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CagriSema: what a filed FDA application means

Written by The Peptide Record editorialClinical review not yet completedLast reviewed 1 October 2026Funding No ads, no affiliate links, no vendor payment

Novo Nordisk reports it has filed an FDA application for CagriSema. FDA has not approved it, and no FDA decision has been announced as of 1 October 2026. A filed application is not an approval, and no online or compounded product is an approved CagriSema.

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. The short answer
  2. What has been filed
  3. How an FDA application is reviewed
  4. What the application rests on, and a head-to-head result
  5. What cagrilintide is today
  6. How to read news about it
  7. As of this review

In brief

Should you care? Yes, if you have seen CagriSema mentioned as “coming soon” or offered by a seller. A filed application is not an approval, and no FDA decision has been announced.

The short version

  • Filed, not approved: Novo Nordisk announced its FDA application on 18 December 2025 and said CagriSema is not approved in the US or EU.1
  • Review takes months: FDA describes 6 to 10 months to decide on an application its team has found complete.2
  • Large trials, run by the manufacturer: in REDEFINE 1 average weight change was -20.4% with CagriSema against -3.0% with placebo at 68 weeks.3 Head-to-head results against tirzepatide are mixed and company-reported.910
  • Cagrilintide cannot be compounded: FDA says so under federal law.5

The short answer

CagriSema is a once-weekly injection that combines two ingredients: cagrilintide, a long-acting analogue of the hormone amylin, and semaglutide, the GLP-1 medicine in Ozempic and Wegovy. Its developer, Novo Nordisk, reports it has asked FDA to approve it for weight management in adults. Until FDA acts, it is an investigational product, not an approved medicine. For the ingredients and trial data in more depth, see cagrilintide and CagriSema and semaglutide.

What has been filed

On 18 December 2025 Novo Nordisk announced it had submitted a New Drug Application (NDA) to FDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection, to be used with a reduced-calorie diet and increased physical activity in adults with obesity, or with overweight and at least one weight-related condition. The announcement says CagriSema is “not approved in the US or EU” and that the FDA “is expected to review the CagriSema application in 2026.”1 This is the company’s own statement; its February 2026 report says an FDA decision is anticipated by late 2026.9 As of this review, FDA’s novel-approvals list (see below) does not list CagriSema or cagrilintide, and Novo has announced no FDA decision.

How an FDA application is reviewed

The FDA review path for a new drug, as FDA describes it
StageWhat happens
The applicationAn NDA is meant to tell the “full story” of a drug: preclinical data, trial data, proposed labeling, manufacturing information and more. It is how a developer formally asks FDA to approve a drug for sale.24
Completeness checkFDA’s review team decides whether the application is complete. If it is not, FDA can refuse to file it.2
Full reviewIf complete, the team has 6 to 10 months to decide. Each discipline reviews its own section, such as clinical data, statistics and animal studies, and inspectors check clinical study sites.2 FDA’s goal is 6 months for a Priority Review designation and 10 months under standard review.6
Outside adviceFDA may convene an advisory committee when questions need additional consideration.2
DecisionIf FDA finds the drug safe and effective for its intended use, it works with the applicant on the labeling. Often remaining issues must be resolved first, and FDA may ask questions about existing data or require additional studies.2

On FDA’s description, the 6 to 10 months applies to an application the review team has found complete, so it is not a countdown from the day a company announces a submission. FDA’s pages do not give a decision date for any individual application, and this page does not predict one.

What the application rests on, and a head-to-head result

Novo Nordisk says the application rests on two phase 3 trials, REDEFINE 1 and REDEFINE 2, both published in the New England Journal of Medicine in 2025 and both funded by Novo Nordisk.137

REDEFINE 1 and REDEFINE 2 at week 68
REDEFINE 1REDEFINE 2
Who3,417 adults with obesity, or overweight plus a related condition, without diabetes1,206 adults with type 2 diabetes and a body mass index of 27 or more
Average weight change, CagriSema-20.4% (placebo -3.0%)3-13.7% (placebo -3.4%)7
Gastrointestinal side effects, CagriSema79.6% (placebo 39.9%)372.5% (placebo 34.4%)7

Both figures count everyone assigned to treatment, whether or not they stayed on it. The company’s announcement also reports a larger number, 22.7% weight loss in REDEFINE 1, for an idealized case in which all patients stayed on treatment; that is a different, more favorable way of counting.1 Trial results are the evidence FDA will weigh. They are not FDA’s own findings.

The application is not based on every CagriSema trial. In February 2026 Novo reported headline results from REDEFINE 4, an open-label, 84-week phase 3 trial of 809 adults comparing CagriSema with tirzepatide 15 mg, both given weekly. CagriSema did not meet the primary endpoint of non-inferiority on weight loss: 23.0% against 25.5% if everyone adhered to treatment, and 20.2% against 23.6% when counting regardless of adherence.9 These are the company’s headline figures, not a peer-reviewed publication, and Novo’s announcement says the application rests on REDEFINE 1 and 2.1

On 21 September 2026 Novo reported topline results from REIMAGINE 5, a phase 3 trial in adults with inadequately controlled type 2 diabetes that compared a lower-dose CagriSema (1.0 mg/1.0 mg) with a lower dose of tirzepatide (5 mg) over 60 weeks. On the efficacy estimand, estimated weight loss was 12.4% with CagriSema and 9.1% with tirzepatide, which Novo describes as superior, and the reduction in HbA1c (a blood-sugar measure) was 1.71% against 1.67%, which Novo describes as non-inferior.10 This trial used different doses and a different population from REDEFINE 4, and it is also company-reported and not peer reviewed, so the two results should not be added together or averaged.

What cagrilintide is today

FDA states that cagrilintide cannot be used in compounding under federal law, and that it is not a component of an FDA-approved drug and has not been found safe and effective for any condition.5 So, as of this review, no pharmacy-prepared or online product can be an approved or lawful version of CagriSema or of cagrilintide on its own. See what “Research Use Only” actually means and are peptides legal.

How to read news about it

  • “Filed” is not “approved.” The company’s own announcement uses “investigational” and “not approved.”1
  • Check FDA’s own list. FDA publishes Novel Drug Approvals by year. The 2026 list, current as of 28 September 2026, does not include CagriSema or cagrilintide.8
  • Expect the label to matter. If approved, the label sets the approved use, the people it covers and the warnings. This page will not guess at them.
  • Treat “available now” as a warning sign. A product offered today under this name is not an FDA-approved CagriSema.

As of this review

As of 1 October 2026

This page follows Novo Nordisk’s 18 December 2025 announcement, its 23 February 2026 report and its 21 September 2026 announcement, the two REDEFINE publications, FDA’s review-process pages, FDA’s GLP-1 page (current as of 1 October 2026) and FDA’s 2026 Novel Drug Approvals list (current as of 28 September 2026). No FDA decision has been announced as of that date. We will revise and date this page when FDA acts, and if a reader shows us an error (use the “Report an error” topic on About).

What you can do next

References

  1. Novo Nordisk, company announcement, “Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management,” 18 December 2025. novonordisk.com
  2. U.S. Food and Drug Administration, “Step 4: FDA Drug Review,” page current as of 4 January 2018. fda.gov
  3. Garvey WT, Blüher M, Osorto Contreras CK, et al. “Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity” (REDEFINE 1). N Engl J Med 2025;393(7):635-647. DOI 10.1056/NEJMoa2502081. Abstract read in the PubMed record. PubMed
  4. U.S. Food and Drug Administration, “New Drug Application (NDA),” page current as of 21 January 2022. fda.gov
  5. 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
  6. U.S. Food and Drug Administration, “Priority Review,” page current as of 4 January 2018. fda.gov
  7. Davies MJ, Bajaj HS, Broholm C, et al. “Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes” (REDEFINE 2). N Engl J Med 2025;393(7):648-659. DOI 10.1056/NEJMoa2502082. Abstract read in the PubMed record. PubMed
  8. U.S. Food and Drug Administration, “Novel Drug Approvals for 2026,” page current as of 28 September 2026. fda.gov
  9. Novo Nordisk, Form 6-K filed with the U.S. Securities and Exchange Commission, 23 February 2026, “CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved” (company-reported headline results). sec.gov
  10. Novo Nordisk, company announcement, “Novo’s CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trial,” 21 September 2026 (company-reported topline results, efficacy estimand). globenewswire.com