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Ozempic (semaglutide)
Semaglutide, a GLP-1 analogue, binds to and activates GLP-1 receptors, stimulating insulin and inhibiting glucagon secretion in a glucose-dependent manner, and delays gastric emptying.
Semaglutide (Ozempic), developed by Novo Nordisk, is a marketed GLP-1 receptor agonist primarily indicated for glycemic control in type 2 diabetes, competing in a class with other established drugs such as exenatide, liraglutide, lixisenatide, albiglutide, and dulaglutide. Its key competitive advantage lies in its mechanism of action, which effectively stimulates insulin and inhibits glucagon secretion in a glucose-dependent manner while delaying gastric emptying, contributing to its efficacy and safety profile. The primary risk to semaglutide's market position is the patent protection of its competitors, notably liraglutide, which is protected until July 9, 2037, potentially limiting market exclusivity and pricing power.
At a glance
| Generic name | semaglutide |
|---|---|
| Sponsor | Novo Nordisk |
| Drug class | GLP-1 Receptor Agonist [EPC] |
| Target | GLP-1 receptor |
| Modality | Peptide |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 27400 |
Mechanism of action
Semaglutide works by mimicking the natural hormone GLP-1. It binds to GLP-1 receptors, which helps to lower blood glucose levels by increasing insulin production and reducing glucagon release when blood sugar is high. Additionally, it slows down the rate at which food leaves the stomach, further helping to control blood sugar.
Approved indications
- Glycemic Control in Type 2 Diabetes
- Reduction of CV Risk in Type 2 Diabetes
Boxed warnings
- 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 RYBELSUS and OZEMPIC tablets cause 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 )] . • RYBELSUS and OZEMPIC tablets are 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 RYBELSUS or OZEMPIC tablets 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 RYBELSUS or OZEMPIC tablets [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. It is unknown whether RYBELSUS and OZEMPIC tablets cause 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 ). • RYBELSUS and OZEMPIC tablets are 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 ).
Common side effects
- Nausea
- COVID-19
- Diabetic retinopathy
- Diarrhoea
- Vomiting
- Constipation
- Decreased appetite
- Headache
- Dyspepsia
- Upper respiratory tract infection
- Nasopharyngitis
- Fatigue
Drug interactions
- Insulin secretagogue (e.g., sulfonylurea) or insulin
- Other oral drugs with narrow therapeutic index
- Levothyroxine
Key clinical trials
- Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity
- SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer (Phase 1) (PHASE4)
- INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
- Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES) (PHASE2)
- A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity (PHASE1)
- Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus (PHASE1, PHASE2)
- Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients (PHASE3)
- Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ozempic CI brief — competitive landscape report
- Ozempic updates RSS · CI watch RSS
- Novo Nordisk portfolio CI