Albiglutide (Tanzeum)

What is Albiglutide (Tanzeum)?#

Albiglutide (marketed as Tanzeum in the United States and Eperzan in Europe) was a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist developed by GlaxoSmithKline (GSK) for the treatment of type 2 diabetes mellitus. It was FDA-approved in April 2014 and received EMA approval in March 2014.

Albiglutide was a recombinant fusion protein consisting of two tandem copies of modified human GLP-1(7-36 amide) genetically fused to the N-terminus of recombinant human serum albumin. This albumin fusion strategy extended the half-life to approximately 5 days, enabling once-weekly subcutaneous injection.

Despite demonstrating cardiovascular benefit in the landmark HARMONY Outcomes trial (22% MACE reduction), GSK withdrew albiglutide from the worldwide market in July 2017 due to commercial failure. The drug was outcompeted by more efficacious GLP-1 agonists, particularly liraglutide and the then-emerging semaglutide.

Mechanism of Action#

As a GLP-1 receptor agonist, albiglutide activated the same pathways as endogenous GLP-1:

• Glucose-dependent insulin secretion: Stimulated beta-cell insulin release only when blood glucose was elevated
• Glucagon suppression: Inhibited inappropriate glucagon secretion
• Gastric emptying delay: Modest slowing of gastric emptying (less than shorter-acting GLP-1 agonists)
• Appetite effects: Minimal central appetite suppression compared to other GLP-1 agonists, contributing to lower weight loss efficacy

The albumin fusion reduced GLP-1 receptor potency compared to the native peptide, which may partially explain the lower efficacy relative to other GLP-1 agonists.

Research Overview#

Albiglutide was evaluated in the HARMONY clinical trial program, comprising eight phase 3 trials (HARMONY 1-8) enrolling over 5,000 patients with type 2 diabetes. The program established albiglutide's efficacy for glycemic control but revealed consistently lower HbA1c reduction and weight loss compared to competing GLP-1 agonists.

The HARMONY Outcomes trial (Hernandez et al., 2018; n=9,463) demonstrated a 22% reduction in MACE, making albiglutide one of the GLP-1 agonists with proven cardiovascular benefit. This result was published after market withdrawal.

Important Considerations#

• FDA-approved in April 2014 but withdrawn from the worldwide market in July 2017
• Market withdrawal was due to commercial failure, not safety concerns
• HARMONY Outcomes CV benefit was demonstrated but published post-withdrawal
• Lower efficacy than competing GLP-1 agonists for HbA1c and weight loss
• Required reconstitution from lyophilized powder, adding complexity
• No longer manufactured or available through any channel

Key Research Findings#

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial, published in The Lancet (Hernandez AF et al., 2018; PMID: 30291013):

• The study demonstrated relative risk reduction of 22% in cardiovascular death, MI, or stroke
• The study showed median follow up of 1.6 years
• The study showed landmark cardiovascular outcomes trial demonstrating that albiglutide reduced major adverse cardiovascular events by 22% in patients with type 2 diabetes and established cardiovascular disease. Published after market withdrawal.

Related Reading#

• Albiglutide (Tanzeum) research studies and evidence
• Albiglutide (Tanzeum) dosing protocols
• Albiglutide (Tanzeum) side effects profile
• Semaglutide research guide
• Liraglutide research guide