Cagrilintide

Cagrilintide is an investigational long-acting amylin receptor agonist developed by Novo Nordisk, primarily studied in combination with semaglutide as the fixed-dose investigational therapy CagriSema. Cagrilintide is not approved for any indication anywhere as of August 2026, and is sold as a research-use-only compound by third-party laboratories. The CagriSema combination is in Phase 3 (REDEFINE program) for obesity and Phase 3 (REIMAGINE) for type 2 diabetes.

What is cagrilintide and how does the amylin receptor mechanism work?

Cagrilintide is a long-acting analog of human amylin, the pancreatic hormone co-secreted with insulin that signals satiety, slows gastric emptying, and suppresses postprandial glucagon. Native amylin has a 13-minute half-life; cagrilintide's modifications extend that to approximately 7 days for once-weekly subcutaneous dosing. The compound activates calcitonin and amylin receptors, producing complementary appetite-suppression effects when paired with GLP-1 agonism.

Evidence level: human RCT (Phase 2 and Phase 3 monotherapy data; Phase 3 combination)

What does the clinical evidence show for cagrilintide and CagriSema?

In the Phase 2 dose-finding monotherapy trial (Lau et al., The Lancet, 2021; n=706), cagrilintide produced approximately 10.8% weight loss at the 4.5 mg weekly dose over 26 weeks, versus 9.0% with liraglutide 3.0 mg daily and 3.0% with placebo. The Phase 3 REDEFINE 1 trial of CagriSema (cagrilintide + semaglutide; n=3,417) reported 20.4% average weight loss at 68 weeks on the published primary (treatment-policy) estimand — 22.7% on the trial-product estimand — versus 11.5% for cagrilintide 2.4 mg alone and 14.9% for semaglutide 2.4 mg alone. in adults with obesity, slightly below the original "30%-plus" market expectations but still exceeding semaglutide monotherapy. Novo Nordisk filed the CagriSema NDA with the FDA on December 18, 2025; the application is under review — not approved — as of August 2026. Cagrilintide also now has a standalone path: after the REDEFINE 1 monotherapy-arm data were presented in September 2025, Novo Nordisk moved cagrilintide into its own dedicated Phase 3 programme, RENEW, in people with obesity or overweight.

Sources: Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial, Lau D.C.W. et al. (optional, non-blocking: complete list), Lancet, 2021; Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity, Garvey W.T. et al., N Engl J Med, 2025; CagriSema — NDA filed with FDA 18 Dec 2025; not approved (status tracker), Drugs.com (Judith Stewart, BPharm) / Novo Nordisk announcement, via Drugs.com NDA + history pages; Novo Nordisk presents phase 3 data for next-generation amylin cagrilintide, leading to advancement into dedicated clinical programme (RENEW), Novo Nordisk, via GlobeNewswire (company release; fetched via BioSpace copy) · Evidence level: human RCT (Phase 2 and Phase 3 monotherapy data; Phase 3 combination)

How does cagrilintide compare to other weight-loss peptides?

Cagrilintide alone produces modest weight loss similar to semaglutide; the strategic value is in combination — CagriSema's 20.4% result outperforms semaglutide monotherapy and is competitive with tirzepatide. Unlike retatrutide, cagrilintide does not engage glucagon or GIP receptors; the amylin mechanism is genuinely additive rather than overlapping.

Within its own class, cagrilintide sits between two reference points: pramlintide (Symlin) — the only FDA-approved amylin-analog drug, a short-acting mealtime adjunct for insulin-treated diabetes rather than a weight-loss therapy — and petrelintide (Zealand Pharma/Roche), a rival long-acting amylin analog that its sponsors announced in April 2026 they are advancing into Phase 3 for chronic weight management.

Sources: SYMLIN (pramlintide acetate) injection — US Prescribing Information, AstraZeneca Pharmaceuticals LP (labeler), via DailyMed; Zealand Pharma and Roche to advance petrelintide, an amylin analog, to Phase 3 trials for chronic weight management, Zealand Pharma / Roche, via GlobeNewswire (company release; fetched via BioSpace syndication)

What are the documented side effects of cagrilintide?

The most common cagrilintide side effects in Phase 2 monotherapy and Phase 3 combination trials were gastrointestinal — nausea, vomiting, constipation — generally mild and concentrated in the dose-escalation phase, with profile broadly similar to GLP-1 monotherapy. Injection-site reactions occurred more frequently with cagrilintide than with semaglutide alone. The CagriSema combination's tolerability profile in REDEFINE-1 was acceptable but did not show the expected step-change improvement over semaglutide monotherapy.

Evidence level: human RCT (Phase 2 and Phase 3)

What is the regulatory status of cagrilintide?

Cagrilintide is not approved for any indication anywhere as of August 2026 — neither on its own nor in combination. The combination is furthest along: Novo Nordisk filed the CagriSema NDA on December 18, 2025, and the FDA is expected to review the application in 2026; no PDUFA date has been publicly confirmed. The REIMAGINE 2 type 2 diabetes trial has since been published in The Lancet Diabetes & Endocrinology. For cagrilintide by itself, Novo Nordisk announced in September 2025 that it would advance the compound into the dedicated Phase 3 RENEW programme for obesity and overweight — any standalone approval sits years behind the combination. Research-grade cagrilintide sold by third-party vendors is not part of any of these programmes. Current regulatory context is in our FDA peptide regulation 2025–2026 timeline.

Sources: CagriSema — NDA filed with FDA 18 Dec 2025; not approved (status tracker), Drugs.com (Judith Stewart, BPharm) / Novo Nordisk announcement, via Drugs.com NDA + history pages; Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2), Buse J.B. et al., Lancet Diabetes Endocrinol, 2026; Novo Nordisk presents phase 3 data for next-generation amylin cagrilintide, leading to advancement into dedicated clinical programme (RENEW), Novo Nordisk, via GlobeNewswire (company release; fetched via BioSpace copy)

Why does cagrilintide vendor verification require special attention?

The manufacturing base for cagrilintide is narrow — fewer laboratories produce it at scale than semaglutide or tirzepatide — which creates wider purity variance and higher risk of inconsistent batches. Independent HPLC purity testing and mass spectrometry identity confirmation are the only meaningful purity signals a research-grade vendor can provide. Buyers should also verify whether they're purchasing cagrilintide alone or a pre-combined CagriSema research blend; these are not interchangeable. Learn how to interpret COAs in our how-to-test-peptides hub.

How does Peptigrity verify cagrilintide vendors?

Peptigrity collects independent third-party Certificates of Analysis for cagrilintide from shops' official channels and verifies each for authenticity before publishing. Because shops choose which COAs to publish, results reflect the batches shops have made public rather than every production batch — a selection bias we state openly. A community-funded Testing Grant to purchase and test vials anonymously is in development. The lab test table above this section shows the cross-shop dataset. Tests come from labs including Freedom Diagnostics, Janoshik Analytical, and Chromate. Methodology in how we calculate trust scores.

Frequently asked questions

How can I verify a cagrilintide vendor is selling real product?

The only reliable purity signal is an independent third-party HPLC certificate of analysis from a lab the vendor does not own or pay. Peptigrity publishes independent cagrilintide test results from independent labs in the table above. Compare vendors against the independent cagrilintide lab tests on file. For COA interpretation, see red flags in peptide certificates of analysis.

Is cagrilintide legal to purchase?

Cagrilintide is legal to purchase as a research chemical for laboratory use in most jurisdictions, but it is not approved for human consumption. Buyers are responsible for verifying local import rules — full country breakdown in our peptide legal status guide.

When will cagrilintide or CagriSema be FDA-approved?

Neither is approved as of August 2026, but the timeline is no longer hypothetical: Novo Nordisk filed the CagriSema NDA on December 18, 2025, and the FDA is expected to review the application in 2026 — no PDUFA date has been publicly confirmed. Standalone cagrilintide is earlier in development: the dedicated Phase 3 RENEW monotherapy programme was announced in September 2025, so any approval of cagrilintide by itself would come years later. Track regulatory developments in FDA peptide regulation 2025–2026 timeline.

Sources: CagriSema — NDA filed with FDA 18 Dec 2025; not approved (status tracker), Drugs.com (Judith Stewart, BPharm) / Novo Nordisk announcement, via Drugs.com NDA + history pages; Novo Nordisk presents phase 3 data for next-generation amylin cagrilintide, leading to advancement into dedicated clinical programme (RENEW), Novo Nordisk, via GlobeNewswire (company release; fetched via BioSpace copy)

What's the difference between cagrilintide and CagriSema?

Cagrilintide is the amylin receptor agonist on its own; CagriSema is the fixed-dose combination of cagrilintide plus semaglutide in a single weekly injection. Cagrilintide monotherapy produces moderate weight loss (11.5% at 68 weeks in REDEFINE 1's monotherapy arm on the primary estimand; 10.8% at 26 weeks in Phase 2); CagriSema produces larger weight loss (20.4% on the published primary estimand). For the mechanism deep-dive, see the cagrilintide amylin science guide. because the amylin and GLP-1 mechanisms are additive.

Source: Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity, Garvey W.T. et al., N Engl J Med, 2025

Does Peptigrity recommend a cagrilintide dose?

No. Cagrilintide is not approved for human consumption and Peptigrity is an independent review platform, not a medical authority. The doses studied in Phase 2 monotherapy (0.3 mg through 4.5 mg weekly) and Phase 3 CagriSema combination were administered under clinical supervision. Anyone considering investigational compound use should consult a licensed physician.

How does cagrilintide compare to tirzepatide for weight loss?

Tirzepatide monotherapy outperforms cagrilintide monotherapy; CagriSema (cagrilintide + semaglutide) lands close to tirzepatide on weight loss but has not been compared head-to-head in Phase 3. SURMOUNT-1 reported 22.5% for tirzepatide; REDEFINE-1 reported 20.4% for CagriSema. Cross-compound comparison context in comparing semaglutide and tirzepatide.

This section is for educational and informational purposes only and does not constitute medical advice. Cagrilintide is an investigational compound not approved by the FDA or any other regulator for human use. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.