PeptideAmerica

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.

Status verified for this index · August 2026

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].

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.

Elsewhere in this index

Filed under

Reference tables

Same class

References

  1. PubMed, National Library of Medicine. Census run 2026-08-31 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 2026-08-31. 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 2026-08-31. 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 2026-08-31. 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 2026-08-31. 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 2026-08-31; 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 2026-08-31: liraglutide appears in none of Category 1, Category 2, or Category 3. Source