GLP-1 receptor agonists

Liraglutide

Victoza; Saxenda

US status
FDA-approved
Class
GLP-1 receptor agonists
Approved product
Victoza (2010), Saxenda (2014), and approved generics
Route
Subcutaneous injection, once daily

Regulatory record

5 dated actions on record.
January 2010
FDA approves liraglutide injection as Victoza under new drug application 022341, effective January 25, 2010; the indication is now an adjunct to diet and exercise for glycemic control in type 2 diabetes and reduction of major adverse cardiovascular events in adults with established cardiovascular disease.
December 2014
FDA approves a second liraglutide product, Saxenda, under new drug application 206321, effective December 23, 2014, for chronic weight management alongside a reduced-calorie diet and increased physical activity.
July 2023
Liraglutide injection is entered in FDA's drug shortage database, with a date first posted of July 18, 2023.
December 2024
FDA approves the first generic liraglutide injection referencing Victoza, under abbreviated new drug application 215503, effective December 23, 2024. The agency's announcement notes that liraglutide injection and certain other GLP-1 medicines are in shortage.
August 2026
The shortage entry still reads currently in shortage. Two generic manufacturers report both presentations available; the brand manufacturer reports limited availability, with Saxenda 6 mg/mL available until discontinuation in January 2027 and Victoza 6 mg/mL delayed in shipping with no estimated duration.

Every entry above is dated; the record is current as of the review date.

Definition

Liraglutide is a GLP-1 receptor agonist and the oldest member of that class in this index. It is administered once daily rather than weekly, which is the practical difference a reader will notice against semaglutide and tirzepatide, and which is also why it has largely been displaced commercially.

It holds two separate approvals under two brand names for two different purposes, and a generic version has existed since 2024. Its regulatory record is the most complete of any molecule here, and the only one whose supply problem has not been declared over.

Evidence

The trial literature is large and belongs to an approved product. Across three name variants PubMed returns 5,901 indexed records, of which 3,668 carry the Humans subject heading, 632 the clinical-trial publication type, and 575 the randomized-controlled-trial type [1]. A literature of that size is reported as a magnitude; this index did not itemize it.

The registrational anchor for weight management is a 56-week randomized controlled trial of 3.0 mg daily in adults with overweight or obesity, published in 2015 [2]. The approved indications state what the evidence was accepted for: glycemic control in type 2 diabetes and reduction of major adverse cardiovascular events in adults with established cardiovascular disease for one product [3], and chronic weight management alongside a reduced-calorie diet and increased physical activity for the other [4].

Both labels carry the same limitation of use, and it is the one most often ignored in practice: the products contain liraglutide, and coadministration with other liraglutide-containing products is not recommended [3][4].

Side effects

The Saxenda label lists the adverse reactions reported in at least 5 percent of treated patients: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, fever and gastroenteritis [9]. In the adult weight-management trials, 9.8 percent of treated patients stopped because of an adverse reaction against 4.3 percent on placebo, and nausea was the most common reason [9]. The Victoza label, written for type 2 diabetes, names nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation as its most common reactions [10].

Both labels carry a boxed warning for thyroid C-cell tumors. Liraglutide caused them in rats and mice, whether it does so in humans is unknown, and postmarketing reports of medullary thyroid carcinoma in treated patients are insufficient to establish or exclude a causal link [9][10]. The drug is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2, and for anyone with a prior serious hypersensitivity reaction to liraglutide [9].

The other warnings cover acute pancreatitis, including fatal hemorrhagic or necrotizing cases; acute gallbladder disease, with gallstones reported in 2.2 percent of Saxenda-treated adults against 0.8 percent on placebo; hypoglycemia when combined with insulin or an insulin secretagogue; a rise in resting heart rate; acute kidney injury after dehydration from vomiting or diarrhea; severe gastrointestinal reactions; serious allergic reactions; and pulmonary aspiration during general anesthesia or deep sedation [9]. The Saxenda label does not recommend the drug for people with severe gastroparesis [9].

Generic liraglutide carries the same boxed warning as the brand it references [11].

Educational summary of the cited sources, not medical advice; a prescriber weighs these risks against a person’s own history.

Lawful access

The lawful route is the approved product, and there are now several. FDA approved liraglutide as Victoza under new drug application 022341, effective January 25, 2010, and as Saxenda under new drug application 206321, effective December 23, 2014 [3][4]. On December 23, 2024 it approved the first generic liraglutide injection referencing Victoza, and noted in its own announcement that liraglutide injection and certain other GLP-1 medicines were then in shortage [5].

The shortage has not been declared resolved. FDA's drug shortage database lists liraglutide injection with a status of currently in shortage and a date first posted of July 18, 2023 [6]. On the date this page was checked, two generic manufacturers reported both presentations available while the brand manufacturer reported limited availability, with one product available until a stated discontinuation in January 2027 and the other delayed in shipping with no estimated duration [6]. That distinguishes this molecule from semaglutide and tirzepatide, whose shortages FDA has formally resolved.

The compounding consequence follows from the statute rather than from any liraglutide-specific announcement, and this index does not invent one: FDA's published statements on compounded GLP-1 drugs address semaglutide, tirzepatide, retatrutide and cagrilintide by name and do not address liraglutide [7]. What can be said without inference is that liraglutide is a component of approved drug products, which is the condition section 503A sets for compounding from a bulk substance without bulks-list listing, and that it appears in no category of the 503A bulks list published on May 14, 2026 [8]. The approved page states how the copy rule works.

Supply

The approved product (Victoza (2010), Saxenda (2014), and approved generics) is the supply route; no telehealth supplier is listed in this index yet. The index notes suppliers as they are verified.

Questions

Is liraglutide FDA-approved?

Yes. FDA approved liraglutide as Victoza for type 2 diabetes in January 2010 and as Saxenda for chronic weight management in December 2014 [3][4]. The index records it as approved as of September 2026.

What is the difference between Saxenda and Victoza?

They contain the same molecule under two labels. Saxenda is indicated, with diet and exercise, to reduce excess body weight in adults and in children 12 and older who weigh more than 60 kg and have obesity, and in adults with overweight and a weight-related condition [9]; Victoza is indicated for blood sugar control in type 2 diabetes and to reduce major cardiovascular events in adults with type 2 diabetes and cardiovascular disease [10].

Is there a generic liraglutide?

Yes. FDA approved the first generic liraglutide referencing Victoza in December 2024 [5], and generic liraglutide labeled for weight management is also on DailyMed [11].

What are the most common side effects of liraglutide?

Gastrointestinal effects lead the Saxenda label: nausea, diarrhea, constipation, vomiting and abdominal pain, followed by injection site reactions, headache, low blood sugar, fatigue and dizziness [9]. The side effects section above lists the label's warnings as well.

Does liraglutide cause thyroid cancer?

It is not known. Liraglutide caused thyroid C-cell tumors in rodents, both labels carry a boxed warning for that finding, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [9][10].

How is liraglutide different from semaglutide?

Both are GLP-1 receptor agonists approved for chronic weight management, but liraglutide is given once daily and semaglutide once weekly. The weight-loss peptides by status review sets every molecule sold for weight side by side.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

References

  1. PubMed, National Library of Medicine. Census run August 2026 across three name variants — "liraglutide" OR "Victoza" OR "Saxenda" — returning 5,901 indexed records, 3,668 carrying the Humans MeSH term, 632 under "clinical trial"[Publication Type] and 575 under "randomized controlled trial"[Publication Type]. A literature of this size is reported as a magnitude and was not itemized record by record. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. Source
  2. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11–22. PMID 26132939
  3. US Food and Drug Administration. VICTOZA (liraglutide) injection, for subcutaneous use — prescribing information, NDA 022341 supplement 046, approved October 14, 2025; Indications and Usage and Limitations of Use. Read August 2026. Source
  4. US Food and Drug Administration. SAXENDA (liraglutide) injection, for subcutaneous use — prescribing information, NDA 206321 supplement 024, approved June 2, 2026; Indications and Usage and Limitations of Use. Read August 2026. Source
  5. US Food and Drug Administration. FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. Press announcement, December 23, 2024. Read August 2026. Source
  6. US Food and Drug Administration. Drug Shortages database, active ingredient detail for Liraglutide Injection: status "Currently in Shortage", date first posted July 18, 2023, with company availability panels revised August 2026. Read August 2026. Source
  7. US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of June 15, 2026. Read in full August 2026; the page addresses semaglutide, tirzepatide, retatrutide and cagrilintide, and states no liraglutide-specific compounding position. Source
  8. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full August 2026: liraglutide appears in none of Category 1, Category 2, or Category 3. Source
  9. Novo Nordisk. SAXENDA (liraglutide) injection, US prescribing information. Revised June 2026. DailyMed set ID 3946d389-0926-4f77-a708-0acb8153b143. Read September 2026. Source
  10. Novo Nordisk. VICTOZA (liraglutide) injection, US prescribing information. Revised October 2025. DailyMed set ID 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4. Read September 2026. Source
  11. Liraglutide injection, US prescribing information for a generic product approved under ANDA 214568 and indicated to reduce excess body weight and maintain weight reduction long term. Revised February 2026. DailyMed set ID 625ac780-70a9-41e4-a892-bcba0f803f1c. Read September 2026. Source