Albiglutide

Also known as: Tanzeum · Eperzan

Approved, discontinued

Last verified: October 30, 2026

At a glance

FDA approval Approved, discontinued 1 application
Randomized controlled trials 30 of 287 publications on PubMed
Registered clinical trials 39 2 active
Adverse event reports 8,909 750 classified as serious
  • Albiglutide was approved by the FDA (Tanzeum, April 15, 2014), but the products are no longer marketed.
  • PubMed lists 287 publications mentioning it, including 30 randomized controlled trials and 3 animal-only studies.
  • ClinicalTrials.gov lists 39 registered studies testing it (2 active).
  • FDA's adverse event system (FAERS) holds 8,909 reports mentioning it; 750 classified as serious. Reports do not prove causation.

Research topics

  • Diabetes Mellitus, Type 2 125
  • Hypoglycemic Agents 123
  • Glucagon-Like Peptide-1 Receptor Agonists 89
  • Glucagon-Like Peptide 1 73
  • Glucagon-Like Peptide-1 Receptor 41
  • Cardiovascular Diseases 40
  • Glucagon-Like Peptides 39
  • Liraglutide 39
  • Exenatide 32
  • Blood Glucose 29

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
BLA125431 TANZEUM Approved, discontinued April 15, 2014 GLAXOSMITHKLINE LLC

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 287
  • Human (MeSH) 214
  • Animal only 3
  • Clinical trials 32
  • Randomized controlled trials 30
  • Systematic reviews & meta-analyses 51
  • Case reports 2
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
39
Active
2
With posted results
24

Conditions studied

  • Diabetes Mellitus, Type 2 30
  • Diabetes Mellitus 3
  • Type 2 Diabetes Mellitus 2
  • Cardiovascular Kidney Metabolic Syndrome 1
  • Cardiovascular Events 1
  • Type2 Diabetes 1
  • Renal Disease 1
  • Type2diabetes 1
  • Cardiovascular Diseases 1
  • Diabetes Mellitus, Type 1 1
Study Status Phase Start
Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
NCT07188545 Ohio State University
Active, not recruiting — September 15, 2025
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
NCT05220917 Brigham and Women's Hospital
Active, not recruiting — August 1, 2021
Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh
NCT06449235 Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
Unknown status Phase 4 Sep 2024
A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
NCT03492580 Janssen Research & Development, LLC
Completed — February 22, 2018
A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus
NCT03015519 GlaxoSmithKline
Withdrawn Phase 3 August 14, 2017
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
NCT02750930 GlaxoSmithKline Results posted
Terminated Phase 4 October 7, 2016
An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects
NCT02793154 GlaxoSmithKline Results posted
Terminated Phase 4 September 26, 2016
A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects
NCT02802514 GlaxoSmithKline Results posted
Terminated Phase 4 September 20, 2016
Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
NCT02846233 University of California, San Francisco Results posted
Completed N/A Aug 2016
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period
NCT02787551 Sanofi Results posted
Completed Phase 3 July 6, 2016
Show 29 more studies
Study Status Phase Start
Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
NCT02683746 GlaxoSmithKline Results posted
Completed Phase 3 March 16, 2016
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
NCT02660736 GlaxoSmithKline
Completed Phase 1 Feb 2016
Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
NCT02229240 GlaxoSmithKline
Withdrawn Phase 3 Aug 2015
Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
NCT02465515 GlaxoSmithKline Results posted
Completed Phase 4 July 1, 2015
A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
NCT02496221 GlaxoSmithKline Results posted
Completed Phase 4 June 11, 2015
Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
NCT02229227 GlaxoSmithKline Results posted
Completed Phase 3 November 21, 2014
Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus
NCT02284009 GlaxoSmithKline Results posted
Completed Phase 2 October 10, 2014
A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
NCT01777282 GlaxoSmithKline Results posted
Completed Phase 3 February 23, 2013
A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT01733758 GlaxoSmithKline Results posted
Completed Phase 3 Feb 2013
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes
NCT01475734 GlaxoSmithKline Results posted
Completed Phase 2 Dec 2011
Albiglutide Thorough ECG Study in Healthy Volunteers
NCT01406262 GlaxoSmithKline
Completed Phase 1 July 6, 2011
Pharmacokinetics/Pharmacodynamics of Albiglutide
NCT01357889 GlaxoSmithKline Results posted
Completed Phase 2 Jul 2011
A Drug Interaction Study of Albiglutide and Digoxin
NCT01147718 GlaxoSmithKline
Completed Phase 1 June 11, 2010
A Drug Interaction Study With Albiglutide and Warfarin
NCT01147731 GlaxoSmithKline
Completed Phase 1 June 4, 2010
A Drug Interaction Study of Simvastatin and Albiglutide
NCT01147692 GlaxoSmithKline
Completed Phase 1 May 19, 2010
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
NCT01128894 GlaxoSmithKline Results posted
Completed Phase 3 May 2010
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
NCT01098539 GlaxoSmithKline Results posted
Completed Phase 3 May 2010
Dose Ranging Study of Albiglutide in Japanese Subjects
NCT01098461 GlaxoSmithKline Results posted
Completed Phase 2 Apr 2010
An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
NCT01077505 GlaxoSmithKline
Completed Phase 1 March 15, 2010
A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine
NCT00976391 GlaxoSmithKline Results posted
Completed Phase 3 Sep 2009
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
NCT00938158 GlaxoSmithKline
Completed Phase 1 August 5, 2009
A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes
NCT00838916 GlaxoSmithKline Results posted
Completed Phase 3 Feb 2009
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
NCT00838903 GlaxoSmithKline Results posted
Completed Phase 3 Feb 2009
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
NCT00839527 GlaxoSmithKline Results posted
Completed Phase 3 Feb 2009
Safety and Efficacy of Albiglutide in Type 2 Diabetes
NCT00849056 GlaxoSmithKline Results posted
Completed Phase 3 Jan 2009
Safety and Efficacy Study of Albiglutide in Type 2 Diabetes
NCT00849017 GlaxoSmithKline Results posted
Completed Phase 3 Jan 2009
Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.
NCT00537719 GlaxoSmithKline
Completed Phase 1 December 7, 2007
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
NCT00518115 GlaxoSmithKline Results posted
Completed Phase 2 Apr 2007
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
NCT00354536 GlaxoSmithKline
Completed Phase 2 Feb 2006

All 39 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
8,909
Serious
750
With death outcome
42

Most reported reactions

  • Device use error 4,057
  • Drug dose omission 1,281
  • Device leakage 1,195
  • Accidental exposure to product 1,182
  • Product quality issue 1,007
  • Wrong technique in device usage process 929
  • Product preparation error 692
  • Underdose 666
  • Wrong technique in product usage process 537
  • Nausea 462
  • Blood glucose increased 356
  • Weight decreased 283

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.