What it is
Cagrilintide is a lab-made copy of amylin, a hormone the pancreas releases alongside insulin after meals. Amylin slows the stomach and signals fullness to the brain through a different route than GLP-1. Novo Nordisk engineered cagrilintide to last a week and to avoid clumping, a known problem with natural amylin.
On its own it produced slightly more weight loss than liraglutide in a mid-stage trial. Combined with semaglutide in one pen, called CagriSema, it produced about 20% weight loss in the main Phase 3 trial. Neither cagrilintide nor CagriSema is approved yet; CagriSema is under FDA review.
Cagrilintide (NNC0174-0833) is a 37-residue amylin analogue with substitutions at residues prone to β-sheet aggregation and a C20 fatty diacid attached through a linker for albumin binding. It is a dual amylin and calcitonin receptor agonist (DACRA), acting on calcitonin receptor and RAMP-associated amylin receptor complexes in the area postrema and hypothalamus. In a Phase 1b study its half-life was 159–195 hours, against 145–165 hours for co-administered semaglutide. The combination rationale is additive appetite suppression through non-overlapping central pathways, with the amylin component possibly offsetting some GLP-1 receptor agonist tolerance.
Who made it and when
Novo Nordisk developed it in the mid-2010s and published the chemistry in 2021. The company then ran it alone and with semaglutide. The Phase 3 program, REDEFINE, started in 2022 and reported its first results in December 2024. Novo Nordisk filed CagriSema with the FDA in December 2025, and a decision was expected in 2026.
Kruse and colleagues at Novo Nordisk described the medicinal chemistry in 2021. Phase 2 monotherapy (n=706) reported in 2021; Phase 2 CagriSema in T2D reported in 2023. The REDEFINE program includes REDEFINE 1 (obesity), REDEFINE 2 (obesity with T2D), REDEFINE 3 (cardiovascular outcomes, event-driven) and REDEFINE 4 (head-to-head vs tirzepatide). Novo Nordisk announced on 2025-12-18 that it had submitted a New Drug Application for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) for weight management in adults with obesity, or overweight with comorbidities. No FDA approval appears in Drugs@FDA as of September 2026. Patents are held by Novo Nordisk.
What the data say
Alone, the highest dose of cagrilintide produced about 11% weight loss in 26 weeks, slightly more than liraglutide. With semaglutide, the Phase 3 REDEFINE 1 trial showed about 20% loss over 68 weeks, compared with 15% for semaglutide alone and 3% for placebo; the figure was about 23% if everyone had stayed on treatment. Many participants did not stay on the full dose. In people with diabetes, CagriSema produced about 14% loss. In a direct comparison, it did not match tirzepatide.
Phase 2 monotherapy: 4.5 mg gave −10.8% at 26 weeks vs −3.0% placebo. REDEFINE 1 (n=3,417): CagriSema −20.4% vs semaglutide 2.4 mg −14.9%, cagrilintide 2.4 mg −11.5%, placebo −3.0% at 68 weeks (treatment-policy); −22.7% vs −2.3% by trial-product estimand. The flexible-dosing protocol meant only 57.3% of CagriSema participants were on the full 2.4/2.4 mg dose at the end of treatment. REDEFINE 2 (T2D, n=1,206): −13.7% vs −3.4%. REDEFINE 4 (n=809, open-label, 84 weeks) did not show non-inferiority to tirzepatide 15 mg (−23.0% vs −25.5% if all adhered). Gastrointestinal adverse events were the main tolerability issue, reported in 79.6% vs 39.9% on placebo in REDEFINE 1.
Regulatory picture
Cagrilintide has no approval anywhere. CagriSema, the combination with semaglutide, was submitted to the FDA in December 2025 and was still under review in September 2026. The FDA states that cagrilintide cannot legally be used in compounding in the United States and is not part of any FDA-approved drug. Anything sold online under this name is an unapproved drug.
Cagrilintide is investigational under IND. It is not a component of an approved product and has no USP monograph. FDA’s guidance page on unapproved GLP-1 drugs states that cagrilintide cannot be used in compounding under federal law, so neither the 503A nor the 503B pathway is available. The CagriSema NDA was submitted to the FDA in December 2025; Novo Nordisk guided to a US decision in 2026, and no approval is listed in Drugs@FDA as of September 2026. Any approval would cover the fixed-dose combination product, not cagrilintide as a stand-alone drug.
