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

Class: peptide
Synonyms: cagrilintide
a long-acting amylin analog
a dual amylin and calcitonin receptor agonist (DACRA)
combined with semaglutide as CagriSema. Developer: Novo Nordisk. INCI: none
Function tags: metabolic
obesity / weight
amylin (investigational)
Overall evidence grade: B
WADA prohibited: no
Last updated: 2026-07-13

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).

## 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.

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

Legal status:
region: INT
status: See note
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.

Cosmetic claims:

Note: 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.
Status note: fast-moving — re-check the late-2026 FDA decision on CagriSema

Sources:
Lau DCW, Le Roux CW, et al. Cagrilintide, a long-acting amylin analogue: a Phase 2 randomised dose-finding study in obesity. Lancet. 2021.
Frias JP, et al. (Cagrilintide + semaglutide in type-2 diabetes — Phase 2.) Lancet. 2023.
Garvey WT, et al. (CagriSema — REDEFINE-1 Phase 3.) N Engl J Med. 2025.
Novo Nordisk — REDEFINE-1 topline (Dec 2024) and FDA NDA submission (Dec 2025).