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lactulose

Trade name: cephulac

Small moleculeapproved

Approved

Mar 25, 1976

Lactulose is a non-absorbable sugar used in the treatment of constipation and hepatic encephalopathy. It is administered orally for constipation, and either orally or rectally for hepatic encephalopathy. It generally begins working after 8–12 hours, but may take up to 2 days to improve constipation. — Wikipedia

Clinical trial activity

105 trials · 119 clinical orgs · 26 marketing orgs

Phase 1
10
Phase 2
24
Phase 3
17
Phase 4
26

Earliest trial started Nov 1, 1994 (NCT00004796)

Timeline

1970s

  1. Mar 25, 1976

    Sanofi-Aventis — Earliest FDA Approval

  2. Mar 25, 1976

    Sanofi-Aventis — NDA Secondary Org

  3. Mar 25, 1976

    Sanofi-Aventis — NDA Organization

1980s

  1. Jul 26, 1988

    Alta Pharma — Marketing Organization

  2. Aug 15, 1988

    Actavis — Marketing Organization

1990s

  1. May 29, 1992

    Roxane Laboratories — Marketing Organization

  2. May 29, 1992

    West-Ward Pharmaceutical — Marketing Organization

  3. May 29, 1992

    Hikma — Marketing Organization

  4. May 29, 1992

    Boehringer Ingelheim — Marketing Organization

  5. Sep 30, 1992

    VistaPharm, Inc. — Marketing Organization

  6. May 28, 1993

    Nostrum Laboratories — Marketing Organization

  7. May 28, 1993

    Teva — Marketing Organization

  8. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  9. Jul 3, 1995

    Hi Tech Pharmaceuticals — Marketing Organization

  10. Jul 3, 1995

    Akorn, Inc. — Marketing Organization

  11. Jul 30, 1996

    Pharmaceutical Associates — Marketing Organization

  12. Oct 31, 1996

    Wockhardt — Marketing Organization

  13. Dec 10, 1997

    Cumberland Pharmaceuticals — Marketing Organization

2000s

  1. Jul 26, 2001

    Lannett Company, Inc. — Marketing Organization

  2. Feb 21, 2002

    Xttrium Laboratories — Marketing Organization

  3. Feb 21, 2002

    Department of Veteran Affairs — Marketing Organization

  4. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  5. Nov 28, 2007

    Ani Pharmaceuticals — Marketing Organization

  6. Jan 1, 2009

    Department of Veteran Affairs — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 25, 2012

    Fresenius — Marketing Organization

  2. Mar 27, 2015

    Torrent Pharmaceuticals Limited — Marketing Organization

  3. Nov 23, 2018

    Lifepharma — Marketing Organization

  4. Nov 23, 2018

    Chartwell Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetUnclear

    Unclear

    Increases water content in the colon

Approval history

  • approvedPriority reviewMar 25, 1976

Chemistry & pharmacology

Loading structure…

SMILES

O.OC[C@H]1O[C@@H](O[C@@H]2[C@@H](CO)O[C@](O)(CO)[C@H]2O)[C@H](O)[C@@H](O)[C@H]1O
Mol. weight
360.31 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 4-o-beta-d-galactopyranosyl-d-fructofuranose
  • 4-o-beta-d-galactopyranosyl-d-fructofuranose
  • 4-o-beta-d-galactopyranosyl-d-fructose
  • 4-o-beta-d-galactopyranosyl-d-fructose
  • acilac
  • acilac
  • bifiteral
  • bifiteral
  • bifiteral
  • cephulac
  • cephulac
  • cephulac
  • cephulac
  • cholac
  • cholac
  • chronulac
  • chronulac
  • constilac
  • constilac
  • constulose
  • constulose
  • crystalline lactulose
  • d-lactulose
  • duphalac
  • duphalac
  • duphalac dry
  • enulose
  • enulose
  • evalose
  • evalose
  • generlac
  • generlac
  • heptalac
  • heptalac
  • isolactose
  • lactulone
  • lactulosa
  • lactulosa
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose
  • lactulose hydrate
  • lactulose hydrate
  • lactulose hydrate
  • lactulosum
  • lactulosum
  • lattulose
  • laxilose
  • laxilose
  • laxose orange
  • lemlax
  • osmolax
  • portalac
  • portalac
  • regulose

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07273734N/AJan 1, 2026Chongqing Medical University, Kunming Medical University, Sichuan University
NCT06995586N/ASep 1, 2025Cyprus University of Technology, Government of Russia, University of Cyprus
NCT07084350N/AAug 25, 2025People's Liberation Army of China
NCT07060222Phase 4Jul 20, 2025University of Guadalajara
NCT07002827N/AMay 30, 2025Institute of Liver and Biliary Sciences, India
NCT06808009N/AFeb 5, 2025Institute of Liver and Biliary Sciences, India
NCT06802042N/AJan 9, 2025Chinese Academy of Medical Sciences
NCT07037394Phase 4Dec 2, 2024Islamia University of Bahawalpur
NCT06483737N/AOct 1, 2024People's Liberation Army of China
NCT06748638Phase 4Sep 1, 2024Jinlin University, Nanjing Medical University
NCT06538077N/AAug 31, 2024Indian Council of Medical Research, Postgraduate Institute of Medical Education and Research
NCT06835361Phase 2/Phase 3 (Phase 3)Feb 29, 2024Government of Russia
NCT05794555Phase 3Jun 13, 2023Patient-Centered Outcomes Research Institute, University of Michigan, University of Pennsylvania
NCT05788627Phase 4Apr 30, 2023Khyber Medical University Peshawar
NCT05878639N/AMar 28, 2023Wenzhou Medical University
NCT05726344N/AFeb 10, 2023Hospital de Clínicas Dr. Manuel Quintela
NCT05700695Phase 1Jan 17, 2023All India Institute of Medical Sciences, Amrita Institute of Medical Sciences, Asian Institute of Gastroenterology, Kalinga Institute of Medical Sciences, Bhubaneswar, Postgraduate Institute of Medical Education and Research
NCT06411314Phase 3Dec 29, 2022Avva Rus, JSC
NCT05498714N/AJul 18, 2022Wuhan University
NCT05341180Phase 2/Phase 3 (Phase 3)May 27, 2022All India Institute of Medical Sciences
Showing 20 of 105 trials
Page 1 / 6

Organizations

Research & Development (119)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital8812010
Cumberland PharmaceuticalsFor profit5332009
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital5532004
All India Institute of Medical SciencesAcademic/Hospital3122009
Avva Rus, JSCFor profit3312010
Department of Veteran AffairsGovernment3322007
Govind Ballabh Pant Institute of Postgraduate Medical Education and ResearchAcademic/Hospital3322008
Huazhong University of Science and TechnologyAcademic/Hospital3212013
NorgineFor profit3222000
People's Liberation Army of ChinaGovernment3212020
Tanta UniversityAcademic/Hospital3332015
Aga Khan UniversityAcademic/Hospital2222007
Bausch Health CompaniesFor profit2222013
Bnai Zion Medical CenterAcademic/Hospital2222005
ClinSearch, LLCFor profit2012013
Cornell UniversityAcademic/Hospital2222008
FreseniusFor profit2222016
Government of RussiaGovernment2122024
Indian Council of Medical ResearchAcademic/Hospital2022009
Mayo ClinicAcademic/Hospital2222007
119 organizations
Page 1 / 6

Marketing (29)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGAug 15, 1988
Akorn, Inc.For profitMKTGJul 3, 1995
Alta PharmaFor profitMKTGJul 26, 1988
Ani PharmaceuticalsFor profitMKTGNov 28, 2007
Boehringer IngelheimFor profitMKTGMay 29, 1992
Chartwell PharmaceuticalsFor profitMKTGNov 23, 2018
Cumberland PharmaceuticalsFor profitMKTGDec 10, 1997
Department of Veteran AffairsGovernmentMKTGFeb 21, 2002
FreseniusFor profitMKTGJan 25, 2012
Hi Tech PharmaceuticalsFor profitMKTGJul 3, 1995
HikmaFor profitMKTGMay 29, 1992
HikmaFor profitSYNMay 29, 1992
Lannett Company, Inc.For profitMKTGJul 26, 2001
LifepharmaFor profitMKTGNov 23, 2018
Morton Grove PharmaceuticalsFor profitMKTG—
Nostrum LaboratoriesFor profitMKTGMay 28, 1993
PacoFor profitMKTG—
Pharmaceutical AssociatesFor profitMKTGJul 30, 1996
Roxane LaboratoriesFor profitMKTGMay 29, 1992
Sanofi-AventisFor profitNDA2Mar 25, 1976
Sanofi-AventisFor profitNDAMar 25, 1976
SolvayFor profitNDA2—
SolvayFor profitMKTG—
TevaFor profitMKTGMay 28, 1993
Torrent Pharmaceuticals LimitedFor profitMKTGMar 27, 2015
VistaPharm, Inc.For profitMKTGSep 30, 1992
West-Ward PharmaceuticalFor profitMKTGMay 29, 1992
WockhardtFor profitMKTGOct 31, 1996
Xttrium LaboratoriesFor profitMKTGFeb 21, 2002