Clinical Trials

A Phase 3 clinical trial sponsored by industry entity Edmond Pharma evaluated the long-term safety and therapeutic efficacy of Erdosteine in patients with chronic obstructive pulmonary disease (COPD) and chronic respiratory impairment. Although the trial's recruitment status is currently documented as unknown, this research reflects a focused effort to validate the compound's therapeutic benefits for chronic respiratory conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01032304 Unknown status
Chronic Obstructive Pulmonary Disease (COPD)
Edmond Pharma
 2009-08 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Erdosteine undergoes metabolic conversion to generate active thiol metabolites with free sulfhydryl groups that cleave disulfide bonds within mucin proteins while simultaneously inhibiting lipopolysaccharide-induced nuclear factor kappa B (NF-κB) activation. This combined mucolytic and anti-inflammatory mechanism reduces mucus viscosity and promotes mucociliary clearance, directly counteracting airway obstruction and hypersecretion in Chronic Obstructive Pulmonary Disease (COPD).

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.