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Published Phase 2 human RCT
Cagrilintide is an investigational once-weekly amylin analogue studied for weight management, with no standalone FDA, UK, or EU approval; this page covers what it is, its regulatory status, pharmacology, and safety context — for dosing math, use the calculator.
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Cagrilintide: reference record
| Regulatory status | Investigational; no standalone FDA/UK/EU marketing approval |
|---|---|
| Route | Subcutaneous |
| Dosing frequency | Once weekly |
| Published range | 0.3–4.5 mg |
| Evidence basis | Published Phase 2 human RCT |
| Common vial sizes | 5, 10 |
Sources
- PubMed - PMID 34798060Basis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is Cagrilintide?
Cagrilintide is an investigational long-acting amylin analogue studied for weight management. It is frequently studied alongside semaglutide as a combination, which is a different subject from cagrilintide on its own.
Is Cagrilintide FDA-approved?
No. Cagrilintide has no standalone FDA, UK or EU marketing approval. Published figures come from a Phase 2 monotherapy trial rather than an approved product label.
How is Cagrilintide given?
Subcutaneously, once weekly, in the cited monotherapy trial. There is no approved route or presentation outside a trial.
What are the known safety concerns with Cagrilintide?
There is no approved standalone product concentration or label. Combination-study figures describe a different regimen and should not be substituted for the monotherapy data shown here.
Phase 2 monotherapy trial tested 0.3, 0.6, 1.2, 2.4 and 4.5 mg weekly
Study range only; do not substitute CagriSema combination-study doses.
Investigational amylin analogue; no approved standalone product concentration or label.
Supply-chain quality · Finnrick
Avg quality score
6.5
/10
Purity range
94.45
–
99.94
%
Qty divergence
±
36
%
Vendors · samples
16
·
89
Common vial sizes
5, 10
mg
Test window
Apr 2025 - Mar 2026
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