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sodium picosulfate

Trade name: Preopik

Small moleculeapproved

Approved

Jul 16, 2012

Picosulfuric acid (as sodium picosulfate) is a contact laxative, which is used in combination with: magnesium oxide, and anhydrous citric acid for cleansing of the colon as a preparation for colonoscopy in adults. Sodium picosulfate is a prodrug. It has no significant direct physiological effect on the intestine. But it is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis — NCATS

Clinical trial activity

65 trials · 65 clinical orgs · 4 marketing orgs

Phase 1
3
Phase 2
24
Phase 3
18
Phase 4
27

Earliest trial started Jul 1, 2005 (NCT00312481)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 16, 2012

    Ferring — Earliest FDA Approval

  2. Jul 16, 2012

    Ferring — NDA Secondary Org

  3. Jul 16, 2012

    Ferring — NDA Organization

  4. Nov 21, 2016

    Par Pharmaceuticals — Marketing Organization

  5. Nov 21, 2016

    Bristol-Myers Squibb — Marketing Organization

2020s

  1. Jul 18, 2022

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Stimulant laxative

  • ElectrolyteSupplementation

    Electrolyte supplementation

Combination products

Approval history

  • approvedJul 16, 2012

Chemistry & pharmacology

Loading structure…

SMILES

O=S(=O)(O)Oc1ccc(C(c2ccc(OS(=O)(=O)O)cc2)c2ccccn2)cc1
Mol. weight
437.45 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 4,4'-(2-picolylidene)bisphenylsulfuric acid
  • 4,4'-(picoliliden)-bis-phenylsulphate
  • citrafleet
  • da-1773
  • da-1773
  • dulcolax pico
  • fe 999169
  • la-391
  • la-391
  • laxoberal
  • natrium picosulfate
  • otc concepts
  • pe
  • pe
  • picolax
  • picolax
  • picolax
  • picolax
  • picolax
  • picoprep
  • picoprep
  • picoprep
  • picosalax
  • pico-salax
  • pico-salax
  • picosulfate
  • picosulfate
  • picosulfate
  • picosulfate
  • picosulfate sodium
  • picosulfate sodium
  • picosulfol
  • picosulfol
  • picosulfuric acid
  • picosulfuric acid
  • picosulfuric acid
  • picosulphate
  • picosulphate
  • picosulphate
  • prepopik
  • prepopik
  • prepopik
  • rapilax
  • sodium picosulfate
  • sodium picosulfate
  • sodium picosulfate
  • sodium picosulfate
  • sodium picosulfate
  • sodium picosulfate, magnesium oxide and citric acid
  • sodium picosulphate
  • sodium picosulphate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06719505N/AMay 31, 2025Universidade Estadual do Norte do Parana
NCT06580366Phase 4Aug 22, 2024Hitit University
NCT07206329N/AJan 1, 2024Unidade Local de Saúde do Alto Ave, EPE
NCT05726097Phase 3Feb 1, 2023Lund University, Region Skane, University of Southern Denmark
NCT06339697Phase 4Dec 1, 2022Peking University
NCT05436054Phase 4Oct 1, 2022Aalborg University, Norgine, Region of North Jutland
NCT05484908N/AAug 1, 2022Sun Yat-Sen University
NCT05498714N/AJul 18, 2022Wuhan University
NCT05446792N/AJun 1, 2022Universidade Estadual do Norte do Parana
NCT05148494Phase 4Feb 1, 2022Government of Canada
NCT05144295Phase 3Dec 15, 2021Alexandria University
NCT04767633Phase 3Apr 30, 2021ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy, Azienda Ospedaliera Sant'Andrea, Roma
NCT04598880Phase 4Nov 6, 2020Clinica Universidad de Navarra, Hospital del Mar (Barcelona, Spain), Institut Hospital del Mar d'Investigacions Mèdiques
NCT04593446Phase 2Nov 1, 2020Daehang Hospital, National Cancer Center, Korea, Seoul National University
NCT04474002Phase 4Aug 31, 2020The University of Hong Kong
NCT04161599Phase 4Feb 29, 2020Universidad Autonoma de Barcelona
NCT04483037Phase 4Jan 1, 2020Changhua Christian Hospital
NCT04113382Phase 1/Phase 2 (Phase 2)Oct 31, 2019Ferring
NCT04033250N/AAug 31, 2019Technion University
NCT03965182N/AJun 1, 2019Dalin Tzu Chi General Hospital
Showing 20 of 65 trials
Page 1 / 4

Organizations

Research & Development (65)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
FerringFor profit10932010
Queen's University, BelfastAcademic/Hospital6622006
NorgineFor profit4332005
National Cancer Center, KoreaGovernment3312013
Boehringer IngelheimFor profit2222007
Luigi Sacco University HospitalAcademic/Hospital2212011
Lund UniversityAcademic/Hospital2122012
McMaster UniversityAcademic/Hospital2122012
Teaching Hospital Královské Vinohrady (FNKV)Academic/Hospital2012016
Technion UniversityAcademic/Hospital2112010
Tomas Bata Hospital ZlinAcademic/Hospital2212016
Universidade Estadual do Norte do ParanaAcademic/Hospital2212022
Aalborg UniversityAcademic/Hospital1112022
Alexandria UniversityAcademic/Hospital1112021
American Society for Gastrointestinal EndoscopyAcademic/Hospital1012008
American University of BeirutAcademic/Hospital1112018
Apices Soluciones S.L.For profit1012010
ASO SS Antonio e Biagio e C Arrigo Alessandria, ItalyAcademic/Hospital1012021
Azienda Ospedaliera Sant'Andrea, RomaAcademic/Hospital1112021
Cairo UniversityAcademic/Hospital1112016
65 organizations
Page 1 / 4

Marketing (5)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitMKTGNov 21, 2016
FerringFor profitNDA2Jul 16, 2012
FerringFor profitNDAJul 16, 2012
Hetero Labs LtdFor profitMKTGJul 18, 2022
Par PharmaceuticalsFor profitMKTGNov 21, 2016