Albiglutide
A weekly GLP-1 fused to albumin: approved in 2014, now discontinued, with a positive cardiovascular outcomes trial
Albiglutide was GlaxoSmithKline's once-weekly GLP-1 receptor agonist, sold as Tanzeum in the US and Eperzan in the EU. It joined two copies of a modified human GLP-1 to human albumin, which stretched its half-life to about five days. It lowered blood sugar less than some rivals and caused fewer stomach side effects, and in Harmony Outcomes it reduced heart attacks, strokes and cardiovascular deaths against placebo. FDA now lists it as discontinued.
What is it?
Albiglutide belongs to the GLP-1 receptor agonist class, the family that includes liraglutide, dulaglutide and semaglutide. Its distinguishing feature was its construction: two copies of a modified human GLP-1 sequence fused to recombinant human albumin. The albumin keeps the molecule in circulation, giving a half-life of about five days and allowing one injection a week.
The European Union approved it first, as Eperzan, and FDA approved it as Tanzeum on April 15, 2014, for adults with type 2 diabetes. The HARMONY programme tested it against placebo and against nearly every other class of diabetes medicine then in use: sitagliptin, glimepiride, pioglitazone, insulin glargine and insulin lispro among them. It lowered HbA1c against all of them, by less than some competitors, and it tended to produce modest weight loss where the comparators produced gain.
Its most important trial came last. Harmony Outcomes randomised 9,463 people with type 2 diabetes and cardiovascular disease to albiglutide or placebo and found 22% fewer major cardiovascular events on the drug. Reviewers also noted what set its tolerability apart: gastrointestinal side effects close to placebo, against more injection-site reactions and a small excess of pancreatitis cases in the approval programme.
Albiglutide is no longer sold. FDA's Drugs@FDA database lists Tanzeum's marketing status as discontinued. What remains useful is its evidence: a completed set of phase 3 trials and an outcomes trial that helped establish cardiovascular benefit as a feature of the GLP-1 class rather than of one molecule.
Mechanism of Action
Albiglutide works the way the GLP-1 class works; what it changed was how long each dose lasts. The GLP-1 portion activates the receptor, and the albumin carries it.
Glucose-dependent insulin release
Activating the GLP-1 receptor on pancreatic beta cells increases insulin secretion when glucose is high. In clinical pharmacology studies, albiglutide enhanced beta-cell secretion during hyperglycaemia and suppressed it during hypoglycaemia, which is why the class carries a low risk of low blood sugar on its own.
Glucagon suppression, with the counter-response intact
GLP-1 agonists suppress inappropriate glucagon secretion after meals. Albiglutide did not impair the alpha cells' glucagon response to hypoglycaemia, the body's main defence when blood sugar falls too far.
Slower gastric emptying
Like the rest of the class, albiglutide delays gastric emptying, which blunts the rise in glucose after a meal and contributes to the gastrointestinal side effects GLP-1 medicines are known for.
Albumin fusion and DPP-4 resistance
Native GLP-1 is broken down by the enzyme DPP-4 within minutes. Albiglutide's GLP-1 copies were modified to resist DPP-4, and fusion to albumin slowed clearance to 67 mL/h, giving a half-life of about five days and steady state after four to five weeks of weekly doses.
Published Research
These are the trials that defined albiglutide, read from their PubMed abstracts. Nearly all enrolled adults with type 2 diabetes; the one animal study measured brain uptake in mice.
Harmony Outcomes: cardiovascular events in 9,463 people with type 2 diabetes and cardiovascular disease
Randomised to weekly albiglutide or placebo at 610 sites in 28 countries and followed for a median 1.6 years, the primary composite of cardiovascular death, myocardial infarction or stroke occurred in 338 of 4,731 patients (7%) on albiglutide and 428 of 4,732 (9%) on placebo: hazard ratio 0.78 (95% CI 0.68 to 0.90), superior to placebo (p=0.0006).
Three years across five HARMONY trials
Among 3,132 participants, more stayed free of rescue therapy on albiglutide (55% to 71%) than on placebo (35% to 51%); the share did not differ from glimepiride or insulin glargine, was higher than with sitagliptin and lower than with pioglitazone. At three years HbA1c had fallen 0.52 to 0.98 points in rescue-free participants, with modest weight reductions against comparators that caused weight gain.
HARMONY 1: added to pioglitazone
In 310 adults on pioglitazone, with or without metformin, albiglutide lowered HbA1c by 0.8 points more than placebo at 52 weeks and fasting glucose by 1.3 mmol/L (against a 0.4 rise); hyperglycaemia rescue was needed by 24.4% against 47.7%. Weight did not change, and severe hypoglycaemia occurred in two patients.
HARMONY 4: against insulin glargine
In 779 patients on metformin, with or without a sulfonylurea, HbA1c fell from 8.28% to 7.62% on albiglutide and from 8.36% to 7.55% on glargine, meeting the non-inferiority margin. Weight fell 2.61 kg relative to glargine, and documented symptomatic hypoglycaemia was less common (17.5% against 27.4%).
HARMONY 3: against sitagliptin, glimepiride and placebo for 104 weeks
In patients on metformin, albiglutide lowered HbA1c at week 104 more than placebo (by 0.9 points), sitagliptin (0.4) and glimepiride (0.3). Weight changed by minus 1.21 kg on albiglutide against plus 1.17 kg on glimepiride. The mean albiglutide dose at week 104 was 40.5 mg, after blinded titration from 30 mg towards 50 mg.
Replacing mealtime insulin with a weekly GLP-1
In a treat-to-target trial, albiglutide plus glargine was non-inferior to lispro plus glargine on HbA1c at 26 weeks (6.7% against 6.6%). 54% of the albiglutide group dropped mealtime insulin entirely, weekly injections fell from 29 to 13, weight changed by minus 2.0 kg against plus 2.4 kg, and hypoglycaemia was less frequent (57.2% against 75.0%); gastrointestinal adverse events were more frequent (26% against 13%).
Phase 2: weekly, fortnightly and monthly schedules
In 356 people over 16 weeks, HbA1c fell by 0.87 points on 30 mg weekly, 0.79 on 50 mg every two weeks and 0.87 on 100 mg monthly, against 0.17 on placebo and 0.54 on twice-daily exenatide. Weight fell 1.1 to 1.7 kg. Gastrointestinal adverse events were less frequent on 30 mg weekly than on the highest fortnightly and monthly doses.
Integrated safety across seven phase 3 trials
Adverse events (84.8% against 82.3% on all comparators) and serious adverse events (13.1% against 12.9%) were similar, as were nausea (12.0% against 11.3%) and vomiting (5.3% against 4.7%). Only diarrhoea (13.7% against 9.9%), injection-site reactions (9.0% against 2.0%) and peripheral oedema (4.5% against 6.8%) differed by 2 points or more; pancreatitis occurred more often on albiglutide (0.3% against 0.1%).
Cardiovascular safety meta-analysis of the HARMONY programme
Across eight phase 3 trials and one phase 2b trial, the composite of major cardiovascular events or hospital admission for unstable angina occurred 58 times on albiglutide and 58 times on comparators (hazard ratio 1.00, 95% CI 0.68 to 1.49), meeting FDA's non-inferiority requirement. Atrial fibrillation or flutter was more common on albiglutide (1.4% against 0.6%).
Harmony Outcomes by age
In a post hoc analysis of 9,462 participants, the hazard ratio for major cardiovascular events was 0.66 under 65 and 0.86 at 65 or older (interaction p=0.07); analysed as a continuous variable, age did not modify albiglutide's effect.
Harmony Outcomes by heart-failure history
20% of participants had a history of heart failure. Against placebo, the effect on cardiovascular death or heart-failure hospitalisation was stronger in patients without heart failure (hazard ratio 0.73) than in those with it (1.06; interaction p=0.062), and the same pattern held for heart-failure hospitalisation (interaction p=0.025).
Latino and Hispanic patients across the phase 3 programme
Among 1,204 Latino or Hispanic patients within seven phase 3 trials of 4,400 participants, the HbA1c difference from placebo was minus 0.94 points, against minus 0.86 in the whole population.
Drug interactions: digoxin, warfarin and an oral contraceptive
In three phase 1 studies in healthy volunteers at steady-state albiglutide (50 mg weekly for 4 to 5 weeks), the pharmacokinetics of digoxin, warfarin, norethindrone and ethinyl estradiol were unaffected, warfarin's INR did not change, and hormone levels showed no clinically meaningful differences; no dose adjustments were judged necessary.
Brain uptake of four incretin agonists in mice
Of four radiolabelled incretin receptor agonists injected intravenously into mice, albiglutide and dulaglutide entered the brain fastest within one hour; tirzepatide crossed slowly over six hours. The work was aimed at Alzheimer's and Parkinson's research, not diabetes.
Clinical pharmacology of albiglutide
Albiglutide is absorbed mainly through the lymphatic system, peaks 3 to 5 days after a dose and reaches steady state after 4 to 5 weeks of weekly injections; its half-life is about 5 days and clearance 67 mL/h. It did not prolong the QT interval, had a modest effect on heart rate, and showed no clinically relevant drug interactions in trials; experience in severe renal impairment was limited.
Patient considerations at approval
Written after FDA approved Tanzeum on April 15, 2014, this review summarises the HARMONY trials: weekly albiglutide lowered fasting glucose, post-meal glucose and HbA1c with weight loss, was clinically less effective than pioglitazone and liraglutide, and most often caused mild gastrointestinal complaints and injection-site redness.
Albiglutide's place in 2018
Drawing on the EU and FDA approval documents, the review found albiglutide's gastrointestinal side effects not much greater than placebo, unlike competitors, and saw it as safe across stages of renal failure, while noting an imbalance of pancreatitis cases and injection-site reactions that led to stopping treatment in up to 2% of participants.
Dosing Data
Albiglutide is no longer marketed, so these are the doses its trials and US label used, recorded for reference rather than use.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Side Effects & Contraindications
Reported Side Effects
The approval programme's integrated safety analysis gives the rates, against all comparators combined.
Contraindications & Cautions
The practical point comes first: albiglutide is not available, so these are lessons from its evidence rather than instructions.
Legal Status
Albiglutide was approved in the US and the EU in 2014 and is no longer marketed in the US.
Frequently Asked Questions
?Is albiglutide still available?
No. FDA's Drugs@FDA database lists Tanzeum, the US product, as discontinued. People who need a once-weekly GLP-1 medicine are prescribed one that is still marketed, such as dulaglutide or semaglutide.
?Did albiglutide reduce heart attacks and strokes?
Yes, in its outcomes trial. In Harmony Outcomes, 9,463 people with type 2 diabetes and cardiovascular disease were followed for a median 1.6 years; major cardiovascular events occurred in 7% on albiglutide and 9% on placebo, a hazard ratio of 0.78.
?How did albiglutide compare with other GLP-1 medicines?
It lowered HbA1c less than liraglutide and pioglitazone in head-to-head comparisons, but its gastrointestinal side effects were close to placebo's, which reviewers saw as its main advantage. It caused more injection-site reactions than its comparators.
?Why could albiglutide be given once a week?
Because it was fused to human albumin. The albumin slows clearance, giving a half-life of about five days, and its GLP-1 copies were modified to resist the enzyme DPP-4, which breaks native GLP-1 down within minutes.
?Does albiglutide interact with other drugs?
In phase 1 studies it did not change the pharmacokinetics of digoxin, warfarin or a low-dose oral contraceptive, and warfarin's INR was unaffected. Like other GLP-1 agonists, it can add to the glucose-lowering effect of insulin and sulfonylureas.
?What did albiglutide's side-effect profile look like?
In the integrated phase 3 analysis, diarrhoea (13.7% against 9.9%) and injection-site reactions (9.0% against 2.0%) were more common than on comparators, nausea was about the same, and pancreatitis occurred in 0.3% against 0.1%.
References
- [fda-pi] FDA. Tanzeum (albiglutide) prescribing information. GlaxoSmithKline, 2014.
- [pubmed] Hernandez 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." Lancet, 2018;392(10157):1519-1529. PMID: 30291013.
- [pubmed] Home PD, et al. "Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy." Diabetes Res Clin Pract, 2017;131:49-60. PMID: 28683300.
- [pubmed] Reusch J, et al. "Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin." Diabetes Obes Metab, 2014;16(12):1257-64. PMID: 25155146.
- [pubmed] Weissman PN, et al. "HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea." Diabetologia, 2014;57(12):2475-84. PMID: 25208756.
- [pubmed] Ahrén B, et al. "HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin." Diabetes Care, 2014;37(8):2141-8. PMID: 24898304.
- [pubmed] Rosenstock J, et al. "Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial." Diabetes Care, 2020;43(10):2509-2518. PMID: 32694215.
- [pubmed] Rosenstock J, et al. "Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing." Diabetes Care, 2009;32(10):1880-6. PMID: 19592625.
- [pubmed] Ahrén B, et al. "Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials." Diabetes Res Clin Pract, 2017;126:230-239. PMID: 28284167.
- [pubmed] Fisher M, et al. "Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis." Lancet Diabetes Endocrinol, 2015;3(9):697-703. PMID: 26276240.
- [pubmed] Gilbert MP, et al. "Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial." Diabetes Obes Metab, 2024;26(5):1714-1722. PMID: 38317618.
- [pubmed] Ferreira JP, et al. "Albiglutide in patients with type 2 diabetes and heart failure: a post-hoc analysis from Harmony Outcomes." Eur J Heart Fail, 2022;24(10):1792-1801. PMID: 36053803.
- [pubmed] Davidson JA, et al. "Albiglutide efficacy and safety in the Latino/Hispanic subpopulation for the integrated phase III program." Postgrad Med, 2017;129(8):849-857. PMID: 29083275.
- [pubmed] Bush M, et al. "Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive." Postgrad Med, 2012;124(6):55-72. PMID: 23322139.
- [pubmed] Rhea EM, et al. "Brain uptake pharmacokinetics of albiglutide, dulaglutide, tirzepatide, and DA5-CH in the search for new treatments of Alzheimer's and Parkinson's diseases." Tissue Barriers, 2024;12(4):2292461. PMID: 38095516.
- [pubmed] Young MA, et al. "Clinical pharmacology of albiglutide, a GLP-1 receptor agonist." Postgrad Med, 2014;126(7):84-97. PMID: 25387217.
- [pubmed] Woodward HN, et al. "Once-weekly albiglutide in the management of type 2 diabetes: patient considerations." Patient Prefer Adherence, 2014;8:789-803. PMID: 24926194.
- [pubmed] Rendell MS. "Albiglutide for the management of type 2 diabetes." Expert Rev Endocrinol Metab, 2018;13(1):1-8. PMID: 30063441.
- [fda] FDA. Drugs@FDA (openFDA), BLA 125431: TANZEUM (albiglutide), GlaxoSmithKline LLC; original approval April 15, 2014; marketing status Discontinued. Read September 30, 2026.
Sources & Citations
Every study on this page was read from its PubMed record; the approval and marketing status come from FDA's Drugs@FDA database. Albiglutide's US label was withdrawn with the product, so no current label is cited.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.