ethanol

Small moleculeapproved

Approved

Jan 17, 1946

Alcohols exhibit rapid broad-spectrum antimicrobial activity against vegetative bacteria (including mycobacteria), viruses, and fungi but are not sporicidal. They are, however, known to inhibit sporulation and spore germination, but this effect is reversible. Because of the lack of sporicidal activity, alcohols are not recommended for sterilization but are widely used for both hard-surface disinfection and skin antisepsis. Lower concentrations may also be used as preservatives and to potentiate the activity of other biocides. Many alcohol products include low levels of other biocides (in particular chlorhexidine), which remain on the skin following evaporation of the alcohol, or excipients (including emollients), which decrease the evaporation time of the alcohol and can significantly increase product efficacy. Ethanol in combination with: chlorhexidine gluconate 1% was approved to use in surgical hand antiseptic. It significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. Ethanol is also used as a co-solvent to dissolve many insoluble drugs and to serve as a mild sedative in some medicinal formulations. Ethanol is metabolized by the hepatic enzyme alcohol dehydrogenase. Ethanol affects the brain’s neurons in several ways. It alters their membranes as well as their ion channels, enzymes, and receptors. Alcohol also binds directly to the receptors for acetylcholine, serotonin, GABA, and the NMDA receptors for glutamate. The sedative effects of ethanol are mediated through binding to GABA receptors and glycine receptors (alpha 1 and alpha 2 subunits). It also inhibits NMDA receptor functioning. In its role as an anti-infective, ethanol acts as an osmolyte or dehydrating agent that disrupts the osmotic balance across cell membranes. — NCATS

Clinical trial activity

308 trials · 272 clinical orgs · 12 marketing orgs

Phase 1
98
Phase 2
66
Phase 3
28
Phase 4
33

Earliest trial started Jan 1, 1997 (NCT00000263)

Timeline

1940s

  1. Jan 17, 1946

    B. Braun — Earliest FDA Approval

  2. Jan 17, 1946

    Evidence of US Marketing

  3. Jan 17, 1946

    B. Braun — Marketing Organization

  4. Jan 17, 1946

    B. Braun — NDA Secondary Org

  5. Jan 17, 1946

    B. Braun — NDA Organization

1970s

  1. Feb 26, 1974

    Hospira — Marketing Organization

1990s

  1. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jun 7, 2001

    3M — Marketing Organization

  2. Jun 7, 2001

    3M — NDA Secondary Org

  3. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 21, 2018

    Belcher Pharmaceuticals — Marketing Organization

  2. Jun 21, 2018

    Belcher Pharmaceuticals — NDA Secondary Org

  3. Jun 21, 2018

    BPI — Marketing Organization

  4. Jun 21, 2018

    BPI — NDA Secondary Org

2020s

  1. Jun 23, 2025

    Accord Research — Marketing Organization

  2. Jun 23, 2025

    Esteve Labs — Marketing Organization

  3. Jun 23, 2025

    X Gen Pharmaceuticals — Marketing Organization

  4. Jul 9, 2025

    Ingenus Pharmaceuticals — Marketing Organization

  5. Oct 23, 2025

    ROYAL PHARMS — Marketing Organization

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJan 17, 1946
  • approvedJan 17, 1946

Chemistry & pharmacology

Loading structure…

SMILES

CCO
Mol. weight
46.0684 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Over the Counter

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • 1-hydroxyethane
  • 1-hydroxyethane
  • 40 g ethanol
  • alcohol
  • alcohol
  • alcohol
  • alcohol
  • alcohol
  • alcohol
  • alcohol
  • alcohol
  • alcohol anhydrous
  • alcohol anhydrous
  • alcohol denatured
  • alcohol denatured
  • alcohol, denatured
  • alcohol, denatured
  • alcohol, diluted
  • alcohol, diluted
  • alcohol (ethyl)
  • alcohol (ethyl)
  • alcohol etílico
  • alcohol etílico
  • alcohol, rubbing
  • alcohol, rubbing
  • alcool éthylique
  • alcool éthylique
  • alkohol
  • alkohol
  • äthanol
  • äthanol
  • äthylalkohol
  • äthylalkohol
  • dehydrated alcohol
  • dehydrated alcohol
  • dehydrated ethanol
  • dehydrated ethanol
  • e1510
  • e1510
  • etanol
  • etanol
  • ethanol
  • ethanol
  • ethanol
  • ethanol
  • ethanol
  • ethanol
  • ethanol
  • ethanol
  • éthanol
  • éthanol
  • ethyl alcohol
  • ethyl alcohol
  • ethyl alcohol
  • ethyl alcohol
  • ethyl alcohol
  • gelified ethanol
  • grain alcohol
  • grain alcohol
  • grain alcohol
  • hazel
  • hazel
  • hydroxyethane
  • hydroxyethane
  • methylated mineral
  • methylcarbinol
  • methylcarbinol
  • prf
  • spirigel
  • spiritus vini
  • spiritus vini
  • surg

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07027839Phase 1Dec 2, 2025National Institute of Mental Health (NIMH)
NCT07282405N/ANov 11, 2025University of Wisconsin
NCT07176208Phase 1Sep 22, 2025Food and Drug Administration, Spaulding Clinical Research Inc.
NCT07083765Phase 3Sep 1, 2025Ablative Solutions, Inc., Piedmont Healthcare, University of Basel
NCT07125534N/AAug 9, 2025University of Illinois
NCT06719908Phase 1Jul 1, 2025Afasci Inc
NCT06865872N/AApr 18, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Colorado, Denver
NCT06815237Phase 2/Phase 3 (Phase 3)Mar 31, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pennsylvania
NCT06819189Phase 1Mar 20, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT06627803N/AFeb 28, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Southern California
NCT06747364N/AFeb 28, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of North Texas, University of Texas, San Antonio
NCT06887322Phase 1/Phase 2 (Phase 2)Feb 13, 2025Padjadjaran University
NCT06822257N/AFeb 1, 2025Carnegie Mellon University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT06712602Phase 1Jan 31, 2025National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pop Test Oncology LLC, University of Kentucky
NCT06293040Phase 1Sep 26, 2024Johns Hopkins University, National Institute on Drug Abuse (NIDA)
NCT06576674N/ASep 3, 2024University of North Carolina at Chapel Hill
NCT06559878N/ASep 1, 2024University of Helsinki
NCT06579521N/AAug 31, 2024National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington
NCT06520384N/AJul 25, 2024Tanta University
NCT06326684Early Phase 1 (Phase 1)Jun 7, 2024National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Kentucky
Showing 20 of 308 trials
Page 1 / 16

Organizations

Research & Development (272)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government40942001
Yale UniversityAcademic/Hospital131222001
University of KentuckyAcademic/Hospital12932015
Harvard UniversityAcademic/Hospital111052006
National Institute on Drug Abuse (NIDA)Government9031997
University of PennsylvaniaAcademic/Hospital9742005
Institut Hospital del Mar d'Investigacions MèdiquesAcademic/Hospital8812009
Department of Veteran AffairsGovernment7142001
Johnson and JohnsonFor profit7722016
University of ChicagoAcademic/Hospital7721997
University of CopenhagenAcademic/Hospital7742012
National Institutes of Health (NIH)Government6032007
Brown UniversityAcademic/Hospital5522005
University of TorontoAcademic/Hospital5532013
Boston UniversityAcademic/Hospital4132003
GlaxoSmithKlineFor profit4422007
Johns Hopkins UniversityAcademic/Hospital4322007
Ohio State UniversityAcademic/Hospital4342014
Salus ResearchFor profit4022018
University Clermont AuvergneAcademic/Hospital4432007
272 organizations
Page 1 / 14

Marketing (17)

OrganizationOrg typeRelationshipDate
3MFor profitMKTGJun 7, 2001
3MFor profitNDA2Jun 7, 2001
Accord ResearchFor profitMKTGJun 23, 2025
B. BraunFor profitMKTGJan 17, 1946
B. BraunFor profitNDA2Jan 17, 1946
B. BraunFor profitNDAJan 17, 1946
BPIFor profitMKTGJun 21, 2018
BPIFor profitNDA2Jun 21, 2018
BaxterFor profitMKTG
Belcher PharmaceuticalsFor profitMKTGJun 21, 2018
Belcher PharmaceuticalsFor profitNDA2Jun 21, 2018
Esteve LabsFor profitMKTGJun 23, 2025
HospiraFor profitMKTGFeb 26, 1974
Ingenus PharmaceuticalsFor profitMKTGJul 9, 2025
MilesFor profitMKTG
ROYAL PHARMSFor profitMKTGOct 23, 2025
X Gen PharmaceuticalsFor profitMKTGJun 23, 2025