InvestigationalCagrilintide is not FDA-approved.[1] The FDA states: "Retatrutide and cagrilintide cannot be used in compounding under federal law."[8] This page reports the trial record; it has no calculator, because no product is approved and none may be compounded.
What is the cagrilintide peptide?
Cagrilintide is "a long-acting amylin analogue", a modified version of the pancreatic hormone amylin, developed by Novo Nordisk to be injected once a week.[4]
- Structure
- A 37-amino-acid amylin analogue with a disulfide bond and a fatty-acid (C20 diacid) side chain that extends its action[15]
- Formula and weight
- C194H312N54O59S2, about 4,409 g/mol
- Peptide or protein?
- At 37 amino acids (our count from PubChem's structure) it is under the 40-amino-acid line that U.S. law uses for proteins.[16]
- CagriSema
- A fixed combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, once weekly[2]
CagriSema FDA status in November 2026
CagriSema has been under FDA review since December 2025, and no decision had been announced by November 12, 2026.[2][1]
- Filing. Novo Nordisk submitted CagriSema for weight reduction and long-term weight maintenance in adults with obesity, or overweight with at least one weight-related condition, on December 18, 2025.[2]
- Company outlook. In November 2026 Novo said it was "preparing for the US launch of CagriSema in early 2027, subject to regulatory approval".[3]
- Cagrilintide alone is not the product under review; it has no approval anywhere we found.
What the trials showed
Cagrilintide alone produced up to 10.8% weight loss in a phase 2 trial; combined with semaglutide it produced about 20% in phase 3.[4][5]
| Trial | People | Dose (weekly, under the skin) | Weight change | Stomach side effects |
|---|---|---|---|---|
| Phase 2, Lau 2021[4] | 706 on cagrilintide, 101 placebo; 26 weeks | Cagrilintide 0.3–4.5 mg | −6.0% to −10.8% vs −3.0% | 41–63% vs 32% |
| REDEFINE 1[5] | 3,417 without diabetes; 68 weeks | Cagrilintide 2.4 mg + semaglutide 2.4 mg | −20.4% vs −3.0% | 79.6% vs 39.9% |
| REDEFINE 2[6] | 1,206 with type 2 diabetes; 68 weeks | Same combination | −13.7% vs −3.4% | 72.5% vs 34.4% |
| REDEFINE 4[7] | 809; 84 weeks, vs tirzepatide 15 mg | Same combination | 20.2% vs 23.6% (treatment-regimen) | Mostly mild to moderate |
REDEFINE 4 did not show CagriSema to be non-inferior to tirzepatide.[7] In REDEFINE 1, 5.9% stopped treatment for side effects against 3.5% on placebo.[2] Trial doses were given with gradual increases under medical supervision; they are not instructions.
Compounding and "research" cagrilintide
Cagrilintide cannot legally be compounded, and the FDA has warned several sellers of research-labeled cagrilintide.[8]
| Date | Recipient | Product named |
|---|---|---|
| Dec 10, 2024[10] | Summit Research Peptides | Cagrilintide |
| Dec 10, 2024[11] | Xcel Research LLC | Cagrilintide, and a cagrilintide + semaglutide product |
| Dec 8, 2025[9] | Darmerica, LLC (API distributor) | Cagrilintide acetate, "ineligible" for 503A compounding |
| Mar 31, 2026[12] | Prime Sciences | Cagrilintide |
| Mar 31, 2026[13] | PekCura Labs | A cagrilintide + tirzepatide blend |
The FDA adds that cagrilintide is "not a component of an FDA-approved drug" and has "not been found safe and effective for any condition".[8] WADA 2026 does not name it; its S0 class covers substances "with no current approval by any governmental regulatory health authority for human therapeutic use".[14] For the rules in general, see are peptides legal? and are peptides safe?
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- MOTS-cNot approved 16-amino-acid mitochondrial peptide. No human trials of MOTS-c itself.
- SS-31 (elamipretide)FDA-approved Forzinity, approved 2025 for Barth syndrome. Ready-to-use; no mixing.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
- TB-500Not approved A 7-amino-acid fragment of thymosin beta-4. No human trials of TB-500 itself.
- BPC-157 + TB-500 blendNot approved Two peptides in one vial: the arithmetic of a fixed ratio.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
Frequently asked questions
Is cagrilintide FDA-approved?
What is CagriSema?
A once-weekly injection combining cagrilintide 2.4 mg and semaglutide 2.4 mg, developed by Novo Nordisk for weight management.[2]
How much weight did people lose on CagriSema?
Can cagrilintide be compounded?
No. The FDA states that cagrilintide "cannot be used in compounding under federal law".[8]
Sources
- openFDA Drugs@FDA searches for AOD-9604, KPV, epitalon, semax, selank, cagrilintide, melanotan and NAD (no application found)
- Novo Nordisk files for FDA approval of CagriSema
- Novo Nordisk financial report, January–September 2026 (Form 6-K)
- Lau DCW et al. Once-weekly cagrilintide for weight management: phase 2 dose-finding trial (Lancet 2021;398:2160–2172)
- Garvey WT et al. Cagrilintide–semaglutide in adults with overweight or obesity (REDEFINE 1) (NEJM 2025;393:635–647)
- Davies MJ et al. Cagrilintide–semaglutide in adults with obesity and type 2 diabetes (REDEFINE 2) (NEJM 2025;393:648–659)
- Novo Nordisk: REDEFINE 4 headline results, CagriSema vs tirzepatide (Form 6-K)
- FDA's concerns with unapproved GLP-1 drugs used for weight loss
- Warning letter: Darmerica, LLC (API distributor)
- Warning letter: Summit Research Peptides
- Warning letter: Xcel Research LLC
- Warning letter: Prime Sciences
- Warning letter: PekCura Labs
- World Anti-Doping Code: Prohibited List 2026
- PubChem CID 171397054: cagrilintide
- Final rule: Definition of the term "biological product" (85 FR 10057)