What Is Cagrilintide? FDA Status and CagriSema Explained
The short answer
Cagrilintide is a synthetic, long-acting analogue of human amylin, developed by Novo Nordisk. It is not an FDA-approved drug on its own. Novo Nordisk filed for FDA approval in December 2025, but that filing is for a fixed-dose combination product called CagriSema, not for cagrilintide by itself. As of this writing, cagrilintide has no independent approval anywhere and remains investigational.
What cagrilintide is, chemically
Cagrilintide is built on a 37-amino-acid backbone related to pramlintide, itself a modified version of human amylin. The molecule carries three substitutions (N14E, V17R, P37Y) and is acylated at one end with a 20-carbon fatty diacid through a gamma-glutamic acid linker, according to the medicinal chemistry paper that first described its development (Kruse et al., Journal of Medicinal Chemistry, August 2021). That fatty-acid attachment is the same general strategy used in several long-acting injectable peptides, and it is what stretches the molecule’s half-life out to roughly 180 hours, or about 7.5 days, the same paper reports, consistent with once-weekly dosing in the trials that followed.
| Compound | Cagrilintide (AM833) |
|---|---|
| Molecular weight | About 4,409 Da |
| Formula | C194H312N54O59S2 |
| CAS number | 1415456-99-3 |
| Reported half-life | About 180 hours (Kruse et al., 2021) |
| Developer | Novo Nordisk |
Is cagrilintide FDA approved?
No. Cagrilintide has never been submitted to the FDA as a standalone product. In December 2025, Novo Nordisk filed a New Drug Application for CagriSema, a fixed-dose, once-weekly injectable that pairs cagrilintide 2.4 mg with semaglutide 2.4 mg, based on the company’s REDEFINE 1 and REDEFINE 2 Phase 3 trial program. The FDA is reviewing that application in 2026, and as of this writing no decision has been announced. A filing does not ensure approval, and the agency can ask for more data or decline to approve a drug at any point in its review.
Separately, Novo Nordisk has also tested cagrilintide by itself, without semaglutide, in an arm of the REDEFINE 1 trial. That is the only Phase 3 dataset so far for cagrilintide as a monotherapy. The company has since started a new Phase 3 program, called RENEW, built specifically to evaluate cagrilintide alone in adults with a BMI of 30 or higher, or 27 and above with a related health condition. Novo Nordisk has not filed, and has not said it plans to file, for approval of cagrilintide as its own product. Everything the FDA is currently reviewing is the combination, CagriSema.
Cagrilintide and CagriSema are not the same filing
This distinction matters because the two names get used interchangeably online. CagriSema is Novo Nordisk’s brand name for the fixed-dose cagrilintide-plus-semaglutide combination, and it is that combination product, not cagrilintide on its own, that is sitting in front of the FDA right now. If CagriSema is approved, that approval would cover the combination as manufactured and dosed by Novo Nordisk. It would not make cagrilintide, sold on its own as a research compound, an approved drug. The same logic applies to semaglutide itself: semaglutide is already FDA-approved under other brand names (Ozempic, Wegovy), but that approval does not extend to cagrilintide, a different molecule entirely.
What this means for research use
Peptryn supplies cagrilintide as a lyophilized laboratory research material, not as CagriSema, not as a weight-management product, and not for human or animal use. We do not sell semaglutide, and we do not give dosing or administration guidance for anything in our catalog. A certificate of analysis for this product is not yet published in our COA library. If you need the current lot report before ordering, email [email protected] with your order number. See our cagrilintide product page for current specifications, and our guide to peptide legality for how research-use sales are treated.
Common questions
Is cagrilintide the same as CagriSema?
No. Cagrilintide is one molecule. CagriSema is Novo Nordisk’s brand name for a fixed-dose combination of cagrilintide and semaglutide. The FDA application filed in December 2025 covers the combination, not cagrilintide by itself.
When will cagrilintide be approved?
Cagrilintide alone has not been filed for approval, so there is no filing date or review clock to point to. The CagriSema combination was filed in December 2025 and is under FDA review in 2026. A filing does not ensure approval, and the agency has not announced a decision.
Is cagrilintide the same as retatrutide?
No. They are different investigational compounds from different companies. See our comparison of cagrilintide and retatrutide for how they differ.
Does Peptryn sell CagriSema?
No. Peptryn’s catalog does not include CagriSema or semaglutide. See our cagrilintide listing for the compound we do sell, supplied strictly for laboratory research.
Related: Cagrilintide vs retatrutide · Buying retatrutide for research · Popular peptides · Are peptides legal?
For laboratory research use only. Not for human or veterinary use, and not a drug, food, dietary supplement or cosmetic. You must be 21 or older to buy.
