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.

Status recorded · FDA source document

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.

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Status as of

Key takeaway

Liraglutide is a once-daily GLP-1 receptor agonist and the first of its kind, engineered from human GLP-1 with a fatty-acid chain that binds albumin to extend its action. Sold as Victoza for type 2 diabetes and Saxenda for weight management, it produced about 8% average weight loss in the SCALE trial and became the first GLP-1 shown to reduce cardiovascular events in LEADER. Its albumin-binding design paved the way for once-weekly semaglutide.

At a glance

What it is
FDA-approved GLP-1 peptide, sold as Victoza for type 2 diabetes and Saxenda for weight management
History
First once-daily GLP-1 drug; helped establish the GLP-1 class that now includes semaglutide and tirzepatide
Route and results
Once-daily injection; produced about 8% average body-weight loss in trials
Evidence strength
FDA approved

Summary

Liraglutide, sold as Victoza and Saxenda, is a once-daily GLP-1 agonist for type 2 diabetes and weight management. Learn how it works and its evidence.

What is liraglutide?

Liraglutide is a GLP-1 receptor agonist, a peptide that closely mimics the natural gut hormone GLP-1. It shares about 97% of its structure with human GLP-1 and has a fatty-acid chain added so it binds to proteins in the blood and lasts long enough to be dosed once a day.

It is made by Novo Nordisk and sold under two brand names, Victoza for type 2 diabetes and Saxenda for weight management, and a generic version is now available. Both branded forms are once-daily subcutaneous injections.

The history of liraglutide

Liraglutide's history includes three U.S. milestones:

Study findings for Liraglutide
Year Milestone
2010Reached the U.S. market as Victoza, the first once-daily GLP-1 drug
2014A higher-dose version called Saxenda became one of the first GLP-1 drugs approved specifically for weight management
2016The LEADER trial made liraglutide the first GLP-1 shown to reduce cardiovascular events

Victoza improved on the earlier exenatide, which had to be injected twice a day. Its key engineering step, attaching a fatty-acid chain so the peptide clings to albumin and survives longer in the body, is the same approach Novo Nordisk later used to create once-weekly semaglutide.

In that sense, liraglutide paved the way for the current generation of GLP-1 medicines, including semaglutide and tirzepatide.

How does it work?

Liraglutide activates the GLP-1 receptor, mimicking a natural gut hormone the body releases after eating. Through that receptor it prompts the pancreas to release insulin when blood sugar is high. Because this effect is glucose-dependent, meaning it works mainly when blood sugar is already elevated, liraglutide on its own carries a low risk of causing hypoglycemia. It also reduces the release of glucagon (a hormone that raises blood sugar) and slows the rate at which the stomach empties, which blunts the rise in blood sugar after a meal and helps a person feel full for longer.

Beyond the gut and pancreas, liraglutide acts on appetite centers in the brain, where it increases feelings of fullness and reduces hunger and how much a person eats. This appetite effect is a large part of why it produces weight loss, not just better blood sugar control.

Native GLP-1 breaks down within minutes, so liraglutide is engineered with a fatty-acid chain that binds to albumin in the blood. This extends its half-life to about 13 hours and allows once-daily dosing. In the SCALE weight-management trial, adults on the 3.0 mg dose lost about 8% of their body weight over 56 weeks, compared with about 2.6% on placebo.

Is it FDA-approved?

Editor’s note

Status: Yes. Victoza was first approved in 2010 for type 2 diabetes, and later to reduce cardiovascular risk in people with type 2 diabetes and heart disease. Saxenda was approved in 2014 for weight management, and both have since been approved for use in adolescents.

Category: FDA-approved · Primary body area: Digestive & weight

Yes. Victoza was first approved in 2010 for type 2 diabetes, and later to reduce cardiovascular risk in people with type 2 diabetes and heart disease. Saxenda was approved in 2014 for weight management, and both have since been approved for use in adolescents.

What is liraglutide prescribed for?

For type 2 diabetes, Victoza is prescribed to improve blood sugar control alongside diet and exercise. For weight management, Saxenda is approved for adults with obesity (a BMI of 30 or higher) or overweight (a BMI of 27 or higher) plus a weight-related condition such as high blood pressure or high cholesterol, and for adolescents aged 12 and older with obesity.

It should not be used by people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, or by anyone with a known allergy to liraglutide.

What are the side effects?

The most common side effects are gastrointestinal, and they are usually strongest when the dose is increased:

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Decreased appetite
  • Headache
  • Fatigue

Less common but more serious risks include:

  • Thyroid C-cell tumors: liraglutide carries a boxed warning based on rodent studies. It is not known whether this happens in humans.
  • Pancreatitis, or inflammation of the pancreas
  • Gallbladder problems, including gallstones
  • Acute kidney injury, usually from dehydration caused by vomiting or diarrhea
  • Low blood sugar, especially when combined with insulin or a sulfonylurea
  • Increased heart rate

Sources: FDA prescribing information for Victoza and Saxenda (liraglutide); the SCALE weight-management trial (Pi-Sunyer et al., 2015, DOI: 10.1056/NEJMoa1411892) and the LEADER cardiovascular outcomes trial (Marso et al., 2016, DOI: 10.1056/NEJMoa1603827) in the New England Journal of Medicine, both indexed on PubMed; and a review of the history of GLP-1 receptor agonists. 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. [1]

    GLP-1 receptor agonist (PDF)

    Primary U.S. Food and Drug Administration

  2. [2]

    generic

    Primary drugs.com

  3. [3]

    first once-daily

    Primary sciencedirect.com

  4. [4]
  5. [5]

    appetite centers in the brain (PDF)

    Primary U.S. Food and Drug Administration

  6. [6]

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