Ozempic
GLP-1 receptor agonist. Developed by Novo Nordisk. Clinical, regulatory, and source evidence are connected below.
Latest signals
The three most recent source-backed changes linked to this drug.
Phase 4 · NOT_YET_RECRUITING · University of Minnesota
Phase 3 · RECRUITING · Novo Nordisk A/S
NOVO · AP · SUPPL
Approved uses
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.
1 INDICATIONS AND USAGE OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults 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. • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
1 INDICATIONS AND USAGE RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
1 INDICATIONS AND USAGE 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: • adults and pediatric patients aged 12 years and older with obesity. • adults with overweight in the presence of at least one weight-related comorbid condition. • for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies ( 14.4 )] . Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse 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 adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Concomitant use of WEGOVY (semaglutide) tablets or WEGOVY (semaglutide) injection with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in combination with other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescents (≥12 years) Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity* and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC). Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)
EMA's summary; the full indication is in the product information on the EPAR page.
Not covered here: NDA213182 (Rybelsus) (Not on Novo Nordisk's current Rybelsus label, which lists NDA213051.)
Regulatory history
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.
Patents and exclusivity
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.
The Orange Book lists no approved generic (ANDA).
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.
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 OZEMPIC 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 )] . • OZEMPIC 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 OZEMPIC 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 OZEMPIC [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] .
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 • 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 )] .
None on FDA's list names this drug.
Clinical trials
A focused view of recently updated studies · 12 linked records.
University of Minnesota · Updated Oct 20, 2026
Novo Nordisk A/S · Updated Oct 19, 2026
Massachusetts General Hospital · Updated Oct 19, 2026
Novo Nordisk A/S · Updated Oct 19, 2026
Novo Nordisk A/S · Updated Oct 19, 2026
Novo Nordisk A/S · Updated Oct 19, 2026
Regulatory timeline
Verified regulatory records in reverse chronological order.
Related intelligence
Records connected through the current intelligence graph.
Source evidence
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.
