WEGOVY
Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for chronic weight management and the reduction of major adverse cardiovascular events. It is used in adults and pediatric patients aged 12 and older with obesity, and in adults with overweight who have at least one weight-related comorbid condition. The injection form
Details
- Status
- Prescription
- First Approved
- 2021-06-04
- Routes
- SUBCUTANEOUS, ORAL
- Dosage Forms
- SOLUTION, TABLET
WEGOVY Approval History
What WEGOVY Treats
8 FDA approvalsOriginally approved for its first indication in 2021 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Jun 2021) PriorityLabel Letter
- • Approved indication (Dec 2022) PriorityLabel Letter
- • Approved indication (Jul 2023)Label Letter
- • Approved indication (Mar 2024) PriorityLabel Letter
- • Approved indication (Nov 2024)Label Letter
- • Approved indication (Aug 2025) Priority NewLabel Letter
- • Approved indication (Nov 2025) NewLabel Letter
- • Approved indication (Dec 2025) NewLabel Letter
WEGOVY Boxed Warning
RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • WEGOVY is contraindicated in patients with a per...
WARNING: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of WEGOVY 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 WEGOVY [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. ( 5.1 , 13.1 ) • WEGOVY 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 symptoms of thyroid tumors. ( 4 , 5.1 )
WEGOVY 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.
WEGOVY 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.
WEGOVY FDA Label Details
ProIndications & Usage
FDA Label (PDF)WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. • To reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity. o Adults with overweight in the presence of at least one weight-related comorbid condition. • For the treatment of noncirrhotic metabolic dysfuncti...
WARNING: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human r...
WEGOVY Patents & Exclusivity
Patents (325 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.