Overview
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In plain language
Cagrilintide is an experimental long-acting weight-loss injection related to the hormone amylin. It is not approved by the FDA and cannot legally be compounded by U.S. pharmacies.
It is being developed only as part of a two-drug combination called CagriSema, which pairs it with the GLP-1 medicine semaglutide. In large trials the combination produced about 22.7% average weight loss over 68 weeks, more than semaglutide alone but less than was hoped. The FDA is expected to decide on the combination in late 2026.
For students
Cagrilintide is a 38-residue amylin analogue with a C18 fatty diacid side chain, achieving a half-life suitable for once-weekly dosing through reversible albumin binding. It activates amylin (calcitonin receptor-family) receptors, producing satiety, slowed gastric emptying, and reduced glucagon, complementing GLP-1 receptor agonism with minimal overlapping nausea biology.
As CagriSema (fixed combination with semaglutide), the REDEFINE 1 trial reported 22.7% mean weight loss at 68 weeks versus about 15% for semaglutide alone, and REDEFINE 2 showed 15.7% in diabetes. However, a 2025 head-to-head (ATTAIN-1) showed tirzepatide superior (about 20% versus 15% weight loss), and CagriSema missed its 25% benchmark. Novo Nordisk filed in December 2025 with a U.S. decision expected in Q4 2026; the FDA has separately stated cagrilintide is not eligible for compounding under the current rules.
For researchers and instructors
Biochemistry. Combines an amylin-superfamily pharmacophore with acylation-based half-life extension, exploiting that amylin and GLP-1 produce complementary satiety signals with partially distinct receptor biology.
Pharmacology. Weekly dosing, dose-escalation over 8-16 weeks; combination fixed-ratio dosing with semaglutide 2.4 mg; principal adverse events are GI, consistent with both components.
Human evidence. REDEFINE 1 (n=3,417) and REDEFINE 2 (n=1,606) are peer-reviewed in NEJM; ATTAIN-1 head-to-head versus tirzepatide is published; regulatory file under active FDA review as of November 2026.
Open questions. Whether amylin agonism adds durable benefits beyond GLP-1-based therapy, real-world effectiveness, and muscle-mass outcomes.
Molecular identity
- Amino acids
- 38-residue amylin analogue
- Molecular weight
- ~4,409 Da
- Formula
- C₁₉₄H₃₁₂N₅₄O₅₉S₂
- Sequence
- Long-acting amylin analogue with a C18 fatty diacid
Origin and history
Cagrilintide is Novo Nordisk's long-acting analogue of amylin, with a fatty side chain for weekly dosing. It is being developed only in fixed combination with semaglutide, as CagriSema. In the REDEFINE 1 trial the combination produced about 22.7% average weight loss over 68 weeks, more than semaglutide alone, though a head-to-head trial against tirzepatide favored tirzepatide.
Novo Nordisk filed for U.S. approval in December 2025; a decision is expected by late 2026. As of November 2026 it is not approved anywhere.
Key people
- Novo Nordisk research teamDeveloped cagrilintide
Timeline
- 2023
REDEFINE 1 results reported
- 2025
CagriSema filed with the FDA
- 2026
FDA decision expected
See every peptide on one history timeline.
Human evidence
Phase 3 trials (REDEFINE program) are published in peer-reviewed journals, but the drug remains investigational.
Registration and enrollment are not proof of benefit; check study results directly.
Explore original publications and distinguish preclinical findings from controlled human evidence.
Safety and regulatory status
See every compound on the regulatory tracker.
Investigational; not FDA-approved. FDA states cagrilintide cannot be used in compounding.
This profile is educational and does not provide treatment, dosing or sourcing guidance.
Sources
- PubMed literature search: Cagrilintide
- PubChem compound search: Cagrilintide
- DailyMed (FDA label search): Cagrilintide
- UniProt search: Cagrilintide
- ClinicalTrials.gov search: Cagrilintide
Hernandez Gener, E. (November 8, 2026). Cagrilintide: molecular data, research history and evidence. VALREXA Biosciences. https://valrexa.com/peptides/cagrilintide.html
APA style · Last reviewed November 8, 2026 · Our editorial standardsLast reviewed November 8, 2026. Trial and regulatory status can change; confirm in the linked registries. This profile is educational and is not medical advice, a treatment recommendation, or dosing or sourcing guidance. Report an error · Corrections policy