“Can a clinician prescribe it off label?”
Off-label use begins with an approved drug. There is no approved cagrilintide product to prescribe.
“What if a compounding pharmacy makes it?”
The FDA says cagrilintide cannot be used in pharmacy compounding under federal law.
“What if the vial has a National Drug Code, or NDC, number?”
The code can make a listing look official, but it is not FDA approval. Raw cagrilintide powder has appeared in that directory without an approved application.
“Is the large weight-loss result for cagrilintide alone?”
No. The largest headline result came from CagriSema, the combination. Cagrilintide alone produced less average loss in the same trial.
“Did CagriSema beat every other weight medicine?”
No. It beat semaglutide in one direct trial. In another, its average result was lower than tirzepatide, the other weight-loss drug tested.
“Can a research label make the sale okay?”
No. FDA letters say the way a product is marketed for human use matters more than that label.
“What number identifies a real study?”
Ask for the NCT code and check it on ClinicalTrials.gov.
“When will the FDA decide?”
Novo Nordisk expected a decision late in 2026, but no exact public decision date was available on September 28, 2026.
Chapter recap
The best questions force an offer to name its product, route, maker, and public record.