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simethicone

Trade name: IMODIUM

Small moleculeapproved

Approved

Jun 26, 1997

Simeticone (INN), also known as simethicone (USAN), is an anti-foaming agent used to reduce bloating, discomfort or pain caused by excessive gas. — Wikipedia

Clinical trial activity

72 trials · 90 clinical orgs · 8 marketing orgs

Phase 1
12
Phase 2
17
Phase 3
15
Phase 4
22

Earliest trial started May 1, 2003 (NCT01928888)

Timeline

1990s

  1. Jun 26, 1997

    Johnson and Johnson — Earliest FDA Approval

  2. Jun 26, 1997

    Johnson and Johnson — NDA Secondary Org

  3. Jun 26, 1997

    Johnson and Johnson — NDA Organization

2000s

  1. Aug 30, 2002

    Perrigo — Marketing Organization

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  3. Sep 6, 2006

    Sun Pharmaceuticals — Marketing Organization

  4. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Dec 14, 2020

    Aurobindo Pharma — Marketing Organization

  2. May 27, 2021

    Guardian Drug — Marketing Organization

  3. Jun 17, 2021

    Hetero Labs Ltd — Marketing Organization

  4. Sep 10, 2021

    Bionpharma Inc — Marketing Organization

  5. Aug 29, 2022

    Granules India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Anti-gas, surfactant

  • Unspecified targetOTHER

    Antifoaming agent

    Rupture of thick liquid films by surface tension disruption

Combination products

Approval history

  • approvedJun 26, 1997

Chemistry & pharmacology

Loading structure…

SMILES

O=C([O-])[O-].[Al+3].[Al+3].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-].[OH-]
Mol. weight
531.91 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • altacite
  • altacite
  • altacite
  • ancid
  • antifoam a
  • antifoam a
  • antifoam af
  • asilone windcheaters
  • dextoma
  • dimethicone 410
  • epumisan
  • espumisan
  • gastro-hek
  • gas-x
  • gas-x
  • hydrotalcite
  • hydrotalcite
  • hydrotalcite
  • hydrotalcite
  • hydrotalcit-ratiopharm
  • infacol
  • manasseite
  • megalac
  • mylanta gas relief
  • mylanta gas relief
  • mylicon infant's drops
  • mylicon infant's drops
  • phazyme
  • phazyme
  • polydimethylsiloxane
  • sentry simethicone
  • sentry simethicone
  • sentry simethicone emulsion
  • sentry simethicone emulsion
  • silicone fluid 350
  • simethicone
  • simethicone
  • simethicone
  • simethicone
  • simethicone
  • simethicone
  • simethicone
  • simethicone
  • simeticone
  • simeticone
  • simeticone
  • talcid
  • talcid
  • talcid
  • talidat
  • ultacit
  • ultacite
  • wind-eze
  • windsetlers

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07245095Phase 2Sep 12, 2025Hospital General de Mexicali
NCT06919120Phase 4Jun 1, 2025Zhejiang University
NCT06812832Phase 4Mar 31, 2025United States Army
NCT06581783N/ANov 1, 2024Asian Institute of Gastroenterology
NCT06098742N/AJan 15, 2024Valenta Pharm JSC
NCT05808010N/AJun 7, 2023Shandong Provincial Hospital
NCT05801055Phase 3Apr 1, 2023Sanjay Gandhi Postgraduate Institute of Medical Sciences
NCT05100719N/ASep 30, 2022University of Pecs
NCT05951712N/AJun 16, 2022Asian Institute of Gastroenterology
NCT05249725Phase 4Apr 30, 2022Lee's Pharmaceutical
NCT05108571Phase 1Nov 3, 2021Dong-A Pharmaceutical
NCT05098275Phase 1Oct 29, 2021Dong-A Pharmaceutical
NCT05098262Phase 1Oct 26, 2021Dong-A Pharmaceutical
NCT05098886Phase 1Oct 26, 2021Dong-A Pharmaceutical
NCT04802785Phase 2/Phase 3 (Phase 3)Jun 30, 2021lurye Clinic
NCT05570669Phase 4May 25, 2021Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS Saverio de Bellis, Societa Italiana di Endoscopia Digestiva, University of Bologna, University of Naples Frederico II, University of Roma La Sapienza
NCT04709770Phase 4Feb 1, 2021Alfasigma S.p.A., University of Bari
NCT04666324N/ADec 31, 2020The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
NCT04641455N/ADec 1, 2020Vitkovice Hospital
NCT05175131Phase 3Nov 27, 2020Abbott
Showing 20 of 72 trials
Page 1 / 4

Organizations

Research & Development (90)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Dong-A PharmaceuticalFor profit4412021
Johnson and JohnsonFor profit4432005
University of Roma La SapienzaAcademic/Hospital3122005
Asian Institute of GastroenterologyAcademic/Hospital2212022
Assiut UniversityAcademic/Hospital2222014
Changhai HospitalAcademic/Hospital2222015
Laboratoires Mayoly SpindlerFor profit2212007
McNeilFor profit2122008
Peking UniversityAcademic/Hospital2122016
People's Liberation Army of ChinaGovernment2112015
Portuguese Oncology Institute, CoimbraAcademic/Hospital2222015
The President Stanisław Wojciechowski State University of Applied Sciences in KaliszAcademic/Hospital2222020
University of Naples Frederico IIAcademic/Hospital2112014
Vitkovice HospitalAcademic/Hospital2212016
Zhejiang UniversityAcademic/Hospital2122015
AbbottFor profit1112020
Albany Medical CollegeAcademic/Hospital1112017
AlexionFor profit1112018
Alfasigma S.p.A.For profit1012021
Alfa WassermannFor profit1112016
90 organizations
Page 1 / 5

Marketing (11)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGDec 14, 2020
Bionpharma IncFor profitMKTGSep 10, 2021
Bionpharma IncFor profitSYNSep 10, 2021
Granules IndiaFor profitMKTGAug 29, 2022
Guardian DrugFor profitMKTGMay 27, 2021
Hetero Labs LtdFor profitMKTGJun 17, 2021
Johnson and JohnsonFor profitNDA2Jun 26, 1997
Johnson and JohnsonFor profitNDAJun 26, 1997
PerrigoFor profitMKTGAug 30, 2002
PerrigoFor profitSYNSep 5, 2018
Sun PharmaceuticalsFor profitMKTGSep 6, 2006