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Cagrilintide

Also known as AM833.

Not approved by the FDA or the EMA. It was mainly studied combined with semaglutide, and the FDA is reviewing that combination.

LysCysAsnThrAlaThrCysAlaThrGlnArgLeuAlaGluPheLeuArgHisSerSerAsnAsnPheGlyProIleLeuProProThrAsnValGlySerAsnThrPro
37 amino acids, in order. A double ring marks a mirror-image, modified or non-standard one. End caps, bridges and anything attached to the chain are not drawn. Source: FDA substance registry.
Human evidence
Grade B

Some trials

Completed randomized trials
3
Approved?
No

Not approved in the US or the EU

Sport (WADA)
Not named

Not named on WADA's list. That is not clearance.

Checked on .

How we count a trial
Short answer

As of September 2026, the FDA and the EMA have not approved cagrilintide, alone or in combination. Its combination with semaglutide, CagriSema, finished Phase 3 trials and is under FDA review. A decision is expected in 2026. None of that covers a vial sold as cagrilintide. If one reached you, you cannot tell from the outside what is in it.

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What is cagrilintide?

Cagrilintide is a lab-made, long-acting version of amylin, a hormone the pancreas releases alongside insulin. Novo Nordisk developed it by adding a fatty-acid tail to amylin so that it lasts longer. It has mainly been studied combined with semaglutide, under the name CagriSema, and no approved product exists yet.

Does cagrilintide work?

Published trials found greater weight loss with cagrilintide plus semaglutide than with semaglutide alone. The FDA has not ruled on that combination yet, and neither the FDA nor the EMA has approved cagrilintide by itself.

What we found. 3 completed randomized trials counted on the record. 3 study rows listed below. Two tested cagrilintide together with semaglutide, and one early trial tested it alone.

Studies on the cagrilintide record: each study, what it was tested in, its status and what it shows.
Phase 2 trial of cagrilintide with semaglutide (Lancet, 2023)PeoplePublishedIn type 2 diabetes, the two together improved blood sugar and weight results compared with semaglutide alone
REDEFINE-1, Phase 3 trial (NEJM, 2025)PeoplePublishedCagrilintide and semaglutide together led to significantly greater weight loss than semaglutide alone
Phase 1/2 trial of cagrilintide alonePeoplePublishedIt set out how well people tolerated cagrilintide by itself
How we count a trial

Is cagrilintide safe?

The record says stomach and gut side effects are common, as with related drugs. Long-term safety beyond the trial periods is still being gathered. Long-term heart-outcome data are still pending. So over the long term, nobody knows. Those findings come from Novo Nordisk's trial product, mainly paired with semaglutide. What a vial labeled cagrilintide holds is a different question, and the vial section takes it up.

What is in a vial sold as cagrilintide?

The trials above tested Novo Nordisk's own product, and two of the three tested it together with semaglutide. This record holds no sign that cagrilintide is on sale. If a vial with this name reached you, none of those trials tested it, and the checklist lists what to ask the seller.

What don't we know?

  • Whether the FDA will approve CagriSema. A decision is expected in 2026.
  • What cagrilintide does on its own. It has mainly been studied with semaglutide.
  • What long-term use does to heart outcomes and safety. Those data are still pending.
  • What is in any vial sold as cagrilintide.

The other side

Cagrilintide has published randomized trials, one of them a Phase 3 trial in the New England Journal of Medicine. The FDA is reviewing the combination now. Two of the three listed trials tested the pairing with semaglutide, so they cannot speak for cagrilintide by itself.

What would change this record?

  • An FDA approval decision on the CagriSema application, expected in 2026.

Change log

  • Record checked. No change logged yet.
Every change on the Table

Three questions to ask next

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More questions about cagrilintide

Is cagrilintide FDA approved?

No. As of September 2026 the FDA has not approved cagrilintide, alone or in combination. Its review of CagriSema is under way, with a decision expected in 2026.

Is cagrilintide the same as CagriSema?

No. CagriSema is the name for cagrilintide combined with semaglutide. Novo Nordisk filed CagriSema with the FDA in December 2025.

Has cagrilintide been tested in people?

Yes. The record lists three published trials. Two tested it together with semaglutide, and one early trial tested it alone.

Is cagrilintide the same as pramlintide?

No. Both are lab-made versions of amylin. The FDA approved pramlintide in 2005 as Symlin. Cagrilintide is not approved by the FDA or the EMA.

Is cagrilintide banned in sport?

It is not named on WADA's list. That is not clearance.
Sources

Record checked on . Each source shows the date it was checked.

Metabolic and weight

In the same group

All 12 in this group
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