Clinical Trials

Multiple clinical trials evaluate the clinical applications of this compound in endodontic interventions, specifically addressing dental pulp disease, irreversible pulpitis, and pulpotomy outcomes in primary and young permanent molars. Classified as phase not applicable, these studies are sponsored by academic institutions, including the British University in Egypt and Suez Canal University. Current recruitment statuses range from actively recruiting to unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06227390 Recruiting
Pulp Disease Dental
British University In Egypt
2023-10-15 Not Applicable
NCT04243733 Unknown status
Irreversible Pulpitis
Suez Canal University
2018-10-10 Not Applicable

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

Check the 5'-Deoxy-5'-(methylthio)adenosine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

5'-Deoxy-5'-(methylthio)adenosine functions as a nucleoside agonist that selectively binds adenosine receptors (A1, A2A, A2B, and A3), modulating downstream adenylate cyclase activity and cAMP-mediated signaling cascades to attenuate cellular inflammatory responses. Through this purinergic receptor activation, the compound limits tissue damage and promotes cellular preservation, providing therapeutic relevance for inflammatory endodontic conditions such as dental pulp disease and irreversible pulpitis.

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>).

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