{{Infobox medical intervention | name = Gelesis100 | image = | caption = | alt = | pronounce = | synonyms = Plenity <br />Oral superabsorbent hydrogel | ICD10 = | ICD9 = | ICD9unlinked = | MeshID = | LOINC = | other_codes = | MedlinePlus = | eMedicine = }} '''Gelesis100''', sold under the brand name '''Plenity''', is an oral hydrogel used to treat overweight and obesity.<ref name=Pass /> It absorbs water and expands in the stomach and small bowel thereby increasing feelings of fullness. Possible side effects include primarily gastrointestinal symptoms,<ref name=Kahan /> such as diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence.<ref name=Forbes /> It is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.<ref name=Pass /> The US Food and Drug Administration approved it in 2019 as a medical device. Gelesis100 was developed by the company Gelesis.
==History== The US Food and Drug Administration approved the use of Gelesis100 in April 2019 as a medical device.<ref>{{cite web |title=De Novo request for classification of Plenity |url=https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180060.pdf |archive-url=https://web.archive.org/web/20190417211049/https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180060.pdf |archive-date=April 17, 2019 |publisher=U.S. Food & Drug Administration}}</ref> On January 19, 2024, Plenity received authorization from the U.S. Food and Drug Administration to be marketed over the counter without a prescription.<ref>{{cite web |title=K230133 - FDA Decision Summary |url=https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230133.pdf |publisher=U.S. Food and Drug Administration |date=January 19, 2024 |access-date=February 12, 2026}}</ref> Gelesis100 is the first treatment of its kind for overweight and obesity.<ref name=Kahan>{{cite journal |last1=Kahan |first1=S |last2=Kumbhari |first2=V |title=A Weight Loss Device That Looks Like a Pill. |journal=Obesity |date=February 2019 |volume=27 |issue=2 |page=189 |doi=10.1002/oby.22399 |pmid=30677264|s2cid=59252036 |doi-access=free }}</ref> In 2022, the American Gastroenterology Association published a guideline for the management of obesity, which recommended the use of Gelesis100 be limited to clinical trials due to limited evidence.<ref name=AGA_Obesity_Guidelines_2022 />
== Uses and effectiveness == Gelesis100 is used to treat obesity and overweight as an anti-obesity medication.<ref name=Pass>{{cite journal |last1=Pass |first1=A |last2=Bialonczyk |first2=D |last3=Chiquette |first3=E |last4=Goldman |first4=JD |title=Oral Superabsorbent Hydrogel (Plenity) for Weight Management. |journal=The Annals of Pharmacotherapy |date=2020-12-21 |volume=55 |pages=1146–1152 | issue=9 | doi=10.1177/1060028020983046 |pmid=33348994|s2cid=229351539 }}</ref> Gelesis100 is taken as a pill before meals with water.<ref name="Umashanker">{{cite journal |last1=Umashanker |first1=D |last2=Igel |first2=LI |last3=Kumar |first3=RB |last4=Aronne |first4=LJ |title=Current and Future Medical Treatment of Obesity. |journal=Gastrointestinal Endoscopy Clinics of North America |date=April 2017 |volume=27 |issue=2 |pages=181–190 |doi=10.1016/j.giec.2016.12.008 |pmid=28292399}}</ref><ref name=GLOW>{{cite journal |last1=Greenway |first1=FL |last2=Aronne |first2=LJ |last3=Raben |first3=A |last4=Astrup |first4=A |last5=Apovian |first5=CM |last6=Hill |first6=JO |last7=Kaplan |first7=LM |last8=Fujioka |first8=K |last9=Matejkova |first9=E |last10=Svacina |first10=S |last11=Luzi |first11=L |last12=Gnessi |first12=L |last13=Navas-Carretero |first13=S |last14=Alfredo Martinez |first14=J |last15=Still |first15=CD |last16=Sannino |first16=A |last17=Saponaro |first17=C |last18=Demitri |first18=C |last19=Urban |first19=LE |last20=Leider |first20=H |last21=Chiquette |first21=E |last22=Ron |first22=ES |last23=Zohar |first23=Y |last24=Heshmati |first24=HM |title=A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. |journal=Obesity |date=February 2019 |volume=27 |issue=2 |pages=205–216 |doi=10.1002/oby.22347 |pmid=30421844|pmc=6587502 }}</ref>
Gelesis100 has been criticized for its small impact on weight loss relative to side effects.<ref>{{cite journal |last1=Miller |first1=LE |last2=Bhattacharyya |first2=R |title=Unclear Benefit of Gelesis100 for Body Weight Loss. |journal=Obesity |date=September 2019 |volume=27 |issue=9 |page=1383 |doi=10.1002/oby.22532 |pmid=31264776|s2cid=195771241 }}</ref>
==Mechanism and physiology== Gelesis100 is an oral superabsorbent hydrogel, which is produced from carboxymethylcellulose and citric acid.<ref name=Pass /><ref name=Naguy>{{cite journal |last1=Naguy |first1=A |last2=Alamiri |first2=B |title=2019 FDA approved psychotherapeutic medications. |journal=Asian Journal of Psychiatry |date=March 2020 |volume=49 |article-number=101976 |doi=10.1016/j.ajp.2020.101976 |pmid=32120296|s2cid=211831891 }}</ref> The cross-linked product forms a hydrophilic matrix, which absorbs water.<ref name=Pass /> Taken in capsule form by mouth,<ref name=Appleby>{{cite news |last1=Appleby |first1=Julie |title=New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results |url=https://khn.org/news/article/new-weight-loss-treatment-is-marked-by-heavy-marketing-and-modest-results/ |work=Kaiser Health News |date=June 22, 2022}}</ref> as Gelesis100 absorbs water, it expands in the stomach and small intestine.<ref name=Forbes>{{cite news |last1=Lee |first1=Bruce Y. |title=Plenity Now Is FDA-Approved For Weight Management |url=https://www.forbes.com/sites/brucelee/2019/04/18/plenity-now-is-fda-approved-for-weight-management/?sh=3beed8b312a8 |work=Forbes |date=Apr 18, 2019}}</ref><ref name=Umashanker /> After absorbing water, a semisolid gel structure forms, which may promote satiety and result in weight loss<ref name=Pass /> via reduced caloric intake.<ref name=AGA_Obesity_Guidelines_2022>{{cite journal |last1=Grunvald |first1=E |last2=Shah |first2=R |last3=Hernaez |first3=R |last4=Chandar |first4=AK |last5=Pickett-Blakely |first5=O |last6=Teigen |first6=LM |last7=Harindhanavudhi |first7=T |last8=Sultan |first8=S |last9=Singh |first9=S |last10=Davitkov |first10=P |last11=AGA Clinical Guidelines |first11=Committee |title=AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity. |journal=Gastroenterology |date=November 2022 |volume=163 |issue=5 |pages=1198–1225 |doi=10.1053/j.gastro.2022.08.045 |pmid=36273831|doi-access=free }}</ref>
==Contraindications== Gelesis100 is contraindicated in pregnancy, chronic malabsorption syndromes, and cholestasis.<ref name=Pass />
==Side effects== Side effects consist of minor gastrointestinal symptoms,<ref name=Kahan /> including diarrhea, abdominal distention, infrequent bowel movements, constipation, abdominal pain, and flatulence.<ref name=Forbes /> Gelesis100 is not associated with any severe adverse events.<ref name=Mechanick>{{cite journal |last1=Mechanick |first1=JI |last2=Apovian |first2=C |last3=Brethauer |first3=S |last4=Garvey |first4=WT |last5=Joffe |first5=AM |last6=Kim |first6=J |last7=Kushner |first7=RF |last8=Lindquist |first8=R |last9=Pessah-Pollack |first9=R |last10=Seger |first10=J |last11=Urman |first11=RD |last12=Adams |first12=S |last13=Cleek |first13=JB |last14=Correa |first14=R |last15=Figaro |first15=MK |last16=Flanders |first16=K |last17=Grams |first17=J |last18=Hurley |first18=DL |last19=Kothari |first19=S |last20=Seger |first20=MV |last21=Still |first21=CD |title= Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures – 2019 Update |journal=Endocrine Practice |date=December 2019 |volume=25 |issue=12 |pages=1346–1359 |doi=10.4158/GL-2019-0406 |pmid=31682518|doi-access=free }}</ref> However, long-term safety data beyond 24 weeks is not available.<ref name=Mechanick />
== References == {{reflist}}
==External links== * [https://www.myplenity.com Official website]
{{Anorectics}}
Category:Gastroenterology Category:Anti-obesity drugs Category:Bariatrics Category:Management of obesity Category:Medical devices