At a glance
- Semaglutide is an FDA-approved drug, marketed as Ozempic, Rybelsus, Wegovy (first approval: December 5, 2017).
- PubMed lists 5,929 publications mentioning it, including 313 randomized controlled trials and 276 animal-only studies.
- ClinicalTrials.gov lists 798 registered studies testing it (375 active).
- FDA's adverse event system (FAERS) holds 100,912 reports mentioning it; 50,788 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA209637 | OZEMPIC | Approved, marketed | December 5, 2017 | NOVO |
| NDA213051 | OZEMPIC, RYBELSUS | Approved, marketed | September 20, 2019 | NOVO |
| NDA213182 | RYBELSUS | Approved, marketed | January 16, 2020 | NOVO NORDISK INC |
| NDA215256 | WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | Approved, marketed | June 4, 2021 | NOVO |
| NDA218316 | WEGOVY | Approved, marketed | December 22, 2025 | NOVO |
| ANDA220314 | SEMAGLUTIDE | Tentative approval | — | APOTEX INC |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Metabolic effects of a GLP-1 analog combined with aerobic training in ovariectomized rats.
- Analysis Asks: Are GLP-1 Drugs Safe in People With Frailty?
- Glucagon-Like Peptide-1 Analog-Type Amyloidosis: A Case Report and Review of the Literature.
- Cutaneous vasculitis associated with subcutaneous semaglutide.
- Early Treatment Trajectory and Long-Term Persistence to Semaglutide for Obesity: A Population-Based Cohort Study.
- Neuropsychiatric Safety of GLP-1 Receptor Agonists and Tirzepatide in Adults with Type 2 Diabetes Mellitus or Obesity.
- Semaglutide versus other GLP-1 RAs and cardiovascular risk in obesity-related cancer survivors.
- Comparative Effects of Pharmacological Treatment on Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.
- Comparative adverse-event reporting patterns of semaglutide and tirzepatide: a disproportionality analysis of FAERS.
- Estimating the population eligible for Medicare's obesity-coverage demonstration.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 798
- Active
- 375
- With posted results
- 110
Conditions studied
Show 40 more studies
All 798 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 100,912
- Serious
- 50,788
- With death outcome
- 1,613
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) 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 See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC 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 ). • 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). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ). Source: DailyMed / openFDA
In the news
Latest headlines and official notices that mention this substance, in their original language. Third-party content, not medical advice.
- Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
- STAT+: Lilly’s triple-G drug beats Ozempic in head-to-head study
- STAT+: Lilly says ‘triple-G’ drug beat Novo’s Ozempic in diabetes study
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026
Agency summary (EMA): Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting. Rasonque (daraxonrasib)…
Change history
No changes since monitoring began on October 30, 2026.