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Legal status · United States

Is Cotadutide legal in the United States?

Written by Reviewed Sep 2026

Not approvedMetabolicStudies in people cited: 8

Direct answer

No. Cotadutide is not approved for any medical use in the United States. Its legal category is "Investigational, not approved". The only legal way to get it is to join a registered clinical trial (an official study in people). A "research use only" label on vials sold online does not make them legal to use in people. On the evidence, 6 completed human trials are cited on its profile.

People given it
1,221
Found nothing
1

Legal category

Investigational, not approved

The company stopped work on it in 2023. It never applied for approval.

Reviewed Sep 2026. This is a legal category, not legal advice.

A "research use only" label on a vial does not make it legal to use on people.

Cotadutide in the United States at a glance

Legal categoryInvestigational, not approved
NoteThe company stopped work on it in 2023. It never applied for approval.
FDA approval statusNever approved anywhere. AstraZeneca stopped work on it in early 2023, and said it was a business choice about which drugs to pursue (ClinicalTrials.gov NCT05668936 and NCT05517226). No final-stage study was ever registered.
Studies in people8 of 10 sources on the profile
ReviewedSep 2026

The legal category and note come from the Cotadutide profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.

What this means

  • 01

    Cotadutide is being tested in registered clinical trials (official studies in people). FDA has not approved it for sale in the United States.

  • 02

    The only legal ways for a person to get it are to join a trial, or to use an official early-access program where one exists. There is no pharmacy product to prescribe.

  • 03

    Vials sold online "for research use only" are not trial supplies. That label does not make them legal to use in people.

What Cotadutide is

A once-a-day shot that acts on both GLP-1 and glucagon. AstraZeneca stopped developing it in 2023. Its own registry entries call the reason strategic pipeline planning, not safety. It leaves mid-stage studies in more than a thousand people with type 2 diabetes, kidney disease and fatty liver inflammation (MASH). It never reached a large final-stage study.

Cotadutide is a lab-made peptide that acts evenly on two hormone receptors, GLP-1 and glucagon. It was a daily shot under the skin.

How it works: In people, cotadutide's GLP-1 side does the familiar things for this drug family. It boosts insulin after meals, slows how fast the stomach empties, and cuts how much people eat.

Approval history: Never approved anywhere. AstraZeneca stopped work on it in early 2023, and said it was a business choice about which drugs to pursue (ClinicalTrials.gov NCT05668936 and NCT05517226). No final-stage study was ever registered.

How FDA treats this kind of product

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Cotadutide on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Cotadutide in sport and the military

Whether Cotadutide is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Cotadutide by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

The rules you compete or serve under decide this, not this page.

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 legal category is "Investigational, not approved". The only legal way to get it is to join a registered clinical trial (an official study in people). A "research use only" label on vials sold online does not make them legal to use in people. On the evidence, 6 completed human trials are cited on its profile. Note: The company stopped work on it in 2023. It never applied for approval.

Can I buy Cotadutide in the United States?

There is no approved product to buy. In the United States, Cotadutide has the legal category "Investigational, not approved". So no licensed pharmacy product exists. Sellers who list it "for research use only" are not selling it for use in people, and that label does not change its legal status. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything. Note: The company stopped work on it in 2023. It never applied for approval.

Is Cotadutide FDA approved?

No. FDA status: Never approved anywhere. AstraZeneca stopped work on it in early 2023, and said it was a business choice about which drugs to pursue (ClinicalTrials.gov NCT05668936 and NCT05517226). No final-stage study was ever registered.. Current US legal category: "Investigational, not approved". On the evidence, 6 completed human trials are cited on its profile.

Related compounds in the United States

Full research profile

How Cotadutide works, the studies we cite, FDA status and the full legal summary are all on its compound profile.

Cotadutide profile

This page is general information about the legal status of Cotadutide in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.