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Liraglutide regulatory status

Current status of Liraglutide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Liraglutide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 27, 2026
FDA and compounding
FDA approved products (Victoza January 2010, Saxenda December 2014). FDA approved the first generic liraglutide referencing Victoza in December 2024, and generic products referencing Saxenda followed in 2025, so branded, generic, and authorized generic pens are all on the market. FDA listed liraglutide injection as in shortage in its October 2024 and February 2025 GLP-1 updates, and FDA's Drug Shortages database still lists it as of September 27, 2026 (first posted July 18, 2023; updated September 22, 2026), with Victoza and Saxenda presentations at limited availability and unbranded presentations available. FDA states that a compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA's drug shortage list. On April 30, 2026 FDA proposed not to include liraglutide on the 503B bulks list; that proposal was not final as of September 2026. Ask any pharmacy offering compounded liraglutide which FDA rule it relies on.
WADA
Not WADA prohibited
Access path
  1. Prescription from a licensed provider (in person or telehealth) filled at a retail pharmacy as Victoza, Saxenda, or generic liraglutide.
  2. Compounded liraglutide: FDA's Drug Shortages database lists liraglutide injection as in shortage as of September 27, 2026, and FDA states that the limit on compounding essentially a copy of an approved drug does not apply to drugs on that list. Generic liraglutide is also marketed. Ask any pharmacy offering compounded liraglutide which FDA rule it relies on.
  3. FDA's Drug Shortages database lists Saxenda (NDC 0169-2800-15) as To Be Discontinued, posted August 25, 2026.
  4. Products labeled research use only are not lawful for human use.

Full Liraglutide page: evidence, dosing in the literature, and sources

How has the status of Liraglutide changed over time?

  1. FDA

    FDA proposes to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list

    FDA proposed not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list, after tentatively finding no clinical need for outsourcing facilities to compound them from bulk. The notice was published May 1, 2026, and the comment period was extended to July 30, 2026. The proposal was not final as of September 2026. It does not change the 503A rules for patient specific compounding.

  2. FDA

    FDA approves the first generic liraglutide injection

    In December 2024 FDA approved the first generic version of once-daily liraglutide injection referencing Victoza, the first generic GLP-1 receptor agonist in the US.

    Regulatory: FDA approvedSource: First generic drug approvals
  3. FDA

    FDA approves Saxenda (liraglutide 3 mg) for chronic weight management

    FDA approved liraglutide 3 mg injection (Saxenda) for chronic weight management in adults with obesity or overweight with at least one weight-related condition, as an adjunct to diet and exercise.

  4. FDA

    FDA approves Victoza (liraglutide) for type 2 diabetes

    FDA approved once-daily liraglutide injection (Victoza) to improve glycemic control in adults with type 2 diabetes, with a boxed warning about thyroid C-cell tumors seen in rodents.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Liraglutide and the source of each dated event.

  1. [1]FDA prescribing information for Saxenda (liraglutide) injection, via DailyMedFDA, 2025
  2. [2]FDA prescribing information for Victoza (liraglutide) injection, via DailyMedFDA, 2025
  3. [3]FDA: First generic drug approvals (includes liraglutide injection, December 2024)FDA, 2025
  4. [4]FDA: concerns with unapproved GLP-1 drugs used for weight loss, including shortage resolution and compounding deadlinesFDA, 2025
  5. [5]WADA Prohibited ListWADA, 2026
  6. [6]WADA 2027 Prohibited List (published September 21, 2026, in force January 1, 2027)WADA, 2026
  7. [7]FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (GLP-1 shortage status updates, including liraglutide, and the April 1, 2026 policy update on essentially copies)FDA, 2026
  8. [8]Federal Register 2026-08552: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposed May 1, 2026; comments extended to July 30, 2026)Federal Register, 2026
  9. [9]FDA Drug Shortages: liraglutide injection (currently in shortage; checked September 27, 2026)FDA, 2026
  10. [10]Drugs@FDA: Saxenda (liraglutide) NDA 206321FDA, 2014
  11. [11]Drugs@FDA: Victoza (liraglutide) NDA 022341FDA, 2010