CDEK
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bisacodyl

Trade name: Halflytely

Small moleculeapproved

Approved

May 10, 2004

Bisacodyl is typically prescribed for relief of constipation and for the management of neurogenic bowel dysfunction as well as part of bowel preparation before medical examinations, such as for a colonoscopy. Some drugs (e.g., diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) increase risk due to fluid and electrolyte changes. Most common adverse reactions (> 3%) are overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting. — NCATS

Clinical trial activity

63 trials · 74 clinical orgs · 3 marketing orgs

Phase 1
4
Phase 2
19
Phase 3
14
Phase 4
28

Earliest trial started Oct 1, 2003 (NCT02211976)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  2. May 10, 2004

    Earliest FDA Approval

  3. May 10, 2004

    Braintree Laboratories — NDA Secondary Org

  4. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. May 27, 2010

    Novel Anti-Infective Technologies, LLC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Combination products

Approval history

  • approvedMay 10, 2004

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)OC1=CC=C(C=C1)C(C2=CC=C(OC(C)=O)C=C2)C3=CC=CC=N3
Mol. weight
361.3906 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

  • biolax
  • bisacodilo
  • bisacodilo
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyl
  • bisacodyle
  • bisacodyle
  • bisacodylum
  • bisacodylum
  • brocalax
  • correctol tablets, caplets
  • correctol tablets, caplets
  • dulcodos
  • dulcolax
  • dulcolax
  • dulcolax
  • dulcolax
  • dulcolax
  • entrolax
  • feen-a-mint tablets
  • feen-a-mint tablets
  • phenol, 4,4'-(2-pyridinylmethylene)bis-, diacetate (ester)
  • phenol, 4,4'-(2-pyridinylmethylene)bis-, diacetate (ester)
  • sk-bisacodyl
  • sk-bisacodyl
  • spirolax
  • spirolax
  • theralax
  • theralax

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07127237Early Phase 1 (Phase 1)Sep 30, 2025Hospital de Clínicas Dr. Manuel Quintela
NCT06455813Phase 4Sep 2, 2024Government of Denmark, University of Southern Denmark
NCT06298461Phase 4May 31, 2024University of Manitoba
NCT05409157Phase 1Jun 17, 2022Bristol-Myers Squibb
NCT05144295Phase 3Dec 15, 2021Alexandria University
NCT05032794N/AOct 13, 2021Corporacion Parc Tauli, Universidad Autonoma de Barcelona
NCT04903470N/AJun 1, 2021California Medical Innovations Institute, University of California, San Diego
NCT04446312Phase 3Jul 13, 2020Braintree Laboratories, Sebela Pharmaceuticals
NCT04446299Phase 3Jul 13, 2020Braintree Laboratories, Sebela Pharmaceuticals
NCT04238091Phase 2Feb 29, 2020Columbia University
NCT04129788Phase 4Dec 1, 2019Sanofi, University of Nottingham
NCT04132661Phase 4Dec 1, 2019Sanofi, University of Nottingham
NCT03992365Phase 3Jun 10, 2019China Medical University, Universal Integrated Corp.
NCT03247595N/ASep 26, 2017LifeBridge Health
NCT03849196N/AJul 31, 2017Sungkyunkwan University
NCT03226145N/AJul 20, 2017University of London, University of Nottingham
NCT03248726N/AJul 14, 2017Taipei Medical University
NCT03146052N/AMar 27, 2017University of Milan
NCT02976805Phase 3Feb 13, 2017Academic Medical Organization of Southwestern Ontario, McGill University, Pendopharm, University of Alberta, University of Montreal, University of Western Ontario
NCT02977286Phase 4Nov 1, 2016Tufts University
Showing 20 of 63 trials
Page 1 / 4

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Braintree LaboratoriesFor profit5522006
Boehringer IngelheimFor profit3322003
FerringFor profit3322010
University of British ColumbiaAcademic/Hospital3322011
University of NottinghamAcademic/Hospital3322017
Corporacion Parc TauliAcademic/Hospital2222013
McGill UniversityAcademic/Hospital2122015
Queen's University, BelfastAcademic/Hospital2222006
SanofiFor profit2012019
Sebela PharmaceuticalsFor profit2012020
Shandong UniversityAcademic/Hospital2212015
University of MilanAcademic/Hospital2222011
University of Western OntarioAcademic/Hospital2222012
Academic Medical Organization of Southwestern OntarioAcademic/Hospital1012017
Alexandria UniversityAcademic/Hospital1112021
BayerFor profit1112013
Binzhou Medical UniversityAcademic/Hospital1012015
Boston UniversityAcademic/Hospital1112010
Bristol-Myers SquibbFor profit1112022
California Medical Innovations InstituteAcademic/Hospital1012021
74 organizations
Page 1 / 4

Marketing (3)

OrganizationOrg typeRelationshipDate
Braintree LaboratoriesFor profitNDA2May 10, 2004
GeigyFor profitNDA—
Novel Anti-Infective Technologies, LLCFor profitMKTGMay 27, 2010