Legal status · United States
Is Albiglutide legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. Albiglutide is not an approved medicine in the United States; its classification is "Approved, product discontinued". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. On the evidence, 6 human studies are cited on its profile.
Albiglutide in the United States at a glance
| Classification | Approved, product discontinued |
|---|---|
| Note | BLA 125431 approved 15 April 2014; Drugs@FDA marketing status Discontinued as of 11 September 2026. Not available. |
| FDA approval status | FDA approved 15 April 2014 (Tanzeum, BLA 125431) for glycaemic control in adults with type 2 diabetes. Drugs@FDA marketing status: Discontinued. EU authorisation (Eperzan) granted March 2014 and withdrawn 29 October 2018 at the holder's request. |
| Human studies cited | 6 of 8 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the Albiglutide profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
No product containing Albiglutide is approved by FDA for any use in the United States, so nothing on the market is authorized for people.
- 02
"Research use only" is a vendor label, not a legal category that permits human use. It does not exempt a product from medicines law.
- 03
Importing, supplying or promoting it for human use can fall under medicines legislation in the United States. This page is general information, not legal advice.
What Albiglutide is
A once-weekly GLP-1 receptor agonist approved in 2014 and withdrawn from every market by 2018. In the 9,463 person Harmony Outcomes trial it reduced cardiovascular death, heart attack or stroke by 22 percent against placebo, and in a head to head trial it lowered HbA1c less than liraglutide. The drug is no longer available anywhere.
Albiglutide is a recombinant fusion protein: two tandem copies of human GLP-1 (7-36), each with glycine replacing alanine at position 8 to resist DPP-4, fused to human albumin. The albumin gives it a half-life of about 5 days and once-weekly dosing, and a molecular weight of 72,970 daltons, which makes it by far the largest molecule ever sold as a GLP-1 drug.
Mechanism: Albiglutide activates the GLP-1 receptor: glucose-dependent insulin secretion, suppression of glucagon, slower gastric emptying and reduced appetite, the same mechanism as every drug in the class. Two features set it apart.
Regulatory history: FDA approved 15 April 2014 (Tanzeum, BLA 125431) for glycaemic control in adults with type 2 diabetes. Drugs@FDA marketing status: Discontinued. EU authorisation (Eperzan) granted March 2014 and withdrawn 29 October 2018 at the holder's request.
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 Albiglutide 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.
Albiglutide in other countries
Frequently asked questions
Is Albiglutide legal in the United States?
No. Albiglutide is not an approved medicine in the United States; its classification is "Approved, product discontinued". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. On the evidence, 6 human studies are cited on its profile. Note: BLA 125431 approved 15 April 2014; Drugs@FDA marketing status Discontinued as of 11 September 2026. Not available.
Can I buy Albiglutide in the United States?
No approved product exists to buy. In the United States Albiglutide is classified as "Approved, product discontinued", 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: BLA 125431 approved 15 April 2014; Drugs@FDA marketing status Discontinued as of 11 September 2026. Not available.
Is Albiglutide FDA approved?
No. FDA status: FDA approved 15 April 2014 (Tanzeum, BLA 125431) for glycaemic control in adults with type 2 diabetes. Drugs@FDA marketing status: Discontinued. EU authorisation (Eperzan) granted March 2014 and withdrawn 29 October 2018 at the holder's request.. Current US classification: "Approved, product discontinued". On the evidence, 6 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 Albiglutide live on its compound profile.
Albiglutide profileThis page is general information about the regulatory status of Albiglutide 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.