At a glance
| Former products | Tanzeum; Eperzan |
|---|---|
| Design | GLP-1–albumin fusion |
| Original use | Adult type 2 diabetes |
| Outcome trial | HARMONY Outcomes |
| EU status | Authorization withdrawn in 2018 |
Overview
Albiglutide was marketed as Tanzeum in the United States and Eperzan in Europe. Its albumin-fusion design prolonged GLP-1 activity and supported weekly injection for adult type 2 diabetes. The HARMONY Outcomes study later demonstrated cardiovascular benefit in a high-risk diabetes population. Despite that clinical record, the manufacturer discontinued marketing, and the European Commission withdrew the Eperzan authorization in 2018 at the company’s request for commercial reasons. This profile preserves the evidence and approval history without implying that a currently obtainable albiglutide product is a routine treatment option in every market.
How it works
The molecule joins modified GLP-1 sequences to human albumin, extending circulation time and protecting activity compared with native GLP-1. Receptor activation increases glucose-dependent insulin release, reduces inappropriate glucagon secretion and affects gastric emptying. Albumin fusion changes exposure and delivery but does not remove the physiological consequences of GLP-1 signaling, including gastrointestinal adverse effects and interactions with other glucose-lowering treatment.
Original approved indication
The original FDA label approved albiglutide with diet and exercise for glycemic control in adults with type 2 diabetes. It was not an approved type 1 diabetes or obesity medicine.
Supporting sources [1]
Cardiovascular findings
HARMONY Outcomes enrolled patients with type 2 diabetes and cardiovascular disease and found fewer major cardiovascular events with albiglutide than placebo. This later trial is more informative about cardiovascular efficacy than the older initial label’s statement that outcomes evidence was not yet available.
Supporting sources [2]
Known adverse effects
The historical label identifies gastrointestinal symptoms and injection-site reactions, with warnings about pancreatitis, serious allergy and hypoglycemia when combined with insulin or insulin secretagogues. Medullary thyroid carcinoma history and MEN2 were contraindications.
Supporting sources [1]
Why the withdrawal matters
EMA states that the European Commission withdrew Eperzan’s authorization on 29 October 2018 after the manufacturer permanently discontinued marketing for commercial reasons. That is different from claiming a demonstrated new safety failure caused the withdrawal.
Supporting sources [3]
How this record should be used
The article supports understanding of the GLP-1 class and historical evidence. It does not establish that an online albiglutide listing is an authorized or available replacement for a currently marketed diabetes medicine.
Reading this profile
Jurisdiction: Historical FDA approval; commercial discontinuation. European Union authorization withdrawn in 2018 at the manufacturer’s request.. Molecular class: GLP-1 analog fused to human albumin.
This profile was written with AI-assisted research and checked against the linked sources. It has not been represented as a clinician’s review. Evidence summaries describe the cited studies and products; they do not establish that a separately purchased preparation is equivalent.
Sources & references
Follow the original material. Product labels define specific formulations and uses; trial registration describes a study and does not by itself establish benefit.
- FDA: historical Tanzeum prescribing information ↗Regulatory source · Checked 2026-10-27
- Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. ↗Original research · Checked 2026-10-27
- EMA: Eperzan withdrawal and authorization history ↗Regulatory source · Checked 2026-10-27
- FDA Purple Book: Tanzeum approval and discontinued marketing record ↗Regulatory source · Checked 2026-10-27