Semaglutide
Approved · FDA / EMAAlso known as Ozempic, Rybelsus, Wegovy, Sémaglutide.
Recent clinical, regulatory, research and industry developments relating to this drug.
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Label change: SEMAGLUTIDE (NDA218316)
Supplemental approval: SEMAGLUTIDE (NDA215256)
Label change: SEMAGLUTIDE (NDA218316)
Supplemental approval: SEMAGLUTIDE (NDA215256)
Evidence confidence
How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.
Confidence is high because multiple independent trials consistently report body weight, with a narrow uncertainty band.
- 87%
- 36%
Evidence in comorbid disease reaches a different conclusion (weak) from the general population (supported).
Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.
High point estimate, but substantial uncertainty remains.
Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.
- 59%
- 31%
Evidence in comorbid disease reaches a different conclusion (weak) from the general population (supported).
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to… Show full indicationShow less
Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Indication: 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… Show full indicationShow less
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)
Indication: 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… Show full indicationShow less
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.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
A Study of Cardiovascular Events iN Diabetes Plus
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- Diabetes, obesity & metabolism14
- The New England journal of medicine8
- Lancet (London, England)7
- The lancet. Diabetes & endocrinology6
- JAMA4
- Cardiovascular diabetology3
- Lingvay I14
- Rosenstock J9
- Wadden TA7
- Davies M6
- Aroda VR5
- Bain SC5
- Jeppesen OK5
- Pedersen SD5
- Brigham and Women's Hospital7
- Diabetes Research Centre7
- Dallas Diabetes Research Center at Medical City6
- Pennington Biomedical Research Center6
- Perelman School of Medicine6
- University of Texas Southwestern Medical Center6
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Acts on the same molecular target as Semaglutide, with 20 overlapping disease areas.
Studied across 16 of the same disease areas as Semaglutide in the shared literature.
Acts on the same molecular target as Semaglutide, with 12 overlapping disease areas.
Acts on the same molecular target as Semaglutide, with 9 overlapping disease areas.
Studied across 27 of the same disease areas as Semaglutide in the shared literature.
Studied across 13 of the same disease areas as Semaglutide in the shared literature.
Studied across 9 of the same disease areas as Semaglutide in the shared literature.
Studied across 3 of the same disease areas as Semaglutide in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.