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Cagrilintide / CagriSema

Written by The Peptide Record editorialClinical review not yet completedLast reviewed 1 October 2026Funding No vendor payment

Not FDA-approved on its own or as the CagriSema combination. Real, large, peer-reviewed Phase 3 data exists for both, Novo Nordisk reports it has filed an FDA application for CagriSema, and no FDA decision has been announced as of 1 October 2026.

Evidence grade B: what kinds of studies support the claims on this page, with limits. It is not a verdict on any product. How we grade

On this page

  1. What it is
  2. The trial evidence
  3. Regulatory status
  4. What's not yet resolved

In brief

Should you care? Yes if you're weighing it against tirzepatide or semaglutide — real Phase 3 data exists, but so does a real reported head-to-head result worth knowing before assuming it's simply "better."

The short version

  • Cagrilintide is a long-acting amylin analog; "CagriSema" pairs it with semaglutide in one injection.
  • Real Phase 3 data exists for both cagrilintide alone and the CagriSema combination.
  • Not yet approved — Novo Nordisk reports it filed an FDA application in December 2025, and no FDA decision has been announced as of 1 October 2026.

Correction, 1 October 2026

This page previously said CagriSema’s application was “under FDA review,” that an FDA decision “could land at any time,” and that a head-to-head result against tirzepatide could only be confirmed through secondary industry coverage. FDA’s own pages do not describe the application, so the page now says what the sources support: Novo Nordisk reports it filed an application, FDA has not approved CagriSema, and no FDA decision has been announced as of 1 October 2026. The head-to-head result is now sourced to Novo’s own February 2026 report. The Library card and the legal-status tracker row were corrected to match. No evidence grade changed.

What it is

Cagrilintide is a long-acting amylin receptor agonist from Novo Nordisk. "CagriSema" is the fixed-dose combination of cagrilintide (2.4mg) and semaglutide (2.4mg) in a single injection, positioned as a follow-on to Wegovy with an added appetite-signaling mechanism.

The trial evidence

REDEFINE-1, the peer-reviewed Phase 3 trial in adults with obesity or overweight without diabetes (Davies et al., N Engl J Med 2025, DOI 10.1056/NEJMoa2502081), enrolled roughly 3,400 participants over 68 weeks: CagriSema produced a mean −20.4% body-weight change versus −3.0% on placebo, with about 60% of participants reaching at least 20% weight loss. REDEFINE-2, in adults with type 2 diabetes (Davies, Bajaj, Broholm, Eliasen, Garvey, le Roux, Lingvay, Lyndgaard, Rosenstock, Pedersen, N Engl J Med 2025;393:648-659, DOI 10.1056/NEJMoa2502082, PMID 40544432), reported −13.7% versus −3.4% on placebo. Cagrilintide alone, at 2.4mg, also showed independently meaningful weight loss within the same program — smaller than the combination, but a real result for an amylin analog used on its own.

Regulatory status

Novo Nordisk announced on 18 December 2025 that it had submitted a New Drug Application to FDA for CagriSema. FDA has not approved it: FDA’s 2026 novel-approvals list (current as of 28 September 2026) does not list CagriSema or cagrilintide, and Novo has announced no FDA decision.35 FDA also states that cagrilintide cannot be used in compounding under federal law and is not a component of an FDA-approved drug.6 For how an application is reviewed, see CagriSema: what a filed FDA application means.

What's not yet resolved

Head-to-head results against tirzepatide are mixed and company-reported. In a February 2026 report Novo said REDEFINE 4, an open-label 84-week trial, did not meet its primary non-inferiority endpoint against tirzepatide 15 mg (23.0% against 25.5% on the efficacy estimand).4 A September 2026 announcement reports REIMAGINE 5, a type 2 diabetes trial at lower doses, in which CagriSema 1.0 mg/1.0 mg produced more weight loss than tirzepatide 5 mg (12.4% against 9.1%).7 Both are company headline results, not peer-reviewed papers, and they used different doses and populations. Details are on the CagriSema application page.

What you can do next

References

  1. Davies et al., "CagriSema in Adults with Overweight or Obesity," N Engl J Med 2025, DOI 10.1056/NEJMoa2502081 (REDEFINE-1).
  2. Davies, Bajaj, Broholm, Eliasen, Garvey, le Roux, Lingvay, Lyndgaard, Rosenstock, Pedersen, "Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes," N Engl J Med 2025;393:648-659, DOI 10.1056/NEJMoa2502082, PMID 40544432 (REDEFINE-2).
  3. Novo Nordisk, company announcement, 18 December 2025, CagriSema application submitted to FDA — company-reported. novonordisk.com
  4. Novo Nordisk, Form 6-K, 23 February 2026 (REDEFINE 4 headline results) — company-reported. sec.gov
  5. U.S. Food and Drug Administration, “Novel Drug Approvals for 2026,” page current as of 28 September 2026. fda.gov
  6. U.S. Food and Drug Administration, “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss,” page current as of 1 October 2026. fda.gov
  7. Novo Nordisk, company announcement, 21 September 2026, REIMAGINE 5 topline results — company-reported. globenewswire.com