Legal status · United States
Is Azelaprag legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Azelaprag is not approved for any medical use in the United States. Its legal category is "Investigational; development stopped". 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, no completed trial in people is cited on its profile (2 human records with no result or no dose given).
- People given it
- 0
- Found nothing
- 0
Legal category
Investigational; development stopped
The mid-stage study was stopped in February 2025 because of raised liver enzymes, a sign of liver damage. No approval and no active registered trial.
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.
Azelaprag in the United States at a glance
| Legal category | Investigational; development stopped |
|---|---|
| Note | The mid-stage study was stopped in February 2025 because of raised liver enzymes, a sign of liver damage. No approval and no active registered trial. |
| FDA approval status | Not approved. Investigational only. The mid-stage study that combined it with tirzepatide was stopped because of raised liver enzymes, a sign of liver damage. No further azelaprag trial is registered. |
| Studies in people | 2 of 4 sources on the profile |
| Reviewed | Sep 2026 |
The legal category and note come from the Azelaprag profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.
What this means
- 01
Azelaprag 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 Azelaprag is
The mid-stage study of azelaprag with tirzepatide, in 204 adults with obesity, was stopped. The registry says why: liver enzymes rose in some people taking azelaprag. No azelaprag study has been registered since.
Azelaprag is a pill from BioAge Labs. It switches on the apelin receptor, called APJ.
How it works: It switches on APJ, a receptor on the cell surface whose natural keys are apelin and elabela. Working muscle releases apelin, and the level falls with age.
Approval history: Not approved. Investigational only. The mid-stage study that combined it with tirzepatide was stopped because of raised liver enzymes, a sign of liver damage. No further azelaprag trial is 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 Azelaprag 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.
Azelaprag in sport and the military
Whether Azelaprag 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 Azelaprag 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.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
Azelaprag in other countries
Frequently asked questions
Is Azelaprag legal in the United States?
No. Azelaprag is not approved for any medical use in the United States. Its legal category is "Investigational; development stopped". 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, no completed trial in people is cited on its profile (2 human records with no result or no dose given). Note: The mid-stage study was stopped in February 2025 because of raised liver enzymes, a sign of liver damage. No approval and no active registered trial.
Can I buy Azelaprag in the United States?
There is no approved product to buy. In the United States, Azelaprag has the legal category "Investigational; development stopped". 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 mid-stage study was stopped in February 2025 because of raised liver enzymes, a sign of liver damage. No approval and no active registered trial.
Is Azelaprag FDA approved?
No. FDA status: Not approved. Investigational only. The mid-stage study that combined it with tirzepatide was stopped because of raised liver enzymes, a sign of liver damage. No further azelaprag trial is registered.. Current US legal category: "Investigational; development stopped". On the evidence, no completed trial in people is cited on its profile (2 human records with no result or no dose given).
Related compounds in the United States
Full research profile
How Azelaprag works, the studies we cite, FDA status and the full legal summary are all on its compound profile.
Azelaprag profileThis page is general information about the legal status of Azelaprag 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.