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liraglutide
FDA-approved since 2010 and marketed in the US as Liraglutide, Saxenda, Victoza, authorised in the EU as Saxenda, Victoza, Xultophy, currently listed in shortage by the FDA (9 active records). 17 active trials, the next due to complete 2027-03-31.
GLP-1 agonist, SC, from Novo Nordisk. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- marketed
- Target
- GLP-1
- Route
- SC
- Sponsor
- Novo Nordisk
- First FDA approval
- 2010-01-25
- EU authorisation
- Victoza (2017), Xultophy (2018), Saxenda (2018)
- Active trials
- 17 (2 in phase 3)
- Participants enrolled
- 2,721
- Trials with a reporting date
- 3
- Approved FDA submissions
- 77
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
Liraglutide Injection 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. Limitations of Use : Liraglutide Injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide Injection is a glucagon-like peptide-1 (GLP-1) receptor agonist 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 ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.
Liraglutide injection 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. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. Liraglutide injection is a glucagon like peptide 1 (GLP-1) receptor agonist 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. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. ( 1 )
Liraglutide injection 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 Limitations of Use : Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist 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 ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.
Liraglutide injection 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 : Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist 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. ( 1 ) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) Limitations of Use: Coadministration with other liraglutide-containing products is not recommended.
Liraglutide injection 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. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. Liraglutide injection is a glucagon like peptide-1 (GLP-1) receptor agonist 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. ( 1 ) Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. ( 1 )
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. Limitations of Use • SAXENDA contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist 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. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: • Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. ( 1 )
Liraglutide 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 : Liraglutide contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist 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. ( 1 ) • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) Limitations of Use : • Coadministration with other liraglutide-containing products is not recommended.
Liraglutide injection 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 Limitations of Use: Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist 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 ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.
Liraglutide injection 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. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. Liraglutide injection is a glucagon like peptide 1 (GLP-1) receptor agonist 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. ( 1 ) Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established. ( 1 )
XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: • XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions ( 5.5 )]. • XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis. • XULTOPHY 100/3.6 has not been studied in combination with prandial insulin. XULTOPHY 100/3.6 is a combination of insulin degludec, a long-acting human insulin analog, and liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : ( 1 ) • Coadministration with any other product containing liraglutide or another GLP-1 receptor agonist is not recommended. • Not recommended for the treatment of diabetic ketoacidosis. • Has not been studied in combination with prandial insulin.
Liraglutide injection 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 : Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist 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 ( 1 ). to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( 1 ). Limitations of Use : Coadministration with other liraglutide-containing products is not recommended.
Supply status
| Updated | Status | Presentation | FDA note |
|---|---|---|---|
| 10/14/2026 | Current | Liraglutide, Injection, 6 mg/1 mL (NDC 0143-9144-02) | |
| 10/14/2026 | Current | Liraglutide, Injection, 6 mg/1 mL (NDC 0143-9144-03) | |
| 08/27/2026 | Current | Liraglutide, Injection, 6 mg/1 mL (NDC 71288-563-84) | |
| 08/27/2026 | Current | Liraglutide, Injection, 6 mg/1 mL (NDC 71288-563-85) | |
| 09/22/2026 | Current | Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15) | Product will be available until discontinuation in January 2027 |
| 09/22/2026 | Current | Victoza, Injection, 6 mg/1 mL (NDC 0169-4060-12) | Estimated shortage duration: TBD |
| 09/22/2026 | Current | Victoza, Injection, 6 mg/1 mL (NDC 0169-4060-13) | Estimated shortage duration: TBD |
| 09/22/2026 | Current | Liraglutide, Injection, 6 mg/1 mL (NDC 0480-3667-20) | Distributed by Teva |
| 09/22/2026 | Current | Liraglutide, Injection, 6 mg/1 mL (NDC 0480-3667-22) | Distributed by Teva |
| 08/25/2026 | To Be Discontinued | Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15) | Product will be available until discontinuation in January 2027; Discontinuation of the manufacture of the drug |
| 05/14/2026 | To Be Discontinued | Liraglutide, Injection, 6 mg/1 mL (NDC 0480-7250-46) | Discontinuation of the manufacture of the drug |
Recent changes
| Detected | Change | Trial | Detail | Phase |
|---|---|---|---|---|
| 2026-09-21 | Results date moved | A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis NCT07225829 · 4Moving Biotech | 2026-08-28 → 2026-08-31 | P2 |
| 2026-08-31 | Status changed | A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes NCT06559722 · Tonghua Dongbao Pharmaceutical Co.,Ltd | Not yet recruiting → Unknown | P3 |
| 2026-08-28 | field_changed | · |
When these trials report
Next 3 of 3 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2027-03-31 | Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery NCT06361238 · The incidence of delirium | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | P3 | 260 |
| 2027-08-31 | RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients. NCT07301437 · weight loss | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | P4 | 120 |
| 2027-12-31 | Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control NCT07244003 · The change of HbA1c compared to the baseline | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | P4 | 430 |
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2026-07-01 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA212972 |
| 2026-06-15 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA213155 |
| 2026-06-02 | Labeling | SAXENDA | NDA206321 · label |
| 2026-03-30 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA212552 |
| 2026-03-11 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA215245 |
| 2026-02-25 | Labeling | SAXENDA | NDA206321 · label |
| 2026-02-24 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA217063 |
| 2026-02-24 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA217234 |
| 2026-01-14 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA217590 |
| 2025-10-15 | Labeling | LIRAGLUTIDE | ANDA218115 |
| 2025-10-14 | Labeling | XULTOPHY 100/3.6 | BLA208583 · label |
| 2025-10-14 | Labeling | VICTOZA | NDA022341 · label |
| 2025-10-14 | Labeling | SAXENDA | NDA206321 · label |
| 2025-08-27 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA214568 |
| 2025-07-22 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA215421 |
| 2025-05-28 | Labeling | XULTOPHY 100/3.6 | BLA208583 · label |
| 2025-05-28 | Labeling | VICTOZA | NDA022341 · label |
| 2025-05-28 | Labeling | SAXENDA | NDA206321 · label |
| 2025-04-02 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA218115 |
| 2025-02-12 | Labeling | VICTOZA | NDA022341 · label |
| 2024-12-23 | Generic approval (ANDA) original | LIRAGLUTIDE | ANDA215503 · label |
| 2024-11-01 | Labeling | XULTOPHY 100/3.6 | BLA208583 · label |
| 2024-11-01 | Labeling | VICTOZA | NDA022341 · label |
| 2024-11-01 | Labeling | SAXENDA | NDA206321 · label |
| 2023-07-10 | Labeling | XULTOPHY 100/3.6 | BLA208583 · label |
Indications under study
Atrial Fibrillation; Cardiovascular Function; Childhood Obesity; Delirium, Postoperative; Echocardiography; Growth Hormone Deficiency; Healthy; Hyperglycaemia (Diabetic); Infertility; Knee Osteoarthritis; Liraglutide; Maturity Onset Diabetes of the Young; Metabolic Syndrome; Obesity; Obesity, Adolescent; Overweight and Obese Adults; Overweight and Obesity; PCOS; Severe Obesity; Speckle Tracking; Synovitis of Knee; T2DM (Type 2 Diabetes Mellitus); Type 1 Diabetes; Type 2 Diabetes; Type 2 Diabetes Patients; Type 2 Diabetic Patients; Type2 Diabetes.
Recent papers
Every liraglutide trial on file
All 290 registered trials of liraglutide, largest first. Each links to its own page and to the registry record.