Clinical Trials

A clinical trial sponsored by Rockefeller University evaluated the genetic basis underlying human odor discrimination and sensory perception in response to (-)-Carvone among non-smokers. This completed observational study lacked a formal interventional phase, employing an epidemiological and physiological framework to assess olfactory receptor responses to monoterpene compounds. Currently, the clinical landscape for (-)-Carvone remains specialized, with no active or recruiting interventional studies documented.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01039935 Completed
Non-smokers
Rockefeller University
 2009-11 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the (-)-Carvone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(-)-Carvone irreversibly binds to and inhibits acetylcholinesterase, which blocks the hydrolysis of acetylcholine and leads to hyperaccumulation of the neurotransmitter at synaptic junctions. This sustained cholinergic disruption triggers severe neuromuscular toxicity in pest species while providing a functional basis for assessing olfactory sensory processing in human clinical trials involving non-smokers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.