Clinical Trials

Several clinical trials evaluate therapeutic interventions across neurodegenerative, cardiovascular, and auditory conditions. Actively recruiting Phase 2 academic studies, including those sponsored by Cedars-Sinai Medical Center, assess treatments for pre-motor Parkinson's disease, symptomatic Parkinson's disease, and REM sleep behavior disorder, whereas a Phase 4 trial sponsored by Xuzhou Central Hospital evaluates coronary heart disease therapies with an unknown recruitment status. Additionally, completed Phase 1 trials sponsored by Frequency Therapeutics have assessed safety in patients with sensorineural, noise-induced, and sudden hearing loss, as well as presbycusis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05109364 Recruiting
Symptomatic Parkinson Disease|REM Sleep Behavior Disorder|Pre-motor Parkinson''s Disease
Cedars-Sinai Medical Center
 2022-09-23 Phase 2
NCT04826497 Unknown status
Coronary Heart Disease
Xuzhou Central Hospital
 2021-04 Phase 4
NCT04386317 Recruiting
REM Sleep Behavior Disorder|Pre-motor Parkinson''s Disease|Symptomatic Parkinson Disease
Cedars-Sinai Medical Center
 2020-11-01 Phase 2
NCT04629664 Completed
Hearing Loss Sensorineural|Noise Induced Hearing Loss|Sudden Hearing Loss
Frequency Therapeutics
 2020-11-02 Phase 1
NCT04601909 Completed
Presbycusis|Hearing Loss Sensorineural|Noise Induced Hearing Loss|Sudden Hearing Loss
Frequency Therapeutics
 2020-09-17 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Wilforine directly binds to and inhibits the efflux activity of P-glycoprotein (P-gp), thereby blocking ATP-dependent substrate transport across cell membranes. This blockade decreases cellular drug efflux and increases intracellular accumulation, enhancing therapeutic penetration across physiological barriers relevant to clinical conditions such as Parkinson's disease and sensorineural hearing loss.

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.