Directory
GLP-1 & MetabolicMETABOLIC
Evidence grade B
Cagrilintide
Graded B: phase 2 and phase 3 randomized trials (including REDEFINE 1) studied it, but it is not FDA-approved alone or in any combination.
- Strengths
- 5, 10 mg
- Also known as
- Long-acting amylin analog, Half of CagriSema (with semaglutide)
- Molecule
- 37-amino-acid lipidated peptide (amylin analog)
- Formula
- C194H312N54O59S2
- Mol. weight
- 4409.07 g/mol
- CAS
- 1415456-99-3
Origin
Developed by Novo Nordisk on the human amylin backbone. A fatty-acid side chain and stabilizing changes give it a roughly one-week half-life, unlike the short-acting older amylin drug pramlintide.
How it works
Mimics amylin, a hormone released with insulin. In studies it acts on brainstem appetite centers to reduce meal size, slow stomach emptying and blunt glucagon after meals. Because amylin uses a different receptor family than GLP-1, it is studied as an add-on to GLP-1 drugs.
What the research shows
A 706-person phase 2 trial reported dose-dependent weight reductions of 6–11% over 26 weeks. In the phase 3 REDEFINE 1 trial, the cagrilintide-alone arm reported about 11.5–11.8% weight reduction over 68 weeks, versus about 16% for semaglutide alone and about 23% for the two combined. A small phase 2 diabetes arm also reported lower HbA1c. Novo announced a dedicated standalone phase 3 program (RENEW). Open questions include safety beyond 68 weeks and the meaning of common anti-drug antibodies.
Key studies
- Lau et al., Lancet 2021 (phase 2) 706 adults; weight change −6.0% to −10.8% vs −3.0% on placebo over 26 weeks.
- Enebo et al., Lancet 2021 (phase 1b) Added to semaglutide, gave about 6–7 points more weight reduction than semaglutide alone.
- REDEFINE 1, NEJM 2025 (phase 3) Cagrilintide-alone arm: −11.8% vs −2.3% on placebo over 68 weeks.
- Frias et al., Lancet 2023 (phase 2, type 2 diabetes) Cagrilintide-alone arm: HbA1c −0.9 points, weight −8.1%.
Safety findings
Trials reported mostly mild-to-moderate nausea, vomiting, constipation and diarrhea, concentrated during dose increases, plus more injection-site reactions than placebo. Anti-drug antibodies were common (46–73% by week 26). The older amylin drug pramlintide carries a boxed warning for severe low blood sugar with insulin; that is class information, not cagrilintide data.
Regulatory status
Not approved alone. It is also not approved as part of CagriSema, which Novo Nordisk filed with FDA in December 2025 (decision expected Q4 2026). It is in no approved drug, so it has no lawful compounding pathway. Not named on WADA's 2026 list, but as an unapproved substance it may fall under the S0 category.
Catalog notes
Available in 5 and 10 mg. No purity figure or certificate is published yet for either strength. Reference sources list C194H312N54O59S2 and 4409.07 g/mol for cagrilintide.