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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR TANZEUM


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All Clinical Trials for TANZEUM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02787551 ↗ 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 Completed Sanofi Phase 3 2016-07-06 Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TANZEUM

Condition Name

Condition Name for TANZEUM
Intervention Trials
Type 2 Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for TANZEUM
Intervention Trials
Diabetes Mellitus, Type 2 1
Diabetes Mellitus 1
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Clinical Trial Locations for TANZEUM

Trials by Country

Trials by Country for TANZEUM
Location Trials
United States 28
Estonia 1
Italy 1
Spain 1
Canada 1
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Trials by US State

Trials by US State for TANZEUM
Location Trials
Maryland 1
Louisiana 1
Kentucky 1
Iowa 1
Indiana 1
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Clinical Trial Progress for TANZEUM

Clinical Trial Phase

Clinical Trial Phase for TANZEUM
Clinical Trial Phase Trials
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for TANZEUM
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for TANZEUM

Sponsor Name

Sponsor Name for TANZEUM
Sponsor Trials
Sanofi 1
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Sponsor Type

Sponsor Type for TANZEUM
Sponsor Trials
Industry 1
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TANZEUM (Albiglutide): Clinical Trials, Market Analysis, and Future Outlook

Last updated: February 9, 2026

Clinical Trials Overview

TANZEUM (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist developed for type 2 diabetes management. Its key clinical development phases include:

  • Phase 3 Trials (Harmony Series): Conducted between 2010 and 2017, these studies involved approximately 10,000 patients across multiple countries. Trials assessed efficacy, safety, and tolerability.

  • Efficacy Outcomes: Demonstrated significant reductions in HbA1c levels, averaging 0.7-1.0%, compared with placebo. Patients showed weight loss ranging from 2–4 kg.

  • Safety Profile: Common adverse effects included gastrointestinal symptoms and injection site reactions. Serious adverse events were rare, aligning with other GLP-1 receptor agonists.

  • Regulatory Submission & Approval: The FDA approved TANZEUM in September 2014 for adults with type 2 diabetes. The European Medicines Agency (EMA) granted approval in late 2014.

  • Market Withdrawal: In 2018, GlaxoSmithKline (GSK) announced the discontinuation of the drug's marketing outside the U.S., citing commercial reasons. Production ended in 2019.

Market Analysis

Market Size and Trends:

  • Global Type 2 Diabetes Market: Valued at USD 64 billion in 2021, with an expected compound annual growth rate (CAGR) of 7% through 2028 (Grand View Research).[1]

  • GLP-1 Receptor Agonists Segment: Leading the market with a CAGR of approximately 8%. In 2021, it was valued at USD 10 billion, driven by increased adoption due to proven cardiovascular benefits.[2]

Key Competitors:

  • Eli Lilly's Trulicity (dulaglutide): Market leader with sales exceeding USD 4 billion in 2021.

  • Novo Nordisk’s Ozempic (semaglutide): Rapidly growing, with USD 5 billion plus revenue.

  • Others: Semaglutide (marketed as Rybelsus/Semaglutide) and dulaglutide.

Market Dynamics:

  • Driving Factors: Increasing prevalence of diabetes, favorable reimbursement policies, and positive cardiovascular trial results boosting GLP-1 therapies.

  • Barriers: High therapy costs and injectable administration devices limit adoption. Patent expiries are poised to increase generic competition.

Projection for the Next Decade

Despite TANZEUM being withdrawn, the class of GLP-1 receptor agonists is expected to expand substantially.

Year Projected Market Size (USD) Key Drivers Challenges
2023 USD 15 billion Continued diabetes prevalence; new formulations (oral, weekly) Market saturation; safety concerns with long-term use
2025 USD 20 billion Broader payer acceptance; cardiovascular indications approved Cost pressures; competitive landscape
2030 USD 35 billion Increasing approval for obesity and cardiovascular indications Generic entry; innovation in drug delivery

The market’s growth hinges on new product launches, enhanced cardiovascular benefits, and broader approvals for related indications.

Implications for Developers and Investors

  • Lack of TANZEUM Re-Entry: GSK has not announced plans to reintroduce TANZEUM. However, the data and market interest validate the ongoing demand for GLP-1 therapies.

  • Pipeline Opportunities: Companies developing next-generation GLP-1 receptor agonists with oral formulations, extended duration, or dual mechanisms could capture market share.

  • Investment Focus: Firms with strong R&D pipelines targeting cardiovascular risks, obesity, and treatment adherence issues are poised for growth.

Conclusion

TANZEUM's clinical progress demonstrated the therapeutic potential of albiglutide, although commercial withdrawal reflects strategic reconsiderations rather than efficacy concerns. The broader GLP-1 receptor agonist market remains robust, with growth driven by expanding indications and innovations. Stakeholders should focus on pipeline developments, competitive positioning, and evolving regulatory landscapes for future opportunities.


Key Takeaways

  • The clinical development of TANZEUM showed effective glycemic control and a favorable safety profile, but market withdrawal in 2018 curtailed its commercial impact.

  • The global GLP-1 receptor agonist market is projected to grow at a CAGR of 8%, reaching USD 20 billion by 2025 and USD 35 billion by 2030.

  • The dominance of key players like Novo Nordisk and Eli Lilly underscores high competition; innovation in formulation and indications remains critical.

  • Future investment opportunities exist in oral or long-acting GLP-1 analogs targeting obesity and cardiovascular disease.

  • Market expansion will be influenced by cost considerations, regulatory approvals, and health policy shifts toward reimbursement for inflammatory and metabolic therapies.


FAQs

1. Why was TANZEUM withdrawn from the market?
GSK cited commercial reasons, including limited market uptake and competition, rather than safety or efficacy issues.

2. Will there be a new version of albiglutide?
No public plans for reformulation or reintroduction of albiglutide have been announced.

3. How does the efficacy of albiglutide compare to other GLP-1 receptor agonists?
Albiglutide's HbA1c reduction (~0.7-1.0%) aligns with its peers, though it has a less favorable dosing frequency and market profile.

4. What are the major drivers of growth in the GLP-1 market?
Prevalence of type 2 diabetes, cardiovascular benefits demonstrated in clinical trials, and development of oral formulations.

5. How might upcoming therapies affect market dynamics?
New formulations with improved convenience and expanded indications will intensify competition, potentially displacing older therapies like TANZEUM.


References

[1] Grand View Research. Diabetes Drugs Market Size & Trends, 2021-2028.
[2] IQVIA. The Global Diabetes Care Market Analysis 2022.

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