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Albiglutide

/ Recombinant GLP-1-(7-37) fusion to human serum albumin (long-acting GLP-1 receptor agonist)

TIER 1 · ClinicalN = 0 · TESTING PENDINGMW 72970.00 g·mol⁻¹

ALIAS · Tanzeum (trade — US) · Eperzan (trade — EU) · GSK-716155 · GLP-1-albumin fusion

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Research use onlyAny dose figures below describe what specific cited studies used, reported factually. Nothing on this page is guidance for human use.READ FIRST →

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§ A · Identity

Primary sequence— sequence not captured —

MW · 72970.00CLASS · Recombinant GLP-1-(7-37) fusion to human serum albumin (long-acting GLP-1 receptor agonist)CATEGORY · Metabolic

Tier 1. FDA-approved 2014 (Tanzeum) and EMA-approved 2014 (Eperzan) for type 2 diabetes based on the HARMONY Phase 3 program. GSK voluntarily withdrew albiglutide from the global market in 2017 for commercial reasons (sales below expectations) — explicitly NOT for safety. The practical consequence is that albiglutide is no longer commercially available in the US or EU.

§ B · Mechanism of action

Albiglutide is a recombinant fusion protein consisting of two tandem copies of a modified human GLP-1-(7-37) sequence (with an Ala8 to Gly substitution conferring DPP-4 resistance) genetically fused to recombinant human serum albumin. Covalent albumin tethering extends the plasma half-life to approximately five days, supporting once-weekly subcutaneous dosing. The GLP-1 moiety engages the GLP-1 receptor on pancreatic beta cells (glucose-dependent insulinotropic effect), alpha cells (glucagon suppression), gastric smooth muscle (delayed gastric emptying), and central appetite circuits.

§ C · Human clinical evidence

Tier 1. The HARMONY Phase 3 program (eight registration trials) evaluated albiglutide across the type 2 diabetes treatment continuum versus placebo, sitagliptin, glimepiride, insulin glargine, and liraglutide. The Harmony Outcomes cardiovascular outcomes trial (Hernandez and colleagues, Lancet 2018) randomised 9,463 participants with type 2 diabetes and established cardiovascular disease and demonstrated a statistically significant reduction in major adverse cardiovascular events versus placebo.

§ D · Primary literature

PubMed24703047Pratley RE et al. — Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study · The Lancet Diabetes & Endocrinology · human-phase-3-rctOnce-weekly albiglutide failed to demonstrate non-inferiority versus once-daily liraglutide for HbA1c reduction at 32 weeks; albiglutide produced lower nausea/vomiting rates but more injection-site reactions.Limitations: Open-label design; non-inferiority margin not met for primary endpoint.2014

PubMed30291013Hernandez AF et al. — Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial · The Lancet · human-phase-3-rctAlbiglutide reduced the composite of cardiovascular death, myocardial infarction, or stroke versus placebo (HR 0.78, 95% CI 0.68-0.90) over median 1.6-year follow-up in T2D with established CV disease.Limitations: Trial completed after sponsor's market-withdrawal decision; shorter follow-up than other GLP-1 RA CVOTs.2018

§ F · Safety signal

Class GLP-1 receptor agonist adverse events: nausea, diarrhoea, and injection-site reactions were the most common. Injection-site reactions (including induration and erythema) were reported more frequently with albiglutide than with comparator GLP-1 receptor agonists, attributed to the albumin-fusion structure. Pancreatitis and medullary thyroid C-cell tumour signals are class concerns; rodent C-cell hyperplasia/neoplasia data prompted a class boxed warning.

§ H · Regulatory status

Regulatory status

FDA status:: Previously approved, discontinued

§ I · Notable gaps and controversies

GSK announced voluntary withdrawal of Tanzeum/Eperzan from the global market in 2017, citing commercial considerations rather than any safety or efficacy concern. Existing supply was withdrawn through 2018. Albiglutide remains a regulatory-history reference but is not commercially available; researchers seeking comparator data must rely on the published HARMONY and Harmony Outcomes datasets. The withdrawal also illustrates that approval and continued availability are independent: a drug can be FDA-approved with positive cardiovascular outcomes data and still leave the market for commercial reasons.