Clinical Trials

A clinical trial sponsored by the University of Houston, an academic institution, evaluates the pharmacokinetic parameters and pharmacological features of dictamnine in healthy volunteers. This study currently has an unknown recruitment status and no formally designated trial phase listed in the record. Overall, the clinical research on dictamnine remains in an early exploratory stage.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04230057 Unknown status
Healthy Adults
University of Houston
 2019-12-12 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dictamnine interacts with microbial cellular targets to disrupt essential biochemical pathways, thereby compromising membrane integrity and suppressing pathogen proliferation. This inhibition of cellular growth drives its broad antimicrobial properties, providing the mechanistic context for clinical trial assessments investigating its pharmacokinetic properties in healthy adults.

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.