Track CagriSema in Peptimes™
CagriSema is an investigational injection from Novo Nordisk that contains two drugs in one product, cagrilintide and semaglutide. It is being studied in Phase 3 trials, including REDEFINE 1. (Source: ClinicalTrials.gov.)
Is CagriSema FDA-approved?
No. CagriSema is investigational: it's being studied in clinical trials, and Drugs@FDA lists no approved CagriSema product.
CagriSema
Also: cagrilintide and semaglutide
- Status label in the Peptimes Library
- Phase 3 Trials
- Routes in Peptimes
- Subcutaneous
- Updated
- 5 Nov 2026
US regulatory status
FDA status
Not FDA-approved for any use. Drugs@FDA lists no product with cagrilintide as an active ingredient.
Source: Drugs@FDA, checked 5 Nov 2026
Investigational
Yes.
Source: ClinicalTrials.gov, checked 1 Nov 2026
How to track it in Peptimes
Add CagriSema in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Phase 3 Trials”, which describes its investigational status. It isn’t an approval. It is one investigational product with its own trials; FDA-approved semaglutide medicines don’t make it approved.
- Logging: the amount you took and how you feel.
- Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell CagriSema or any other compound.
More sources
- NIH, ClinicalTrials.gov, REDEFINE 1 (NCT05567796), checked 1 Nov 2026: a Phase 3 study of CagriSema sponsored by Novo Nordisk, active, not recruiting.
- NIH, ClinicalTrials.gov, studies of CagriSema, checked 1 Nov 2026: registered studies, all sponsored by Novo Nordisk, including Phase 3 studies.
- FDA, Drugs@FDA, searched 1 Nov 2026: no application lists cagrilintide as an active ingredient.
- FDA, Novel Drug Approvals for 2026, checked 1 Nov 2026 (list current to 20 Oct 2026): CagriSema is not listed.