# Liraglutide: FDA Status, Research and Uses

> Liraglutide FDA status, Victoza, Saxenda and generic labels, its ongoing FDA shortage listing, compounding rules, key trials and label safety.

- Canonical URL: https://livingpluspeptides.com/peptides/liraglutide/
- Last updated: October 25, 2026
- Publisher: Living+

Liraglutide is a once-daily GLP-1 receptor agonist. The FDA first approved it in 2010. It is sold as Victoza and generics for type 2 diabetes and as Saxenda for weight. FDA approved the first generic in December 2024, and its database still listed a liraglutide shortage in October 2026 [1, 2, 9, 10].

## Regulatory status

- FDA approved: Yes: [Victoza (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4), [Saxenda (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143), [Liraglutide injection, generic (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2100ec49-57b2-4330-ab5f-057ce9b7e4d0)
- 503A compounding: [Component of an FDA-approved drug](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c). Active ingredient of approved drugs. FDA's shortage database still listed liraglutide injection as currently in shortage (first posted Jul 18, 2023; entries updated Oct 14, 2026).
- 503B bulks list: [FDA proposed not to include](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal). FDA proposed not to include liraglutide on the 503B bulks list (Federal Register May 1, 2026; comment period extended to July 30, 2026 by a Jun 26, 2026 notice). No final decision found as of Oct 25, 2026. Liraglutide remained on the FDA shortage list, which is a separate 503B route.
- WADA prohibited: [No](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 Prohibited List or the 2026 Monitoring Program)
- FDA drug shortage: [Currently in shortage](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c). Liraglutide injection is listed as currently in shortage, first posted July 18, 2023, with entries updated through Oct 14, 2026. Saxenda is listed as available until discontinuation in January 2027.
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: Drug Shortages database, liraglutide injection](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c), [FDA: FDA approves first generic of once-daily GLP-1 injection (Dec 23, 2024)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes), [FDA: FDA proposes to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list](https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list), [Federal Register: 503B bulks list notice (May 1, 2026)](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [WADA: 2026 Monitoring Program](https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf), [Federal Register: 503B bulks list notice, extension of comment period (Jun 26, 2026)](https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal), [Drugs@FDA: NDA 022341 Victoza](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022341), [openFDA drug shortages query: liraglutide](https://api.fda.gov/drug/shortages.json?search=generic_name:%22liraglutide%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: GLP-1 receptor agonist (GLP-1 analog) [1]
- Amino-acid length: Modified GLP-1(7-37) peptide, 97% matched to human GLP-1, with a C-16 fatty acid attached [1]
- Half-life: About 13 hours (label) [1]
- Route used in studies: Under the skin once daily [1, 2]
- First studied: 2000 (first description of the fatty acid GLP-1 derivatives); first U.S. approval 2010 [4, 1]

## How it works

Liraglutide is a man-made copy of GLP-1, a hormone the gut releases after eating. It binds to and activates the GLP-1 receptor [1]. The label says its peptide chain is 97% the same as human GLP-1. One building block was swapped, arginine for lysine at position 34 [1].

Natural GLP-1 lasts only 1.5 to 2 minutes in the blood, because enzymes break it down fast. Liraglutide has a 16-carbon fatty acid (palmitic acid) attached at position 26 [1]. This lets it bind to blood proteins and cluster together under the skin, which slows absorption and protects it from those enzymes [1]. Its half-life is about 13 hours, so it is given once a day [1]. Early work in 2000 showed that adding fatty acids of 12 carbons or longer made GLP-1 last long enough for once-daily use [4].

Like natural GLP-1, liraglutide raises insulin release and lowers glucagon release when blood sugar is high. It also slows stomach emptying [1]. The Saxenda label says GLP-1 is a regulator of appetite and calorie intake, and that liraglutide lowers body weight through lower calorie intake [2].

Victoza and generic liraglutide go up to 1.8 mg a day for diabetes. Saxenda uses a higher 3 mg daily dose for weight [1, 2].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: SCALE Teens | 2020 | 251 adolescents aged 12 to under 18 with obesity | Randomized, double-blind, placebo-controlled, 56 weeks plus 26-week follow-up, 3.0 mg daily | BMI fell at least 5% in 43.3% vs 18.7% with placebo. BMI rose again after the drug was stopped [8] | [Source](https://pubmed.ncbi.nlm.nih.gov/32233338/) |
| Human trial: Ellipse | 2019 | 134 youth aged 10 to under 17 with type 2 diabetes | Randomized, double-blind, placebo-controlled, 26 weeks plus 26-week open-label extension, up to 1.8 mg daily | A1c fell 0.64 points with liraglutide and rose 0.42 points with placebo at 26 weeks [7] | [Source](https://pubmed.ncbi.nlm.nih.gov/31034184/) |
| Human trial: LEADER | 2016 | 9,340 adults with type 2 diabetes at high heart risk | Randomized, double-blind, placebo-controlled, median follow-up 3.8 years | Heart death, heart attack or stroke: 13.0% vs 14.9% (hazard ratio 0.87) [5] | [Source](https://pubmed.ncbi.nlm.nih.gov/27295427/) |
| Human trial: SCALE Obesity and Prediabetes | 2015 | 3,731 adults with obesity or overweight, without type 2 diabetes | Randomized, double-blind, placebo-controlled, 56 weeks, 3.0 mg daily plus lifestyle advice | Mean weight loss 8.4 kg vs 2.8 kg with placebo [6] | [Source](https://pubmed.ncbi.nlm.nih.gov/26132939/) |
| Lab study: Knudsen et al. (fatty acid GLP-1 derivatives) | 2000 | Lab studies (cloned human GLP-1 receptor) | Medicinal chemistry and receptor potency testing of fatty acid GLP-1 derivatives | Derivatives with fatty acids of 12 carbons or longer lasted much longer than GLP-1 [4] | [Source](https://pubmed.ncbi.nlm.nih.gov/10794683/) |

## Doses used in studies

Label dosing for Victoza starts at 0.6 mg once daily for one week. It then rises to 1.2 mg daily, and to 1.8 mg daily if more glucose control is needed. The 0.6 mg dose is only to reduce stomach side effects at the start [1]. Saxenda starts at 0.6 mg a day and rises in weekly steps to 3 mg daily. Children who cannot tolerate 3 mg may be lowered to 2.4 mg daily [2].

In published trials, LEADER used liraglutide added to standard care, SCALE and SCALE Teens used 3.0 mg daily, and Ellipse used up to 1.8 mg daily in youth [5, 6, 8, 7].

**Dosing is set by a licensed provider.**

## Side effects and safety

Victoza, Saxenda and generic liraglutide carry a boxed warning for thyroid C-cell tumors. Liraglutide caused these tumors in rats and mice, and it is not known if it causes them in people. It must not be used by people with a personal or family history of medullary thyroid cancer or MEN 2 [1, 2, 3].

The most common side effects on the Victoza label are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation [1]. Saxenda label warnings include pancreatitis, gallbladder disease, low blood sugar, faster heart rate, kidney injury from dehydration, severe stomach side effects, allergic reactions, and a risk of breathing in stomach contents during anesthesia [2].

In SCALE Teens, 64.8% on liraglutide had stomach side effects vs 36.5% on placebo [8]. In SCALE, serious events occurred in 6.2% on liraglutide vs 5.0% on placebo [6].

## Legal and regulatory status

- 2026-10-14: FDA's drug shortage database still listed liraglutide injection as currently in shortage. It notes Saxenda will be available until it is discontinued in January 2027 [9]. [Source](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c)
- 2026-05-01: FDA published a notice proposing not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list. A June 26, 2026 notice extended the comment period to July 30, 2026. No final decision was found as of Oct 25, 2026 [12, 13, 16]. [Source](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
- 2024-12-23: FDA approved the first generic of Victoza (liraglutide injection 18 mg/3 mL) [10]. [Source](https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes)
- 2023-07-18: FDA first posted liraglutide injection to its drug shortage list [9]. [Source](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-liraglutide).

## Frequently asked questions

### Is liraglutide FDA approved?

Yes. It was first approved in 2010. It is the active ingredient in Victoza, Saxenda and generic liraglutide injection [1, 2, 3].

### What is the difference between Victoza and Saxenda?

Both contain liraglutide. Victoza is labeled for type 2 diabetes and heart risk, up to 1.8 mg daily. Saxenda is labeled for weight reduction at 3 mg daily [1, 2].

### Is there a generic liraglutide?

Yes. FDA approved the first generic referencing Victoza on Dec 23, 2024 [10]. Generic labels are on DailyMed [3].

### Is liraglutide still in shortage?

FDA's shortage database listed liraglutide injection as currently in shortage as of October 2026, with some products in limited supply [9].

### Can liraglutide be compounded?

It is part of approved drugs, so copy rules apply to pharmacies. In May 2026 FDA proposed not to add liraglutide to the 503B bulks list for outsourcing facilities [12, 13].

### How is liraglutide different from semaglutide?

Both act on the GLP-1 receptor. Liraglutide has a half-life of about 13 hours and is taken daily [1]. Semaglutide was designed from liraglutide for once-weekly use [11].

### Is liraglutide banned in sports?

It is not named on the WADA 2026 Prohibited List, and its monitoring program names only semaglutide and tirzepatide [14, 15].

### What are the most common side effects of liraglutide?

Nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation are the most common on the Victoza label [1].

## Sources

1. [DailyMed: Victoza (liraglutide) injection label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4)
2. [DailyMed: Saxenda (liraglutide) injection label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143)
3. [DailyMed: Liraglutide injection (generic) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2100ec49-57b2-4330-ab5f-057ce9b7e4d0)
4. [Knudsen et al. 2000, J Med Chem: Potent derivatives of GLP-1 for once daily use (PubMed)](https://pubmed.ncbi.nlm.nih.gov/10794683/)
5. [Marso et al. 2016, NEJM: LEADER (PubMed)](https://pubmed.ncbi.nlm.nih.gov/27295427/)
6. [Pi-Sunyer et al. 2015, NEJM: SCALE Obesity and Prediabetes (PubMed)](https://pubmed.ncbi.nlm.nih.gov/26132939/)
7. [Tamborlane et al. 2019, NEJM: Ellipse (PubMed)](https://pubmed.ncbi.nlm.nih.gov/31034184/)
8. [Kelly et al. 2020, NEJM: SCALE Teens (PubMed)](https://pubmed.ncbi.nlm.nih.gov/32233338/)
9. [FDA: Drug Shortages database, liraglutide injection](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c)
10. [FDA: FDA approves first generic of once-daily GLP-1 injection (Dec 23, 2024)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes)
11. [Lau et al. 2015, J Med Chem: Discovery of semaglutide (PubMed)](https://pubmed.ncbi.nlm.nih.gov/26308095/)
12. [FDA: FDA proposes to exclude semaglutide, tirzepatide and liraglutide on 503B bulks list (Apr 30, 2026)](https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list)
13. [Federal Register: List of bulk drug substances for which there is a clinical need under section 503B (May 1, 2026)](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
14. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
15. [WADA: 2026 Monitoring Program](https://www.wada-ama.org/sites/default/files/2025-09/2026_list_monitoring_program_en_final_clean_september_2025.pdf)
16. [Federal Register: 503B bulks list notice, extension of comment period (Jun 26, 2026)](https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)

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