The ordinary pharmacy route
The US agency that regulates drugs is called the Food and Drug Administration, or FDA.
Cagrilintide and CagriSema had no FDA-approved US product at the September 28, 2026 check.
- Compounding is making a medicine to order.
- Federal law did not permit cagrilintide in compounding. This was FDA guidance checked September 26, 2026.
- A prescription did not make cagrilintide available as an approved pharmacy medicine at the September 28, 2026 check.
A study is a different route
Cagrilintide was used in clinical trials—studies involving volunteers—with FDA oversight. Public records showed this on September 28, 2026.
- Expanded access is a possible FDA route outside a study for a serious or life-threatening illness when suitable treatments are unavailable.
- It also requires that joining a study is not possible.
- No cagrilintide or CagriSema expanded-access program was listed on ClinicalTrials.gov, the public US study register, on September 28, 2026.
- A request for one person may not appear in that register. FDA and a doctor must judge whether a person meets the rules.
- Ask your doctor whether this route could apply to your illness.
A request for approval is still a request
CagriSema was submitted for FDA review in December 2025. No decision had been announced by September 28, 2026.
- The application covered the combination for adult weight management, not cagrilintide on its own.
- Novo Nordisk, the developer, expected a decision late in 2026. That estimate was checked September 28, 2026.
- That was an estimate, not a set approval date.