Evidence review
Liraglutide: What the Evidence Actually Shows
Liraglutide is a real, FDA-approved once-daily GLP-1 drug (Victoza, Saxenda) — and it just quietly went generic. Here's the real approval history.
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Liraglutide is different from almost everything else in this site's corpus in one specific way worth stating before anything else: it is not a compounded or grey-market research peptide. It is a real, FDA-approved drug, made by Novo Nordisk, sold under two brand names — Victoza for type 2 diabetes and Saxenda for chronic weight management — and it predates semaglutide (Ozempic/Wegovy) by half a decade. This article covers its real approval history, how it actually compares to semaglutide and tirzepatide in head-to-head trials rather than by assumption, and a genuinely current finding this review located live: liraglutide has quietly gone generic, on both of its approved uses, in a wave that is still running.
The real approval history, pulled directly from FDA's own record
Liraglutide's first FDA approval predates Ozempic by seven years. Victoza (liraglutide injection, for type 2 diabetes) was approved under NDA022341, with an original approval date of January 25, 2010, confirmed directly against openFDA's Drugs@FDA database rather than a press release6. Saxenda (the same molecule, at a higher 3.0mg daily dose, for chronic weight management in adults and — per its own current label — pediatric patients 12 and older with obesity) followed under a separate application, NDA206321, approved December 23, 20147. Both products ship as an 18mg/3mL (6mg/mL) solution in a pre-filled, multi-dose pen — not a lyophilized powder — confirmed directly from each application's own product record.
A real, twice-approved drug — and now a generic one
2010-01-25
Victoza approved (NDA022341)
Type 2 diabetes — liraglutide's first FDA approval, 7 years before Ozempic
2014-12-23
Saxenda approved (NDA206321)
Chronic weight management, at a higher 3.0mg daily dose
2024-12-23 to 2026-03-11
Eight generic ANDAs approved
Hikma, Nanjing King Friend/Meitheal, Lupin, Teva, Orbicular (×2), Biocon (×2) — a wave still running as of this review
The finding this article didn't go looking for: liraglutide has gone generic
Here's what a live check of FDA's own drug-application database turned up that most current liraglutide content doesn't mention: a search for every approved product containing liraglutide as an active ingredient returns 11 total applications, not 2. Alongside Victoza and Saxenda themselves, eight separate generic manufacturers now hold FDA-approved ANDAs for liraglutide injection, each independently confirmed by this article's own live check of its original approval date8: Hikma (approved December 23, 2024 — exactly ten years to the day after Saxenda's own approval), Nanjing King Friend/Meitheal (April 2, 2025), Lupin (July 22, 2025), Teva (August 27, 2025), two separate Orbicular approvals (January and February 2026), and two separate Biocon approvals (February and March 2026). A ninth application, Xultophy — a liraglutide/insulin-degludec combination product — also exists on the same record. This is a real, current, and still-running wave: the most recent approval in this list landed within weeks of this article being written. It means a reader asking whether to seek out compounded liraglutide has an alternative most coverage of this drug doesn't surface: multiple AB-rated, insurance-billable generic versions of both the diabetes and weight-management products, sitting on the exact same FDA record as the brand names.
Every FDA-approved liraglutide product on file today
| Applicant | Application | Rating | Approved |
|---|---|---|---|
| Novo Nordisk (Victoza) | NDA022341 | Reference (AP1) | 2010-01-25 |
| Novo Nordisk (Saxenda) | NDA206321 | Reference (AP2) | 2014-12-23 |
| Hikma | ANDA215503 | AP1 | 2024-12-23 |
| Nanjing King Friend / Meitheal | ANDA218115 | AP1 | 2025-04-02 |
| Lupin | ANDA215421 | AP1 | 2025-07-22 |
| Teva | ANDA214568 | AP2 | 2025-08-27 |
| Orbicular | ANDA217590 / ANDA217234 | AP1 / AP2 | 2026-01-14 / 2026-02-24 |
| Biocon | ANDA217063 / ANDA215245 | AP2 / AP1 | 2026-02-24 / 2026-03-11 |
A separate, more cautionary finding from the same live check is worth reporting with precision rather than rounding it into either "liraglutide is in crisis" or "liraglutide is fully resolved": openFDA's drug-shortages database currently lists 10 liraglutide records, and several — including Victoza itself (cited reason: "Delay in shipping of the drug") and Saxenda — still carry a "Current," unresolved status9. But the underlying record for those specific entries has not been updated since July 18, 2023. That is reported here exactly as it reads: a shortage listing that has not been marked resolved on FDA's own database, not an active, escalating supply crisis on the scale of what tirzepatide and semaglutide went through in 2022-2024. Readers should weigh that distinction directly — a stale "Current" flag is not the same claim as a live one.
How it actually compares to semaglutide — real head-to-head trials, not an assumption
Liraglutide is often described online as "like semaglutide but weaker," without a source. Two real, Novo-Nordisk-sponsored, head-to-head phase 3b trials tested that claim directly, and both are worth reporting at their actual magnitude rather than flattened into a one-line verdict. STEP 8, a 68-week randomized trial in adults with overweight or obesity but no diabetes, compared semaglutide 2.4mg once-weekly against liraglutide 3.0mg once-daily — Saxenda's own approved dose, head-to-head, in the same trial1. Mean weight change from baseline was -15.8% with semaglutide versus -6.4% with liraglutide, a difference of 9.4 percentage points (95% CI -12.0 to -6.8, P<.001). Liraglutide's own discontinuation rate was more than double semaglutide's — 27.6% versus 13.5% — despite similar rates of gastrointestinal adverse events between the two drugs (84.1% with semaglutide, 82.7% with liraglutide)1. SUSTAIN 10 ran the same comparison in type 2 diabetes: semaglutide 1.0mg once-weekly against liraglutide 1.2mg once-daily — Victoza's most frequently prescribed dose in Europe — over 30 weeks in 577 patients2. HbA1c fell 1.7 percentage points with semaglutide versus 1.0 with liraglutide (estimated treatment difference -0.69%, P<.0001); body weight fell 5.8kg versus 1.9kg (ETD -3.83kg, P<.0001)2. Both trials show semaglutide outperforming liraglutide by a real, statistically significant margin — and both also show liraglutide's own arm producing genuine, clinically meaningful weight loss and glycemic improvement on its own, not a null result standing next to a positive one.
Real head-to-head trials — not an assumption
| Trial | Semaglutide arm | Liraglutide arm | Result |
|---|---|---|---|
| STEP 8 (overweight/obesity, 68wk, n=338) | 2.4mg once-weekly: -15.8% body weight | 3.0mg once-daily (Saxenda dose): -6.4% body weight | Difference -9.4 points, P<.001 |
| SUSTAIN 10 (type 2 diabetes, 30wk, n=577) | 1.0mg once-weekly: -1.7% HbA1c, -5.8kg | 1.2mg once-daily (Victoza dose): -1.0% HbA1c, -1.9kg | HbA1c ETD -0.69%, weight ETD -3.83kg, both P<.0001 |
The mechanism behind the dosing difference — once-daily vs. once-weekly, sourced to the label
The once-daily-versus-once-weekly split between liraglutide and semaglutide/tirzepatide isn't a marketing detail — it's a direct consequence of a real pharmacokinetic difference, stated plainly in Victoza's own current FDA label. Native human GLP-1 has a plasma half-life of "1.5 to 2 minutes," rapidly degraded by the enzymes DPP-4 and NEP. Liraglutide is structurally modified (a fatty-acid acylation that promotes albumin binding, alongside amino-acid substitutions that resist that same enzymatic degradation) to extend that half-life to 13 hours after subcutaneous administration — the label's own words, "which makes it suitable for once daily administration6." Semaglutide's own further chemical modifications extend that half-life to roughly a week, which is what allows once-weekly dosing; tirzepatide's dual GIP/GLP-1 mechanism carries a similarly long half-life. That is a real, clinically meaningful pharmacokinetic distinction, not a cosmetic dosing-schedule choice — a reader deciding between a daily injection and a weekly one is deciding between genuinely different drug-exposure profiles, not just a convenience trade-off.
Liraglutide's own trial record — real, and more substantial than "the older drug" implies
Two more trials are worth reading directly rather than skipped in favor of the semaglutide comparisons above. SCALE Obesity and Prediabetes, the pivotal 56-week, 3,731-patient randomized trial behind Saxenda's own approval, found liraglutide 3.0mg produced a mean weight loss of 8.4kg versus 2.8kg with placebo (P<.001), with 63.2% of the liraglutide group losing at least 5% of body weight versus 27.1% on placebo3. And LEADER — a real, large (n=9,340), hard-outcomes cardiovascular trial, not a surrogate-endpoint study — found liraglutide reduced major adverse cardiovascular events (cardiovascular death, non-fatal MI, or non-fatal stroke) to 13.0% versus 14.9% with placebo (hazard ratio 0.87, 95% CI 0.78-0.97, P=0.01 for superiority), reduced cardiovascular death specifically (4.7% vs. 6.0%, HR 0.78, P=0.007), and reduced all-cause mortality (8.2% vs. 9.6%, HR 0.85, P=0.02)5. That trial is the direct basis for a real line on Victoza's current FDA label: an indication "to reduce the risk of major adverse cardiovascular events... in adults with type 2 diabetes mellitus and established cardiovascular disease6," confirmed against the label's own indications section. That is genuinely substantial hard-outcomes human evidence — more than most compounds in this site's corpus carry — and it argues against treating liraglutide as merely a weaker, obsolete predecessor rather than a real drug with its own independent, positive cardiovascular-outcomes trial. Liraglutide has also been tested directly against the drug it itself predates by seven years: LEAD-6, a 26-week, open-label trial, randomized patients to liraglutide 1.8mg once daily or exenatide 10mcg twice daily — the original, first-ever-approved GLP-1 drug — and found liraglutide produced significantly greater HbA1c reduction (-1.12% vs. -0.79%, estimated treatment difference -0.33%, P<0.0001)4, a real result worth knowing given how often exenatide and liraglutide get grouped together as "the older GLP-1 drugs" without a source.
What's actually been tested for liraglutide specifically
- Weight loss (SCALE Obesity and Prediabetes, own pivotal trial)STRONG evidence
3,731-patient RCT behind Saxenda's own FDA approval — -8.4kg vs. -2.8kg placebo, P<.001.
- Cardiovascular outcomes in type 2 diabetes (LEADER)STRONG evidence
9,340-patient hard-outcomes RCT — real MACE, CV-death, and all-cause-mortality reduction, the basis for Victoza's FDA-labeled CV indication.
- Head-to-head efficacy vs. semaglutide (STEP 8, SUSTAIN 10)MODERATE evidence
Real positive effect on its own; significantly outperformed by semaglutide in direct randomized comparison on both weight and HbA1c.
The safety picture, read from the label itself
Victoza's boxed warning is real and worth quoting directly rather than summarizing: "Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined6." That is a rodent-carcinogenicity finding of uncertain human relevance, stated by FDA at exactly that precision — not a confirmed human risk, and not a warning to dismiss either. Semaglutide and tirzepatide carry the same class-wide boxed warning for the same structural reason, so this is not a liraglutide-specific liability, but it is a real regulatory fact worth reading in the drug's own words rather than a summary.
Why this site doesn't have a liraglutide reconstitution calculator
Every FDA-approved liraglutide product on file — Victoza, Saxenda, and all eight generics — ships as a pre-filled, multi-dose pen containing an 18mg/3mL solution, confirmed directly from each product's own openFDA record. None require reconstitution. That is a fundamentally different real-world product than the lyophilized-powder vials this site's tirzepatide and semaglutide calculators are built around, where compounded pharmacies commonly dispense a freeze-dried vial a patient mixes with bacteriostatic water before injecting. This article's own check found no comparable, well-documented compounded-liraglutide-as-lyophilized-vial market pattern to build a calculator against — and with multiple FDA-approved, pharmacy-fillable generic pen options now on the market across both of liraglutide's approved uses, the practical case for seeking out a compounded vial version is also genuinely weaker than it is for tirzepatide or semaglutide, where compounding rose specifically to fill a supply gap no generic yet addresses.
What this means if you're considering it
None of the 31 providers this site's own reviews cover sell liraglutide as a boarded product — several reviewed providers' own listings note they also sell compounded liraglutide, but this site does not currently rank or board it the way it does tirzepatide, sermorelin, and semaglutide. Put simply: liraglutide is a real, twice-approved (Victoza in 2010, Saxenda in 2014), once-daily GLP-1 drug with a genuinely substantial trial record of its own — including a real cardiovascular-outcomes benefit most weight-loss-drug marketing never mentions — that has been outperformed, head-to-head, by once-weekly semaglutide in two real randomized trials, and that has recently and quietly gone generic across both of its approved uses. A reader weighing liraglutide against semaglutide or tirzepatide is weighing a real efficacy gap (smaller weight loss and glycemic improvement, by a statistically significant and clinically meaningful margin, in direct trials) against a daily-injection schedule and, as of this review, a wider set of FDA-approved generic options than either newer drug currently has. If you're researching the newer GLP-1 drugs this site covers in more depth, our tirzepatide vs. semaglutide evidence review covers that specific head-to-head comparison directly.
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Frequently asked questions
Is liraglutide a real FDA-approved drug, or a compounded peptide?
It's a real, twice-approved FDA drug, not a compounded/grey-market peptide the way most peptide-research-market compounds are. Victoza (for type 2 diabetes) was approved January 25, 2010; Saxenda (the same molecule, at a higher weight-management dose) was approved December 23, 2014. Both are made by Novo Nordisk and ship as pre-filled multi-dose pens.
Is there a generic version of liraglutide?
Yes — and this is recent. A live FDA database check found eight separate FDA-approved generic manufacturers (Hikma, Nanjing King Friend/Meitheal, Lupin, Teva, Orbicular, and Biocon) now hold approved ANDAs for liraglutide injection, with approvals landing between December 2024 and March 2026 across both the Victoza (type 2 diabetes) and Saxenda (weight management) dosage ratings.
How does liraglutide compare to semaglutide (Ozempic/Wegovy)?
Two real head-to-head randomized trials tested this directly. STEP 8 found semaglutide 2.4mg once-weekly produced -15.8% body weight change versus -6.4% for liraglutide 3.0mg once-daily over 68 weeks (P<.001). SUSTAIN 10 found semaglutide 1.0mg once-weekly reduced HbA1c by 1.7 percentage points versus 1.0 for liraglutide 1.2mg once-daily over 30 weeks (P<.0001). Semaglutide significantly outperformed liraglutide in both trials, though liraglutide's own arm still produced real, clinically meaningful improvement.
Why is liraglutide taken once daily instead of once weekly like semaglutide?
Victoza's own FDA label states liraglutide's plasma half-life is 13 hours, versus native human GLP-1's half-life of 1.5 to 2 minutes — a real chemical modification (fatty-acid acylation plus amino-acid substitutions) that extends its activity enough for once-daily dosing but not further. Semaglutide's additional chemical modifications extend its half-life to roughly a week, which is what allows once-weekly dosing — a genuine pharmacokinetic difference, not a marketing choice.
Does this site have a liraglutide reconstitution calculator?
No. Every FDA-approved liraglutide product — brand and all eight generics — ships as a pre-filled, multi-dose pen containing a ready-to-use solution, confirmed directly from each product's FDA record. None require reconstitution, so there is no vial-and-diluent arithmetic for a calculator to perform.
References
- Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sørrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators (2022). Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. https://pubmed.ncbi.nlm.nih.gov/35015037/
- Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Vergès B, Marre M (2020). Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes & Metabolism. https://pubmed.ncbi.nlm.nih.gov/31539622/
- Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group (2015). A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/26132939/
- Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group (2009). Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). The Lancet. https://pubmed.ncbi.nlm.nih.gov/19515413/
- Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators (2016). Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. New England Journal of Medicine. https://pubmed.ncbi.nlm.nih.gov/27295427/
- U.S. Food and Drug Administration (2026). Drugs@FDA — VICTOZA (liraglutide), NDA022341, original approval 2010-01-25; current label (setid 5a9ef4ea-c76a-4d34-a604-27c5b505f5a4) — 13-hour half-life, boxed warning on thyroid C-cell tumors, and MACE-risk-reduction indication, all quoted directly. openFDA — drug/drugsfda public API, and DailyMed structured product label. https://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:%22Victoza%22
- U.S. Food and Drug Administration (2026). Drugs@FDA — SAXENDA (liraglutide), NDA206321, original approval 2014-12-23. openFDA — drug/drugsfda public API. https://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:%22Saxenda%22
- U.S. Food and Drug Administration (2026). Drugs@FDA — full liraglutide substance search, confirming 11 total applications: Victoza, Saxenda, Xultophy, and 8 approved generic ANDAs (Hikma, Nanjing King Friend/Meitheal, Lupin, Teva, Orbicular ×2, Biocon ×2), each ORIG approval date independently pulled. openFDA — drug/drugsfda public API. https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name:LIRAGLUTIDE
- U.S. Food and Drug Administration (2026). Drug Shortages database — 10 liraglutide records (Victoza, Saxenda, and early generics); several still "Current" status, underlying record last updated 2023-07-18. openFDA — drug/shortages public API. https://api.fda.gov/drug/shortages.json?search=generic_name:liraglutide
Medical disclaimer: This content is for general educational purposes only and is not medical advice, diagnosis, or treatment. Always consult a licensed healthcare professional before starting, stopping, or changing any treatment.
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