GLP-1 receptor agonist (acylated GLP-1 analogue)
Semaglutide
An approved GLP-1 receptor agonist marketed under three brand names in the United States. It is not on any FDA compounding safety-risk category, but has been the subject of specific FDA compounding communications.
Also listed as: Ozempic, Wegovy, Rybelsus, NN9535
Chemical identity
- Compound class
- GLP-1 receptor agonist (acylated GLP-1 analogue)
- Sequence
- 31-residue GLP-1 analogue with Aib at position 2 and Lys20 acylated via two AEEA linkers and γ-Glu to octadecanedioic acid
- Molecular formula
- C187H291N45O59
- Molecular weight
- 4114 g/mol
- CAS number
- 910463-68-2
- PubChem CID
- 56843331
- Research categories
- Incretin analogues, Approved drug substances
United States regulatory status
FDA-approved drug substance
NDA 209637 (Ozempic), NDA 213051 (Rybelsus), NDA 215256 (Wegovy)
Marketed in the United States as three approved prescription products: Ozempic and Rybelsus (type 2 diabetes mellitus) and Wegovy (chronic weight management).
- Approved prescription drug substance. Ozempic approved 5 December 2017; Rybelsus 20 September 2019; Wegovy 4 June 2021.
- Not placed in FDA's Category 2 of bulk substances that may present significant safety risks.
- FDA proposed in April 2026 to exclude semaglutide from the 503B bulks list, stating it did not identify sufficient evidence for inclusion.
- FDA has issued separate communications concerning unapproved GLP-1 products marketed for weight loss.
Regulatory status describes how a substance is classified. It is not a safety assessment, and it says nothing about the quality of any particular material.
Sources
Last reviewed 3 September 2026 · Compiled by Therapept Editorial · How these records are built