An application is under review
Novo Nordisk filed a U.S. application for CagriSema in December 2025. It seeks approval for weight management, and no FDA decision had been announced by September 28, 2026.
That application covers the combination for adults. It does not turn cagrilintide by itself into an approved drug.
Compounding is not a back door
The FDA says cagrilintide cannot be used in compounding under federal law.
Compounding usually means a pharmacy makes a medicine for a particular need. Compounded products lack FDA approval, and nobody at the FDA inspects each one before it is sold.
A research label does not change a sale
FDA letters have named cagrilintide sold online as an unapproved drug. The agency said a “research only” label did not change how the product was being marketed for people.
Chapter recap
By September 2026 the U.S. still had no approved cagrilintide product, and no lawful path existed there to compound it.