lactose

Small moleculeexperimental

Lactose is the most important carbohydrate in the milk of most species. Its biosynthesis takes place in the mammary gland. The molecular structures of α- and β -lactose differ in the orientation of a hydrogen- and a hydroxyl group on carbon atom no.1 in the glucose moiety. Both forms change into one another continuously. At room temperature, the equilibrium results in a ratio of about 40% α-lactose and 60% β-lactose. The fact that two forms of lactose exist which differ in molecular structure has profound effects on various properties of lactose such as crystallization behavior, crystal morphology, solid-state properties, and solubility. The intestine does not actively absorb lactose unless it is split into its two-monosaccharide components, i.e. glucose and galactose. This hydrolysis of lactose is affected by the enzyme lactase, which is produced by the epithelium cells in the brush-border of the small intestine. Thus, the capacity of mammals to digest lactose is dependent on the lactase activity in the intestine. The maximum activity of the enzyme occurs shortly after birth and declines during the weaning period, after which it remains at a relatively constant level. Genetically determined factors governing residual lactase activity also exist. Individuals having low lactase activity are called lactose malabsorbers. Lactose intolerance is a condition in which people have symptoms due to the decreased ability to digest lactose. The principal symptom of lactose intolerance is an adverse reaction to products containing lactose (primarily milk), including abdominal bloating and cramps, flatulence, diarrhea, nausea, borborygmi, and vomiting (particularly in adolescents). These appear one-half to two hours after consumption. — NCATS

Clinical trial activity

90 trials · 124 clinical orgs · 0 marketing orgs

Phase 1
7
Phase 2
41
Phase 3
18
Phase 4
13

Earliest trial started Nov 1, 1994 (NCT00002620)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • D-lactoseSupplementation

    D-lactose supplementation

Chemistry & pharmacology

Loading structure…

SMILES

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

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • aletobiose
  • anhydrous lactose
  • anhydrous lactose
  • anhydrous lactose
  • anhydrous lactose
  • anhydrous lactose
  • dibromdulcit
  • dibromodulcitol
  • dibromodulcitol
  • dibromodulcitol
  • dibromodulcitol
  • dibromogalactitol
  • dilactose
  • elobromol
  • lactobiose
  • lactol
  • lactol
  • lactose
  • lactose
  • lactose
  • lactose
  • lactose
  • lactose
  • lactose
  • lactose
  • (+)-lactose
  • lactose, anhydrous
  • lactose, anhydrous
  • lactose monohydrate
  • lactose monohydrate
  • lactose monohydrate
  • mitolactol
  • mitolactol
  • mitolactol
  • mitolactol
  • mitolactol
  • mitolactol
  • respitose

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06724705N/ADec 5, 2024University of Maryland
NCT06177938N/ADec 31, 2023Agroscope Liebefeld-Posieux Research Station ALP, University of Zurich
NCT05416229Phase 2Oct 31, 2022University of Copenhagen
NCT06618573Phase 2/Phase 3 (Phase 3)Aug 15, 2022Padjadjaran University
NCT05245175N/AFeb 22, 2022Fraunhofer, University of California, Irvine
NCT05712616Phase 4Nov 1, 2021Aga Khan University
NCT04924530N/AJun 7, 2021British Heart Foundation, University of Bath, University of Oxford
NCT04894617Phase 3Jun 1, 2021University of Copenhagen
NCT04791943Phase 2May 12, 2021Yeshiva University
NCT04481971Phase 2Aug 9, 2020King Saud University
NCT04237090Phase 3Feb 29, 2020Ciusss de L'Est de l'Île de Montréal
NCT04100109N/ANov 1, 2019University of Minnesota
NCT04450134N/AOct 2, 2019Ghent University, Government of Belgium, University of Copenhagen
NCT03497598Phase 4May 9, 2018Kantonsspital Aarau
NCT03476447N/AApr 6, 2018Evolve Biosystems, Inc., University of California, Davis
NCT02999022Phase 2Apr 17, 2017Canadian Institutes of Health Research (CIHR), University of Toronto
NCT03161652Phase 2May 1, 2016Instituto Mexicano de Oftalmologia, National Autonomous University of Mexico, Paracelsus Medical University, Universidad Autonoma de Queretaro, Universidad Nacional Autonoma de Mexico
NCT04389931N/AMar 31, 2016Universidad Nacional Andres Bello
NCT03670212Phase 1Jan 7, 2016National Institute on Drug Abuse (NIDA), Wayne State University
NCT02566798N/ADec 1, 2015University of Nantes
Showing 20 of 90 trials
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Organizations

Research & Development (124)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of CopenhagenAcademic/Hospital5332009
Ansun Biopharma, Inc.For profit4422009
All India Institute of Medical SciencesAcademic/Hospital3022008
Icahn School of Medicine at Mount SinaiAcademic/Hospital3312007
Indian Council of Medical ResearchAcademic/Hospital3322008
Queen's University, BelfastAcademic/Hospital3212012
University of TorontoAcademic/Hospital3312014
Boehringer IngelheimFor profit2221998
Danone ResearchFor profit2112006
Monash UniversityAcademic/Hospital2222006
Multidisciplinary Association for Psychedelic StudiesAcademic/Hospital2222004
National Heart, Lung, and Blood Institute (NHLBI)Government2022011
National Institute of Allergy and Infectious Diseases (NIAID)Government2012009
National Institute on Drug Abuse (NIDA)Government2022005
National Institutes of Health (NIH)Government2022009
Northern Ireland Clinical Trials UnitFor profit2012012
Stanley Medical Research InstituteAcademic/Hospital2022006
The Alfred HospitalAcademic/Hospital2022006
Universidad Nacional Andres BelloAcademic/Hospital2212015
University Clermont AuvergneAcademic/Hospital2222012
124 organizations
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