Tirzepatide in Australia: where things stand.
Tirzepatide is the active ingredient in Mounjaro, a once-weekly injectable medicine registered in Australia for type 2 diabetes and for chronic weight management. This page sets out its regulatory status, how it is supplied, what the PBS has decided, why compounded or imported versions are unlawful, and what the trials found. It is information, not advice.
Tirzepatide is TGA-registered in Australia as Mounjaro (Eli Lilly Australia), a prescription-only medicine for adults with type 2 diabetes and, since September 2024, for chronic weight management in adults with a BMI of 30 or more, or 27 or more with a weight-related condition. As of 1 October 2026 it is not on the PBS. Pharmacy compounding of GLP-1 medicines has been banned since 1 October 2024, and vials sold online as “tirzepatide” are unapproved, unlawful and linked to serious harm.
- December 2022: Mounjaro registered for type 2 diabetes. TGA record.
- September 2024: Chronic weight management indication added (BMI ≥30, or ≥27 with a comorbidity). TGA record.
- 1 October 2024: Pharmacist compounding of GLP-1 analogues no longer permitted. TGA media release.
- March 2026: PBAC recommended a type 2 diabetes PBS listing after three rejections. PBS medicine status.
- April 2026: Eli Lilly declined to list on the recommended terms. RACGP newsGP.
- June 2026: TGA named unapproved injectable peptides a compliance priority. TGA media release.
What tirzepatide is.
Tirzepatide is a synthetic peptide that acts on two gut-hormone receptors at once: the glucagon-like peptide-1 (GLP-1) receptor and the glucose-dependent insulinotropic polypeptide (GIP) receptor. It is therefore called a dual GIP/GLP-1 receptor agonist rather than a plain GLP-1 medicine. Both are incretin hormones released by the gut after eating; they prompt insulin release when glucose rises, slow stomach emptying and act on appetite centres in the brain.
It is injected once a week, starting low and increasing in steps to limit gastrointestinal side effects. Six strengths are registered: 2.5, 5, 7.5, 10, 12.5 and 15 mg. It is not insulin, a stimulant or a supplement. Decisions to start, continue or stop it belong to a patient and their doctor.
Mounjaro here, Zepbound in the United States.
In Australia the only registered tirzepatide product is Mounjaro, sponsored by Eli Lilly Australia Pty Ltd. One brand carries both indications.
In the United States, Eli Lilly markets tirzepatide for weight management under a second brand, Zepbound, approved by the FDA in November 2023. Zepbound is not on the Australian Register of Therapeutic Goods (ARTG); anything so labelled and offered here has not been assessed by the TGA, and personal importation of prescription medicines is tightly restricted. Brand names are trademarks of their owners.
TGA registration and approved indications.
The TGA assesses quality, safety and efficacy for a specific indication. Mounjaro has been through that process twice; multi-dose KwikPen presentations were added to the ARTG later.
| Date | Decision | Registered indication (summary) |
|---|---|---|
| December 2022 | Initial registration | Adults with insufficiently controlled type 2 diabetes, as an adjunct to diet and exercise, alone when metformin is unsuitable or with other diabetes medicines. |
| September 2024 | Indication extension | Chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity, in adults with a BMI of 30 kg/m² or more, or 27 kg/m² or more with at least one weight-related comorbidity. |
Sources: TGA registration records for type 2 diabetes and chronic weight management; ARTG entry 439690. Registration criteria are not a recommendation for any individual.
PBS status: not listed.
TGA registration and PBS subsidy are separate decisions. The Pharmaceutical Benefits Advisory Committee (PBAC) advises on cost-effectiveness; the sponsor and the Commonwealth must then agree on price and conditions.
Eli Lilly sought a type 2 diabetes listing four times. The PBAC declined in July 2023, November 2024 and July 2025, then recommended listing in March 2026 on equity-of-access grounds. In April 2026 Eli Lilly announced it would not proceed, describing the proposed price as lower than any other reimbursed price globally.
For weight management, no PBS submission had been lodged when the PBAC published its equitable-access advice in December 2025. As of 1 October 2026, Mounjaro is not PBS-listed for any indication. This page does not report prices. The wider subsidy picture, including the Wegovy recommendation, is in GLP-1 medicines in Australia.
How tirzepatide is dispensed in Australia.
Prescription-only. A registered prescriber must assess the patient; every supply needs a valid prescription.
Mounjaro KwikPen is a multi-dose pre-filled pen delivering four weekly doses at one strength. Single-dose vials came first.
Dispensed by registered pharmacies against the prescription.
Compounded tirzepatide, imported vials, “research-use” peptides and products labelled Zepbound are not registered medicines and cannot lawfully be advertised or supplied.
Preptide does not sell, prescribe or arrange prescriptions for any medicine.
The compounding ban and grey-market vials.
Until late 2024 some pharmacies compounded semaglutide and tirzepatide under an exemption meant for one-off preparations. The TGA found it happening at scale, with ingredients of unknown origin and no safety evaluation. From 1 October 2024, GLP-1 receptor agonist analogues were removed from the exemption. Compounding them in any dosage form is unlawful, with civil and criminal penalties.
Supply then shifted to injectable “peptides” sold online, often labelled for research use and shipped from overseas. In April 2026 the TGA warned of severe allergic reactions and hospitalisations linked to such products, and in June 2026 made them a compliance priority after joint seizures with Australian Border Force and Victoria Police. The same month Victoria’s Chief Health Officer reported acute liver injuries in people who had injected a product labelled “retatrutide”, an experimental molecule approved by no regulator anywhere.
Nobody has verified what is in these vials, at what concentration, or whether they are sterile. There is no Product Information, adverse-event reporting or recall. TGA testing of online “tirzepatide” alternatives has found no GLP-1 analogue at all. Anyone who has used one and feels unwell should seek medical care.
TGA safety communications.
The most common side effects in trials were gastrointestinal: nausea, diarrhoea, vomiting, constipation and reduced appetite, mostly during dose escalation. Less common but serious risks in the Australian Product Information include pancreatitis, gallbladder disease, dehydration affecting the kidneys, and low blood glucose when combined with insulin or sulfonylureas. It is not for use in pregnancy.
Anaesthesia and sedation
June 2025: all GLP-1 and dual GIP/GLP-1 medicines must warn about inhaling stomach contents during general anaesthesia or deep sedation, because they slow gastric emptying.
Mood and suicidal thoughts
Class warnings were aligned to advise monitoring for new or worsening depression or suicidal thoughts; a causal link is not established.
Rare eye condition
A safety update covered reports of non-arteritic anterior ischaemic optic neuropathy (NAION). Sudden vision change needs urgent care.
Counterfeits
Alerts have identified counterfeit “GLP-1” products sold online, some with no active ingredient.
Patients and health professionals can report suspected side effects to the TGA. Full warnings are in the Consumer Medicine Information.
What the key trials found.
Registration rests on the SURPASS (type 2 diabetes) and SURMOUNT (weight management) programmes, all funded by Eli Lilly, all with lifestyle counselling in every arm, and all reporting frequent gastrointestinal adverse events. Results are group averages, not predictions for an individual.
| Trial | Population and duration | Main result | Safety note |
|---|---|---|---|
| SURPASS-2 NEJM 2021 | 1,879 adults with type 2 diabetes on metformin; 40 weeks; versus semaglutide 1 mg. | HbA1c fell 2.01 to 2.30 percentage points versus 1.86 with semaglutide; weight loss also greater. | Open-label. Nausea, diarrhoea and vomiting common in all arms. |
| SURMOUNT-1 NEJM 2022 | 2,539 adults with obesity or overweight plus a complication, no diabetes; 72 weeks; placebo-controlled. | Mean weight change −16.0% (5 mg), −21.4% (10 mg), −22.5% (15 mg) versus −2.4% placebo. | Gastrointestinal events were the main reason for stopping. Weight tends to return after cessation. |
| SURMOUNT-5 NEJM 2025 | 751 adults with obesity without diabetes; 72 weeks; tirzepatide versus semaglutide 2.4 mg, open-label. | Mean weight change −20.2% versus −13.7%; waist −18.4 cm versus −13.0 cm. | Stopped for gastrointestinal events: 2.7% versus 5.6%. No placebo arm. |
Citations: Frías et al., doi:10.1056/NEJMoa2107519; Jastreboff et al., doi:10.1056/NEJMoa2206038; Aronne et al., doi:10.1056/NEJMoa2416394. Long-term cardiovascular outcome data were still emerging as of 1 October 2026.
Nutrition considerations.
Because tirzepatide slows gastric emptying and lowers appetite, people taking it often eat far less, which raises questions about protein, fibre and fluid from smaller meals and about which foods sit better with nausea. Prescribers and Accredited Practising Dietitians address these individually, particularly for people with diabetes, kidney disease or a history of disordered eating.
Preptide’s food guides cover the general principles: the tirzepatide food guide, a flexible Mounjaro diet plan, the GLP-1 portion guide and foods for nausea. Food supports a treatment plan; it does not replace medical or dietetic care.
Read alongside this page.
GLP-1 medicines in Australia: every registered GLP-1-based medicine and its PBS status.
Weight loss medication in Australia: what is approved for chronic weight management.
Mounjaro vs Wegovy, Mounjaro side effects and Mounjaro doses cover the single medicine in more depth.
Is tirzepatide approved in Australia?
Yes. It is TGA-registered as Mounjaro (Eli Lilly Australia) for type 2 diabetes (December 2022) and chronic weight management (September 2024). It is prescription-only.
Is Mounjaro on the PBS?
No. As of 1 October 2026 it is not PBS-listed for any indication. The PBAC recommended a type 2 diabetes listing in March 2026; Eli Lilly declined in April 2026. No weight-management submission has been made.
Is Zepbound available in Australia?
No. Zepbound is the United States brand of tirzepatide for weight management. In Australia the registered brand for both indications is Mounjaro; Zepbound is not on the ARTG.
Can a pharmacy compound tirzepatide in Australia?
No. Since 1 October 2024 pharmacists must not compound GLP-1 receptor agonist analogues, including tirzepatide. Only the registered product may be supplied, on prescription.
What did the tirzepatide trials show?
SURPASS-2 found greater HbA1c and weight reductions than semaglutide 1 mg in type 2 diabetes. SURMOUNT-1 found mean weight change of 16 to 22.5 per cent at 72 weeks versus 2.4 per cent with placebo. SURMOUNT-5 found 20.2 versus 13.7 per cent against semaglutide 2.4 mg. Gastrointestinal side effects were common.
What safety notices has the TGA issued about tirzepatide?
Warnings about inhaling stomach contents under anaesthesia or deep sedation (June 2025), aligned class warnings on suicidal thoughts, an update on a rare optic nerve condition, and alerts about counterfeit GLP-1 products.
Primary sources checked for this page.
- TGA: Mounjaro registration (type 2 diabetes).
- TGA: Mounjaro registration (weight management).
- PBS: tirzepatide medicine status.
- RACGP newsGP: Lilly rejects PBS recommendation.
- TGA: GLP-1 RA pharmacy compounding changes.
- TGA safety update: GLP-1 medicines and anaesthesia.
- TGA safety update: suicidal thoughts warnings aligned.
- TGA: unapproved peptide products (April 2026).
- Victorian CHO alert: retatrutide-labelled product.
- Jastreboff et al., SURMOUNT-1, NEJM 2022.
Editorial method: Australian regulatory sources (TGA, PBS, state health departments) were checked first, then peer-reviewed trial publications. Status statements are dated and may change. A named clinical review is pending; until then this is editorial research, not clinical opinion. See the Preptide editorial policy.
Important: General information only, not medical advice. Brand names are registered trademarks of their respective owners; Preptide is independent and is not affiliated with, endorsed by or sponsored by any medicine manufacturer. Preptide is food, not medication, and does not prescribe, sell, recommend or promote prescription medicines. Talk to your doctor or pharmacist about any medicine. In an emergency call 000. Read our editorial policy and Health Acknowledgement.