ethanolamine

Trade name: ethamolin

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 22, 1988

Ethanolamine oleate is a salt of ethanolamine, a basic substance, and oleic acid. It is marketed under a trade name of Ethamoline as a sclerotic agent for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. In vitro studies revealed that ethanolamine oleate inhibits fibrin clot formation because of the Ca2+-chelating ability of its constituent ethanolamine. Nevertheless, from in vivo studies it was suggested that intravascular injection of ethamoline activates the local coagulation system. The activation may be accelerated by an acute inflammatory process provoked by oleate, which is supported by such clinical manifestations as mild fever, retrosternal pain leukocytosis and an increase in plasma fibrinogen level. — NCATS

Clinical trial activity

5 trials · 6 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
3
Phase 3
1
Phase 4
0

Earliest trial started Jan 1, 2016 (NCT03388125)

Timeline

1980s

  1. Mar 22, 1984

    Orphan Drug Designation

  2. Dec 22, 1988

    QOL Medical, LLC — Earliest FDA Approval

  3. Dec 22, 1988

    QOL Medical, LLC — NDA Organization

  4. Dec 22, 1988

    QOL Medical, LLC — NDA Secondary Org

2010s

  1. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

  • Unspecified targetSurfactant

    surfactant

Approval history

  • approvedPriority reviewDec 22, 1988

Chemistry & pharmacology

Loading structure…

SMILES

NCCO.CCCCCCCC\C=C/CCCCCCCC(O)=O
Mol. weight
343.5444 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • beta-hydroxyethylammonium oleate
  • beta-hydroxyethylammonium oleate
  • calcium 2-aminoethanol phosphate
  • ethamolin
  • ethamolin
  • ethamolin
  • ethamolin
  • ethamolin
  • ethanolamine
  • ethanolamine
  • ethanolamine
  • ethanolamine oleate
  • ethanolamine oleate
  • ethanolamine oleate
  • ethanolamine oleate
  • ethanolamine oleate
  • ethanolamine oleate
  • ethanolamine phosphate
  • monoethanolamine oleate
  • monoethanolamine oleate
  • monoethanolamine oleate
  • oldamin
  • oldamin
  • oleic acid, 2-aminoethyl ester
  • phosphoethanolamine
  • phosphoethanolamine
  • phosphoethanolamine
  • phosphorylethanolamine
  • phosphorylethanolamine, 3h-labeled cpd
  • phosphorylethanolamine ca (1:1) salt
  • phosphorylethanolamine, cobalt (2+) (1:1) salt
  • phosphorylethanolamine magnesium (1:1) salt
  • phosphorylethanolamine zinc salt

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07199673N/AJul 7, 2025Gulab Devi Hospital
NCT06325982N/AJun 11, 2024Fujian Medical University
NCT05797623Phase 2Apr 26, 2023Hengrui Therapeutics, Inc.
NCT02950103Phase 2Aug 1, 2016Instituto do Cancer do Estado de São Paulo, Secretaria de Estado da Saúde
NCT03388125Phase 3Jan 1, 2016Tanta University
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Fujian Medical UniversityAcademic/Hospital1112024
Gulab Devi HospitalAcademic/Hospital1112025
Hengrui Therapeutics, Inc.For profit1112023
Instituto do Cancer do Estado de São PauloAcademic/Hospital1012016
Secretaria de Estado da SaúdeGovernment1112016
Tanta UniversityAcademic/Hospital1112016
6 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
QOL Medical, LLCFor profitNDADec 22, 1988
QOL Medical, LLCFor profitNDA2Dec 22, 1988