Drugs / Menthol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SALONPAS | — | 2008-02-20 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07030725 | Mar 2025 → Mar 2026 overdue | — | Indiana University | Recruiting | No outcome recorded |
| Phase 0 | NCT06811051 | Jan → Oct 2025 | pharyngitis | Atlas University | Unknown | No outcome recorded |
| Phase 0 | NCT06444594 | Jul 2024 → Dec 2025 overdue | premature aging syndrome | Penn State University | Recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05106400 | Jul 2021 | — | Scilex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04900129 | Dec 2020 | COVID-19 | Sher-E-Bangla Medical College | Completed | No outcome recorded |
| Phase 1 | NCT02201238 | Oct → Nov 2014 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02192203 | Apr → Jul 2014 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00299559 | Mar → Aug 2006 | common cold | Technical University Dresden | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07693400 | Apr 2026 → Feb 2028 expected | atopic eczema | Taiwan Municipal An-Nan Hospital-China Medical University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07294469 | Dec 2025 → Jul 2027 expected | Parkinson disease | Taipei Medical University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07109609 | Aug → Nov 2025 overdue | dry eye syndrome | Reinhold Vieth | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07693387 | May 2025 → Jan 2027 expected | chemotherapy-induced neuropathy | Taiwan Municipal An-Nan Hospital-China Medical University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05877079 | May 2023 → Jun 2024 | ischemic stroke | Taipei Medical University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01855607 | Aug 2013 → Nov 2016 | breast cancer, colorectal cancer, peripheral neuropathy | Columbia University | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07482046 | May → Oct 2023 | exercise-induced malignant hyperthermia | Taisho Pharmaceutical Indonesia | Completed | No outcome recorded |
| Phase 2/3 | NCT04351594 | Nov 2020 → Jan 2024 | osteoarthritis, knee | Memorial University of Newfoundland | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07475663 | Nov 2025 → Feb 2026 | epicondylitis, osteoarthritis, knee, patellofemoral pain syndrome, tenosynovitis of foot and ankle | Taisho Pharmaceutical Indonesia | Completed | No outcome recorded |
| Phase 3 | NCT02581397 | May 2015 → Dec 2016 | — | Ache Laboratorios Farmaceuticos S.A. | Terminated | No outcome recorded |
| Phase 3 | NCT02100670 | Nov 2013 → Mar 2015 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01411189 | Sep 2011 → May 2012 | gastric adenoma, gastric cancer, tubular adenoma | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01119534 | May → Oct 2011 | — | Azidus Brasil | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06503029 | Jul 2024 → Jan 2025 overdue | malposition of teeth with or without hypodontia/oligodontia, poisoning | Riyadh Elm University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05302804 | May → Oct 2022 | — | University of Nebraska | Completed | No outcome recorded |
| Phase 4 | NCT03888820 | Mar 2018 → Mar 2019 overdue | chronic pain syndrome | Sport and Spine Rehab Clinical Research Foundation | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03888807 | Mar 2018 → Jul 2024 | osteoarthritis, knee | Sport and Spine Rehab Clinical Research Foundation | Terminated | No outcome recorded |
| Phase 4 | NCT03179735 | Jun 2017 → Mar 2018 | gingivitis | University of Taubate | Unknown | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07501962 | Apr → Dec 2026 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| — | NCT07162454 | Nov 2024 → May 2025 | diabetic polyneuropathy | Universidad Complutense de Madrid | Completed | No outcome recorded |
| — | NCT04677985 | May → Oct 2019 | disease of the tendon | Memorial University of Newfoundland | Completed | No outcome recorded |
| — | NCT03506178 | Sep 2017 → May 2018 | obstructive sleep apnea syndrome | Beijing Tongren Hospital | Unknown | No outcome recorded |
| — | NCT02102100 | Mar 2014 → Jul 2016 | nicotine dependence | Yale University | Completed | No outcome recorded |
| — | NCT03012503 | Jan → May 2013 | — | Marquette University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06106880 Comparator | May 2022 → Apr 2023 | Achoo syndrome, common cold, headache disorder, pharyngitis +1 | Applied Biological Laboratories Inc | Completed | No outcome recorded |
| Phase 1 | NCT02666846 Comparator | Mar → May 2015 | — | Futura Medical Developments Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02169154 Comparator | Jun → Jul 2014 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02728687 Background | Mar 2017 → Mar 2020 | diabetic polyneuropathy | University of British Columbia | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04484428 Comparator | Aug 2020 → Mar 2021 | — | Kowa Research Institute, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04276727 Comparator | Nov 2019 → Mar 2022 | chemotherapy-induced neuropathy | University of Edinburgh | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01408446 Comparator | Aug 2012 → Jun 2013 | hypertensive disorder | Zhiming Zhu | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01565070 Comparator | Apr → Oct 2012 | osteoarthritis, knee | University of Chile | Withdrawn | No outcome recorded |
| Phase 3 | NCT01411176 Comparator | Sep 2011 → May 2012 | gastric cancer | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02984072 Comparator | Oct 2018 → Oct 2019 | actinic keratosis | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT02400320 Background | Mar → Jun 2016 | irritant dermatitis | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02749123 Comparator | Apr → May 2016 | arthritic joint disease | J.A.R. Laboratories | Unknown | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Menthol | “The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the...” NCT03888820 ↗43“The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the...” NCT03888807 ↗ “Five minutes before cervical manipulation, controls received a placebo gel applied to their neck while the treatment group received a menthol containing gel (Biofreeze®)...” NCT03012503 ↗ “The gel contains 0.5% Piroxicam as the anti-inflammatory agent, combined with three counterirritants: Methyl Salicylate, Menthol, and Eugenol.” NCT07475663 ↗ “Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.” NCT06503029 ↗ “containing a fixed combination of four essential oils (eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%)” NCT03179735 ↗ “The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.” NCT06106880 ↗ “Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.” NCT02400320 ↗ “received a topical cream with cannabidiol, Urea 10%, arnica and menthol as active ingredients” NCT07162454 ↗ “Each Suppository Transpulmin contains eucalyptol, menthol, camphor and guaiacol.” NCT02581397 ↗ “Biofreeze® is a topical ointment that has menthol and alcamphor.” NCT01565070 ↗ “Biofreeze gel with active manufactured ingredient (Menthol 4%)” NCT04351594 ↗ “gel containing either menthol (3%) or placebo” NCT04276727 ↗ “menthol gel 4-10%” NCT06444594 ↗ |
| Action | Activate | “TRPM8 activation by menthol attenuated vasoconstriction” PMID 24637663 ↗ Mar 2014 |
| Modality | Small molecule | “Menthol, a natural terpenoid compound found in peppermint oil” NCT07501962 ↗ |
| Route | Topical | “application to skin” NCT00299559 ↗ |
| Target | TRPM8 | “TRPM8 activation by menthol attenuated vasoconstriction via RhoA/Rho kinase pathway inhibition” PMID 24637663 ↗ Mar 2014 |