GLP-1ApprovedEvidence tier: Human RCT

Liraglutide

Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.

FDA status

Approved

Approved. FDA-approved drug products containing liraglutide include Saxenda (chronic weight management) and Victoza (type 2 diabetes). Approval is specific to the product, indication, and route.

Drugs@FDA: Saxenda (NDA 206321)

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 5,800 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

Liraglutide in the literature

GLP-1 receptor agonist with 13-hour half-life via albumin binding; reduces appetite centrally, slows gastric emptying, and improves beta-cell function in type 2 diabetes.

What the literature studies

GLP-1 Weight & Metabolic Management

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
5/5

Regulatory record

Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source not verified; no checked date is assigned.

Regulatory context and verification limits are documented below.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Liraglutide is an FDA-approved daily GLP-1 receptor agonist sold as Victoza for type 2 diabetes (and CV-risk reduction) and as Saxenda for chronic weight management, with large outcomes and obesity trials (LEADER, SCALE).

What it is

A human GLP-1 analog (97% homology to native GLP-1) developed by Novo Nordisk; once-daily subcutaneous injection under branded labels Victoza and Saxenda [R3][R4].

Legal / FDA status (as of Oct 27 2026)

  • Victoza (NDA 022341) is FDA-approved for glycemic control in type 2 diabetes and to reduce major adverse cardiovascular events in adults with type 2 diabetes and established CVD [R4].
  • Saxenda (NDA 206321) was FDA-approved Dec 23 2014 as an adjunct to diet and activity for chronic weight management in adults with BMI >=30, or >=27 with a weight-related comorbidity; labeling later incorporated longer-term SCALE and LEADER-related updates [R1][R3].
  • Victoza and Saxenda must not be used together (same active ingredient at different labeled regimens) [R3].
  • Compounded liraglutide is a separate regulatory question; peptidex.ai does not advise on compounding legality for any pharmacy.

Human evidence

  • SCALE Obesity and Prediabetes (NEJM 2015): liraglutide 3.0 mg vs placebo for weight management; significant mean weight loss versus placebo at 56 weeks [R2].
  • LEADER (NEJM 2016): in 9,340 adults with type 2 diabetes and high CV risk, liraglutide 1.8 mg (Victoza dose) reduced major adverse cardiovascular events versus placebo over median 3.5 years [R5].

Animal / lab evidence

Rodent thyroid C-cell tumor findings support the boxed warning on GLP-1 agonist labels including Saxenda/Victoza [R3][R4].

Risks and unknowns

Label warnings include risk of thyroid C-cell tumors (boxed), pancreatitis, gallbladder disease, hypoglycemia when combined with insulin or sulfonylureas, and other class effects [R3][R4]. Gray-market "research" vials are not the approved products.

What's coming

Newer weekly dual/triple agonists and oral GLP-1 options continue to reshape the market; liraglutide remains an approved daily option. Watch CagriSema and other pipeline incretins for competitive context (see semaglutide / cagrilintide pages).

Sources

  1. [R1] FDA. Saxenda approval package NDA 206321. Dec 23 2014. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000Approv.pdf
  2. [R2] Pi-Sunyer X et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med 2015;373:11-22. PMID 26132939
  3. [R3] Saxenda (liraglutide) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206321s016lbl.pdf
  4. [R4] Victoza (liraglutide) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022341s046lbl.pdf
  5. [R5] Marso SP et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375:311-322. PMID 27295427

Last checked 2026-10-27

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