docosanol

Trade name: abreva

Small moleculeapproved

Approved

Jul 25, 2000

Docosanol is a saturated 22-carbon aliphatic alcohol which exhibits antiviral activity against many lipid enveloped viruses including herpes simplex virus (HSV). Docosanol speeds the healing of cold sores and fever blisters on the face or lips. It also relieves the accompanying symptoms, including tingling, pain, burning, and itching. Docosanol works by inhibiting fusion between the human cell plasma membrane and the herpes simplex virus (HSV) envelope, thereby preventing viral entry into cells and subsequent viral replication. Unlike other cold-sore antivirals, docosanol does not act directly on the virus, and as such it is unlikely it will produce drug resistant mutants of HSV. Used for the topical treatment of recurrent oral-facial herpes simplex episodes (cold sores or fever blisters). — NCATS

Clinical trial activity

3 trials · 4 clinical orgs · 7 marketing orgs

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

Earliest trial started Apr 17, 2007 (NCT00467662)

Timeline

2000s

  1. Jul 25, 2000

    Avanir — Earliest FDA Approval

  2. Jul 25, 2000

    Avanir — NDA Organization

  3. Jul 25, 2000

    GlaxoSmithKline — Marketing Organization

  4. Jul 25, 2000

    GlaxoSmithKline — NDA Secondary Org

2010s

  1. Nov 19, 2018

    Actavis — Marketing Organization

  2. Nov 19, 2018

    P&L Development — Marketing Organization

  3. Jan 1, 2019

    Earliest Phase 2 Sponsor(trial)

2020s

  1. May 3, 2022

    Alembic — Marketing Organization

  2. Oct 7, 2022

    Encube Ethicals Pvt. Ltd. — Marketing Organization

  3. Oct 26, 2023

    Taro Pharmaceuticals — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJul 25, 2000

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCCCCCCCCCCCCCCCCO
Mol. weight
326.6 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-docosanol
  • 1-docosanol
  • 1-docosanol
  • 1-docosanol
  • abreva
  • abreva
  • abreva
  • abreva
  • abreva
  • behenic alcohol
  • behenic alcohol
  • behenic alcohol
  • behenyl alcohol
  • behenyl alcohol
  • behenyl alcohol
  • behenyl alcohol
  • behenyl alcohol
  • docosan-1-ol
  • docosan-1-ol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosanol
  • docosyl alcohol
  • docosyl alcohol
  • docosyl alcohol
  • ik.2
  • lidakol
  • lidakol
  • n-docosanol
  • n-docosanol
  • n-docosanol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04893577Phase 2Nov 30, 2021University of Utah
NCT03977792Phase 2Jul 31, 2019Ecogene 21, Laboratoire Boreaderme Inc.
NCT00467662Phase 4Apr 17, 2007Hebrew University
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ecogene 21Academic/Hospital1012019
Hebrew UniversityAcademic/Hospital1112007
Laboratoire Boreaderme Inc.For profit1112019
University of UtahAcademic/Hospital1112021
4 organizations
Page 1 / 1

Marketing (9)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGNov 19, 2018
AlembicFor profitMKTGMay 3, 2022
AlembicFor profitSYNMay 3, 2022
AvanirFor profitNDAJul 25, 2000
Encube Ethicals Pvt. Ltd.For profitMKTGOct 7, 2022
GlaxoSmithKlineFor profitMKTGJul 25, 2000
GlaxoSmithKlineFor profitNDA2Jul 25, 2000
P&L DevelopmentFor profitMKTGNov 19, 2018
Taro PharmaceuticalsFor profitMKTGOct 26, 2023