Novo Nordisk Seeks FDA Approval for New Obesity Drug CagriSema
Novo Nordisk has taken a significant step in combating obesity. They have filed for approval from the FDA for their newly discovered drug, Cagrisema. This drug is an injection that is administered once a week. The company filed the approval on December 18, 2025, and is expected to review it in 2026.
This drug is designed to help people with obesity or overweight adults who suffer from health issues. If this drug is approved, it will be combined with a low-calorie diet and regular physical activity to achieve better results.
This drug works differently from the other weight loss drugs. It combines two active compounds in one shot. One compound that is used is semaglutide (the one that is used by Novo Nordisk to develop Wegovy), and the other compound is cagrilintide. This compound is an analogue of amylin that helps to regulate appetite. This drug will help people feel less hungry and eat fewer calories.
The company conducted large clinical trials known as the REDEFINE programme, and they support the FDA filing. The results of the trials show that adults taking CagriSema for 68 weeks lost a good amount of weight. In one of the results, people who were treated with CagriSema lost about 20–22% of their body weight during the study period. This was much more than the weight loss shown by people who received a placebo.
Apart from weight loss, this drug might also reduce blood pressure and lower inflammation in people with obesity, and reduce the risk of heart disease. There are a few studies that support these results. Researchers and doctors are encouraged by these added health benefits, and further studies are being conducted by many scientists.
Though this drug has strong results, not all experts agree that CagriSema’s performance is a win. In the final stage of the trials, the drug did not meet the weight loss capability expectations of the company. This raised a few questions among investors and analysts, who had hoped for a little stronger results. But Novo Nordisk has stressed the fact that the data is still showing promising results for the patients.
Novo Nordisk has planned big for obesity in its portfolio. The company is working on an oral form of Wegovy, apart from CagriSema. If that drug gets approved, it will be the first pill-form drug and will stand out as unique. That application is currently under review and could be decided by the end of 2025.
The market for obesity drugs is rapidly evolving and is getting more competitive. Other companies, like Eli Lilly, are also advancing new treatments, including daily oral pills and other injectable drugs. This gives a view that patients might have so many choices when it comes to managing their weight or obesity realted health conditions.
Currently, people, doctors, and scientists who are following the pharma space are curiously waiting to see how the FDA will respond to the drug application. If CagriSema is approved, it could offer a new treatment option for millions of adults facing obesity. Currently, obesity is a condition that is affecting the health and quality of life across the world and a solution to this would be good news to all of us.
