Victoza (Liraglutide 1.8 mg): Evidence Review, Side Effects, Generic

Victoza is liraglutide 1.8 mg — a once-daily GLP-1 receptor agonist injection from Novo Nordisk, FDA-approved January 25, 2010 for type 2 diabetes^[12]. It was the first daily GLP-1 RA on the US market and remained the category leader until once-weekly Ozempic launched in 2017. Today, in 2026, Victoza is still on the market, has a hard cardiovascular indication from the LEADER trial^[8], and now has two generic versions: Hikma generic liraglutide (approved December 2024, the first generic GLP-1 receptor agonist in the US)^[13] and Teva generic liraglutide 3 mg for the Saxenda weight-management indication (approved August 2025)^[14].

What is Victoza?

Victoza is the brand name for liraglutide injection 6 mg/mL, manufactured by Novo Nordisk. It comes in a prefilled multi-dose pen (18 mg / 3 mL) and is titrated from 0.6 mg to 1.2 mg to a maximum maintenance dose of 1.8 mg once daily as a subcutaneous injection^[10]. Victoza was approved by the FDA on January 25, 2010 (NDA 022341) for improving glycemic control in adults with type 2 diabetes, making it the first daily GLP-1 receptor agonist approved in the United States^[12]. Byetta (exenatide twice-daily) preceded it by four years (2005), but Victoza was the first once-daily GLP-1 RA and the first human-sequence GLP-1 analogue (97% homologous to native human GLP-1)^[6].

Mechanistically, liraglutide is a long-acting GLP-1 receptor agonist that lowers blood glucose by enhancing glucose-dependent insulin secretion, suppressing inappropriate glucagon release, and slowing gastric emptying. As a secondary effect — mediated by the central GLP-1 receptor in the hypothalamus and brainstem — it suppresses appetite and food intake, which produces modest weight loss in adults with type 2 diabetes (typically 2–3 kg in the LEAD trials at 26 weeks)^[7]. Liraglutide’s ~13-hour half-life supports once-daily dosing — meaningfully shorter than once-weekly semaglutide (~165 hours) but meaningfully longer than the 2.4-hour half-life of native GLP-1.

Important: Victoza is FDA-approved only for type 2 diabetes, not for chronic weight management. The FDA-approved weight-management version of liraglutide is Saxenda (NDA 206321, approved December 23, 2014), dosed at 3.0 mg once daily — the same active ingredient at a 1.67× higher dose for a different indication^[11].

Victoza vs Saxenda (same drug, different dose)

Victoza and Saxenda are both liraglutide injection 6 mg/mL in a 3 mL multi-dose pen — the same molecule, the same vial concentration, the same manufacturer (Novo Nordisk), the same active ingredient on FDA filings. They differ in maximum dose, FDA indication, and labeling.

Because Victoza and Saxenda contain the same molecule at the same vial concentration, the multi-dose pens are pharmacologically fungible — the same 3 mL cartridge can deliver any dose from 0.6 mg up to 3.0 mg in 0.6 mg increments. The two products differ in FDA-approved labeled use and in the dose at which the pen’s titration stops. Prescribing Victoza off-label at 3.0 mg/day to chase the Saxenda effect size is dose-escalating outside the FDA-approved label and is not a substitute for the Saxenda indication.

Victoza side effects from the LEAD trials and FDA label

Victoza’s registrational program was the LEAD trial family (Liraglutide Effect and Action in Diabetes) — six Phase 3 trials in adults with type 2 diabetes, each pairing liraglutide with a different background therapy or comparator. The integrated safety profile from LEAD 1–5 was published by Blonde and Russell-Jones in 2009^[7].

The six LEAD trials

Side-effect pattern across LEAD 1-5

In the pooled LEAD 1-5 overview, the most frequently reported adverse events with liraglutide were gastrointestinal — nausea, vomiting, and diarrhea^[7]. The nausea rate was highest in the first 4–6 weeks of titration and decreased substantially over time. Approximately 5–10% of trial participants discontinued liraglutide due to gastrointestinal symptoms across the LEAD program. Hypoglycemia rates were low when liraglutide was used as monotherapy or with metformin, but rose meaningfully when combined with a sulphonylurea — consistent with the established class effect.

The FDA Victoza prescribing information^[10] lists the following boxed warning and warnings:

• Boxed warning: thyroid C-cell tumors. Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in rodents. The human relevance is unknown. Victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Pancreatitis. Acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, has been observed. Discontinue if pancreatitis is suspected.
• Hypoglycemia. Increased risk when combined with insulin secretagogues (e.g. sulphonylureas) or insulin.
• Acute kidney injury. Reported in patients with severe dehydration secondary to GI side effects.
• Hypersensitivity reactions. Including anaphylaxis and angioedema.
• Acute gallbladder disease. Cholelithiasis and cholecystitis have been observed in liraglutide trials and the broader GLP-1 class.

The full label is published as DailyMed SetID 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4 (Novo Nordisk)^[10]. The class warnings are shared with Saxenda, Ozempic, Wegovy, Mounjaro, and Zepbound. Our GLP-1 side effects evidence review walks through the full class-wide side-effect taxonomy with the verbatim FDA-label quotes for each drug.

Victoza for cardiovascular protection (LEADER trial)

The single largest piece of Victoza-specific evidence beyond the LEAD glycemic-control program is the LEADER trial (Marso 2016 N Engl J Med, PMID 27295427)^[8] — a placebo-controlled cardiovascular outcomes trial of 9,340 adults with type 2 diabetes and established cardiovascular disease, or at high cardiovascular risk, randomized to liraglutide 1.8 mg/day (Victoza dosing) vs placebo on top of standard care. Median follow-up was 3.8 years.

The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (3-point MACE). LEADER reported:

• Primary endpoint: 13.0% of liraglutide-treated participants had a 3-point MACE event vs 14.9% of placebo-treated participants — hazard ratio 0.87 (95% CI 0.78–0.97; p=0.01 for superiority).
• Cardiovascular mortality: hazard ratio 0.78 (95% CI 0.66–0.93).
• All-cause mortality: hazard ratio 0.85 (95% CI 0.74–0.97).
• Adverse events broadly consistent with the LEAD program; no excess pancreatitis or pancreatic cancer signal identified in the trial.

LEADER was the first GLP-1 cardiovascular outcomes trial to demonstrate superiority (not just non-inferiority) on the 3-point MACE primary endpoint in adults with type 2 diabetes. The FDA added a cardiovascular risk-reduction indication to the Victoza label on August 25, 2017 based on the LEADER result^[12], making Victoza the first GLP-1 RA in the United States with a hard cardiovascular indication. Ozempic (SUSTAIN-6) followed in 2020.

LEADER is also the closest analogue in the GLP-1 portfolio to the SELECT trial that later anchored Wegovy’s cardiovascular indication in adults without diabetes. See our SELECT trial review for the non-diabetic CV-outcomes story; the two trials together establish a class-level cardiovascular benefit for GLP-1 receptor agonists, with each agent independently anchored to its own randomized trial.

Generic liraglutide: Hikma 2024, Teva 2025

The Victoza-vs-Saxenda generic landscape changed substantially in late 2024 and 2025. Both reference products now have FDA-approved generics.

Hikma generic liraglutide (Victoza reference)

FDA application: ANDA 215503.
Approval date: December 23, 2024.
Sponsor: Hikma Pharmaceuticals USA Inc.
Strength: liraglutide 6 mg/mL, supplied as an 18 mg / 3 mL multi-dose prefilled pen — bioequivalent to Victoza (TE code AP1).
Indication: type 2 diabetes (matches the Victoza listed-drug label).
Significance: the first generic GLP-1 receptor agonist approved in the United States. The FDA press release at the time of approval described the approval as a milestone for generic GLP-1 access^[13].

Teva generic liraglutide 3 mg (Saxenda reference)

FDA application: ANDA 214568.
Approval date: August 27, 2025.
Sponsor: Teva Pharmaceuticals USA.
Strength: liraglutide 6 mg/mL, supplied as an 18 mg / 3 mL multi-dose prefilled pen, dosed up to 3.0 mg per day for chronic weight management.
Indication: chronic weight management in adults with obesity or overweight plus a weight-related comorbidity, and pediatric obesity ages 12+ (matches the Saxenda listed-drug label).
Significance: the first generic GLP-1 receptor agonist for weight management approved in the United States^[14].

The clinical implication: as of mid-2025, both Victoza (1.8 mg/day, T2D) and Saxenda (3.0 mg/day, weight management) have a generic-equivalent option. Liraglutide is now the only GLP-1 receptor agonist molecule with FDA-approved generics in any indication. Semaglutide (Ozempic / Wegovy / Rybelsus) and tirzepatide (Mounjaro / Zepbound) remain branded-only through their FDA-approved patent and exclusivity periods.

Victoza for weight loss (off-label) — what to expect

Victoza is not FDA-approved for chronic weight management, and the FDA-approved version of liraglutide for that purpose is Saxenda. Some prescribers nonetheless prescribe Victoza off-label for weight loss in patients without diabetes, because the active ingredient and the multi-dose pen are identical to Saxenda — only the maximum titrated dose differs.

Realistic expectations for Victoza-dose (1.8 mg/day) off-label weight loss, anchored to the LEAD trial program (T2D population)^[7]:

• Mean weight loss in T2D: approximately 2–3 kg at 26 weeks at the 1.8 mg/day dose. Pooled across LEAD 1-5, the magnitude was consistent across background therapies, with slightly more weight loss in metformin-combination arms than in sulphonylurea arms (the SU class can blunt GLP-1 weight loss).
• Saxenda dose (3.0 mg/day) reference: ~8.0% mean body weight loss at 56 weeks in the SCALE Obesity trial^[9] — meaningfully larger than the 1.8 mg dose. The dose-response is real.
• How it stacks against the modern injectables: ~5× less mean weight loss than tirzepatide 15 mg (SURMOUNT-1, ~20.9% at 72 weeks) and ~3× less than semaglutide 2.4 mg (STEP-1, ~14.9% at 68 weeks). See our weight-loss injections guide for the full magnitude comparison.

Clinical bottom line: if the goal is glycemic control in type 2 diabetes with a cardiovascular-benefit indication, Victoza (1.8 mg) is a clinically reasonable choice with a hard CV outcomes trial behind it^[8]. If the goal is chronic weight management without diabetes, the FDA-approved choice in the liraglutide molecule is Saxenda (3.0 mg). And if the goal is the largest weight-loss magnitude available, the GLP-1 class has moved past liraglutide entirely — once-weekly semaglutide (Wegovy) and the dual-agonist tirzepatide (Zepbound) both deliver substantially more weight loss in head-to-head magnitude.

How Victoza fits in 2026 (vs Ozempic, Mounjaro, Wegovy, Zepbound)

Victoza is now 16 years post-approval and the GLP-1 class has expanded significantly around it. Where does Victoza still fit?

When Victoza is still prescribed in 2026

• Type 2 diabetes patient with established CVD. The LEADER trial benefit is liraglutide-specific (HR 0.87 on 3-point MACE)^[8]. While semaglutide (SUSTAIN-6, SELECT) and dulaglutide (REWIND) have similar benefits, Victoza is one of the few GLP-1 RAs with a dedicated cardiovascular outcomes trial in a T2D-CVD population at a daily dose.
• Patients who need a daily dosing schedule rather than weekly. Some patients prefer the daily dosing rhythm for adherence; some have side-effect tolerability that’s better with daily exposure than weekly peak-trough cycling.
• Cost-sensitive patients in T2D where Hikma generic liraglutide is on formulary. The Hikma generic (approved December 2024)^[13] creates a cost path that does not exist for Ozempic, Mounjaro, Wegovy, or Zepbound.
• Patients with intolerance or insurance denial of tirzepatide/semaglutide. When step therapy requires a GLP-1 trial before tirzepatide, Victoza or generic liraglutide is sometimes the cheapest gateway option.

When Victoza is not the best choice in 2026

• Primary goal is chronic weight management. Use Saxenda (or Teva generic liraglutide 3 mg) for the FDA-approved indication; or consider Wegovy / Zepbound / Foundayo for substantially more weight loss.
• Primary goal is HbA1c reduction with weekly dosing. Ozempic (semaglutide 1.0–2.0 mg weekly) and Mounjaro (tirzepatide 5–15 mg weekly) both deliver larger HbA1c reductions than Victoza in head-to-head data.
• Patient preference for oral dosing. Rybelsus (oral semaglutide) and Foundayo (oral orforglipron, approved April 2026) are oral alternatives.

FAQ

Is Victoza the same drug as Saxenda?

Yes — Victoza and Saxenda are both liraglutide injection 6 mg/mL, the same active ingredient in the same multi-dose pen, manufactured by Novo Nordisk. The difference is in maximum daily dose (Victoza titrates up to 1.8 mg/day for type 2 diabetes; Saxenda titrates up to 3.0 mg/day for chronic weight management) and in FDA-approved indication. They are filed under separate FDA applications (NDA 022341 for Victoza, NDA 206321 for Saxenda)^[12][11].

How much weight loss does Victoza cause?

Approximately 2–3 kg at 26 weeks at the 1.8 mg/day dose in adults with type 2 diabetes, per the pooled LEAD 1-5 program^[7]. This is meaningfully less than Saxenda (~8.0% body weight at 56 weeks at 3.0 mg/day in SCALE Obesity)^[9], and substantially less than once-weekly Wegovy (~14.9% at 68 weeks) or Zepbound (~20.9% at 72 weeks). Victoza is not FDA-approved for chronic weight management.

What are Victoza’s most common side effects?

Per the FDA prescribing information and the pooled LEAD program^[10][7], the most frequent adverse events are gastrointestinal: nausea, vomiting, and diarrhea, mostly in the first 4–6 weeks of titration and decreasing over time. About 5–10% of LEAD participants discontinued liraglutide due to GI symptoms. The boxed warning covers thyroid C-cell tumor risk (contraindicated in personal/family history of medullary thyroid carcinoma or MEN 2). Other warnings: pancreatitis, hypoglycemia when combined with sulphonylureas or insulin, acute kidney injury, hypersensitivity reactions, and gallbladder disease.

Does Victoza reduce cardiovascular events?

Yes. The LEADER trial (Marso 2016 NEJM, PMID 27295427)^[8] randomized 9,340 adults with type 2 diabetes and established CVD (or high CV risk) to liraglutide 1.8 mg/day vs placebo. Liraglutide reduced the 3-point MACE primary outcome (CV death, nonfatal MI, nonfatal stroke) by a hazard ratio of 0.87 (95% CI 0.78–0.97, p=0.01). The FDA added a cardiovascular risk-reduction indication to the Victoza label on August 25, 2017 based on LEADER^[12].

Is there a generic Victoza?

Yes. Hikma generic liraglutide (ANDA 215503, FDA-approved December 23, 2024)^[13] is the first generic GLP-1 receptor agonist approved in the United States. It is bioequivalent to Victoza (TE code AP1), supplied as a liraglutide 6 mg/mL multi-dose pen (18 mg / 3 mL), and indicated for type 2 diabetes. A second generic referencing the Saxenda 3.0 mg dosing is Teva generic liraglutide 3 mg (ANDA 214568, FDA-approved August 27, 2025)^[14].

Should I use Victoza or Ozempic?

Victoza (liraglutide 1.8 mg) and Ozempic (semaglutide 2.0 mg) are both FDA-approved for type 2 diabetes and both have established cardiovascular benefit (LEADER for Victoza, SUSTAIN-6 for Ozempic). Ozempic is dosed once weekly vs Victoza’s once-daily schedule, delivers larger HbA1c and weight reductions on average, and is generally preferred for new T2D patients starting GLP-1 therapy. Victoza retains a role in patients who prefer daily dosing, in patients accessing the Hikma generic for cost reasons, or in patients with documented intolerance or non-response to semaglutide. This is a decision that should be made with a clinician. Our GLP-1 decision quiz walks through the Victoza-vs-Saxenda-vs-Ozempic-vs-Wegovy decision tree.

Has Victoza been discontinued?

No. Victoza remains FDA-approved and on the US market in 2026 (NDA 022341 ORIG-1, status AP per Drugs@FDA)^[12]. Novo Nordisk continues to manufacture Victoza, and the Hikma and Teva generics are also in active production. Note that some other older GLP-1 receptor agonists in the class — Byetta and Bydureon BCise from AstraZeneca — were discontinued in October 2024, but Victoza is not among them.

Related research

Anchor reading for the broader GLP-1 landscape and adjacent drugs to Victoza:

• Full GLP-1 medication reference list — every FDA-approved GLP-1 receptor agonist, dosing, and DailyMed SetIDs.
• Weight-loss injections guide — how the injectable GLP-1s compare on effect size and tolerability.
• SELECT trial: cardiovascular benefits in non-diabetics — the Wegovy cardiovascular outcomes trial; LEADER’s cousin in the GLP-1 CV-outcomes evidence base.
• GLP-1 side effects: what the trials actually showed — verbatim FDA-label side-effect data for every FDA-approved GLP-1 receptor agonist.
• Wegovy reference page and Zepbound reference page — the higher-efficacy weight-management successors to Saxenda.
• GLP-1 decision quiz — helps patients decide between Victoza, Saxenda, Ozempic, Wegovy, Mounjaro, Zepbound, and Foundayo based on indication, dose schedule, and goal.