Albiglutide (Tanzeum): Risks & Legal Status

Critical Safety Information#

Albiglutide (Tanzeum/Eperzan) was voluntarily withdrawn from the worldwide market by GlaxoSmithKline on July 26, 2017 due to low prescribing and declining sales. The withdrawal was a commercial decision, not a safety-driven recall. The drug is no longer manufactured or available through any channel. All safety information below is historical.

Product Withdrawal#

GSK's decision to withdraw albiglutide was driven by commercial failure in an increasingly competitive GLP-1 agonist market:

• Low prescribing rates: Albiglutide captured minimal market share despite weekly dosing convenience
• Inferior efficacy: Lower HbA1c reduction and weight loss compared to liraglutide and subsequently semaglutide
• Complex administration: The ~15-minute reconstitution process deterred prescribers and patients
• HARMONY 7 result: Failure to demonstrate non-inferiority to daily liraglutide undermined the weekly dosing advantage

Historical Safety Warnings#

Thyroid C-Cell Tumors (Boxed Warning)#

Albiglutide carried the FDA boxed warning for thyroid C-cell tumors, a class-wide concern for GLP-1 receptor agonists based on findings in rodent carcinogenicity studies. The relevance to humans remained uncertain throughout the drug's lifecycle. No medullary thyroid carcinoma was attributed to albiglutide in clinical trials.

Pancreatitis#

Acute pancreatitis was reported in clinical trials of albiglutide. While a definitive causal link between GLP-1 agonists and pancreatitis has not been established, the risk was communicated in the prescribing information.

Hypersensitivity#

Hypersensitivity reactions were observed at low rates. Unlike taspoglutide (which had 49% immunogenicity), albiglutide had a relatively low anti-drug antibody rate (<5%).

Regulatory Status#

Albiglutide is classified as a withdrawn product in all markets where it was previously approved. It is not available for clinical use, research purchase, or any other purpose. Patients and researchers interested in GLP-1 receptor agonist therapy should consult currently approved alternatives including semaglutide, liraglutide, dulaglutide, and tirzepatide.

Risk Assessment Context#

Albiglutide (Tanzeum) belongs to the Metabolic category of research peptides. Risk assessment for Albiglutide (Tanzeum) should consider both the compound-specific risks identified in clinical research and the broader regulatory environment. Researchers and healthcare providers should evaluate these risks in the context of the specific patient population and therapeutic indication.

Risk Categories#

The following risk categories have been identified for Albiglutide (Tanzeum) based on available evidence and regulatory assessments:

Product Withdrawal#

GSK withdrew albiglutide (Tanzeum/Eperzan) from the worldwide market on July 26, 2017 due to low prescribing and declining sales. The withdrawal was a commercial decision, not safety-related. The drug is no longer manufactured or available through any channel.

Thyroid C-Cell Tumors (Class Warning)#

Albiglutide carried the GLP-1 agonist class-wide FDA boxed warning for thyroid C-cell tumors. GLP-1 receptor agonists cause thyroid C-cell tumors in rodents at clinically relevant exposures. The relevance to humans is uncertain. No cases of medullary thyroid carcinoma were attributed to albiglutide in clinical trials.

Pancreatitis#

Acute pancreatitis was reported in clinical trials of albiglutide, consistent with the GLP-1 agonist class. While a causal relationship has not been definitively established for any GLP-1 agonist, patients were advised to discontinue treatment if pancreatitis was suspected.

Hypersensitivity#

Hypersensitivity reactions including rash, pruritus, and angioedema were reported. Patients who experienced hypersensitivity to albiglutide were advised to discontinue use and not restart.

Regulatory Status by Jurisdiction#

The regulatory and legal status of Albiglutide (Tanzeum) varies by country and jurisdiction. Researchers should verify current regulations before acquiring or using this compound.

Regulatory classifications can change. Researchers are responsible for complying with all applicable laws and regulations in their jurisdiction.

Important Warnings#

The following warnings apply to Albiglutide (Tanzeum):

• PRODUCT WITHDRAWN: Albiglutide (Tanzeum/Eperzan) was withdrawn from the worldwide market in July 2017 and is no longer manufactured or available for clinical use.
• BOXED WARNING (HISTORICAL): Thyroid C-cell tumors. GLP-1 receptor agonists cause thyroid C-cell tumors in rodents. Contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
• PANCREATITIS RISK: Acute pancreatitis was reported in clinical trials. Patients were advised to discontinue albiglutide if pancreatitis was suspected.
• NOT AVAILABLE: Albiglutide is not available for clinical use, pharmacy dispensing, or any other purpose. Patients requiring GLP-1 agonist therapy should discuss currently available alternatives with their healthcare provider.

These warnings are based on available preclinical and clinical data. The absence of a warning does not indicate safety. Consult qualified professionals before making any decisions regarding peptide research.

Related Reading#

• Albiglutide (Tanzeum) overview and research guide
• Albiglutide (Tanzeum) side effects profile
• Albiglutide (Tanzeum) research evidence