Hormones & metabolism GLP-1 receptor agonist
Albiglutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Albiglutide is a once-weekly GLP-1 receptor agonist made by fusing GLP-1 analog chains to human albumin, approved for type 2 diabetes in 2014 as Tanzeum. It had a somewhat weaker effect on gastric emptying and appetite than some other GLP-1 drugs but showed a cardiovascular benefit in the HARMONY OUTCOMES trial. Despite that, GSK withdrew it from the market in 2018 for commercial reasons, so it remains FDA-approved but is no longer available.
At a glance
- FDA status
- FDA-approved GLP-1 peptide, formerly sold as Tanzeum for type 2 diabetes
- How it's taken
- Once-weekly injection made by fusing a GLP-1 analog to the blood protein albumin
- Market status
- Withdrawn by its manufacturer in 2018 for commercial reasons, despite a positive cardiovascular trial
- Evidence strength
- FDA approved
Summary
Albiglutide is a once-weekly GLP-1 drug approved in 2014 as Tanzeum for type 2 diabetes. Learn how it works, what trials found, and why it was withdrawn.
What is albiglutide?
Albiglutide is a GLP-1 receptor agonist, a peptide that mimics the natural gut hormone GLP-1. It was engineered by fusing two GLP-1 analog chains to human albumin, the most abundant protein in blood, which extended its lifespan enough for once-weekly dosing.
It was made by GlaxoSmithKline and sold as Tanzeum, given as a once-weekly subcutaneous injection.
How does it work?
Albiglutide lowers blood sugar by activating the GLP-1 receptor, mimicking a gut hormone the body releases after eating. Through that receptor it:
- Drives glucose-dependent insulin release, which keeps the risk of hypoglycemia low on its own
- Lowers glucagon
- Slows the rate at which the stomach empties, though it has a somewhat weaker effect on gastric emptying and appetite than some other GLP-1 drugs
Fusing the peptide to albumin is what gave it a long half-life and once-weekly dosing. In the HARMONY OUTCOMES trial, albiglutide reduced major cardiovascular events in people with type 2 diabetes and established heart disease.
Is it FDA-approved?
Editor’s note
Status: FDA-approved GLP-1 peptide, formerly sold as Tanzeum for type 2 diabetes
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes, but it is no longer sold. Tanzeum was approved in 2014 for type 2 diabetes. Despite the later HARMONY OUTCOMES trial showing a cardiovascular benefit, GSK withdrew Tanzeum from the market in 2018 because of low sales, so it remains FDA-approved but is not available.
What is albiglutide prescribed for?
When it was marketed, albiglutide was prescribed to improve blood sugar control in adults with type 2 diabetes, alongside diet and exercise. It was not a treatment for type 1 diabetes, and it was not recommended for people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
What are the side effects?
The most common side effects were:
- Diarrhea
- Nausea
- Injection-site reactions
- Upper respiratory infection
Less common but more serious risks included:
- Thyroid C-cell tumors: albiglutide carried a boxed warning based on rodent studies. It is not known whether this happens in humans.
- Pancreatitis, or inflammation of the pancreas
- Severe allergic reactions, including anaphylaxis
- Low blood sugar, especially when combined with insulin or a sulfonylurea
- Acute kidney injury, usually from dehydration caused by vomiting or diarrhea
Sources: a published review of Tanzeum (albiglutide); the HARMONY OUTCOMES cardiovascular trial (Hernandez et al., The Lancet, 2018, DOI: 10.1016/S0140-6736(18)32261-X), indexed on PubMed; and drug references documenting its 2018 market withdrawal. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
Compare every peptide’s status in the peptide regulatory status database
More for Hormones & metabolism
View all hormones & metabolism peptides →- Not FDA-approved Hormones & metabolism
Compounded-Tesamorelin
Tesamorelin is an FDA-approved growth-hormone-releasing peptide, sold as Egrifta, for excess abdominal fat in HIV-associated lipodystrophy. In a randomized trial of 404 people with HIV (Falutz 2010), visceral fat fell 10.9% on tesamorelin versus 0.6% on placebo over 6 months. Its off-label use for body composition and anti-aging in people without HIV is not an approved indication and lacks dedicated trials. It is banned in sport.
- FDA-approved Hormones & metabolism
Corticotropin
ACTH
Corticotropin (adrenocorticotropic hormone, or ACTH; sold as Acthar Gel and Purified Cortrophin Gel) is a hormone preparation that stimulates the adrenal glands to make their own steroids and also acts directly on immune cells. It is one of the oldest biologic medicines, used today for conditions ranging from infantile spasms to multiple sclerosis relapses. It has been FDA-approved in the U.S. since 1952 and is given as a long-acting injection.
- FDA-approved Hormones & metabolism
Cosyntropin
Cosyntropin (sold as Cortrosyn) is a synthetic fragment of adrenocorticotropic hormone used as a diagnostic agent to test whether the adrenal glands are working. A dose is given and the resulting rise in cortisol shows how well the adrenals respond. It has long been FDA-approved in the U.S. and is given as a single injection during the test.
- FDA-approved Hormones & metabolism
Dulaglutide
Dulaglutide is a once-weekly GLP-1 receptor agonist built by fusing two GLP-1 analog chains to an antibody fragment, which extends its action to about five days. It was approved for type 2 diabetes in 2014 and gained a cardiovascular indication in 2020 after the REWIND trial showed a roughly 12% reduction in major cardiovascular events. It remains on the market as Trulicity.
- In clinical trials Hormones & metabolism
Efpeglenatide
Efpeglenatide is an investigational long-acting GLP-1 receptor agonist, originally developed by Hanmi Pharmaceutical, given as a once-weekly injection for type 2 diabetes and cardiovascular risk. In a large Phase 3 outcomes trial it reduced major cardiovascular events in people with type 2 diabetes. As of 2026, it has not reached approval in major markets.
- In clinical trials Hormones & metabolism
Elamipretide
Elamipretide is a mitochondria-targeting peptide that binds cardiolipin, a key molecule in the energy-producing inner membrane of mitochondria, developed by Stealth BioTherapeutics. It received FDA accelerated approval in 2025 as Forzinity for Barth syndrome, a rare genetic disorder of cardiolipin, making it the first approved treatment for that condition. Its approval rests on a muscle-strength surrogate measure with a confirmatory trial still required, and its other studied uses remain investigational.