What CagriSema is and who makes it
CagriSema is Novo Nordisk's once-weekly injection that combines two medicines: cagrilintide, an amylin analogue, and semaglutide, the GLP-1 medicine in Wegovy and Ozempic. Novo Nordisk says that, if approved, it would be the first injectable combination of a GLP-1 receptor agonist and an amylin analogue. It is being developed for weight management in adults with obesity, or with overweight and at least one weight-related condition.
Sources: Novo Nordisk: CagriSema US filing, 18 December 2025.
Trial stage and published results
The main phase 3 trial, REDEFINE 1, followed 3,417 adults with obesity or overweight for 68 weeks and was published in The New England Journal of Medicine in 2025. Novo Nordisk reports average weight loss of 20.4% with CagriSema against 3.0% with placebo, counting everyone who started treatment. These are trial averages, not a prediction for any one person.
Novo Nordisk says the most common side effects were digestive, including nausea, constipation and vomiting, and that 5.9% of people on CagriSema stopped because of side effects, against 3.5% on placebo.
Sources: NEJM: Garvey et al., Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (2025); Novo Nordisk: CagriSema US filing, 18 December 2025.
EU and Irish regulatory status
United States: Novo Nordisk submitted a New Drug Application to the US Food and Drug Administration on 18 December 2025 and said it expected the FDA to review it in 2026. We found no FDA decision when we checked on 28 October 2026.
European Union and Ireland: the EMA's list of new medicines under evaluation, with data extracted on 5 October 2026, has no entry for cagrilintide. Novo Nordisk's 2025 annual report describes the US filing and does not mention an EU one. Whether an EU application has been made since is UNKNOWN.
Sources: EMA: applications for new human medicines under evaluation, October 2026 list (data extracted 5 October 2026); Novo Nordisk Annual Report 2025: innovation and therapeutic focus.
When could it be available in Ireland?
A new weight-loss medicine like this reaches Irish prescribers through the European Medicines Agency. The EMA says its committee's scientific assessment takes up to 210 active days, not counting the pauses while the company answers questions, and the European Commission then decides within 67 days of the committee's opinion. A company launch and pharmacy stock in Ireland come after that.
Our estimate, not a company date: with no CagriSema application on the EMA's October 2026 list, availability through an Irish prescriber during 2027 looks unlikely. The real date is UNKNOWN, and a US approval would not change the EU timetable.
Sources: EMA: obtaining an EU marketing authorisation, step by step.
What about websites selling it now?
No authorised version of CagriSema exists, so a product sold online under this name is not an approved medicine and may contain anything. We do not list these sellers or their prices. Read the HPRA's warning about buying medicines online.
What people in Ireland can use now
Authorised GLP-1 medicines for weight management, such as Wegovy and Mounjaro, are prescription-only and are prescribed after a clinical assessment. Our guide to getting a GLP-1 prescription in Ireland explains the routes, and the eligibility check shows which ones may fit your BMI and health. Neither offers access to CagriSema.