Is albiglutide FDA-approved, and what does the research show?

What is albiglutide?

Albiglutide was a diabetes drug that GlaxoSmithKline sold under the brand name Tanzeum ¹, ². Its label called it a "GLP-1 receptor agonist," a drug that switches on the body's receptor for GLP-1, short for glucagon-like peptide-1 ². GLP-1 is a hormone the gut releases after a meal.

The molecule is a large protein. The label describes "a recombinant fusion protein comprised of 2 tandem copies of modified human GLP-1 genetically fused in tandem to human albumin" ². Albumin is a protein of human blood, and recombinant means made by engineered cells, here a strain of yeast ². It was given by injection under the skin ².

Albiglutide is not a wellness, weight-loss or performance peptide. It was a prescription medicine for adults with type 2 diabetes ². That disease accounts for about nine in ten cases of diabetes ⁴. In it the body resists insulin, the hormone that lowers blood sugar, and the pancreas gradually makes less of it ⁴.

Is albiglutide FDA-approved?

It was approved in 2014, and FDA's records now list it as discontinued, with its license voluntarily revoked ¹, ³. FDA approved albiglutide, as Tanzeum, on April 15, 2014, under biologics license application (BLA) 125431; the record names GlaxoSmithKline LLC as its sponsor ¹. A BLA is FDA's application for a biological product, and the Purple Book is FDA's database of licensed biological products ³.

Drugs@FDA lists the one Tanzeum product in its record with marketing status "Discontinued" as of November 9, 2026, the date of the record's data ¹. The Purple Book's October 2026 data list both Tanzeum strengths with marketing status "Disc" and licensure "Voluntarily Revoked" ³. Neither record gives a date or a reason for the revocation ¹, ³. GlaxoSmithKline's half-year report of July 26, 2017, said it would "progressively withdraw its support for Tanzeum" and cease manufacturing it ⁵.

For the discontinuation, not the revocation, Drugs.com, a consumer drug reference, reports the maker's stated reason ⁶. It says GlaxoSmithKline "announced that it was discontinuing the manufacturing and sale of Tanzeum on July 26, 2017, due to limited prescribing of the drug and declining sales" ⁶. GlaxoSmithKline's own report tied the withdrawal to "the new business priorities for the Group" ⁵.

While Tanzeum was sold, its label gave one indication: "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus" ². Glycemic control is control of blood sugar, and an adjunct is an addition. The label set limits: Tanzeum was "not recommended as first-line therapy for patients inadequately controlled on diet and exercise," and was not for type 1 diabetes ².

With the approval, FDA required the maker to run further studies, among them a cardiovascular outcomes trial, a 2015 review reports ⁴. FDA also required a risk evaluation and mitigation strategy, a program that told healthcare providers about the drug's serious risks ⁴.

See the FDA status of every peptide, updated weekly.

How does albiglutide work?

The last Tanzeum label in FDA's record, revised in December 2017, states the mechanism in two short sentences ¹, ². Albiglutide "is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion," and it "also slows gastric emptying" ². In plain terms, the pancreas releases more insulin only while blood sugar is raised, and food leaves the stomach more slowly.

The molecule was built to last. In each GLP-1 copy one amino acid, a building block of proteins, was swapped "to confer resistance" to DPP-IV, an enzyme that cuts GLP-1 apart ². The albumin, "together with the DPP-IV resistance, extends the half-life allowing once-weekly dosing" ². The half-life, the time for half the drug to leave the blood, was about 5 days ².

Two measured effects are on the label, both against placebo, a dummy injection ². In a phase 2 trial, a mid-stage study, Japanese patients with type 2 diabetes were tested with a mixed meal at week 16 ². Their blood glucose over the next three hours was 22 percent lower on albiglutide than on placebo ². In healthy volunteers, a single dose twice the largest approved one slowed the stomach's emptying of both solids and liquids ². The label gives no participant count for either study ².

Albiglutide was one of several drugs of its class. The label calls liraglutide "another GLP-1 receptor agonist" ². A 2015 review names exenatide as another ⁴.

What does the research show?

Studied in people: the label reports eight phase 3 trials, the large late-stage trials that precede an approval, in which 2,365 patients received albiglutide ². Each enrolled patients with type 2 diabetes, and the trials gave the drug once a week ². The main measure was HbA1c, or glycated hemoglobin, the standard blood measure of sugar control, with a general adult target below 7 percent, the American Diabetes Association's ⁴, ². Weight change was reported beside the blood sugar results ².

Alone, against placebo: a 52-week trial randomized 296 patients, whose diabetes was inadequately controlled on diet and exercise, to two albiglutide regimens or placebo ². It was double-blind, meaning neither patients nor doctors knew who received which. At week 52, HbA1c had fallen 0.7 percentage points in one albiglutide arm (100 patients) and 0.9 in the other (97) ². It had risen 0.2 on placebo (99 patients) ². Weight fell 0.4 to 0.9 kg on albiglutide and 0.7 kg on placebo, a difference the label calls not significant ².

Many of those final values were estimates. Where a patient left or needed rescue medicine, the last reading before that was carried forward ². That applied to 63 percent of the placebo arm and to 34 and 41 percent of the two albiglutide arms ².

Added to metformin, a common diabetes pill: a 104-week double-blind trial of 999 patients compared albiglutide with placebo and with two other pills, sitagliptin and glimepiride ². HbA1c fell 0.6 points on albiglutide (297 patients), 0.3 on sitagliptin (300) and 0.4 on glimepiride (302), and rose 0.3 on placebo (100) ². Weight fell 1.2 kg on albiglutide, 1.0 kg on placebo and 0.9 kg on sitagliptin, and rose 1.2 kg on glimepiride ². The label states that the weight difference between albiglutide and glimepiride was statistically significant, meaning unlikely to be chance ².

Two more double-blind trials added albiglutide to other diabetes pills for 52 weeks ². In 299 patients on pioglitazone, HbA1c fell 0.8 points on albiglutide (150 patients) and 0.1 on placebo (149) ². Weight rose 0.3 kg on albiglutide and 0.5 kg on placebo, not a significant difference ². In 657 patients on metformin plus glimepiride, HbA1c fell 0.6 points on albiglutide (269 patients) and 0.8 on pioglitazone (273), and rose 0.3 on placebo (115) ². Weight fell 0.4 kg on both albiglutide and placebo and rose 4.4 kg on pioglitazone ².

One trial set albiglutide head to head with liraglutide ². It ran 32 weeks in 805 patients inadequately controlled on diabetes pills, and it was open-label, meaning everyone knew which drug they received ². HbA1c fell 0.8 points on albiglutide (402 patients) and 1.0 on liraglutide (403) ². Albiglutide failed the trial's test of being no worse, called non-inferiority ². Weight fell 0.6 kg on albiglutide and 2.2 kg on liraglutide, a difference of 1.6 kg in liraglutide's favor (95 percent confidence interval 1.1 to 2.1) ².

Two open-label trials compared albiglutide with insulin ². Against insulin glargine, over 52 weeks in 735 patients, HbA1c fell 0.7 points on albiglutide (496 patients) and 0.8 on the insulin (239), which met non-inferiority ². Weight fell 1.1 kg on albiglutide and rose 1.6 kg on insulin glargine ². Against mealtime insulin lispro, over 26 weeks in 563 patients already on insulin glargine, HbA1c fell 0.8 points on albiglutide (282 patients) and 0.7 on lispro (281) ². Weight fell 0.7 kg on albiglutide and rose 0.8 kg on lispro ².

The eighth trial enrolled 486 patients with type 2 diabetes and impaired kidneys, double-blind, for 26 weeks ². HbA1c fell 0.8 points on albiglutide (246 patients) and 0.5 on sitagliptin (240) ². Weight fell 0.8 kg on albiglutide and 0.2 kg on sitagliptin ².

The largest trial came after approval. Harmony Outcomes, published online on October 2, 2018, randomized 9,463 people aged 40 and older with type 2 diabetes and cardiovascular disease ⁷. It ran double-blind at 610 sites in 28 countries: 4,731 people were assigned to weekly albiglutide and 4,732 to a matched placebo, each added to standard care ⁷. The main outcome was a first cardiovascular death, heart attack or stroke, over a median of 1.6 years ⁷.

That outcome occurred in 338 patients (7 percent) on albiglutide and 428 (9 percent) on placebo ⁷. The hazard ratio was 0.78, with a 95 percent confidence interval of 0.68 to 0.90 ⁷. A hazard ratio below 1 means fewer events over time in the albiglutide group, and the interval is the range the true figure plausibly lies in. GlaxoSmithKline funded the trial ⁷. In the trial's posted results, weight fell 1.0 kg on albiglutide and 0.4 kg on placebo by month 8, among patients weighed then ⁸.

The last label in FDA's record predates that trial ¹, ². It says there had been no trials "establishing conclusive evidence of macrovascular risk reduction," meaning fewer heart attacks and strokes ². It also says safety and effectiveness "have not been established in pediatric patients," and that the drug was not studied in people with a history of pancreatitis ².

What are the side effects?

The label's main safety table pools four placebo-controlled trials in adults with type 2 diabetes ². In them 923 patients received albiglutide, for 93 weeks on average, and 468 received placebo ². Diarrhea was reported by 13.1 percent on albiglutide and 10.5 percent on placebo, and nausea by 11.1 and 9.6 percent ². Injection-site reactions of any kind were reported by 18 percent on albiglutide and 8 percent on placebo ².

The label opened with a boxed warning on thyroid C-cell tumors ². It said albiglutide's cancer risk "could not be assessed in rodents," while other GLP-1 receptor agonists "have caused thyroid C-cell tumors in rodents at clinically relevant exposures" ². It is "unknown whether TANZEUM causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans," the warning said ². Across the eight trials, MTC was diagnosed in 1 patient receiving albiglutide and 1 receiving placebo ².

The label contraindicated Tanzeum "in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2" ². It also ruled out patients "with a prior serious hypersensitivity reaction to albiglutide or any of the product components" ². Hypersensitivity here means a serious allergic reaction, and the label reported cases of angioedema, a deep swelling under the skin ². Multiple Endocrine Neoplasia syndrome type 2 is a condition of tumors in the glands ⁶.

Pancreatitis, inflammation of the pancreas, was judged likely related to treatment in 6 of 2,365 patients on albiglutide (0.3 percent) ². The figures beside it were 0 of 468 on placebo and 2 of 2,062 on other comparators (0.1 percent) ². Low blood sugar was more frequent when albiglutide was added to insulin or to a sulfonylurea, a class of diabetes pill that includes glimepiride ². With metformin and a sulfonylurea, 13 percent had a documented symptomatic episode on albiglutide and 7 percent on placebo ².

The kidney warning, revised in December 2017, reported "postmarketing cases of worsening renal function and acute kidney injury," some of which required hemodialysis ². In a pool of seven trials, pneumonia was reported in 1.8 percent on albiglutide and 0.8 percent on all comparators ². Atrial fibrillation, an irregular heart rhythm, was reported in 1.0 and 0.5 percent ². The label said Tanzeum "should not be used during pregnancy unless the expected benefit outweighs the potential risks" ².

In Harmony Outcomes, acute pancreatitis was reported in 10 patients on albiglutide and 7 on placebo, and pancreatic cancer in 6 and 5 ⁷. No patient in either group had medullary thyroid carcinoma ⁷. Investigators judged 2 deaths in the albiglutide group and 3 in the placebo group to be treatment-related ⁷.

In sport

WADA, the World Anti-Doping Agency, does not name albiglutide on its 2026 Prohibited List, and the list does not name GLP-1 receptor agonists as a class ⁹. Section S4.4.2 prohibits "Insulins and insulin-mimetics, e.g. S519, S597," and albiglutide is not among the examples it gives ⁹.

Section S0 covers substances that the later sections do not address ⁹. It reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ⁹. FDA's Purple Book lists the license as "Voluntarily Revoked" ³. In the European Union, albiglutide was authorized as Eperzan ¹⁰. The European Commission withdrew that authorization on October 29, 2018, at GlaxoSmithKline's request ¹⁰.

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JumpstartMD does not prescribe albiglutide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.