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Gelesis SRL - Italy

A hydrogel therapy.
A new approach to weight management.

PLENITY®

LIVE FULLER

Our lead product candidate is a first in class non-systemic, superabsorbent hydrogel therapy. An orally-administered capsule, Plenity™ developed for adults who are overweight or have obesity (BMI 25-40 kg/m2). Plenity® is a completely new approach to aid weight management, with proprietary mechanism of action supported by positive data from large clinical studies. Plenity® was designed as a safe and effective treatment that could have a major impact on human health and weight loss needs.

 

 

 

 

 

 

TWO NATURALLY DERIVED BUILDING BLOCKS

The highly engineered and proprietary patented hydrogel is made by (three-dimensionally) cross-linking 2 naturally derived building blocks:

MODIFIED CELLULOSE       CITRIC ACID

 

 

 

 

 

 

LIVE FULLER

PLENITY is FDA cleared for the largest number of adults struggling with overweight and obesity (BMI 25-40 kg/m2) of any prescription weight-management aid and the first that can be used, along with diet and exercise, in millions of overweight adults who have never before had prescription options

“The scientific data supporting PLENITY’s positive effects on weight make it a powerful tool to help with weight management. The most compelling aspect of this approach are its: effectiveness, novel mechanism of action and impressive safety data.”

Ken Fujioka, M.D., weight loss expert,
endocrinology researcher at Scripps Clinic

HOW PLENITY WORKS

Orally administered in capsules with water before a meal, PLENITY particles rapidly absorb water in the stomach and homogenously mix with ingested foods.

Rather than forming one large mass, it creates thousands of small individual gel pieces with the elasticity (firmness) of solid plant based foods (e.g., vegetables) without caloric value.

Plenity is designed to trigger several important natural weight loss mechanisms in the stomach and small intestine. The PLENITY hydrogel mass increases the volume and elasticity of the stomach and small intestine contents to induce a feeling of fullness and satiety.

Once it 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.

Selected Safety Information
Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium oxide should not take Plenity.

Plenity is to be taken with water 20-30 minutes before lunch and dinner.

Prescription only- For safe and proper use of Plenity, please refer to the Instructions for Use

PLENITY is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with mechanobiology constructs. Because of Plenity’s natural process MOA and safety profile and, we are seeking a Non-Significant Risk (NSR) determination by the FDA for our GLOW pivotal study.*

SEE OUR CLINICAL DATA

SEE THE DATA

LEARN MORE ABOUT OUR ONGOING RESEARCH

Gelesis is conducting a proof-of-concept study for its second candidate, Gelesis200, which is optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes.
GELESIS PIPELINE

SOURCES: American Diabetes Association, National Institues of Health (NIH), Mayo Clinic, WebMD.com, World Health Organization, The Cleveland Clinic Bariatric and Metabolic Institute, ALighterMe.com, Drugs.com