Data updated: May 26, 2026
TANZEUM (albiglutide)
Trial Activity: Declining
Metabolic
Approved 2014-04-15
Development Insights
GlaxoSmithKline conducting 18 trials (95%)
3 indications explored (Focused)
→ diabetes mellitus, type 2 (17 trials)
→ type 2 diabetes mellitus (1 trials)
→ diabetes mellitus (1 trials)
1
Indication
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-04-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TANZEUM Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2014 to 2017
What TANZEUM Treats
1 FDA approvalsOriginally approved for its first indication in 2014 .
- Other (1)
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Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02787551 LixiLan-G results posted | EFC13794 2014-004850-32, U1111-1168-4639 | Ph 3 | completed | 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 |
| NCT02229227 results posted | 200977 2014-001821-34 | Ph 3 | completed | Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus |
| NCT02793154 results posted | 204879 | Ph 4 | terminated | 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 |
| NCT02750930 results posted | 204682 | Ph 4 | terminated | Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects |
| NCT03015519 | 200938 | Ph 3 | withdrawn | A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus |
| NCT00938158 | 108370 | Ph 1 | completed | A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects. |
| NCT01077505 | 107032 | Ph 1 | completed | An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide . |
| NCT01406262 | 107085 | Ph 1 | completed | Albiglutide Thorough ECG Study in Healthy Volunteers |
| NCT01777282 results posted | 116170 | Ph 3 | completed | 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 |
| NCT01098539 results posted | 114130 | Ph 3 | completed | A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment. |
| NCT01128894 results posted | 114179 | Ph 3 | completed | A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide. |
| NCT01098461 results posted | 110932 | Ph 2 | completed | Dose Ranging Study of Albiglutide in Japanese Subjects |
| NCT01475734 results posted | 108372 | Ph 2 | completed | Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes |
| NCT00839527 results posted | 112757 | Ph 3 | completed | A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes |
| NCT00849056 results posted | 112755 | Ph 3 | completed | Safety and Efficacy of Albiglutide in Type 2 Diabetes |
| NCT00838903 results posted | 112753 | Ph 3 | completed | Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes |
| NCT00849017 results posted | 112756 | Ph 3 | completed | Safety and Efficacy Study of Albiglutide in Type 2 Diabetes |
| NCT00838916 results posted | 112754 | Ph 3 | completed | A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes |
| NCT02229240 | 111892 | Ph 3 | withdrawn | Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TANZEUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment