Back to discover
Drug

Semaglutide

Approved · FDA / EMA
ClassGlucagon-like peptide 1 receptor agonistActively researchedLate-stage developmentSteady momentum

Also known as Ozempic, Rybelsus, Wegovy, Sémaglutide.

87
Research papers
52
Active clinical trials
Glucagon-like peptide 1 receptor
Primary target
27
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Evidence confidence

3 claims

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.

Reduces body weight in obesity
87%High confidence
Uncertainty ±6%Evidence coverage: PartialUpdated 1 August 2026

Confidence is high because multiple independent trials consistently report body weight, with a narrow uncertainty band.

Effect differs by population
General population:
87%
comorbid disease:
36%

Evidence in comorbid disease reaches a different conclusion (weak) from the general population (supported).

Improves HbA1c in type 2 diabetes
75%High confidence
Uncertainty ±5%Evidence coverage: LimitedUpdated 3 August 2026

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.

Reduces major adverse cardiovascular events in type 2 diabetes or cardiovascular disease
57%Moderate confidence
Uncertainty ±18%Evidence coverage: LimitedUpdated 3 August 2026

High point estimate, but substantial uncertainty remains.

Confidence is moderated by well-powered no-effect evidence and limited publication incorporation, despite broad trial support.

Effect differs by population
General population:
59%
comorbid disease:
31%

Evidence in comorbid disease reaches a different conclusion (weak) from the general population (supported).

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Semaglutide
Aliases & brands
OzempicRybelsusWegovySémaglutide
RxNorm CUI
1991302
ChEMBL ID
CHEMBL2108724
ATC codes
A10BJ06
UNII
53AXN4NNHX
Primary mechanism
Glucagon-like peptide 1 receptor agonist
Regulatory jurisdictions
emamhrafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

AGONISTGlucagon-like peptide 1 receptor agonist

Regulatory timeline

27 events

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.

Approval / market entry confirmed across FDA and EMA (2020-04-032022-01-06)
Approval / market entry confirmed across FDA and EMA (2025-08-152026-06-18)
Earliest approval
2018-02-08
Latest approval
2026-06-18
Authorities
FDA · EMA · MHRA
Total events
27
fdaU.S. Food and Drug Administration· 22 events
2026-06-18Supplemental approvalMulti-authority
Supplemental approval: SEMAGLUTIDE (NDA215256)
Evidence ↗
2026-06-18Label change
Label change: SEMAGLUTIDE (NDA218316)
Evidence ↗
2026-05-05Supplemental approvalMulti-authority
Supplemental approval: SEMAGLUTIDE (NDA215256)
Evidence ↗
emaEuropean Medicines Agency· 4 events
2026-03-26ApprovalMulti-authority
Approval: Kayshild (EMA)
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 toShow full 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 advanced liver fibrosis (fibrosis stages F2 to F3).

Evidence ↗
2022-01-06ApprovalMulti-authority
Approval: Wegovy (EMA)
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 adultsShow full 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 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)

Evidence ↗
2020-04-03ApprovalMulti-authority
Approval: Rybelsus (EMA)
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 asShow full 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 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.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2026-02-05Safety communicationSafety
Drug Safety Update: Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Evidence ↗

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

169 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
169
registered trials across all phases
LATEST COMPLETION 2026
52
Active studies
42
Recruiting
89
Late-stage (III+)
105
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 169
Early Phase 11Phase 141Phase 238Phase 2 / 33Phase 359Phase 420Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

87 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20162026
Most influential

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

The New England journal of medicine · 2016 · 4,652 cites

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

The New England journal of medicine · 2021 · 3,192 cites

Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.

The New England journal of medicine · 2023 · 1,956 cites

A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis.

The New England journal of medicine · 2021 · 1,430 cites

Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

The New England journal of medicine · 2019 · 1,342 cites
Recent papers
Major research themes8
Glucagon-Like Peptide-1 Receptor Agonists30Glucagon-Like Peptides25Obesity24Diabetes Mellitus, Type 221Hypoglycemic Agents11Anti-Obesity Agents9Cardiovascular Diseases8Incretins8
Journals, researchers & institutions
Top journals
  • Diabetes, obesity & metabolism14
  • The New England journal of medicine8
  • Lancet (London, England)7
  • The lancet. Diabetes & endocrinology6
  • JAMA4
  • Cardiovascular diabetology3
Leading researchers
  • Lingvay I14
  • Rosenstock J9
  • Wadden TA7
  • Davies M6
  • Aroda VR5
  • Bain SC5
  • Jeppesen OK5
  • Pedersen SD5
Leading institutions
free-text, unnormalised
  • 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

12 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

8 matches

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.

15 shared papers20 shared diseasesShared target

Studied across 16 of the same disease areas as Semaglutide in the shared literature.

13 shared papers16 shared diseases

Acts on the same molecular target as Semaglutide, with 12 overlapping disease areas.

12 shared diseasesShared target3 shared papers

Acts on the same molecular target as Semaglutide, with 9 overlapping disease areas.

Shared target9 shared diseases4 shared papers

Studied across 27 of the same disease areas as Semaglutide in the shared literature.

27 shared diseases1 shared paper

Studied across 13 of the same disease areas as Semaglutide in the shared literature.

13 shared diseases1 shared paper

Studied across 9 of the same disease areas as Semaglutide in the shared literature.

9 shared diseases2 shared papers

Studied across 3 of the same disease areas as Semaglutide in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • 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.