Albiglutide

Tanzeum

Grade B: Human evidence, not approved for this use

TL;DR: Albiglutide (Tanzeum) was a once-weekly GLP-1 receptor agonist approved by FDA in April 2014 for type 2 diabetes, and voluntarily withdrawn from the worldwide market by GlaxoSmithKline in July 2017 due to commercial failure rather than safety concerns. The drug retains grade B status because human RCT evidence exists from its approved-drug era, including the large Harmony Outcomes cardiovascular trial published in 2018, which enrolled approximately 9,500 patients with type 2 diabetes and established cardiovascular disease and demonstrated a 22% relative reduction in MACE. Notably, the Harmony Outcomes data were published after market withdrawal, adding to the evidence base without restoring commercial availability. Evidence supporting glycemic control comes from the Harmony phase 3 trial program. The drug is no longer obtainable.

Key Takeaways

Grade B: Human evidence, not approved for this use
Withdrawn: Previously approved as Tanzeum (once-weekly subcutaneous injection, type 2 diabetes, 2014); voluntarily withdrawn from the US and worldwide market by GlaxoSmithKline in 2017 for commercial reasons, with remaining stock depleted by 2018.
Compounding: Withdrawn from the worldwide market in 2017 and 2018; no longer available by prescription anywhere. Not compoundable under standard FDA frameworks. No active supply or regulatory pathway exists for patient access.

Albiglutide chemical structure — Structure via PubChem CID 122173812

Mechanism

Albiglutide is a GLP-1 receptor agonist formed by fusion of two copies of modified GLP-1 to human albumin, enabling a prolonged half-life suitable for once-weekly dosing; it activates GLP-1 receptors to stimulate glucose-dependent insulin secretion and suppress glucagon.

Evidence

Albiglutide (Tanzeum) was a once-weekly GLP-1 receptor agonist approved by FDA in April 2014 for type 2 diabetes, and voluntarily withdrawn from the worldwide market by GlaxoSmithKline in July 2017 due to commercial failure rather than safety concerns. The drug retains grade B status because human RCT evidence exists from its approved-drug era, including the large Harmony Outcomes cardiovascular trial published in 2018, which enrolled approximately 9,500 patients with type 2 diabetes and established cardiovascular disease and demonstrated a 22% relative reduction in MACE. Notably, the Harmony Outcomes data were published after market withdrawal, adding to the evidence base without restoring commercial availability. Evidence supporting glycemic control comes from the Harmony phase 3 trial program. The drug is no longer obtainable.

Safety and risks

Albiglutide carried a boxed warning noting that while carcinogenicity of albiglutide itself could not be assessed in rodents (due to rapid antibody clearance that prevented adequate drug exposure in the rodent studies), other GLP-1 receptor agonists have caused thyroid C-cell tumors in rodents at clinically relevant exposures, and human relevance has not been determined; albiglutide was contraindicated in patients with personal or family history of MTC or MEN 2. The safety profile observed during the approved-drug era and in Harmony Outcomes showed no novel safety signals beyond class risks. Acute pancreatitis risk applies as a class-level GLP-1 receptor agonist risk; discontinue if suspected. Worsening renal function secondary to GI-mediated dehydration is a class risk. Hypoglycemia risk is elevated with concomitant insulin secretagogues. Serious hypersensitivity reactions including anaphylaxis were reported. The drug is no longer available; prescribers and patients cannot access it through any standard channel.

Interactions

Hypoglycemia risk increases with insulin or secretagogue co-administration. Class-level gastric-emptying delay may affect oral drug absorption.

Federal compounding status

FDA-approved drug as of 2026-06-02.

An FDA-approved drug that should be obtained as the licensed product. It is not a 503A bulk-substance candidate; compounding from bulk is limited under federal rules and generally permitted only during a declared shortage.

Federal status only, from public FDA records. State pharmacy-board rules vary and are not covered here. This is regulatory reporting, not legal advice. All compounds.

Compounding legality

Withdrawn from the worldwide market in 2017 and 2018; no longer available by prescription anywhere. Not compoundable under standard FDA frameworks. No active supply or regulatory pathway exists for patient access.

Sources

Albiglutide is Withdrawn. PeptideGrids presents evidence and regulatory status for informational purposes only. We do not sell, supply, source, or help anyone obtain this compound, and we provide no dosing or administration guidance. This is not medical advice; consult a licensed clinician. Full disclaimer.

Last reviewed June 1, 2026 by PeptideGrids editorial team (independently audited).