Compound research
Cagrilintide: Research Overview & Current Status
Cagrilintide is a long-acting amylin analog. Current research status: in clinical trials. Cagrilintide is not FDA-approved as a standalone drug; the CagriSema combination (cagrilintide + semaglutide) had a New Drug Application submitted to the FDA in December 2025, with approval anticipated in late 2026 per industry trackers, but as of this review it remains unapproved.
Overview
Cagrilintide is a long-acting, stable synthetic analog of amylin, a pancreatic hormone involved in satiety and glucose regulation, developed by Novo Nordisk. It is under investigation both alone and as a fixed-dose combination with semaglutide (marketed name CagriSema) for obesity and type 2 diabetes.
long-acting amylin analog
Research timeline
2020s
Cagrilintide entered clinical development as a long-acting amylin analog, initially studied as monotherapy and later as a fixed-dose combination with semaglutide (CagriSema).
Source →2025
REDEFINE 1, a 68-week Phase 3 trial in 3,417 adults with obesity/overweight, compared CagriSema against cagrilintide monotherapy, semaglutide monotherapy, and placebo; results presented at the 85th ADA Scientific Sessions reported more than 1 in 5 participants losing 30%+ body weight with CagriSema.
Source →2025
REIMAGINE 2, a Phase 3 trial in 2,713 randomized participants with type 2 diabetes, reported significantly greater HbA1c reduction with cagrilintide-semaglutide versus semaglutide alone.
Source →2025
Novo Nordisk submitted a New Drug Application to the FDA for CagriSema for weight management.
Source →
Active & recent research
REDEFINE 4
head-to-head comparison of CagriSema against tirzepatide (Zepbound/Mounjaro)
REIMAGINE program
cagrilintide-semaglutide combination for type 2 diabetes across multiple trials
Cagrilintide mechanism research
role of brain amylin receptors 1 and 3 in cagrilintide-induced body weight reduction
Key findings
- REDEFINE 1 (N=3,417) reported that adults taking CagriSema lost an average of 23% body weight under the treatment-effect (on-treatment) analysis at 68 weeks.
- REIMAGINE 2 reported a mean HbA1c change of -1.91 percentage points with cagrilintide-semaglutide versus -1.75 with semaglutide alone (estimated treatment difference -0.16, p=0.0035).
- Preclinical mechanistic research reported that cagrilintide lowers body weight via brain amylin receptors 1 and 3.
- Across REDEFINE and REIMAGINE trials, the most common adverse events were gastrointestinal and reported as mostly mild to moderate, diminishing over time, consistent with incretin/amylin-class therapies.
Safety & regulatory notes
Cagrilintide and the CagriSema combination remain investigational; neither is FDA-approved as of this review, though an NDA for CagriSema was submitted in December 2025. Reported adverse events in Phase 3 trials have been predominantly gastrointestinal, similar to other amylin- and GLP-1-based therapies. As an unapproved compound, any cagrilintide sold outside Novo Nordisk's clinical trial program is an unregulated research chemical with unverified purity and no established human safety data outside trial settings.
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Where it's sold for research
We haven't built a dedicated vendor-availability page for Cagrilintide yet. See our full research-peptide vendor rankings →
Cagrilintide FAQ
Is cagrilintide FDA-approved?+
No. Cagrilintide and the CagriSema combination remain investigational; a New Drug Application for CagriSema was submitted to the FDA in December 2025 with a potential approval decision anticipated in late 2026.
What is cagrilintide studied for?+
Phase 3 trials (REDEFINE and REIMAGINE programs) are studying cagrilintide, both alone and combined with semaglutide, for obesity/overweight and type 2 diabetes management.
Is cagrilintide legal to buy for research purposes?+
It is sold by some vendors as a research chemical labeled not for human use; because it remains investigational and unapproved, purity, dosing accuracy, and safety outside Novo Nordisk's clinical trials are not verified.
How is cagrilintide different from semaglutide?+
Cagrilintide is an amylin analog rather than a GLP-1 receptor agonist; it is being developed as a fixed-dose combination with semaglutide (CagriSema) to target complementary satiety and glucose-regulation pathways.
Sources for this page (5)
- 1 https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645862.html
- 2 https://www.adameetingnews.org/redefine-trials-advance-cagrilintide-semaglutide-combination-treatment-for-weight-management/
- 3 https://pubmed.ncbi.nlm.nih.gov/42251859/
- 4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12270663/
- 5 https://bodevolvebariatric.com/cagrisema/
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