Liraglutide

What it is

Liraglutide is a synthetic analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone involved in glucose-dependent insulin secretion, glucagon regulation, gastric emptying, and appetite signaling^{[1 –2 ]}. It is marketed in the United States as Victoza for type 2 diabetes and cardiovascular risk reduction in a specific type 2 diabetes population, and as Saxenda for chronic weight management in label-defined adults and adolescents^{[1 –2 ]}. FDA also approved the first generic liraglutide injection referencing Victoza in December 2024^{[3 ]}.

Chemical structure

Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino-acid sequence homology to endogenous human GLP-1(7-37)^{[1 –2 ]}. The molecule is modified to resist enzymatic degradation and to bind albumin, giving it a longer plasma half-life than native GLP-1^{[1 –2 ]}. The FDA-approved labels state that liraglutide has an approximately 13-hour plasma half-life after subcutaneous administration, which supports once-daily administration in approved products^{[1 –2 ]}.

Mechanism

Liraglutide binds and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G protein Gs^{[1 –2 ]}. In type 2 diabetes, the Victoza label describes glucose lowering through glucose-dependent insulin secretion and reduced glucagon secretion^{[1 ]}. The labels also note delayed gastric emptying, which can reduce the rate at which postprandial glucose appears in circulation and may affect absorption of oral medications^{[1 –2 ]}.

Approved products

Liraglutide was part of an earlier generation of GLP-1 receptor agonists, before once-weekly semaglutide and dual incretin agents became prominent in public discussion. It remains clinically important because it has randomized-trial evidence in type 2 diabetes, cardiovascular outcomes in high-risk type 2 diabetes, adult obesity, pediatric type 2 diabetes, and adolescent obesity^{[7 –15 ]}. It is also one of the GLP-1 drugs involved in current policy debates about shortages, compounding, and generic access^{[3 –6 ]}.

Administration

When used clinically, liraglutide is administered by subcutaneous injection in prefilled pens^{[1 –2 ]}. Victoza and Saxenda contain the same active ingredient but have different approved indications, dose ranges, and clinical contexts^{[1 –2 ]}. This page describes approved product forms and research findings; it does not provide dosing instructions or individualized medical guidance.

Regulatory status

Liraglutide is FDA-approved as a prescription drug in the United States. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease^{[1 ]}. Saxenda is indicated, in combination with reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity, and in adults with overweight and at least one weight-related comorbid condition^{[2 ]}.

Approval history and generics

FDA approved Victoza for adults with type 2 diabetes in 2010, later expanded its labeling for cardiovascular risk reduction and pediatric type 2 diabetes, and approved Saxenda for adult chronic weight management in 2014 and adolescent chronic weight management in 2020^{[1 –2 ,17 –19 ]}. FDA approved the first generic liraglutide injection referencing Victoza on December 23, 2024, noting that liraglutide injection and certain other GLP-1 medications were then in shortage^{[3 ]}.

Compounding policy

Compounding status is more nuanced than the approved-drug status. Liraglutide is an FDA-approved active ingredient available in branded and generic products^{[1 –3 ]}. FDA’s April 30, 2026 announcement proposed excluding liraglutide, along with semaglutide and tirzepatide, from the 503B bulks list after FDA stated that it did not identify a clinical need for outsourcing facilities to compound these drugs from bulk substances^{[5 ]}. FDA also stated that outsourcing facilities generally cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list or the compounded drug is on FDA’s shortage list at the time of compounding, distribution, and dispensing^{[5 ]}.

As of the most recent shortage materials available for this draft, liraglutide injection remained listed as a current shortage by ASHP and Drugs.com’s FDA-linked shortage bulletin, with Victoza in limited availability while Saxenda and several liraglutide generic products were reported available^{[6 ,20 ]}. Because shortage status can change quickly, any conclusion about whether a specific compounded liraglutide product is lawful under 503A or 503B must be verified against FDA’s live shortage database, the final 503B bulks-list decision, and the facts of the prescription and formulation at the time of compounding^{[4 –6 ]}.

Controlled-substance status

Liraglutide is not listed in the federal controlled-substance schedules in 21 CFR Part 1308, and the FDA-approved Victoza and Saxenda labels do not identify it as a controlled substance^{[1 –2 ,21 ]}. International status differs by jurisdiction; the European Medicines Agency has reported that Novo Nordisk plans to stop marketing Victoza across the EU/EEA by the end of 2026 for commercial reasons, separate from safety or quality concerns^{[22 ]}. Last regulatory verification: May 5, 2026.

Research summary

Liraglutide’s clinical evidence base includes more than a decade of randomized trials.

Type 2 diabetes — LEAD program

In LEAD-3 Mono, 746 patients with early type 2 diabetes were randomized to liraglutide or glimepiride for 52 weeks^{[7 ]}. HbA1c decreased by 0.84 percentage points with liraglutide 1.2 mg, 1.14 percentage points with liraglutide 1.8 mg, and 0.51 percentage points with glimepiride; the liraglutide groups also had less weight gain and less hypoglycemia than glimepiride in that trial^{[7 ]}. In LEAD-6, 464 adults with type 2 diabetes inadequately controlled on oral therapy were randomized to once-daily liraglutide or twice-daily exenatide; liraglutide produced a greater HbA1c reduction over 26 weeks in that open-label head-to-head trial^{[8 ]}.

Cardiovascular outcomes — LEADER

Cardiovascular outcomes were evaluated in LEADER, a double-blind trial of 9,340 patients with type 2 diabetes and high cardiovascular risk^{[9 ]}. Over a median follow-up of 3.8 years, the primary composite outcome of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke occurred in 13.0% of the liraglutide group and 14.9% of the placebo group, with a hazard ratio of 0.87^{[9 ]}. Cardiovascular death and all-cause death were also lower in the liraglutide group, while gastrointestinal events were the most common adverse events leading to discontinuation^{[9 ]}. These data supported Victoza’s FDA indication to reduce major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease^{[1 ,9 ]}.

Pediatric type 2 diabetes — ELLIPSE

Pediatric type 2 diabetes was studied in ELLIPSE, a randomized trial of 135 patients aged 10 to less than 17 years^{[10 ]}. Participants received liraglutide or placebo added to metformin, with or without basal insulin, during a 26-week double-blind period followed by a 26-week open-label extension^{[10 ]}. At 26 weeks, HbA1c decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of −1.06 percentage points; gastrointestinal adverse events were more frequent with liraglutide^{[10 ]}.

Chronic weight management — SCALE program

For adult chronic weight management, the SCALE Obesity and Prediabetes trial randomized 3,731 adults without type 2 diabetes to liraglutide 3.0 mg or placebo for 56 weeks, with both groups receiving lifestyle counseling^{[11 ]}. Mean weight loss was 8.4 kg with liraglutide and 2.8 kg with placebo^{[11 ]}. At least 5% body-weight loss occurred in 63.2% of liraglutide-treated participants and 27.1% of placebo-treated participants, and more than 10% body-weight loss occurred in 33.1% and 10.6%, respectively^{[11 ]}. Gastrointestinal adverse events, particularly nausea and diarrhea, were the most frequent adverse events^{[11 ]}.

Longer-term weight and diabetes-risk outcomes were studied in the 3-year SCALE Obesity and Prediabetes trial in adults with prediabetes, which examined whether liraglutide 3.0 mg alongside lifestyle intervention affected progression to type 2 diabetes and maintenance of weight loss over 160 weeks^{[12 ]}. A separate SCALE Maintenance trial studied people who first lost weight through a low-calorie diet and then received liraglutide or placebo; more liraglutide-treated participants maintained at least 5% run-in weight loss and achieved additional weight loss over 56 weeks^{[14 ]}.

Adolescent obesity

Adolescent obesity was evaluated in a randomized trial of 251 adolescents aged 12 to less than 18 years with obesity and poor response to lifestyle therapy alone^{[13 ]}. Participants received liraglutide 3.0 mg or placebo, both with lifestyle therapy, over 56 weeks followed by a 26-week follow-up period^{[13 ]}. Liraglutide improved BMI standard-deviation score compared with placebo at week 56, but BMI increased after treatment discontinuation during follow-up, illustrating the chronic-treatment issue also observed with other anti-obesity pharmacotherapies^{[13 ]}. FDA approved Saxenda for chronic weight management in patients aged 12 years and older meeting label criteria in 2020^{[2 ,19 ]}.

Comparison with newer agents — STEP 8

Comparative research shows that newer incretin drugs may produce larger average weight loss than liraglutide in specific trial settings. STEP 8 randomized adults with overweight or obesity without diabetes to once-weekly semaglutide 2.4 mg, once-daily liraglutide 3.0 mg, or placebo and found greater mean weight reduction with semaglutide than liraglutide^{[15 ]}. This finding is relevant to clinical context and public discourse, but it should not be converted into a generalized “best drug” claim because product choice depends on indication, contraindications, safety history, access, and clinician judgment.

MASH/NASH — LEAN

Liraglutide has also been studied in liver disease. In the LEAN phase 2 trial, 52 patients with biopsy-confirmed nonalcoholic steatohepatitis were randomized to liraglutide 1.8 mg or placebo for 48 weeks^{[16 ]}. NASH resolution without worsening fibrosis occurred in 39% of evaluable liraglutide-treated patients and 9% of placebo-treated patients, while fibrosis progression occurred in 9% and 36%, respectively^{[16 ]}. This was a small phase 2 trial and liraglutide does not have an FDA-approved MASH/NASH indication as of May 5, 2026^{[1 –2 ,16 ]}.

Where the evidence ends

Overall, the strongest evidence for liraglutide is in FDA-approved use cases: glycemic control in type 2 diabetes, cardiovascular risk reduction in adults with type 2 diabetes and established cardiovascular disease, and chronic weight management in label-defined adults and adolescents^{[1 –2 ,7 –13 ]}. Evidence for MASH/NASH is preliminary and not equivalent to an approved indication^{[16 ]}. Claims about general “longevity,” cosmetic body composition, or broad metabolic optimization should not be treated as established clinical evidence.

Public discourse

James Smith, MD, MS, then FDA acting deputy director of the Division of Metabolism and Endocrinology Products, described Saxenda’s 2014 approval as an additional treatment option in the context of reduced-calorie diet and physical activity^{[17 ]}.

Lisa Yanoff, MD, then FDA acting director of the Division of Metabolism and Endocrinology Products, framed the 2019 Victoza pediatric approval around a younger population with limited non-insulin options^{[18 ]}.

Mads Krogsgaard Thomsen, then chief science officer at Novo Nordisk, presented Saxenda from the manufacturer’s perspective at the time of approval. This source should be read as sponsor commentary, not independent medical guidance^{[23 ]}.

Keren Zhou, MD, a Cleveland Clinic endocrinologist, discussed GLP-1 medications including Victoza and Saxenda as daily injections and emphasized that ongoing treatment is commonly needed to maintain benefit^{[24 ]}.

Public discourse reflects the views of the speakers cited and does not represent medical advice or the editorial position of ProPeptideGuide.

Side effects and safety

Victoza and Saxenda carry a boxed warning for thyroid C-cell tumors observed in rodents; the human relevance is unknown^{[1 –2 ]}. Both products are contraindicated in patients with a personal or family history of medullary thyroid carcinoma and in patients with multiple endocrine neoplasia syndrome type 2^{[1 –2 ]}. They are also contraindicated in patients with known serious hypersensitivity to liraglutide or product excipients^{[1 –2 ]}.

Common adverse reactions

Common adverse reactions are mainly gastrointestinal. Victoza’s label lists nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation among common adverse reactions in clinical trials^{[1 ]}. Saxenda’s label lists nausea, diarrhea, constipation, vomiting, injection-site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis among adverse reactions reported in at least 5% of treated patients^{[2 ]}.

Important warnings

Important warnings include acute pancreatitis, acute gallbladder disease, hypoglycemia when used with insulin or insulin secretagogues, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, hypersensitivity reactions, heart-rate increase for Saxenda, and pulmonary aspiration during general anesthesia or deep sedation^{[1 –2 ]}. FDA requested removal of suicidal-ideation and behavior warnings from GLP-1 receptor agonist weight-management labeling in January 2026 after its review did not identify an increased risk, and Saxenda’s February 2026 label reflects removal of that warning^{[2 ,25 ]}.

Drug interactions

Drug-interaction concerns are partly related to delayed gastric emptying. Victoza and Saxenda labels state that liraglutide delays gastric emptying and may affect absorption of concomitantly administered oral medications^{[1 –2 ]}. Victoza labeling also notes increased hypoglycemia risk when used with insulin secretagogues or insulin^{[1 ]}. Saxenda labeling includes risk for hypoglycemia with concomitant anti-diabetic therapy^{[2 ]}.

Long-term safety

Long-term safety data are more extensive than for many non-approved peptide products because liraglutide has cardiovascular-outcomes data and multi-year weight-management trial data^{[9 ,12 ]}. However, safety conclusions should still be tied to studied populations and FDA-approved formulations. Gray-market or unverified products introduce separate quality, sterility, dose-accuracy, and legal concerns not addressed by the clinical trials of approved products.

Available through

FDA-approved liraglutide is available in the United States by prescription through licensed clinicians and pharmacies dispensing approved branded or generic products, when used within applicable prescribing rules and product labeling^{[1 –3 ]}.

Telehealth platform partnerships are pending verification. Provider listings will be added only after legal and editorial review confirms that the platform prescribes FDA-approved liraglutide through licensed clinicians and dispenses through compliant pharmacy channels. ProPeptideGuide does not link to or endorse gray-market vendors, research-chemical sites, or compounded liraglutide products marketed as unlawful copies of FDA-approved products^{[4 –6 ]}.