CagriSema
Semaglutide + cagrilintide combination — NDA filed, FDA decision pending late 2026.
Last Verified: August 14, 2026
Tier 2 — Investigational / Not Currently Approved Late-Stage Investigational — Pending Decision
CagriSema is not FDA-approved, but it's closer to approval than most entries on this page: Novo Nordisk has already filed for approval and a decision is expected within 2026. This page describes the mechanism and trial data — not dosing or usage guidance, and not a recommendation to use it. Talk to a doctor before considering it.
What It Is
CagriSema is Novo Nordisk's combination of two peptides in one weekly injection: semaglutide (the GLP-1 receptor agonist behind Ozempic/Wegovy) and cagrilintide, an amylin receptor agonist. Amylin is a hormone co-released with insulin that also regulates appetite and gastric emptying through a separate pathway from GLP-1 — the combination is designed to produce a larger weight-loss effect than semaglutide alone by working through two complementary hormone systems at once.
What the Trials Actually Show
The Phase 3 REDEFINE 1 trial showed an average of about 22.7% body weight loss at 68 weeks among participants with obesity or overweight, with 91.9% of participants achieving at least 5% weight loss versus 31.5% on placebo. Novo Nordisk has publicly noted that in a head-to-head trial, CagriSema underperformed Eli Lilly's tirzepatide (Zepbound) on weight loss — a useful data point for calibrating expectations rather than treating it as automatically superior to existing approved options.
Clinical Trials Arena — Novo Nordisk's CagriSema Bested by Lilly's Zepbound in Head-to-Head Trial →
Current Regulatory Status — Pending Decision
Novo Nordisk submitted its New Drug Application to the FDA on December 18, 2025, for chronic weight management. As of this writing, no PDUFA date has been publicly confirmed, but company guidance points to an FDA decision in the fourth quarter of 2026, consistent with the standard review clock for a new molecular entity. CagriSema remains not FDA-approved and not available by prescription until that decision is made. This is the entry on this page most likely to change status soon — check back once a decision is announced, since approval, rejection, or a delay are all live possibilities.