Cagrilintide is an investigational, long-acting amylin analog developed by Novo Nordisk, tested on its own and in a fixed-dose combination with semaglutide called CagriSema. As of October 21, 2026, it isn't approved anywhere. Novo filed CagriSema with FDA in December 2025 and expects a decision in the fourth quarter of 2026. FDA says cagrilintide can't be used in compounding.
Notice: Research peptides are sold for in-vitro laboratory research only. They are not FDA-approved, not for human or animal consumption, and this page is not medical advice. It contains no dosing or use guidance.
What amylin is, and what cagrilintide copies
Amylin is a hormone released from the pancreas alongside insulin. It's involved in fullness signals and slows stomach emptying. Natural amylin breaks down quickly, so drug developers build modified versions that last longer. Novo calls cagrilintide "a long-acting amylin analogue for obesity treatment" (Novo Nordisk, September 16, 2025).
Amylin works through a different receptor system than GLP-1. That's the logic behind CagriSema: Novo describes it as a fixed-dose combination of "a long-acting amylin receptor agonist, cagrilintide," and semaglutide, the GLP-1 drug in Wegovy and Ozempic (Novo Nordisk, September 21, 2026). For background on semaglutide itself, see semaglutide vs tirzepatide.
What the trials reported
Peer-reviewed papers carry more weight than company announcements, which are topline summaries. We list both, with the source for each.
REDEFINE 1 and 2 (NEJM, June 2025)
- REDEFINE 1: 3,417 adults with obesity or overweight and no type 2 diabetes, randomized to CagriSema, semaglutide alone, cagrilintide alone or placebo. At 68 weeks, mean body weight change was -20.4% with CagriSema vs -3.0% with placebo (Garvey et al., NEJM, 2025). Gastrointestinal adverse events occurred in about 80% of CagriSema recipients vs 40% on placebo (ACC summary).
- REDEFINE 2: 1,206 adults with type 2 diabetes and obesity or overweight. At 68 weeks, mean body weight change was -13.7% with CagriSema vs -3.4% with placebo (Davies et al., NEJM, 2025).
Cagrilintide on its own
The cagrilintide-only arm of REDEFINE 1 is the best public data on the molecule alone. Novo reported that it "led to 11.8% weight loss compared to 2.3% with placebo after 68 weeks," and said it would start a dedicated phase 3 program, RENEW, in the fourth quarter of 2025 (Novo Nordisk, September 16, 2025). ClinicalTrials.gov lists cagrilintide-only weight-loss studies in people with obesity (NCT07220642) and in people with obesity and type 2 diabetes (NCT07220759). We couldn't open those records to confirm their current status.
Later CagriSema trials (company-reported)
| Trial | Population | Reported result | Source |
|---|---|---|---|
| REDEFINE 4 | Obesity, open-label vs tirzepatide (809 people), 84 weeks | 20.2% vs 23.6% (treatment-regimen estimand); non-inferiority primary endpoint not met | Novo, February 23, 2026 |
| REDEFINE 9 | Obesity or overweight vs placebo, 68 weeks | 21.0% vs 2.0% placebo | Novo, September 21, 2026 |
| REIMAGINE 5 | Type 2 diabetes vs tirzepatide, 60 weeks | Weight loss 12.4% vs 9.1%; HbA1c reduction 1.71 vs 1.67 points (efficacy estimand) | Novo, September 21, 2026 |
Novo says a higher-dose CagriSema phase 3 trial began in 2026, and its REDEFINE program also includes REDEFINE 3, a cardiovascular outcomes trial (Novo, September 30, 2026).
FDA status (October 2026)
- Not approved. Novo submitted a New Drug Application for CagriSema in weight management in December 2025 (Novo, December 18, 2025). Its September 2026 releases say "CagriSema remains investigational" and "A decision is expected in Q4 2026" (Novo, September 21, 2026). A report dated October 20, 2026 still described the decision as expected this quarter (Euronext news feed). There's no standalone cagrilintide filing.
- Can't be compounded. FDA's GLP-1 page, current as of October 1, 2026, says: "Retatrutide and cagrilintide cannot be used in compounding under federal law." FDA adds that "these are not components of FDA-approved drugs" (FDA).
- "Research" labels don't protect sellers. The same FDA page says it has warned companies selling unapproved drugs "falsely labeled 'for research purposes'" or "not for human consumption." FDA's March 31, 2026 warning letter to Prime Sciences named a product sold as "Cagrilintide" alongside coded GLP-1 products.
- Even an approval wouldn't change research vials. If FDA approves CagriSema, the approval covers Novo's product, made and tested under its application. It wouldn't make a gray-market cagrilintide vial an approved drug.
More background: FDA peptide regulation in 2026 and are peptides legal?
Research-grade vials: what the market looks like
As listed on vendors' sites on October 21, 2026, 46 vendors in our price index had cagrilintide in stock, at a median of $12.30 per mg. Prices change often. Current listings are on our cagrilintide price page.
How to check a cagrilintide COA
Cagrilintide is a long, modified peptide, which makes identity testing more important than for short peptides. Use our COA guide or COA checklist and look for:
- The compound named as cagrilintide. Codes such as "CAG" or bundled "Cagri/Sema" blends don't tell you what was tested.
- Identity by mass spectrometry, with a mass that matches cagrilintide. HPLC purity alone can describe the wrong molecule (HPLC purity explained).
- Measured net content against the label (purity vs net content).
- A lot number matching your vial, a recent test date and, ideally, an endotoxin result.
- A lab you can verify and the vendor's FDA record (warning letters).
Summary
Cagrilintide is a Novo Nordisk amylin analog with strong phase 3 data, mainly as half of CagriSema. Neither is approved as of October 21, 2026, with an FDA decision on CagriSema expected this quarter. FDA has said plainly that cagrilintide can't be compounded and has named it in a warning letter to a "research" seller.
Sources are linked inline and were checked October 21, 2026. We'll update this page when FDA decides on CagriSema.
