Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Albiglutide (Tanzeum): what the evidence says
At a glance
What it is: a once-weekly GLP-1 receptor agonist made of two GLP-1 copies fused to human albumin. FDA licensed it as Tanzeum (BLA 125431); Drugs@FDA now lists it as discontinued. R1 UNVERIFIED the GSK discontinuation date (reported as 2017 to 2018).
What the evidence says: in Harmony Outcomes (9,463 people with type 2 diabetes and heart disease), heart attack, stroke or heart death fell from 9% to 7% over a median 1.6 years (HR 0.78). R2
Biggest risks: stomach effects; pancreatitis has been reported in a case report. R3 UNVERIFIED case details (no abstract available).
Rating
| Human Human evidence | Strong: Harmony Outcomes, n = 9,463 R2 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-licensed (BLA 125431), discontinued R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R4, R5, R6 · not named by WADA R7 |
| Established human dose | Label dose existed; product no longer marketed |
Evidence verdict: Type 2 diabetes glucose control: Strong (FDA-approved) · Heart outcomes: Strong (one large RCT, 22% fewer events) · Availability: none (discontinued)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: the heart benefit comes from one large randomized trial. The drug was withdrawn for business reasons, not safety. UNVERIFIED the stated reason; we found no FDA safety withdrawal.
What is it?
Related pages: Dulaglutide, Semaglutide, Liraglutide.
Does it work?
- Human Heart outcomes: 338 of 4,731 (7%) vs 428 of 4,732 (9%) had a major heart event (HR 0.78, 95% CI 0.68 to 0.90). R2
Is it safe?
- Human In Harmony Outcomes, pancreatitis, pancreatic and thyroid cancer and other serious events did not differ from placebo. R2
- Human A case report describes albiglutide-linked pancreatitis. R3
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: licensed but discontinued. R1
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R4, R5, R6
- Sport: not named on WADA's 2026 Prohibited List. R7
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Harmony Outcomes 2018 | 9,463 adults, T2D + CVD | SC weekly | 30 to 50 mg weekly | Median 1.6 years | MACE HR 0.78 | PMID 30291013 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Drugs@FDA, Tanzeum (albiglutide), application BLA 125431 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA 125431
- R2 Hernandez AF, et al. Lancet. 2018. PMID 30291013
- R3 Jain N, et al. Ther Adv Drug Saf. 2016. PMID 27904741
- R4 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R5 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R6 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R7 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Albiglutide (Tanzeum). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Albiglutide is no longer manufactured, so anything sold under this name is not the approved product. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).