SAXENDA (liraglutide)
Saxenda (liraglutide) is a GLP-1 receptor agonist indicated for chronic weight management in combination with a reduced-calorie diet and increased physical activity. The treatment is approved for adults with obesity or those who are overweight with at least one weight-related comorbid condition. It is also indicated for pediatric patients aged 12 years and older with a body weight exceeding 60 kg and obesity. Use of this medication is not recommended in combination with other GLP-1 receptor agonists or liraglutide-containing products.
How SAXENDA Works
Liraglutide is an acylated human GLP-1 receptor agonist that binds to and activates the GLP-1 receptor, which serves as a physiological regulator of appetite and calorie intake. By targeting specific brain regions involved in appetite regulation, such as the hypothalamus, the medication modulates the body's desire for food. Unlike naturally occurring GLP-1, liraglutide is engineered to resist metabolic degradation by endogenous enzymes, providing a prolonged half-life that supports once-daily dosing. This sustained activation of GLP-1 receptors in the brain results in reduced calorie intake to support weight loss.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-12-23
- Patent Cliff
- 2037
- Revenue
- $84M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
SAXENDA Approval History
What SAXENDA Treats
3 indicationsSAXENDA is approved for 3 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity in adults
- Obesity in pediatric patients aged 12 years and older with body weight greater than 60 kg
- Overweight in adults in the presence of at least one weight-related comorbid condition
SAXENDA Boxed Warning
RISK OF THYROID C-CELL TUMORS • 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 [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • SAXENDA is contraindi...
WARNING: RISK OF THYROID C-CELL TUMORS • 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 [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • SAXENDA is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of SAXENDA and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with SAXENDA [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes 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 ( 5.1 ). • SAXENDA is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 , 13.1 ).
SAXENDA Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
SAXENDA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
201 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04575844 ZQL008 | 200065 R01DK125330 | Ph 4 | recruiting | Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome |
| NCT02944500 | 2015P000327 | Ph 4 | active not recruiting | Saxenda: Underlying Mechanisms and Clinical Outcomes |
| NCT03856632 LEAF | 20181182 | Ph 4 | active not recruiting | Liraglutide Effect in Atrial Fibrillation |
| NCT05965908 | Liraglutide Polycystic Ovary | Ph 3 | completed | Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome |
| NCT05681299 | AAAU4280 | Ph 4 | recruiting | Effects of GH and Lirglutide on AgRP |
| NCT02674893 GLP1 et Goût | BRINDISI 2013 | Ph 4 | terminated | Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes |
| NCT02721888 LIRA-NAFLD/LIP | VERGES NOVO 2012 | Ph 4 | terminated | Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism |
| NCT07225816 | NN9536-8438 U1111-1323-7355 | Ph 1 | recruiting | Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected) |
| NCT05579249 results posted | NN9536-4741 U1111-1263-7301 | Ph 4 | completed | A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America |
| NCT07029009 | 2024-0426 | Ph 2 | recruiting | Liraglutide Treatment in Patients With Maturity-onset Diabetes of the Young (MODY) |
| NCT04775082 | NN8022-4392 U1111-1247-8226, 2020-000546-34 | Ph 3 | active not recruiting | SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity |
| NCT07244003 MESSAGE | HD-LLPHYJ-LC-1 | Ph 4 | recruiting | Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control |
| NCT02516657 results posted | 437619-6 | Ph 3 | completed | Liraglutide in Adolescents With Type 1 Diabetes |
| NCT03158805 results posted | 2017-1579 | Ph 2 | completed | Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated) |
| NCT04881110 STARDUST results posted | 2_0401_2021 | Ph 4 | completed | Liraglutide and Peripheral Artery Disease |
| NCT05268237 | BIOL-001 | Ph 1, Ph 2 | recruiting | Safety, Tolerability and Preliminary Efficacy of Sublingual Liraglutide in Patients With Type 2 Diabetes Mellitus |
| NCT03087032 LiraGooD | KYH2017-002 | Ph 4 | recruiting | Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD) |
| NCT04883346 results posted | 10000241 000241-CH | Ph 2 | completed | Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy |
| NCT03555994 results posted | D5670C00022 2017-005081-22 | Ph 2 | completed | A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. |
| NCT03115424 results posted | 16-004253 | Ph 3 | completed | Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy |
| NCT03036800 STRIVE results posted | 0626 | Ph 4 | completed | Saxenda in Obesity Services (STRIVE Study) |
| NCT02403284 | 028 1593855 | Ph 4 | completed | The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans |
| NCT03182426 | Pro00053082 | Ph 1, Ph 2 | completed | Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) |
| NCT06438146 LIROH | 2023P002985 K23DK125162 | Ph 4 | recruiting | LIROH - Liraglutide for Obesity in HIV |
| NCT04311411 results posted | 17223 I8F-MC-GPHH | Ph 1 | completed | A Study of Tirzepatide in Overweight and Very Overweight Participants |
| NCT02953665 results posted | U1111-1173-0106 | Ph 2 | completed | Safety and Efficacy of Liraglutide in Parkinson's Disease |
| NCT03672812 | 87650318100005327 | Ph 3 | completed | The Use of Liraglutide in Brain Death |
| NCT02518945 results posted | 1969 | Ph 3 | completed | Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes |
| NCT01722266 results posted | NN1962 | Ph 3 | completed | Liraglutide in the Treatment of Type 1 Diabetes Mellitus |
| NCT03712098 DAL results posted | 831835 | Ph 2 | completed | Daily Liraglutide for Nicotine Dependence |
| NCT03757130 results posted | 20170139 | Ph 1 | completed | Multiple Ascending Dose Study of AMG 598 in Adults With Obesity |
| NCT05111912 | SCW0502-1121 | Ph 2 | completed | Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity |
| NCT02960659 results posted | 170013 17-DK-0013 | Ph 1, Ph 2 | completed | Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes |
| NCT03374956 results posted | 17-003449 | Ph 3 | completed | Individualized Obesity Pharmacotherapy |
| NCT02527200 results posted | NN8022-4179 2014-004415-37, U1111-1162-7884 | Ph 3 | completed | Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome |
| NCT04605861 | JSWB-LRG2020-301 | Ph 3 | completed | The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients |
| NCT04074161 STEP 8 results posted | NN9536-4576 U1111-1233-0977 | Ph 3 | completed | Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity |
| NCT01779362 RISE Adult results posted | RISE Adult 5U01DK094406-02 | Ph 3 | completed | RISE Adult Medication Study |
| NCT05467514 | F-2022-1901-019 | Ph 3 | completed | Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus |
| NCT05444569 | 18449 J2R-MC-YAAC | Ph 1 | completed | A Study of LY3537021 in Healthy Participants |
| NCT04657939 Lean-DM | 265208 18/0005908, 19/WM/0365 | Ph 4 | completed | Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes |
| NCT03172494 DUAL™ I China results posted | NN9068-4148 U1111-1154-6671, CTR20170004 | Ph 3 | completed | A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) |
| NCT03048578 results posted | 16-01527 | Ph 4 | completed | Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery |
| NCT03101930 results posted | IRB# 170213 | Ph 4 | completed | Cardiovascular Effects of GLP-1 Receptor Activation |
| NCT02743598 | 23284 | Ph 4 | terminated | Liraglutide for HIV-associated Neurocognitive Disorder |
| NCT02863419 PIONEER 4 results posted | NN9924-4224 2015-005210-30, U1111-1176-6029 | Ph 3 | completed | Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus |
| NCT03523273 results posted | 15-001783 Part B R56DK067071, UL1TR000135 | Ph 2 | completed | Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity |
| NCT05360147 | LICD study | Ph 3 | completed | Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus |
| NCT02765399 results posted | LIRA | Ph 4 | completed | The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis |
| NCT02787551 LixiLan-G results posted | EFC13794 2014-004850-32, U1111-1168-4639 | Ph 3 | completed | Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period |
Showing 50 of 201 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SAXENDA FDA Label Details
Indications & Usage
FDA Label (PDF)SAXENDA is indicated for the treatment of Obesity in adults; Obesity in pediatric patients aged 12 years and older with body weight greater than 60 kg; Overweight in adults in the presence of at least one weight-related comorbid condition.
WARNING: RISK OF THYROID C-CELL TUMORS • 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)...
SAXENDA Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for SAXENDA
Revenue Insights
- • Q4-2025: $84M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 4 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment