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 classification is "Investigational; development halted". 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, 2 human studies are cited on its profile.
Azelaprag in the United States at a glance
| Classification | Investigational; development halted |
|---|---|
| Note | Phase 2 terminated in February 2025 for liver transaminitis. No approval and no active registered trial. |
| FDA approval status | Not approved. Investigational only. The phase 2 combination trial with tirzepatide was terminated for liver transaminitis and no further azelaprag trial is registered. |
| Human studies cited | 2 of 4 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Azelaprag profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
Azelaprag 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 Azelaprag is
The phase 2 trial of azelaprag with tirzepatide in 204 adults with obesity was terminated. The registry's stated reason is liver transaminitis in some participants receiving azelaprag, and no azelaprag trial has been registered since.
Azelaprag is BioAge Labs' oral agonist at APJ, the apelin receptor. The scientific case came from a 2018 Nature Medicine paper showing that apelin, a peptide released by contracting muscle, declines with age and that restoring apelin signalling reversed age-related muscle deterioration.
Mechanism: Agonism at APJ (APLNR), a class A G protein-coupled receptor whose endogenous ligands are apelin and elabela. Apelin is released by contracting skeletal muscle, falls with age, and in mice drives mitochondrial biogenesis, autophagy and muscle stem cell function.
Regulatory history: Not approved. Investigational only. The phase 2 combination trial with tirzepatide was terminated for liver transaminitis and no further azelaprag trial is 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 Azelaprag 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.
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 classification is "Investigational; development halted". 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, 2 human studies are cited on its profile. Note: Phase 2 terminated in February 2025 for liver transaminitis. No approval and no active registered trial.
Can I buy Azelaprag in the United States?
No approved product exists to buy. In the United States Azelaprag is classified as "Investigational; development halted", 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: Phase 2 terminated in February 2025 for liver transaminitis. No approval and no active registered trial.
Is Azelaprag FDA approved?
No. FDA status: Not approved. Investigational only. The phase 2 combination trial with tirzepatide was terminated for liver transaminitis and no further azelaprag trial is registered.. Current US classification: "Investigational; development halted". On the evidence, 2 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 Azelaprag live on its compound profile.
Azelaprag profileThis page is general information about the regulatory status of Azelaprag 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.