Liraglutide

FDA status

FDA-approved. Cross-checked against Drugs@FDA on 2026-08-02: NDA 022341 (Victoza, Novo Nordisk Inc) and NDA 206321 (Saxenda, Novo) both carry marketing status 'Prescription' — neither is discontinued. Approval is always for a specific indication and population, and here there are two approvals with non-overlapping ones; see the approval record below.

Evidence

ADMINISTRATION CHECK RUN, NOT ASSUMED. Two pivotal registrations were opened individually on 2026-08-02 and read field by field. LEADER (NCT01179048): intervention type DRUG, liraglutide injected subcutaneously versus placebo, Phase 3, allocation RANDOMIZED, double-masked, enrolment 9,341 ACTUAL, lead sponsor Novo Nordisk A/S, status COMPLETED (primary completion and completion both 2015-12-17 ACTUAL, the date carried in the source above), hasResults true. SCALE Obesity and Prediabetes (NCT01272219): intervention type DRUG, liraglutide injected subcutaneously versus placebo, Phase 3, RANDOMIZED, double-masked, enrolment 3,731 ACTUAL, Novo Nordisk A/S, COMPLETED 2015-03-02 ACTUAL, hasResults true. In both, liraglutide was ADMINISTERED to human participants — it was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. INDEPENDENTLY CORROBORATED AGAINST THE LABELS, which is why these two registrations rather than any others: section 14 of the Victoza label names 'a cardiovascular outcomes trial (LEADER trial)', and section 14.1 of the Saxenda label describes 'three 56-week, randomized, double-blind, placebo-controlled trials' whose Study 1 'enrolled 3,731 patients' — the same figure the SCALE registration reports as actual enrolment. SCOPE, and it is narrow. The tier attaches to the two approved products and their approved indications. It does not transfer to compounded liraglutide, to liraglutide from an unapproved source, or to any use outside those labels. Both trials were sponsored by the manufacturer. Neither tested a compounded preparation. NOT CHECKED, and stated rather than implied: no attempt was made here to verify the generic applications' bioequivalence data, which is a different evidentiary question from the one this tier answers.

What FDA actually approved

Application

NDA 022341 (Victoza); NDA 206321 (Saxenda) — Victoza, Saxenda

Approved indication

VICTOZA (NDA 022341), verbatim: '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, • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use: VICTOZA contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.' — SAXENDA (NDA 206321), verbatim: 'SAXENDA is indicated in combination with a 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. • Adults with overweight in the presence of at least one weight-related comorbid condition.'

The Victoza text above is verbatim from this field's source. The Saxenda text is verbatim from a DIFFERENT document — the Saxenda label — and is recorded again under fdaFindings against that label's own source, so that a claim about two labels is carried by two labels rather than by one label and an inference. Three things worth reading precisely. (1) The two approvals do not overlap. Victoza carries no weight-management indication; Saxenda carries no type 2 diabetes indication and its label states the safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes 'have not been established'. Same molecule, same sponsor, non-interchangeable approvals in both directions. (2) The Saxenda indication is conditioned on 'in combination with a reduced calorie diet and increased physical activity', and Victoza's on 'as an adjunct to diet and exercise' — neither label approves the drug standing alone. (3) The Saxenda weight indication was REWRITTEN: the earlier label framed it as chronic weight management by BMI threshold, and the current one is phrased as reducing excess body weight and maintaining weight reduction long term in named populations. Anything quoting the BMI framing is quoting a superseded label. `discontinued` is false on the strength of Drugs@FDA marketing status for both NDAs, read 2026-08-02. Note separately that FDA's shortage database lists one Teva liraglutide presentation as 'To Be Discontinued' — that is a presentation, not an application.

What FDA found

FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.

• FDA has proposed not to include liraglutide on the 503B Bulks List, alongside semaglutide and tirzepatide, having tentatively found no basis to conclude there is a clinical need for an outsourcing facility to compound using it.

  Two distinctions the coverage collapses. This is section 503B (outsourcing facilities), NOT the 503A bulks list that BPC-157 and the consumer peptides sit against — different statutory provision, different list, different test. And it is a TENTATIVE finding in a proposed notice, not a final determination; comments were due 2026-06-30. What FDA actually evaluated is narrow: whether the nomination identified an attribute of the approved liraglutide products making them medically unsuitable for identified patients.

  List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

  “FDA tentatively finds no basis to conclude that there is a clinical need for an outsourcing facility to compound using the following bulk drug substances: semaglutide, tirzepatide, and liraglutide. Therefore, we propose not to include these bulk drug substances on the 503B Bulks List.”

  Checked against the source on 2 August 2026.

• On liraglutide specifically, FDA tentatively found no basis to conclude that there is an attribute of the FDA-approved liraglutide products that makes them medically unsuitable to treat certain patients for a condition FDA identified for evaluation.

  Recorded separately from the conclusion above because it is the actual reasoning, and because it must not be re-read as a safety blessing. 'No attribute makes the approved products medically unsuitable' is a finding ABOUT THE APPROVED PRODUCTS being adequate — the approved drug being good enough is the reason compounding was refused. It is not a finding that compounded liraglutide is safe, and it is not a finding that it is unsafe. FDA's stated grounds, in its own sequence: the only compounded strength the nominator identified is the same as the approved products'; the nominator never identified which inactive ingredients patients were said to be intolerant of; the propylene-glycol argument was not supported (see below); and the container-closure argument was held inapplicable to this stage of the analysis.

  List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

  “For these reasons, FDA tentatively finds no basis to conclude that there is an attribute of the FDA-approved drug products containing liraglutide that makes them medically unsuitable to treat certain patients for a condition that FDA has identified for evaluation and that the proposed compounded products are intended to address.”

  Checked against the source on 2 August 2026.

• FDA stated it has not identified any data or information to suggest that propylene glycol would cause a drug product containing liraglutide to be medically unsuitable, and reported that the single article the nominator submitted did not evaluate liraglutide at all and did not say what it was cited for.

  This is FDA opening a citation and finding it does not say what it was cited for — the same failure this site exists to correct, caught by the regulator, in a filing, against a represented party. The paper is Snitker et al. (2022), and FDA recorded two separate problems with it: it 'did not evaluate liraglutide' — it compared semaglutide formulations — and its authors concluded that 'The injection-site experience with semaglutide D was almost indistinguishable from semaglutide MPI . . . with either product associated with no or very mild injection-site pain', which runs against the preference claim rather than for it. FDA's own FAERS search found numerous reports of injection site reactions in both Victoza and Saxenda users and NO report whose case narrative contained 'propylene'. FDA also noted that injection site reaction is reported in trials of injectable products not formulated with propylene glycol at all, and that all FDA-approved liraglutide injections are already labeled for injection site reactions. The 'PG-free compounded liraglutide' pitch was evaluated and not sustained.

  List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

  “FDA has not identified any data or information to suggest that propylene glycol would cause a drug product containing liraglutide to be medically unsuitable. […] The article does not, as the nominator claims, find that "95% of patients preferred the formulation without propylene glycol."”

  Checked against the source on 2 August 2026.

• FDA did not reach the second part of its clinical-need analysis for liraglutide. Because it found no basis to conclude an attribute of the approved products makes them medically unsuitable, FDA stated it need not decide whether the proposed compounded products must be compounded from a bulk drug substance rather than from an approved drug product.

  Recorded because it is the finding that cuts BOTH ways. FDA's test is sequential and the liraglutide analysis stopped at the threshold, so a whole set of questions was never opened. Elsewhere in the same notice FDA writes that commenters' and the nominator's arguments 'about safety and quality concerns with the nominated bulk drug substances for use in compounding would be addressed in Part 2 of the clinical need analysis, which we do not reach here.' Sellers read that silence as an absence of adverse findings; critics read the proposal as a determination that compounded liraglutide does not work. Neither is what happened. PRECISION NOTE: the sentence in which FDA says it 'did not consider the Part 2 factors, including the available evidence of effectiveness or lack of effectiveness' appears ONCE in this notice, in the SEMAGLUTIDE section. It is not repeated for liraglutide, and this record does not put it in FDA's mouth for liraglutide. What is quoted above is what the liraglutide section actually says.

  List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

  “Because there is no basis to conclude that there is an attribute of the FDA-approved drug products containing liraglutide which makes them medically unsuitable to treat certain patients, FDA need not decide whether the proposed drug products containing liraglutide must be compounded from a bulk drug substance rather than using an FDA-approved drug product.”

  Checked against the source on 2 August 2026.

• FDA-approved liraglutide injection remains on FDA's drug shortage list. FDA's shortage database returned ten liraglutide injection records on 2026-08-02, nine of them with status 'Current', initially posted 2023-07-18 and most recently reverified 2026-07-13.

  The reason this record exists, and the reason it has to be read carefully. WHY IT MATTERS STRUCTURALLY: section 503B(a)(2)(A) of the FD&C Act sets out two alternative conditions, and the Federal Register notice above states them — an outsourcing facility may not compound with a bulk drug substance unless '(1) the bulk drug substance appears on a list … identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section 506E of the FD&C Act … at the time of compounding, distribution, and dispensing.' FDA is proposing to shut door (1) for liraglutide. Door (2) turns on the shortage list, and liraglutide injection is on it. WHAT THIS DOES NOT ESTABLISH, stated plainly because the gap between the two is where this gets misused. It does not establish that any particular compounded liraglutide product is lawful. The shortage condition is one of several conditions in section 503B, it is assessed at the time of compounding, distribution and dispensing rather than once, and it does not touch the separate 'essentially a copy of a commercially available drug product' restriction. Nothing was verified here about any specific compounder, and no FDA statement addressing compounders' reliance on the liraglutide listing was located on 2026-08-02. This entry is a fact about a list. READ THE LIST ENTRIES, NOT THE HEADLINE: of the nine Current records, six report availability 'Available' and three 'Limited Availability'. A drug can remain listed while most presentations are shipping — FDA's own GLP-1 page says that when a status is noted as 'available,' that 'reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.' The tenth record, a Teva presentation, is 'To Be Discontinued' with reason 'Discontinuation of the manufacture of the drug', posted 2026-05-14 — a discontinuation notice is published in the same database and is not a shortage. COMPARISON, and the limits of it: the same endpoint was queried on 2026-08-02 for semaglutide, tirzepatide, dulaglutide, exenatide, exenatide extended release, lixisenatide, insulin glargine and lixisenatide, insulin degludec and liraglutide, and retatrutide. None returned a record with status 'Current' — semaglutide returned only 'To Be Discontinued' entries for Rybelsus tablets, and the rest returned no matches at all. That is an enumeration of the names queried on one day, not a proof that no other GLP-1 is listed under some name not on that list.

  FDA Drug Shortages Database — liraglutide injection (openFDA drug/shortages endpoint) — FDA, 1 August 2026Checked against the source on 2 August 2026.

• FDA has stated that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list. On the same page, FDA's most recent published GLP-1 shortage status update states that liraglutide injection is in shortage.

  One FDA page, two sentences, opposite answers for three drugs in the same class — which is why the class-wide framing in most 2026 coverage is wrong. DATE DISCIPLINE, because the two halves of the quote are not contemporaneous and joining them without saying so would be sleight of hand. The first sentence sits in the page's current body text; the page's own footer reads 'Content current as of: 04/01/2026'. The second is inside a dated update headed 'Current shortage status of other GLP-1 products (as of February 21, 2025)' — the most recent GLP-1 shortage status list FDA has published on that page, but a snapshot from February 2025, not from 2026. The 2026 currency of the liraglutide listing is carried by the shortage-database entry above, which was reverified by FDA on 2026-07-13, not by this quote. Note also what the February 2025 snapshot shows about drift: it lists dulaglutide injection as in shortage too, and dulaglutide returned no records from the shortage endpoint on 2026-08-02. Shortage listings resolve. This one had not.

  FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize — FDA, 1 April 2026

  “Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list. […] Liraglutide injection : In shortage. Manufacturer has reported two presentations are available, and three have limited availability.”

  Checked against the source on 2 August 2026.

• SAXENDA (NDA 206321) is indicated in combination with a 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 in the presence of at least one weight-related comorbid condition.

  Recorded verbatim against its own label because the brand-name gap is the whole point. The weight-management indication belongs to SAXENDA and not to VICTOZA, and the two are the same molecule at the same concentration from the same sponsor. The label's Limitations of Use add that coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist 'is not recommended', and that safety and effectiveness in pediatric patients with type 2 diabetes 'have not been established' — a limitation that surprises people who assume the diabetes approval carries across from Victoza.

  SAXENDA (liraglutide) injection — Highlights of Prescribing Information — FDA, 25 February 2026

  “SAXENDA is indicated in combination with a 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. Adults with overweight in the presence of at least one weight-related comorbid condition.”

  Checked against the source on 2 August 2026.

• Liraglutide appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 14 May 2026.

  Recorded to close a misreading, not to assert a status. Verified by fetching the PDF with a browser user-agent and extracting its text locally on 2026-08-02: seven pages, header 'Updated May 14, 2026', and zero occurrences of 'liraglutide' anywhere in it. This absence means something different from BPC-157's absence. BPC-157 was nominated for 503A and left Category 2 when the nominators withdrew. Liraglutide was never in the 503A system — a 503A bulks nomination is a route for substances that are not components of an approved drug, and liraglutide is a component of two NDAs and a set of ANDAs. Categorical silence here is neither permission nor a safety finding, and it says nothing about the separate 503B question above.

  Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.

• Liraglutide is available as FDA-approved generic drug products. Drugs@FDA listed eleven approved liraglutide ANDAs on 2026-08-02, from Biocon, Fresenius Kabi, Sandoz, Teva, Lupin, Orbicular, Hikma, Nanjing King Friend and Mylan Institutional, the earliest approved 2024-12-23.

  The fact that distinguishes liraglutide from semaglutide and tirzepatide, neither of which has an approved generic, and the one the compounding argument has to get past. Scope: 'has generics' is not unique to liraglutide across the GLP-1 class — exenatide has one approved ANDA (ANDA 206697, Amneal), checked on the same endpoint the same day. Eleven is the count that is unusual. Eight of the eleven carry therapeutic equivalence code AP1 (rated against Victoza) and three AP2 (rated against Saxenda); all eleven show marketing status 'Prescription'. FDA's own 503B notice names one of them in the passage quoted under fdaStatus above ('liraglutide 18 mg/3 mL, e.g., ANDA 215503'), so the existence of generics is carried by a second primary document and not by this query alone. Why it matters: an approved generic is a therapeutically equivalent, FDA-reviewed product available from multiple manufacturers. It is also the strongest form of the finding FDA made under Part 1(a) — the approved products are what a compounded product would have to be shown medically unsuitable against, and there are now thirteen approved applications to clear rather than two. COUNTING CAVEAT: 'eleven ANDAs' is a count of applications on one day, from one query. Approved is not the same as launched, and this record has not verified which are actually being marketed.

  Drugs@FDA — drug products containing liraglutide (openFDA drug/drugsfda endpoint) — FDA, 31 July 2026Checked against the source on 2 August 2026.

Documented safety signals

• Boxed warning — risk of thyroid C-cell tumors, on VICTOZA (NDA 022341). The labeling states that liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice, and that it is unknown whether VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  FDA's highest-level warning. Read the direction of the evidence precisely, because overstating it is as much an error as omitting it: this is a rodent finding whose human relevance the label says has not been determined, not a demonstrated human cancer risk. The labeling also states that routine monitoring of serum calcitonin or thyroid ultrasound 'is of uncertain value for early detection of MTC' in treated patients — so the protection here is the contraindication screen, which is a question a prescriber asks and a purchaser of an unapproved vial is never asked.

  VICTOZA (liraglutide) injection — Highlights of Prescribing Information — FDA, 14 October 2025

  “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 determined”

  Checked against the source on 2 August 2026.

• Boxed warning — risk of thyroid C-cell tumors, on SAXENDA (NDA 206321) as well. The labeling carries the same warning in the same terms and the same contraindication for personal or family history of MTC and for Multiple Endocrine Neoplasia syndrome type 2.

  Recorded as its own sourced entry rather than folded into the Victoza signal, because this record's argument is that approval attaches to an application and not to a molecule — so 'both products carry it' has to be two documents saying so, not one document and an inference. Worth stating because the weight-management framing invites the assumption that Saxenda is the lighter-touch product. It carries the identical boxed warning and the identical contraindications.

  SAXENDA (liraglutide) injection — Highlights of Prescribing Information — FDA, 25 February 2026

  “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 SAXENDA 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 determined”

  Checked against the source on 2 August 2026.

• VICTOZA labeled warnings and precautions include acute pancreatitis, hypoglycemia, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, hypersensitivity reactions, acute gallbladder disease, pulmonary aspiration during general anesthesia or deep sedation, and a warning never to share a VICTOZA pen between patients.

  Reproduced from sections 5.2 to 5.9 of the label read on 2026-08-02, because 'well-tolerated' is doing heavy lifting in the marketing. The label's Recent Major Changes list Severe Gastrointestinal Adverse Reactions (5.6) at 10/2025 and Pulmonary Aspiration During General Anesthesia or Deep Sedation (5.9) at 11/2024 — both are recent additions, so older summaries of this label are incomplete rather than merely dated. The pen-sharing warning is specific to the presentation and has no analogue for a vial.

  VICTOZA (liraglutide) injection — Highlights of Prescribing Information — FDA, 14 October 2025Checked against the source on 2 August 2026.

• SAXENDA labeled warnings and precautions include acute pancreatitis, acute gallbladder disease, hypoglycemia, heart rate increase, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, hypersensitivity reactions including postmarketing reports of anaphylactic reactions and angioedema, and pulmonary aspiration during general anesthesia or deep sedation.

  From the label read on 2026-08-02. Most common adverse reactions reported at an incidence of 5% or greater, per the label: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia and gastroenteritis. The label states Saxenda is not recommended in patients with severe gastroparesis, and — a point people miss because the trial population did not have diabetes — that hypoglycemia occurred in Saxenda-treated pediatric patients who did not have type 2 diabetes.

  SAXENDA (liraglutide) injection — Highlights of Prescribing Information — FDA, 25 February 2026Checked against the source on 2 August 2026.

• FDA reported that a search of the FAERS database identified numerous reports associated with liraglutide and injection site reactions, occurring in both Victoza and Saxenda users.

  Recorded with FDA's own limitation attached, because the report count is doing two jobs at once and they point in different directions. FDA cites the reports as evidence that injection site reactions happen with the approved products — and cites the absence of 'propylene' in any narrative as evidence that the excipient is not the identified cause. FDA's stated caveat on FAERS in this notice, verbatim: 'there is no certainty that the reported adverse event was due to the suspect product. FDA does not require that a causal relationship between a product and event be proven, and the report may not always contain enough detail to properly evaluate an event.' 'Numerous' is FDA's word; the notice publishes no count, and this record does not supply one.

  List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

  “A search of the FAERS database identified numerous reports associated with liraglutide and injection site reactions occurring in both Victoza and Saxenda users. The search did not retrieve any reports of liraglutide and injection site reactions with a case narrative containing "propylene."”

  Checked against the source on 2 August 2026.

Questions people actually ask

Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.

Is liraglutide FDA approved?

Yes — liraglutide is FDA-approved, under two separate Novo Nordisk applications with different indications, and as generic products. FDA's own words: 'Liraglutide is an active ingredient in FDA-approved drug products: 18 mg/3 mL (6 mg/mL) solution for SC injection (Saxenda, NDA 206321); 18 mg/3 mL (6 mg/mL) solution for SC injection (Victoza, NDA 022341); and 18 mg/3 mL (6 mg/mL) solution for SC injection (liraglutide 18 mg/3 mL, e.g., ANDA 215503).' Victoza is indicated for glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; Saxenda is indicated, with a reduced calorie diet and increased physical activity, for reducing excess body weight and maintaining weight reduction long term in named populations. The approval attaches to those applications and not to the molecule — liraglutide sold by anyone who does not hold an approved application is not an approved drug, whatever the vial says.

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

“Liraglutide is an active ingredient in FDA-approved drug products: 18 mg/3 mL (6 mg/mL) solution for SC injection (Saxenda, NDA 206321); 18 mg/3 mL (6 mg/mL) solution for SC injection (Victoza, NDA 022341); and 18 mg/3 mL (6 mg/mL) solution for SC injection (liraglutide 18 mg/3 mL, e.g., ANDA 215503).”

Checked against the source on 2 August 2026.

Is Victoza approved for weight loss?

No. Both indications in the FDA-approved labeling for Victoza (liraglutide injection, NDA 022341) are confined to type 2 diabetes mellitus: improving glycemic control as an adjunct to diet and exercise in adults and pediatric patients aged 10 years and older with type 2 diabetes, and reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Weight loss is not among them. The liraglutide product that does carry a weight indication is Saxenda (NDA 206321) — the same molecule at the same concentration from the same sponsor, under a different application with different trials behind it. The non-interchangeability runs both ways: Saxenda carries no type 2 diabetes indication, and its label states that its safety and effectiveness in pediatric patients with type 2 diabetes have not been established. Prescribing Victoza for weight loss is off-label use, which is a decision for a licensed prescriber and is not something this label supports.

VICTOZA (liraglutide) injection — Highlights of Prescribing Information — FDA, 14 October 2025

“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, • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.”

Checked against the source on 2 August 2026.

Is liraglutide still on the FDA shortage list in 2026?

Yes. FDA's drug shortage database returned ten records for liraglutide injection when queried on 2 August 2026, nine of them with status 'Current'. All nine were initially posted on 18 July 2023, and the most recent FDA reverification among them is 13 July 2026. Six of the nine report availability as 'Available' and three as 'Limited Availability' — a drug stays listed until FDA determines the shortage is resolved, and FDA states that an 'available' status 'reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.' Two Victoza presentations give the reason as a delay in shipping of the drug, with estimated shortage duration listed as to be determined. A tenth record, a Teva presentation posted 14 May 2026, is a discontinuation notice rather than a shortage. This is a fact about a list and nothing more: it does not by itself make any particular compounded liraglutide product lawful.

FDA Drug Shortages Database — liraglutide injection (openFDA drug/shortages endpoint) — FDA, 1 August 2026Checked against the source on 2 August 2026.

Can compounding pharmacies still make liraglutide in 2026?

The two questions people merge here have different answers, so take them apart. On the 503B Bulks List: FDA proposed on 1 May 2026 not to add liraglutide, stating that it 'tentatively finds no basis to conclude that there is a clinical need for an outsourcing facility to compound using the following bulk drug substances: semaglutide, tirzepatide, and liraglutide.' That proposal is tentative and comments closed on 30 June 2026. On the separate shortage route: section 503B of the FD&C Act permits an outsourcing facility to compound from a bulk drug substance where 'the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section 506E of the FD&C Act … at the time of compounding, distribution, and dispensing' — and unlike semaglutide and tirzepatide, liraglutide injection was still on that list when checked on 2 August 2026. So the two statutory doors are in different positions for this drug. What this record does not tell you is whether any specific compounded liraglutide product is lawful: the shortage condition is one of several conditions in section 503B, it is assessed at the time of compounding, distribution and dispensing rather than once, and it does not touch the separate restriction on compounding a product that is essentially a copy of a commercially available drug — which, with two brands and eleven approved generics on the market, is a question a compounder has to answer.

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

“the outsourcing facility does not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B Bulks List) or (2) the drug compounded from the bulk drug substance appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing.”

Checked against the source on 2 August 2026.

Is there a generic version of Victoza or Saxenda?

Yes — and unlike semaglutide and tirzepatide, which have no approved generics, liraglutide has many. Drugs@FDA listed eleven approved liraglutide ANDAs on 2 August 2026, from Biocon, Fresenius Kabi, Sandoz, Teva, Lupin, Orbicular, Hikma, Nanjing King Friend and Mylan Institutional; the earliest was approved on 23 December 2024. Seven carry therapeutic equivalence code AP1, meaning they are rated as equivalent to Victoza, and three carry AP2, rated against Saxenda; all eleven show marketing status 'Prescription'. FDA's own 503B notice names one of them, describing an FDA-approved 'liraglutide 18 mg/3 mL, e.g., ANDA 215503' alongside the two brands. One caveat worth keeping: this is a count of approved applications on one day, and approved is not the same as launched — which of them are actually being marketed was not verified here.

Drugs@FDA — drug products containing liraglutide (openFDA drug/drugsfda endpoint) — FDA, 31 July 2026Checked against the source on 2 August 2026.

Did FDA find that compounded liraglutide doesn't work?

No — FDA's evaluation stopped before that question. FDA's clinical-need analysis under section 503B is sequential, and for liraglutide it ended at the threshold: 'Because there is no basis to conclude that there is an attribute of the FDA-approved drug products containing liraglutide which makes them medically unsuitable to treat certain patients, FDA need not decide whether the proposed drug products containing liraglutide must be compounded from a bulk drug substance rather than using an FDA-approved drug product.' What FDA actually evaluated was narrow — whether the nomination identified an attribute of the approved liraglutide products making them medically unsuitable for identified patients. It found it did not: the only compounded strength the nominator identified was the same as the approved products', the inactive ingredients patients were said to be intolerant of were never named, and the propylene-glycol argument rested on an article that, as FDA recorded, 'did not evaluate liraglutide'. FDA also noted in the same notice that arguments about safety and quality concerns with the nominated bulk drug substances 'would be addressed in Part 2 of the clinical need analysis, which we do not reach here.' So the proposal is not a verdict that compounded liraglutide is ineffective, and the absence of such a verdict is not evidence that it works.

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Docket No. FDA-2018-N-3240) — Federal Register / FDA, 1 May 2026

“Because there is no basis to conclude that there is an attribute of the FDA-approved drug products containing liraglutide which makes them medically unsuitable to treat certain patients, FDA need not decide whether the proposed drug products containing liraglutide must be compounded from a bulk drug substance rather than using an FDA-approved drug product.”

Checked against the source on 2 August 2026.