Gelesis’ Plenity Weight Management Capsules Cleared

FDA has cleared Gelesis’ Plenity (Gelesis100) as an aid in weight management in adults with a body mass index of 25 to 40 kg/m when used in conjunction with diet and exercise. The prescription device is administered in the form of capsules taken with water before lunch and dinner. It is made by cross-linking two naturally-derived building blocks – cellulose and citric acid – to create a three-dimensional hydrogel matrix, the company says. “The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods (e.g., vegetables) without caloric value,” it says. “The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss.”

Gelesis says that once Plenity arrives in the large intestine, the hydrogel is partially broken down by enzymes and loses its three-dimensional structure along with most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the feces, it says. The company explains that the capsule is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with “mechanobiology constructs.”