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Novo Nordisk Files FDA Application for Weekly CagriSema Obesity Shot as GLP-1 Competition Intensifies

The filing positions a potential 2026 FDA review for what could be the first fixed‑dose GLP‑1 and amylin combination therapy.

Overview

  • CagriSema combines semaglutide 2.4 mg with the amylin analogue cagrilintide 2.4 mg and, if approved, would be the first injectable pairing of these mechanisms.
  • The application cites phase 3 REDEFINE data showing 20.4% average weight loss at 68 weeks versus 3.0% with placebo, with 22.7% on an on‑treatment analysis.
  • Additional trial readouts reported that 91.9% of participants on CagriSema lost at least 5% of body weight and 54% reached a non‑obesity threshold by week 68.
  • Eli Lilly said it has filed for FDA approval of orforglipron, a daily oral GLP‑1 that maintained prior weight loss after Wegovy or Zepbound, and reported 28.7% loss at 68 weeks with its triple‑agonist retatrutide.
  • Pfizer moved to enter the category with a YaoPharma deal for an oral GLP‑1 (YP05002) and plans to acquire Metsera, as a Harvard analysis reported little or no effect of GLP‑1s on risks of several obesity‑related cancers.