Cagrilintide + Semaglutide

Approval status

CagriSema is not approved anywhere. Novo Nordisk submitted it to the FDA for weight management in December 2025 and expects a decision in late 2026; it was not on FDA's list of 2026 new drug approvals as of 20 October 2026. Semaglutide alone is approved; cagrilintide is not.⁶⁷⁸⁹¹⁰

What it’s used or studied for

• Human studies

  Weight loss in adults with overweight or obesity without diabetes, much greater than with placebo (REDEFINE 1 trial).¹

• Human studies

  Weight loss and better blood sugar in adults with overweight or obesity and type 2 diabetes (REDEFINE 2 trial).²

• Human studies

  Blood sugar control in type 2 diabetes treated with diet and exercise alone, tablets or basal insulin (REIMAGINE 1 to 3); it lowered HbA1c slightly more than semaglutide alone.³⁴⁵

• Human studies

  Compared head to head with tirzepatide for weight loss (REDEFINE 4); it did not show that it was at least as effective.⁶

Each label shows how strong the evidence is: an approved use, human studies, animal or lab studies only, or a popular claim with no published studies. Being studied is not the same as being proven safe or effective.

Side effects

These come from trials of Novo Nordisk's product. Stomach and bowel effects were the most common, mostly mild to moderate and temporary, and the safety profile matched the GLP-1 drug class. The semaglutide part carries FDA warnings, including a boxed warning about thyroid tumors; see its page.¹²³¹²

A blend carries the side effects and cautions of each of its parts.

Cautions

• Mixed vials are not an approved product. FDA has warned companies that sell semaglutide labeled "for research purposes" and urges people not to buy these products.⁷¹¹
• Semaglutide is not for people with a personal or family history of medullary thyroid cancer or MEN 2.¹²
• The semaglutide label advises stopping it at least 2 months before a planned pregnancy.¹²
• FDA states that cagrilintide cannot be used in compounding under federal law.¹¹