Legal status · United States
Is Cotadutide legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Cotadutide is not approved for any medical use in the United States; its classification is "Investigational, not approved". 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 the United States at a glance
| Classification | Investigational, not approved |
|---|---|
| Note | Development discontinued by the sponsor in 2023; no application was filed. |
| FDA approval status | 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. |
| Human studies cited | 8 of 10 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Cotadutide profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Cotadutide is being studied in registered clinical trials but has not received FDA marketing approval in the United States.
- 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 FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug 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 the United States?
No. Cotadutide is not approved for any medical use in the United States; its classification is "Investigational, not approved". 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 by the sponsor in 2023; no application was filed.
Can I buy Cotadutide in the United States?
No approved product exists to buy. In the United States Cotadutide is classified as "Investigational, not approved", 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 by the sponsor in 2023; no application was filed.
Is Cotadutide FDA approved?
No. FDA status: 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.. Current US classification: "Investigational, not approved". On the evidence, 8 human studies are cited on its profile.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Cotadutide live on its compound profile.
Cotadutide profileThis page is general information about the regulatory status of Cotadutide in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug 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.