TGA registers Mounjaro for chronic weight management in Australia

Australia's Therapeutic Goods Administration (TGA) registered Mounjaro for chronic weight management on September 10, 2024, adding a weight-loss use to the medicine's existing approval in that country ^[1]. The active ingredient in Mounjaro is tirzepatide, the same molecule sold in the United States under the brand names Mounjaro and Zepbound.

According to the TGA's public registration record, the sponsor is Eli Lilly Australia Pty Ltd, and the agency's evaluation of the weight-management application began October 3, 2023 ^[1]. The TGA reached a decision on September 9, 2024, and the medicine was formally registered the next day ^[1]. The agency lists the total approval time as 191 calendar days, or 255 working days ^[1].

The new Australian indication states that Mounjaro is meant to be used along with a reduced-calorie diet and increased physical activity for chronic weight management, including weight loss and weight maintenance, in adults ^[1]. Under the TGA listing, adults qualify if they have a body mass index (BMI) of 30 or higher, which is classified as obesity, or a BMI of 27 to under 30 combined with at least one weight-related health condition ^[1]. The record lists hypertension, dyslipidaemia (abnormal blood fat levels), obstructive sleep apnoea, cardiovascular disease, prediabetes, and type 2 diabetes as examples of qualifying conditions ^[1].

Why it matters for patients

This is a decision by Australia's medicine regulator, not the US Food and Drug Administration, so it does not change how tirzepatide is prescribed, labeled, or sold in the United States. Still, the BMI-based eligibility criteria in the TGA listing—30 and above, or 27 to under 30 with a weight-related condition such as high blood pressure, high cholesterol, sleep apnea, heart disease, prediabetes, or type 2 diabetes—mirror the kind of thresholds used elsewhere for GLP-1 based weight medicines ^[1]. Readers who are following tirzepatide's rollout in other countries can use this record as a reference point for how one regulator defined the patient group it is meant for.

The TGA record does not say whether Australia's public subsidy program will cover the weight-management use, what it will cost patients there, or when supply will be available at pharmacies ^[1]. Those questions are not answered in the source and are not yet known from what has been published.

For US patients, the main relevance is that tirzepatide's weight-management indication is now recognized in another major regulatory system, following its own separate review process in Australia that took nearly 255 working days from start to decision ^[1]. This does not affect current US prescribing, insurance coverage, or FDA-approved labeling for Mounjaro or Zepbound, none of which is addressed in this source.

What happens next

The TGA registration record does not include a public release date for Australian pharmacy availability, subsidy status, or pricing tied to the new weight-management indication ^[1]. Those details, along with any changes to US labeling or availability, are not covered in this source and remain unknown for now.