methyl salicylate

Small moleculeapproved

Approved

Feb 20, 2008

Methyl salicylate (oil of wintergreen or wintergreen oil) is an organic compound with the formula C8H8O3. It is the methyl ester of salicylic acid. It is a colorless, viscous liquid with a sweet, fruity odor reminiscent of root beer (in which it is used as a flavoring), but often associatively called "minty", as it is an ingredient in mint candies. It is produced by many species of plants, particularly wintergreens. It is also produced synthetically, used as a fragrance and as a flavoring agent. — Wikipedia

Clinical trial activity

6 trials · 8 clinical orgs · 1 marketing orgs

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

Earliest trial started Apr 7, 2009 (NCT03362216)

Timeline

2000s

  1. Feb 20, 2008

    Hisamitsu Pharmaceutical Co., Inc. — Earliest FDA Approval

  2. Feb 20, 2008

    Hisamitsu Pharmaceutical Co., Inc. — NDA Secondary Org

  3. Feb 20, 2008

    Hisamitsu Pharmaceutical Co., Inc. — NDA Organization

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2022

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Combination products

Approval history

  • approvedFeb 20, 2008

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)c1ccccc1O
Mol. weight
152.15 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 2-carbomethoxyphenol
  • 2-carbomethoxyphenol
  • 2-hydroxybenzoic acid methyl ester
  • 2-hydroxybenzoic acid methyl ester
  • 2-(methoxycarbonyl)phenol
  • 2-(methoxycarbonyl)phenol
  • analgit
  • aspellin
  • balmosa
  • bengue's balsam
  • betula oil
  • betula oil
  • betula oil
  • birch oil, sweet
  • birch oil, sweet
  • deep heat
  • deep heat
  • dubam
  • gaultheria
  • gaultheria
  • gaultheria oil
  • gaultheria oil
  • gaultheria oil
  • gppe lin
  • gppe rub
  • hewedolor
  • linsal
  • luma
  • luma
  • menthyl salicylate
  • menthyl salicylate
  • menthyl salicylate, (+/-)-
  • menthyl salicylate, (+/-)-
  • methyl 2-hydroxybenzoate
  • methyl 2-hydroxybenzoate
  • methyl 2-hydroxybenzoate
  • methyl ester 2-hydroxy benzoic acid
  • methyl o-hydroxybenzoate
  • methyl o-hydroxybenzoate
  • methylsalicylate
  • methylsalicylate
  • methylsalicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate
  • methyl salicylate sodium salt
  • metsal liniment
  • nasciodine
  • natural wintergreen oil
  • natural wintergreen oil
  • oil of wintergreen
  • oil of wintergreen
  • oil of wintergreen
  • p.r.
  • p.r.
  • radian-b
  • rheumabal
  • rhodiaflor
  • sloans
  • spicewood oil
  • spicewood oil
  • sweet birch oil
  • sweet birch oil
  • sweet birch oil
  • teaberry oil
  • teaberry oil
  • teaberry oil
  • thera-gesic
  • wintergreen
  • wintergreen
  • wintergreen oil
  • wintergreen oil
  • wintergreen oil

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05411913Phase 3Jul 1, 2022Apothyx, Co.
NCT04900129Phase 1Dec 1, 2020Sher-E-Bangla Medical College
NCT02400320Phase 4Mar 1, 2016GlaxoSmithKline
NCT02874963N/ANov 1, 2015University Clinical Centre of Kosova, University of Ljubljana
NCT02666846Phase 1Mar 1, 2015Futura Medical Developments Ltd., Parexel
NCT03362216N/AApr 7, 2009Peking University
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Apothyx, Co.For profit1112022
Futura Medical Developments Ltd.For profit1112015
GlaxoSmithKlineFor profit1112016
ParexelFor profit1012015
Peking UniversityAcademic/Hospital1112009
Sher-E-Bangla Medical CollegeAcademic/Hospital1112020
University Clinical Centre of KosovaAcademic/Hospital1112015
University of LjubljanaAcademic/Hospital1012015
8 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Hisamitsu Pharmaceutical Co., Inc.For profitNDA2Feb 20, 2008
Hisamitsu Pharmaceutical Co., Inc.For profitNDAFeb 20, 2008