FDA decision watch · cagrilintide + semaglutide

Is CagriSema approved?

Not yet. The FDA has not decided on CagriSema, and Novo Nordisk expects a decision in Q4 2026.

CagriSema is Novo Nordisk’s once-weekly injection for weight management that combines cagrilintide, a long-acting amylin analog, with semaglutide, the GLP-1 drug in Ozempic and Wegovy. Novo filed for FDA approval on December 18, 2025.

The FDA has published no decision date. Novo said on Sep 30, 2026 that “a decision is expected in Q4 2026”. When we checked on October 16, 2026, CagriSema was not on the FDA’s list of 2026 novel drug approvals.

Checked Oct 16, 2026 (ET) · every claim links to its source below

Can you get it now?

  • CagrilintideRestrictedInvestigational only - no approved form exists anywhere; cannot be compounded; the CagriSema combination is under FDA review
  • Semaglutide (compounded)RestrictedEnforcement discretion ended; routine compounding no longer permitted. 503B exclusion proposed - comments closed Jul 30, 2026, decision pending

No legal route exists in the U.S. until the FDA approves it. Cagrilintide is not approved anywhere, the FDA says it cannot be used in compounding, and the FDA has sent warning letters to sellers offering it online as a “research” chemical. Semaglutide alone is an approved drug (Ozempic, Wegovy), but routine compounding of it is no longer allowed.

Cagrilintide, place by place

JurisdictionStatusNote
United States (FDA)RestrictedInvestigational; not approved, not compoundable (not a component of an approved drug, not an eligible bulk substance). The CagriSema NDA is under FDA review; warning letters to sellers, including products sold under coded names.
Australia (TGA)UnscheduledNot individually named or scheduled in the Poisons Standard.
United Kingdom (MHRA)RestrictedNo UK marketing authorisation; supply for human use treated as an unlicensed medicine.
European Union (EMA)RestrictedNo EU marketing authorisation; not on EMA’s August 2026 list of applications under CHMP evaluation; sale as a medicine unlawful EU-wide, with enforcement at member-state level.
Canada (Health Canada)Under reviewCagrilintide/semaglutide new drug submission (Novo Nordisk) accepted into Health Canada review in March 2026; no cagrilintide product yet authorized in the Drug Product Database.
Sport / anti-doping (WADA)RestrictedProhibited at all times, but not listed by name - captured by the S0 catch-all for substances with no regulatory approval for human use.

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

From the cagrilintide entry, last verified Oct 9, 2026 (ET). Canada is deciding separately.

What changes on decision day

  • If the FDA approves it, CagriSema becomes a U.S. prescription medicine. That covers Novo’s finished product only: gray-market “research” cagrilintide stays unapproved.
  • If the FDA declines, nothing becomes legal, and cagrilintide stays an investigational drug with no approved form anywhere.
  • Either way, this page and the cagrilintide entry are updated as soon as the decision is public, with the FDA’s or Novo’s announcement linked.

Timeline

  • Dec 18, 2025Novo Nordisk files the CagriSema new drug application with the FDA.
  • Sep 30, 2026Novo says a decision is expected in Q4 2026.
  • Q4 2026FDA decision expected; no date published.

Asked and answered

Is CagriSema FDA approved?
Not yet. The FDA has not decided on CagriSema, and Novo Nordisk expects a decision in Q4 2026. The FDA has published no decision date. Novo said on Sep 30, 2026 that “a decision is expected in Q4 2026”. When we checked on October 16, 2026, CagriSema was not on the FDA’s list of 2026 novel drug approvals.
When will the FDA decide on CagriSema?
Novo Nordisk expects a decision in Q4 2026. The FDA has not published an action date, so no exact day is known.
Can I buy CagriSema or cagrilintide online?
Not legally in the U.S. Cagrilintide is not approved anywhere and the FDA says it cannot be used in compounding. The FDA has sent warning letters to sellers offering cagrilintide online, including under coded product names and “research use” labels.
Is CagriSema the same as Wegovy?
No. Wegovy is semaglutide alone. CagriSema adds cagrilintide, an amylin analog, to semaglutide in one weekly injection.
Is cagrilintide legal in Canada, the UK or the EU?
Not as an authorized medicine. Health Canada has CagriSema under review; the UK and the EU have authorized no cagrilintide product. Each place is in the table on this page, from the cagrilintide entry.

Sources