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menthol

Trade name: Salonpas

Small moleculeapproved

Approved

Feb 20, 2008

Menthol, (+)- is a fragrance ingredient used in decorative cosmetics, fine fragrances, shampoos, toilet soaps and other toiletries as well as in non-cosmetic products such as household cleaners and detergents. Recent investigations have provided evidence for menthol to increase cough thresholds. Racementhol is used as a topical analgesic. — NCATS

Clinical trial activity

67 trials · 63 clinical orgs · 1 marketing orgs

Phase 1
14
Phase 2
21
Phase 3
14
Phase 4
7

Earliest trial started Jun 1, 2004 (NCT00202956)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

  3. Feb 20, 2008

    Hisamitsu Pharmaceutical Co., Inc. — Earliest FDA Approval

  4. Feb 20, 2008

    Hisamitsu Pharmaceutical Co., Inc. — NDA Secondary Org

  5. Feb 20, 2008

    Hisamitsu Pharmaceutical Co., Inc. — NDA Organization

2010s

  1. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFeb 20, 2008

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O
Mol. weight
156.2652 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • (1alpha,2beta,5alpha)-5-methyl-2(1-methylethyl)cyclohexanol
  • (1alpha,2beta,5alpha)-5-methyl-2(1-methylethyl)cyclohexanol
  • (1r-(1-alpha,2-beta,5-alpha))-5-methyl-2-(1-methylethyl)cyclohexanol
  • (1r-(1-alpha,2-beta,5-alpha))-5-methyl-2-(1-methylethyl)cyclohexanol
  • (-)-(1r,3r,4s)-menthol
  • (-)-(1r,3r,4s)-menthol
  • (1r,3r,4s)-(-)-menthol
  • (1r,3r,4s)-(-)-menthol
  • aqua-cool
  • aquasoothe
  • arjun
  • bugusan
  • catarrh
  • dermacool
  • dl-menthol
  • dl-menthol
  • fisherman's friend lozenges
  • fisherman's friend lozenges
  • halls
  • hexahydrothymol
  • karvol
  • levomenthol
  • levomenthol
  • levomenthol
  • levomenthol
  • levomentholum
  • levomentholum
  • levomentol
  • levomentol
  • l-menthol
  • l-menthol
  • l-menthol
  • l-(-)-menthol
  • l-(-)-menthol
  • lockets
  • meggezones
  • menthacamphor
  • menthol
  • menthol
  • menthol
  • menthol
  • menthol
  • menthol
  • menthol
  • menthol
  • menthol
  • (-)-menthol
  • (-)-menthol
  • (-)-menthol
  • (+)-menthol
  • menthomenthol
  • muirs
  • (r)-(-)-menthol
  • (r)-(-)-menthol
  • therapeutic mineral ice
  • therapeutic mineral ice
  • thymomenthol
  • tixylix decongestant inh
  • vocalzone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07109609Phase 2Aug 17, 2025Stearacl Inc
NCT05932745N/AJun 20, 2025National Institute on Drug Abuse (NIDA), Yale University
NCT07030725Early Phase 1 (Phase 1)Mar 27, 2025Indiana University
NCT06857760N/AFeb 21, 2025Ondokuz Mayıs University
NCT06811051Early Phase 1 (Phase 1)Jan 25, 2025Atlas University, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
NCT06444594Early Phase 1 (Phase 1)Jun 15, 2024Pennsylvania State University
NCT05932693N/AJan 31, 2024National Institute on Drug Abuse (NIDA), Yale University
NCT05888597Phase 2May 24, 2023Lund University, Region Skane
NCT05877079Phase 4May 20, 2023China Medical University, Chung Shan Medical University, Taipei Medical University
NCT05632692N/AApr 10, 2023University of Porto
NCT05785026N/AJan 1, 2023Katholieke Universiteit Leuven
NCT05429814N/AJul 1, 2022Necmettin Erbakan University
NCT05302804Phase 4May 1, 2022University of Montana, University of Nebraska
NCT05106400Phase 1Jul 1, 2021Scilex Pharms Inc, University of California, San Francisco
NCT04711044N/AFeb 1, 2021Aalborg University
NCT04900129Phase 1Dec 1, 2020Sher-E-Bangla Medical College
NCT04484428Phase 2Aug 15, 2020Kowa
NCT04351594Phase 2/Phase 3 (Phase 3)Jun 1, 2020Memorial University of Newfoundland
NCT04994262N/AMay 1, 2020Saglik Bilimleri Universitesi
NCT04276727Phase 2Nov 4, 2019NHS Lothian, University of Edinburgh
Showing 20 of 67 trials
Page 1 / 4

Organizations

Research & Development (63)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Nihon Pharmaceutical Co., LtdFor profit7722008
GlaxoSmithKlineFor profit6532006
Yale UniversityAcademic/Hospital6622014
Aalborg UniversityAcademic/Hospital4412014
AzidusFor profit2212011
Memorial University of NewfoundlandAcademic/Hospital2222019
National Institute on Drug Abuse (NIDA)Government2012024
SandozFor profit2212017
Universidade Estadual de LondrinaAcademic/Hospital2012017
University of Sao PauloAcademic/Hospital2212017
Atlas UniversityAcademic/Hospital1112025
Bakirkoy Dr. Sadi Konuk Research and Training HospitalAcademic/Hospital1012025
Capital Medical UniversityAcademic/Hospital1112017
China Medical UniversityAcademic/Hospital1012023
Chung Shan Medical UniversityAcademic/Hospital1012023
Clinica Quirón Salud, CórdobaAcademic/Hospital1012019
Futura Medical Developments Ltd.For profit1112015
Government of RussiaGovernment1112018
Groupe Hospitalier du HavreAcademic/Hospital1112018
Hospital de MataróAcademic/Hospital1112013
63 organizations
Page 1 / 4

Marketing (2)

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