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acetic acid

Trade name: vosol

Small moleculeapproved

Approved

May 17, 1960

Acetic acid, systematically named ethanoic acid, is an acidic, colourless liquid and organic compound with the chemical formula CH3COOH. Vinegar is at least 4% acetic acid by volume, making acetic acid the main component of vinegar apart from water. Historically, vinegar was produced from the third century BC and was likely the first acid to be produced in large quantities. — Wikipedia

Clinical trial activity

31 trials · 45 clinical orgs · 24 marketing orgs

Phase 1
9
Phase 2
11
Phase 3
1
Phase 4
0

Earliest trial started Feb 1, 2007 (NCT00390403)

Timeline

1960s

  1. May 17, 1960

    Hi Tech Pharmaceuticals — Earliest FDA Approval

  2. May 17, 1960

    Hi Tech Pharmaceuticals — NDA Organization

  3. May 17, 1960

    Hi Tech Pharmaceuticals — NDA Secondary Org

  4. May 17, 1960

    Akorn, Inc. — NDA Secondary Org

  5. May 17, 1960

    Hikma — Marketing Organization

  6. Dec 14, 1966

    Bayer — Marketing Organization

  7. Dec 14, 1966

    Bayer — NDA Secondary Org

1970s

  1. Jun 2, 1976

    ICU Medical Inc — NDA Secondary Org

  2. May 10, 1977

    Lumara Health — Marketing Organization

  3. Aug 6, 1979

    B. Braun — NDA Secondary Org

  4. Oct 26, 1979

    Warner Chilcott — Marketing Organization

1980s

  1. Aug 12, 1981

    Actavis — Marketing Organization

  2. Feb 19, 1982

    Baxalta — NDA Secondary Org

  3. Feb 19, 1982

    Baxter — NDA Secondary Org

  4. Sep 6, 1984

    Taro Pharmaceuticals — Marketing Organization

1990s

  1. Feb 25, 1994

    Bausch & Lomb — Marketing Organization

  2. Jul 26, 1996

    Chartwell Pharmaceuticals — Marketing Organization

  3. Aug 30, 1996

    Wockhardt — Marketing Organization

2000s

  1. Feb 24, 2005

    Mylan — Marketing Organization

  2. Feb 24, 2005

    Lannett Company, Inc. — Marketing Organization

  3. Feb 24, 2005

    Saptalis Pharmaceuticals — Marketing Organization

  4. Feb 24, 2005

    Sciegen Pharmaceticals — Marketing Organization

  5. Feb 6, 2006

    Cosette — Marketing Organization

  6. Feb 6, 2006

    Vintage — Marketing Organization

  7. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  8. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Mar 9, 2018

    ANDA Repository — Marketing Organization

  2. Mar 9, 2018

    Rising Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • domeboro

    with aluminum acetate

    Also known as acetic acid in aqueous aluminum acetate

  • tridesilon

    with prednisone

  • vosol hc

    with urea

    Also known as acetasol hc, acetic acid w/ hydrocortisone, hydrocortisone and acetic aci

Approval history

  • approvedMay 17, 1960

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)O
Mol. weight
60.05 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • acetasol
  • acetasol
  • acetate
  • acetate
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid
  • acetic acid, glacial
  • acetic acid, glacial
  • acetic acid, glacial
  • acetic acid, glacial
  • acetic acid, glacial
  • aceticum acidum
  • aceticum acidum
  • acide acétique
  • acide acétique
  • aci-jel
  • aci-jel
  • e260
  • e260
  • earcalm
  • essigsäure
  • essigsäure
  • ethoic acid
  • ethoic acid
  • ethylic acid
  • ethylic acid
  • ethylic acid
  • glacial acetic acid
  • glacial acetic acid
  • hoac
  • hoac
  • methanecarboxylic acid
  • methanecarboxylic acid
  • orlex
  • orlex
  • vinegar acid
  • vosol
  • vosol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06203080Phase 2Jan 1, 2024Government of China
NCT06356480Phase 1/Phase 2 (Phase 2)Oct 1, 2023Government of Pakistan
NCT05100264N/AOct 25, 2021Alexandra General Hospital, Alexandra Hospital, Athens, Greece, University of Athens
NCT04001855N/AJul 1, 2019University of Arizona
NCT03596099N/AJul 31, 2018Endothelix, Mizkan Holdings Co., Ltd., Sprim Consulting, Tulane University
NCT02697344Phase 1/Phase 2 (Phase 2)Apr 14, 2017Mayo Clinic, National Cancer Institute (NCI)
NCT02614703Phase 2/Phase 3 (Phase 3)Mar 10, 2017Doctors Hospital at Renaissance
NCT02811744Phase 2Jan 1, 2017University of Pennsylvania
NCT02806115Phase 1Jun 1, 2016Shandong University
NCT02800772N/AJun 1, 2016Changhai Hospital
NCT02715583Early Phase 1 (Phase 1)Mar 1, 2016University of Pennsylvania
NCT02549755Phase 2Sep 1, 2015Indiana University
NCT02420665N/ASep 1, 2015National Cancer Institute (NCI), National Institutes of Health (NIH), University of Texas at Houston
NCT02542150N/ASep 1, 2015University of Colorado, Denver
NCT02407392N/AJul 1, 2015Gloucestershire Hospitals NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, University of Leicester, University of Portsmouth, University of Sussex
NCT02231385N/ASep 1, 2014Humanitas University, Istituto Clinico Humanitas - Rozzano (MI), Italy, Nuovo Regina Margherita Hospital
NCT02029794N/AMar 1, 2014Makerere University, University of British Columbia
NCT01003769Phase 1/Phase 2 (Phase 2)Sep 1, 2013Mayo Clinic, National Cancer Institute (NCI)
NCT01983046N/ASep 1, 2013Maastricht University, Top Institute Food and Nutrition
NCT01917136Phase 2Aug 1, 2013Harvard University, The Cardiovascular Medical Research and Education Fund, University of Maryland, University of Pennsylvania, Washington University in St. Louis, Yale University
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (45)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government10632007
Mayo ClinicAcademic/Hospital4212008
University of PennsylvaniaAcademic/Hospital3322013
National Institutes of Health (NIH)Government2022008
University of Texas at HoustonAcademic/Hospital2212013
Alexandra General HospitalAcademic/Hospital1012021
Alexandra Hospital, Athens, GreeceAcademic/Hospital1112021
Changhai HospitalAcademic/Hospital1112016
Doctors Hospital at RenaissanceAcademic/Hospital1112017
EndothelixFor profit1012018
Gloucestershire Hospitals NHS Foundation TrustAcademic/Hospital1012015
Government of ChinaGovernment1112024
Government of PakistanGovernment1112023
Harvard UniversityAcademic/Hospital1012013
Humanitas UniversityAcademic/Hospital1012014
Indiana UniversityAcademic/Hospital1112015
Istituto Clinico Humanitas - Rozzano (MI), ItalyAcademic/Hospital1112014
Johns Hopkins UniversityAcademic/Hospital1112007
Katholieke Universiteit LeuvenAcademic/Hospital1112011
Maastricht UniversityAcademic/Hospital1112013
45 organizations
Page 1 / 3

Marketing (29)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGMar 9, 2018
ActavisFor profitMKTGAug 12, 1981
Akorn, Inc.For profitNDA2May 17, 1960
B. BraunFor profitNDA2Aug 6, 1979
Bausch & LombFor profitMKTGFeb 25, 1994
BaxaltaFor profitNDA2Feb 19, 1982
BaxterFor profitNDA2Feb 19, 1982
BayerFor profitMKTGDec 14, 1966
BayerFor profitNDA2Dec 14, 1966
Chartwell PharmaceuticalsFor profitMKTGJul 26, 1996
CosetteFor profitMKTGFeb 6, 2006
Hi Tech PharmaceuticalsFor profitNDAMay 17, 1960
Hi Tech PharmaceuticalsFor profitNDA2May 17, 1960
HikmaFor profitMKTGMay 17, 1960
ICU Medical IncFor profitNDA2Jun 2, 1976
Lannett Company, Inc.For profitMKTGFeb 24, 2005
Lumara HealthFor profitMKTGMay 10, 1977
MylanFor profitMKTGFeb 24, 2005
PharmafairFor profitMKTG—
Rising PharmaceuticalsFor profitMKTGMar 9, 2018
Rising PharmaceuticalsFor profitSYNMar 9, 2018
Saptalis PharmaceuticalsFor profitMKTGFeb 24, 2005
Sciegen PharmaceticalsFor profitMKTGFeb 24, 2005
Taro PharmaceuticalsFor profitMKTGSep 6, 1984
Taro PharmaceuticalsFor profitSYNMar 4, 1985
VintageFor profitMKTGFeb 6, 2006
Warner ChilcottFor profitMKTGOct 26, 1979
WockhardtFor profitSYNJul 26, 1996
WockhardtFor profitMKTGAug 30, 1996