VICTOZA
Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients aged 10 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise. It is also approved for use in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The medication is not indicated for the treatment of type 1 diabetes mellitus and should not be coadministered with other products containing liraglutide.
How VICTOZA Works
Liraglutide is an acylated human GLP-1 receptor agonist that activates the GLP-1 receptor on pancreatic beta cells. This activation increases intracellular cyclic AMP, leading to the release of insulin when blood glucose concentrations are elevated. The drug further lowers blood glucose by decreasing glucagon secretion in a glucose-dependent manner and delaying gastric emptying. Unlike endogenous GLP-1, liraglutide is stable against metabolic degradation by peptidases, providing a half-life that supports once-daily administration.
Details
- Status
- Prescription
- First Approved
- 2010-01-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
VICTOZA Approval History
What VICTOZA Treats
2 indicationsVICTOZA is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus (glycemic control in patients 10 years and older)
- Major adverse cardiovascular events risk reduction (adults with type 2 diabetes mellitus and established cardiovascular disease)
VICTOZA 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 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 [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. • VICTOZA is contrain...
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 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 [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. • VICTOZA 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 for MTC with the use of VICTOZA 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 VICTOZA [see Contraindications ( 4 ) and 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 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 ( 5.1 , 13.1 ). • VICTOZA 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 ).
VICTOZA 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.
VICTOZA Competitors
Pro6 other drugs also target GLP-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (GLP-1). Earlier expiry dates signal biosimilar/generic opportunities.
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.
VICTOZA FDA Label Details
ProIndications & Usage
FDA Label (PDF)VICTOZA is indicated: • as an adjunct to diet and exercise to improve glycemic control in patients 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 [see Clinical Studies ] . Limitations of Use : VICTOZA should not be used in patients with type 1 diabetes mellitus. VICTOZA contains liraglutide and should not be coadministered with other liraglutide-containing products. VICTOZA is a...
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 VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC)...
VICTOZA Patents & Exclusivity
Patents (4 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.