Plenity FDA Approval History
Last updated by Judith Stewart, BPharm on May 13, 2019.
FDA Approved: Yes (First approved April 12, 2019)
Brand name: Plenity
Generic name: cellulose and citric acid
Dosage form: Capsules
Treatment for: Obesity
Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in adults who are overweight or obese. It works by inducing a feeling of fullness so that patients eat less and lose weight.
- Plenity is administered in the form of capsules taken with water before lunch and dinner.
- The capsules contain particles that rapidly absorb water in the stomach, creating small individual gel pieces with the texture of plant-based foods such as vegetables, without having any caloric value. 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.
- The hydrogel is partially broken down by enzymes once in the large intestine, and it loses its three-dimensional structure and most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the feces.
- Because its mechanism of action is mechanical, Plenity is considered a medical device rather than a drug.
- Plenity has been shown to be effective, safe and well-tolerated in clinical studies.
Development Timeline for Plenity
|Apr 14, 2019||Approval Gelesis Granted FDA Clearance to Market Plenity - a New Prescription Aid in Weight Management|
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