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Legal status · Australia

Is Cotadutide legal in Australia?

Written by Reviewed Sep 2026

Not approvedMetabolicHuman studies cited: 8

Direct answer

No. Cotadutide is not approved for any medical use in Australia; its classification is "Investigational, not registered". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 8 human studies are cited on its profile.

Cotadutide in Australia at a glance

ClassificationInvestigational, not registered
NoteDevelopment discontinued in 2023.
TGA approval statusNot approved by TGA; investigational
Human studies cited8 of 10 citations on the profile
ReviewedSep 2026

Classification and note come from the Cotadutide profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.

What this means

  • 01

    Cotadutide is being studied in registered clinical trials but has not received TGA marketing approval in Australia.

  • 02

    Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.

  • 03

    Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.

What Cotadutide is

A once-daily GLP-1 and glucagon dual agonist that AstraZeneca stopped developing in 2023 for what its own registry entries call strategic pipeline considerations, not safety. It leaves a randomised human record of more than a thousand people across phase 2 trials in type 2 diabetes, kidney disease and biopsy-proven MASH, and it never reached phase 3.

Cotadutide is a synthetic peptide with balanced agonist activity at the GLP-1 receptor and the glucagon receptor, given as a daily subcutaneous injection. It was developed by MedImmune and then AstraZeneca as MEDI0382 for type 2 diabetes with obesity, for diabetic kidney disease and for non-alcoholic steatohepatitis (now called MASH).

Mechanism: In people, cotadutide's GLP-1 receptor action produces the familiar effects of the class: enhanced insulin secretion after meals, slower gastric emptying and reduced food intake. 3 percent rise on placebo, postprandial insulin rose, and gastric emptying half-time lengthened by about two hours.

Regulatory history: Never approved anywhere. Development discontinued by AstraZeneca in early 2023 for stated strategic pipeline reasons (ClinicalTrials.gov NCT05668936 and NCT05517226). No phase 3 was registered.

How TGA treats this kind of product

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods Administration listings for Cotadutide at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.

Cotadutide in other countries

Frequently asked questions

Is Cotadutide legal in Australia?

No. Cotadutide is not approved for any medical use in Australia; its classification is "Investigational, not registered". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 8 human studies are cited on its profile. Note: Development discontinued in 2023.

Can I buy Cotadutide in Australia?

No approved product exists to buy. In Australia Cotadutide is classified as "Investigational, not registered", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors. Note: Development discontinued in 2023.

Is Cotadutide TGA approved?

No. In Australia Cotadutide is classified as "Investigational, not registered", which is not a TGA marketing approval. For comparison, the US FDA status is: Never approved anywhere. Development discontinued by AstraZeneca in early 2023 for stated strategic pipeline reasons (ClinicalTrials.gov NCT05668936 and NCT05517226). No phase 3 was registered.. On the evidence, 8 human studies are cited on its profile.

Related compounds in Australia

Full research profile

Mechanism, cited studies, FDA status and the full legal summary for Cotadutide live on its compound profile.

Cotadutide profile

This page is general information about the regulatory status of Cotadutide in Australia, current as of Sep 2026. It is not legal advice, and classifications change; check Therapeutic Goods Administration directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.