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Research reference — not for sale

Cagrilintide

B
best evidence
Peptide
also called — cagrilintide · a long-acting amylin analog · a dual amylin and calcitonin receptor agonist (DACRA) · combined with semaglutide as CagriSema. Developer: Novo Nordisk. INCI: none
metabolicobesity / weightamylin (investigational)

Reference entry — NOT a sellable lane, NOT yet approved. Notable because it's not a GLP-1 at all — a different class (amylin) with a genuinely different mechanism. Investigational; its future rides on the CagriSema combination, filed with the FDA in Dec 2025. No dosing published here.

In brief

Cagrilintide is a long-acting amylin analog — a genuinely different mechanism from the GLP-1 drugs, acting on amylin/calcitonin receptors in the brainstem. Its future is tied to CagriSema (cagrilintide + semaglutide), the first GLP-1 + amylin combination, which produced ~20–23% weight loss in Phase 3 and was filed with the FDA in December 2025 (decision expected late 2026). The data are strong — but it is not yet approved anywhere, and it already faces a successor in Novo's own pipeline (amycretin).

Legal standing, by region
International
See note

- Everywhere — investigational, not approved. Cagrilintide is not available by prescription or through compounding pharmacies outside clinical trials. CagriSema is under FDA review (filed Dec 2025; decision expected late 2026). - Gray market: "research" cagrilintide is sold online but is unapproved and unregulated — unknown purity/dose. - This venture: not a sellable lane — an investigational drug

Evidence, by outcome

An honest grade per outcome — drawn from the evidence, not any catalogue. Hype and undemonstrated marketing claims grade low.

OutcomeEvidence base · effectGrade
Weight loss — CagriSema (combination)
Strong Phase 3 and FDA-filed, but not yet approved; the result disappointed inflated expectations
Phase 3 REDEFINE-1/-2 (~20–23%); NDA filed Dec 2025 · Substantial (tirzepatide-comparable)
B
Weight loss — cagrilintide monotherapy
Not being filed standalone; lower nausea than GLP-1
Phase 2 (Lancet 2021, ~10.8%) + REDEFINE arm (~11.8%) · Meaningful; comparable to semaglutide alone
B
Amylin / satiety mechanism
Mechanistically distinct from GLP-1
Established amylin biology · Real, complementary pathway
Safety
Combination GI effects are additive; serious events (pancreatitis, gallbladder) similar to semaglutide; investigational
REDEFINE programme · Class-similar; monotherapy has less nausea

Identity a long-acting synthetic analog of amylin — a peptide hormone co-secreted with insulin by pancreatic beta cells that signals fullness. Cagrilintide is engineered with a fatty-acid chain for once-weekly dosing, and it acts on amylin receptors (AMY1/2/3R) and the calcitonin receptor in the area postrema — a brainstem region that sits outside the blood-brain barrier. Critically, it is not a GLP-1 agonist — it's a separate satiety pathway. ## Mechanism (as proposed) a dual amylin + calcitonin receptor agonist acting on the area postrema (brainstem, outside the blood-brain barrier) → promotes satiety, slows gastric emptying, and suppresses glucagon. Because this is a different brain target from GLP-1's hypothalamic action, the two combine additively in CagriSema.

Sources — 4 cited
01Lau DCW, Le Roux CW, et al. Cagrilintide, a long-acting amylin analogue: a Phase 2 randomised dose-finding study in obesity. Lancet. 2021.
02Frias JP, et al. (Cagrilintide + semaglutide in type-2 diabetes — Phase 2.) Lancet. 2023.
03Garvey WT, et al. (CagriSema — REDEFINE-1 Phase 3.) N Engl J Med. 2025.
04Novo Nordisk — REDEFINE-1 topline (Dec 2024) and FDA NDA submission (Dec 2025).
Review status
Not yet reviewed

A credentialed reviewer (PharmD / PhD / MD) will be named before this entry is finalised. Until then, treat it as a working draft. Last updated July 2026 (fast-moving — re-check the late-2026 FDA decision on CagriSema).

Grades reflect the published evidence, not our interest. No dosing, reconstitution, or administration is published for research compounds — that restraint is deliberate.

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Cagrilintide (& CagriSema) — evidence, the amylin story & status · Vallydia