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Novo Nordisk Seeks FDA Approval for CagriSema Weight Loss Shot

MarketDash Editorial Team
17 hours ago
Novo Nordisk has filed an FDA application for its weekly obesity treatment CagriSema, a combination therapy that delivered up to 22.7% weight loss in clinical trials and could hit the market in 2026.

Novo Nordisk A/S (NVO) just threw its hat into what's becoming a very crowded ring. The Danish pharmaceutical giant submitted a New Drug Application to the FDA on Thursday for CagriSema, its once-weekly obesity shot that combines two different weight loss mechanisms into a single injection.

Here's what makes CagriSema different: it's a fixed-dose combination pairing cagrilintide (a long-acting amylin analogue at 2.4 mg) with semaglutide (a GLP-1 receptor agonist, also at 2.4 mg). If the FDA gives it the green light, this would be the first injectable treatment combining these two drug classes. The application covers use alongside a reduced-calorie diet and increased physical activity for treating obesity or overweight patients with at least one weight-related health condition.

The numbers backing this application come from two phase 3 trials called REDEFINE 1 and REDEFINE 2. The 68-week REDEFINE 1 trial delivered some impressive results. Patients on CagriSema lost an average of 20.4% of their body weight, regardless of whether they stuck with treatment the entire time. Compare that to the placebo group's 3.0% weight loss, and you've got a meaningful difference.

When researchers looked at what would happen if everyone stayed on treatment (using statistical modeling), the results got even better. CagriSema showed 22.7% weight loss at 68 weeks versus just 2.3% for placebo. That's the kind of number that gets attention in the obesity treatment world.

The breadth of response was notable too. About 91.9% of CagriSema participants achieved at least 5% body weight reduction, compared to 31.5% in the placebo group. Even more striking, roughly half (54%) of trial participants on CagriSema crossed into non-obesity territory by week 68, versus only 11.1% taking placebo.

The FDA is expected to complete its review sometime in 2026, so don't expect pharmacy shelves to stock this anytime soon. Meanwhile, Novo Nordisk continues investigating CagriSema across two major programs: REDEFINE for obesity and overweight treatment, and REIMAGINE for type 2 diabetes management.

Novo Nordisk shares closed down 0.28% at $47.63 on Thursday.

Back to News

Novo Nordisk Seeks FDA Approval for CagriSema Weight Loss Shot

MarketDash Editorial Team
17 hours ago
Novo Nordisk has filed an FDA application for its weekly obesity treatment CagriSema, a combination therapy that delivered up to 22.7% weight loss in clinical trials and could hit the market in 2026.

Novo Nordisk A/S (NVO) just threw its hat into what's becoming a very crowded ring. The Danish pharmaceutical giant submitted a New Drug Application to the FDA on Thursday for CagriSema, its once-weekly obesity shot that combines two different weight loss mechanisms into a single injection.

Here's what makes CagriSema different: it's a fixed-dose combination pairing cagrilintide (a long-acting amylin analogue at 2.4 mg) with semaglutide (a GLP-1 receptor agonist, also at 2.4 mg). If the FDA gives it the green light, this would be the first injectable treatment combining these two drug classes. The application covers use alongside a reduced-calorie diet and increased physical activity for treating obesity or overweight patients with at least one weight-related health condition.

The numbers backing this application come from two phase 3 trials called REDEFINE 1 and REDEFINE 2. The 68-week REDEFINE 1 trial delivered some impressive results. Patients on CagriSema lost an average of 20.4% of their body weight, regardless of whether they stuck with treatment the entire time. Compare that to the placebo group's 3.0% weight loss, and you've got a meaningful difference.

When researchers looked at what would happen if everyone stayed on treatment (using statistical modeling), the results got even better. CagriSema showed 22.7% weight loss at 68 weeks versus just 2.3% for placebo. That's the kind of number that gets attention in the obesity treatment world.

The breadth of response was notable too. About 91.9% of CagriSema participants achieved at least 5% body weight reduction, compared to 31.5% in the placebo group. Even more striking, roughly half (54%) of trial participants on CagriSema crossed into non-obesity territory by week 68, versus only 11.1% taking placebo.

The FDA is expected to complete its review sometime in 2026, so don't expect pharmacy shelves to stock this anytime soon. Meanwhile, Novo Nordisk continues investigating CagriSema across two major programs: REDEFINE for obesity and overweight treatment, and REIMAGINE for type 2 diabetes management.

Novo Nordisk shares closed down 0.28% at $47.63 on Thursday.

    Novo Nordisk Seeks FDA Approval for CagriSema Weight Loss Shot - MarketDash News