Health Canada Santé Canada STATUS DECISION OF CONTROLLED AND NON-CONTROLLED SUBSTANCE(S) Substance: N-(1-Methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1H-indazole-3carboxamide Based on the current information available to the Office of Controlled Substances, it appears that the above substance is: Controlled Not Controlled ☐ X under the schedules of the Controlled Drugs and Substances Act (CDSA) for the following reason(s): The efficacy of N-(1-methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1Hindazole-3-carboxamide as a cannabinoid receptor agonist has not been established and therefore the substance cannot be included under item 1 of Schedule II to the CDSA. Prepared by: _______________________________________ Vincent Marleau Date: _______________ Verified by: Date: ________________ _______________________________________ Manager, NCED, OCS Approved by: _______________________________________ Date: ________________ DIRECTOR, OFFICE OF CONTROLLED SUBSTANCES This status was requested by: “third party information removed as per agreement with applicant” Drug Status Report Drug: N-(1-Methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1H-indazole-3carboxamide Drug Name Status: N-(1-Methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1Hindazole-3-carboxamide is the common name. Chemical Name: N-(2-Phenylpropan-2-yl)-1-((tetrahydro-2H-pyran-4-yl)methyl)-1H-indazole3-carboxamide Chemical structure: Molecular Formula: C23H27N3O2 CAS-RN: 1400742-50-8 Pharmacological class / Application: Synthetic cannabinoid International status: US: N-(1-Methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1H-indazole-3carboxamide is not listed specifically in the Schedules to the US Controlled Substances Act and is not mentioned anywhere on the DEA website. United Nations: The substance is not listed on the Yellow List - List of Narcotic Drugs under International Control, the Green List - List of Psychotropic Substances under International Control, nor the Red List - List of Precursors and Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances under International Control. Canadian Status: N-(1-Methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1Hindazole-3-carboxamide is not listed in the Schedules to the CDSA. The substance is a synthetic cannabinoid but there are currently no reports in the scientific literature on the efficacy of the substance as a cannabinoid receptor agonist. Cannabinoid receptor agonists are captured under item 1 of Schedule II to the CDSA by virtue of being “similar synthetic preparations” while cannabinoid receptor antagonists are excluded from item 1 of Schedule II to the CDSA. Since it cannot be established whether N-(1-methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4yl)methyl]-1H-indazole-3-carboxamide is an efficient cannabinoid receptor agonist, the substance cannot be included under item 1 of Schedule II to the CDSA. Recommendation: N-(1-Methyl-1-phenylethyl)-1-[(tetrahydro-2H-pyran-4-yl)methyl]-1Hindazole-3-carboxamide is not included in the schedules to the CDSA and is not a controlled substance. Date: November 12th, 2013.