Drug

Levomenthol

As of the edition of 20 October 2026, Levomenthol is a small molecule: marketed, first approved in 1945 (CH); acts on TRPM8.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2010
Kind
Small molecule
Brand name
Dul-X Classic
First approved
30 November 1945 (CH)
Approvals on record
6 in 4 regions
Holder of the most recent approval
Reckitt Benckiser; 4 holders in all
Registered trials
6, 1 stopped early
Disease areas
Lungs and airways; Skin and connective tissue; Immune system; Nervous system

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Levomenthol.

Target

GeneProteinUniProt
TRPM8Transient receptor potential cation channel subfamily M member 8Q7Z2W7

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated2001
Phase 23120
Phase 31000
All trials6

Who has held its approvals

CompanyRoleYears
Reckitt BenckiserApplicant2006 to now
Nihon PharmaceuticalApplicant2010 to now