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Cagrilintide

MED-000015

Cagrilintide is an investigational long-acting amylin analog developed by Novo Nordisk. It is not FDA-approved as a standalone medication. Its main development path is CagriSema, a fixed-dose combination with semaglutide, which was submitted to the FDA for approval in December 2025 and is under review in 2026.

Medication Overview

Generic Name: 

Medication Class: 

Manufacturer:

Route:

Dosing Frequency:

Cagrilintide

Amylin Analog

Novo Nordisk

Injection

Weekly (Investigational)

Status:

Draft

Medication Summary

Cagrilintide is an investigational long-acting amylin analog developed by Novo Nordisk. It is not FDA-approved as a standalone medication. Its main development path is CagriSema, a fixed-dose combination with semaglutide, which was submitted to the FDA for approval in December 2025 and is under review in 2026.

Aliases

Cagrilintide

Search Keywords

cagrilintide

Medication Uses

Part of the DietApp.com GLP-1 Medication Database, a comprehensive, regularly reviewed reference covering every GLP-1-class medication.

Cagrilintide is an investigational amylin analog — a different hormone target than the GLP-1 medications elsewhere in this library. Amylin is a hormone that works alongside insulin to regulate appetite and blood sugar. Cagrilintide is not FDA-approved for any indication, either alone or in combination, and is not available by prescription or through compounding pharmacies.

Cagrilintide's primary development path is as part of CagriSema, a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg. Novo Nordisk submitted a New Drug Application (NDA) for CagriSema to the FDA on December 18, 2025, with FDA review expected during 2026. Standalone cagrilintide is not being pursued for separate approval, since Phase 2 monotherapy data (about 10.8% weight loss at 26 weeks) was weaker than semaglutide or tirzepatide alone — the combination with semaglutide is what makes it commercially competitive.

Dosage

Trial dosing for CagriSema has used a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, administered once weekly. There is no FDA-approved dosing, since neither cagrilintide alone nor CagriSema is currently approved.

Administration

In clinical trials, CagriSema is administered as a once-weekly subcutaneous injection. There are no approved administration instructions available outside the clinical trial setting.

Benefits

In the Phase 3 REDEFINE 1 trial, CagriSema produced approximately 20.4% average weight loss at 68 weeks under the trial product estimand (assuming continuous treatment), with some analyses reporting up to 22.7–23% weight loss — exceeding semaglutide alone (about 14.9-16.1%) and cagrilintide alone (about 11.5-11.8%) in the same trial. These are trial results, not guaranteed outcomes for any individual.

Side Effects

In REDEFINE 1 trial data, injection-site reactions were notably more common with CagriSema and cagrilintide-alone than with semaglutide-alone: about 12% of CagriSema patients and 17% of cagrilintide-alone patients reported injection-site reactions, compared to about 2.6% with semaglutide alone. Gastrointestinal side effects (nausea, vomiting, diarrhea) consistent with other incretin-based therapies have also been reported.

Warnings

Because cagrilintide and CagriSema are not FDA-approved, there is no finalized safety label. Full safety information, including any boxed warnings, will be established as part of the FDA review process. Cagrilintide is not a controlled substance and carries no DEA schedule, but investigational status means it cannot be legally prescribed, dispensed, or sold for human use outside of registered clinical trials.

Drug Interactions

No FDA-reviewed drug interaction data exists yet for cagrilintide or CagriSema, since neither is approved. As a combination product with semaglutide, CagriSema would be expected to carry interaction considerations similar to semaglutide (insulin, sulfonylureas, delayed gastric emptying affecting oral drug absorption), pending official labeling.

Storage

Storage requirements will be established as part of FDA-approved product labeling if and when CagriSema is approved. No consumer storage guidance currently exists outside the clinical trial setting.

References

  • Novo Nordisk: CagriSema NDA submission announcement (December 18, 2025)
  • Garvey WT, et al. REDEFINE 1 Trial, NEJM 2025
  • Drugs.com: CagriSema approval status
  • PharmExec: Novo Nordisk Submits NDA to FDA for CagriSema

Last medically reviewed and updated: July 11, 2026.

Track Your Progress

Since cagrilintide and CagriSema aren't available by prescription yet, there's nothing to log today. If you're currently on an FDA-approved GLP-1 medication, DietApp.com helps you track your dose, nutrition, weight, and symptoms in one place — and we'll update this page as CagriSema's regulatory status changes.

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Related Resources

Related Articles

  • Is CagriSema FDA Approved? Current Status
  • CagriSema vs. Tirzepatide: How Do They Compare?
  • What Is Semaglutide?
  • Frequently Asked Questions About GLP-1 Therapy

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