Is tirzepatide available in Australia? TGA status of Mounjaro, Ozempic and Wegovy

Is tirzepatide (Mounjaro) available in Australia?

Yes, as a registered medicine. The TGA register lists Mounjaro with tirzepatide as the active ingredient. The register records a first registration on 23 December 2022 for adults with insufficiently controlled type 2 diabetes, an extension of indications registered on 10 September 2024 for chronic weight management in adults with a body mass index of 30 or more, or 27 to under 30 with at least one weight-related condition, and a further extension registered on 2 June 2025 for moderate to severe obstructive sleep apnoea in adults with obesity (TGA register entries, read 14 October 2026). The TGA's Medicines Safety Update of 3 June 2025 describes Mounjaro as approved for both type 2 diabetes and chronic weight management.

Registration is a statement about approval, not about stock. The TGA register records that the medicine passed evaluation for safety, quality and efficacy for the listed use. Whether a pharmacy holds stock on a given day is a separate record, and this page did not check it. The tirzepatide research guide covers the compound itself.

The TGA's public assessment report for Mounjaro (AusPAR, finalised 20 September 2024) lists SURMOUNT-1 and SURMOUNT-2 as the phase 3 studies behind the chronic weight management extension. SURMOUNT-1 is reported in Jastreboff et al., New England Journal of Medicine, 2022.

Is tirzepatide a prescription-only medicine in Australia?

Tirzepatide is listed in Schedule 4, headed "Prescription only medicines and prescription animal remedies", of the October 2026 Poisons Standard (read 14 October 2026). The instrument is F2026L01327, the Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, dated 28 September 2026 and commencing 1 October 2026. It also lists tirzepatide in Appendix L, clause 2, the list of additional warning statements for certain human medicines. Semaglutide, the molecule in Ozempic and Wegovy, is also a named Schedule 4 entry in the same instrument. Schedule 4 is the schedule that carries prescription-only medicines.

A schedule entry classifies a substance. It is not a statement about any person's legal position, and it does not replace the product-level question of approval. What Schedule 4 and Appendix D mean explains the scheduling system and how its entries differ.

A later edition of the Poisons Standard replaces this one, so every statement about it needs its date.

Is Ozempic available for weight loss in Australia?

Ozempic is registered in Australia for type 2 diabetes, not for weight loss. The TGA register records Ozempic (semaglutide) as registered on 28 August 2019 for adults with insufficiently controlled type 2 diabetes, and a second entry registered on 18 August 2025 adds reduced risk of sustained kidney function decline and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (read 14 October 2026). The TGA's page on advertising Ozempic and GLP-1 receptor agonists, last updated 11 March 2025, says it is illegal to advertise Ozempic for weight loss, even to health professionals, because weight loss is not an indication on the ARTG. Wegovy, a different semaglutide product, is the one registered for chronic weight management.

Ozempic and Wegovy contain the same molecule and carry different registrations. The TGA register lists Wegovy as registered on 1 September 2022 for chronic weight management in adults, with later entries on 26 February 2024 for adolescents aged 12 and over with obesity and body weight above 60 kg, on 19 December 2024 for reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease, a body mass index of 27 or more and no diabetes, and on 30 March 2026 for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (read 14 October 2026).

Which GLP-1 medicines are registered in Australia, and for what?

The TGA's Medicines Safety Update of 3 June 2025 names six GLP-1 or dual GIP/GLP-1 medicines marketed in Australia at that date, made from four molecules. Ozempic (semaglutide), Trulicity (dulaglutide) and Victoza (liraglutide) are approved for type 2 diabetes. Saxenda (liraglutide) and Wegovy (semaglutide) are approved for chronic weight management. Mounjaro (tirzepatide) is approved for both. The table below sets the three medicines this page covers beside their US label dates. Registered indications can be extended, so the register entry decides, not this summary.

The TGA's advertising page, last updated 11 March 2025, names Ozempic, Wegovy, Mounjaro and Trulicity as prescription-only medicines and says prescription medicines cannot be advertised to the public. The 3 June 2025 update says a warning was added to the product information for Trulicity, Victoza, Saxenda, Ozempic, Wegovy and Mounjaro about the risk of accidentally inhaling stomach contents during general anaesthesia or deep sedation, because medicines in these classes can delay gastric emptying. Tirzepatide side effects records the adverse-event data in trials.

Is Ozempic FDA-approved, and what about Mounjaro?

Yes. The US prescribing information for Ozempic states "Initial U.S. Approval: 2017" for semaglutide, the active ingredient rather than a brand-launch date, and its indications cover type 2 diabetes, reducing major cardiovascular events in people with type 2 diabetes and heart or blood-vessel disease, and slowing kidney-function decline in people with type 2 diabetes and chronic kidney disease (US Ozempic label, DailyMed, published 10 June 2026). The Mounjaro and Zepbound labels both give 2022 for tirzepatide's initial US approval, which is not necessarily either brand's own first approval date (DailyMed, published 2 September 2026). Mounjaro's indications cover type 2 diabetes and reducing major cardiovascular events in adults with type 2 diabetes at high risk for those events. Zepbound's cover excess body weight and obstructive sleep apnoea in adults with obesity.

DailyMed is the US National Library of Medicine's database of current prescribing labels. A US approval is a separate decision from an Australian one. The two regulators publish their own indications, so the same molecule can carry different brand names and different wording in each country.

The US Wegovy label (DailyMed, published 30 June 2026) also gives 2017 for semaglutide's initial US approval; that field does not establish when the Wegovy brand was first approved. Retatrutide, Mounjaro and Ozempic compared sets the three records side by side.

Can Australian pharmacies compound GLP-1 medicines such as semaglutide?

The TGA's update of 18 June 2024 records that amendments to the Therapeutic Goods Regulations 1990 stop pharmacists compounding, and supplying to patients, medicines containing GLP-1 receptor agonist analogues compounded on or after 1 October 2024. The TGA's compounding guidance, published 14 May 2026 and last updated 8 September 2026, states that from 1 October 2024 pharmacists must not compound medicines containing GLP-1 receptor agonist analogues. Compounding is the making of a medicine by a pharmacist for one patient. The TGA's compounding safety information, published 15 December 2023, says compounded semaglutide-like products are unapproved therapeutic goods that it has not evaluated for safety, quality and efficacy, and that Ozempic and Wegovy are the TGA-approved semaglutide products. The TGA's wording names the group, "GLP-1 receptor agonist analogues". This page did not read the regulation's own text, so it does not say whether tirzepatide falls inside that group.

These TGA pages state the rule for pharmacist compounding. This page did not check other kinds of supply.

Is tirzepatide banned in sport?

No. Sport Integrity Australia's retatrutide explainer states that GLP-1 agonists are currently not prohibited in sport and that markers of semaglutide and tirzepatide are listed on the World Anti-Doping Agency (WADA) Monitoring Program (page read 14 October 2026). Its 2026 Prohibited List page states that the urine monitoring of semaglutide includes also the monitoring of tirzepatide (page read 14 October 2026). A monitoring program is a watch list used to look for patterns of misuse. It is not a prohibition, and a later list can differ from the 2026 list. These are sport rules, separate from the Poisons Standard and the ARTG.

The WADA website itself did not load for automated checks on 14 October 2026, so no WADA page is cited.

Is research-use tirzepatide the same as Mounjaro?

No. Mounjaro is a registered medicine, entered on the ARTG after evaluation of its safety, quality and efficacy (TGA register entry, read 14 October 2026). Research-use tirzepatide is a laboratory compound. It is not Mounjaro, is not a substitute for Mounjaro, and is not for human or animal use. A registration describes one product, not a molecule: Mounjaro's entry says nothing about any other material that contains tirzepatide, and a registration does not carry over to a lookalike.

The wider rules for unapproved peptide products, including importation and the effect of a research-use-only label, are set out on the Peptides and Australian Law page. The catalogue lists tirzepatide reference material as freeze-dried laboratory stock. Current certification for that material is unverified, and nothing on this page describes it.

Evidence limits

What can this page not tell you?

This page names the documents and the dates so that anyone can read them for themselves. It does not address the legal position of a particular person or activity.