Digestive & weight Long-acting amylin analog
Cagrilintide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Cagrilintide is an investigational long-acting amylin analog, developed by Novo Nordisk as a once-weekly injection for weight management. In a Phase 2 trial, it produced weight loss over 26 weeks, but most of its late-stage development is as the amylin component of the combination drug CagriSema, though a standalone Phase 3 trial has started. As of 2026, cagrilintide is not approved on its own.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA or any regulator
- What it is
- Long-acting amylin analog given as a once-weekly injection
- Research
- Standalone human evidence is a single Phase 2 trial in overweight and obesity
- Development
- Largely moved to the combination product CagriSema
- Evidence strength
- Moderate research
Summary
Cagrilintide is an investigational long-acting amylin analog from Novo Nordisk. Learn how it works, what trials show, and why it is not approved on its own.
What is cagrilintide?
Cagrilintide is an experimental drug that mimics amylin, a hormone the pancreas releases alongside insulin that signals fullness. It was engineered by Novo Nordisk to last long enough for once-weekly injection and has been studied for weight management. It is investigational and not approved for any use, and much of its development now centers on pairing it with semaglutide in the combination CagriSema. Cagrilintide’s development codes are AM833 and NNC0174-0833.
How does it work?
Cagrilintide acts at amylin and calcitonin receptors, mimicking the natural hormone amylin. Activating these receptors is associated with three effects, which together reduce food intake:
- Greater satiety
- Slower stomach emptying
- Suppression of glucagon after meals
Because this is a different pathway from the GLP-1 incretin system, cagrilintide is also studied in combination with GLP-1 drugs on the theory that the two mechanisms complement each other. This describes the proposed mechanism rather than a proven outcome.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA or any regulator
Category: In clinical trials · Primary body area: Digestive & weight
No. Cagrilintide is investigational and not approved by the FDA or any other regulator. Most of its late-stage development is as part of CagriSema, though Novo Nordisk has also started a standalone Phase 3 trial of cagrilintide alone.
What does the research show?
Editor’s note
Evidence strength: Moderate research
It has one positive but limited Phase 2 trial as a standalone drug, with no completed Phase 3 of cagrilintide alone.
The main standalone evidence is one Phase 2 trial. According to PubMed, a 26-week dose-finding trial in people with overweight or obesity without diabetes reported weight reductions across a range of doses compared with placebo, with gastrointestinal effects as the most common side effect. This is a single, limited Phase 2 study; cagrilintide alone has not completed a Phase 3 trial for obesity, so its standalone efficacy and long-term profile are not established.
Sources: the Phase 2 dose-finding trial of cagrilintide (Lau et al., The Lancet, 2021, DOI: 10.1016/S0140-6736(21)01751-7), indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
started a standalone Phase 3 trial
- ClinicalTrials.gov NCT07220642
- [5]
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
- [14]
- [15]
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