Suplatast Tosylate Clinical Trials

Size	Price	Qty
25mg	USD 88

Clinical Trials

A clinical trial sponsored by Melius Pharma AB is currently evaluating the safety and efficacy of suplatast tosylate (ME-015). This Phase 2, randomized, double-blind, placebo-controlled crossover study targets conditions such as idiopathic pulmonary fibrosis, fibrotic lung disease, chronic cough, and related respiratory symptoms. Presently active, not recruiting, the investigation continues to evaluate the therapeutic potential of the compound for fibrotic and airway-related pathologies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05983471	ACTIVE_NOT_RECRUITING	Idiopathic Pulmonary Fibrosis; Cough; IPF; Fibrotic Lung Disease; Chronic Cough; Coughing	Melius Pharma AB	2024-04-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-04-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Suplatast tosylate acts as a selective Th2 cytokine inhibitor that suppresses the synthesis of interleukin-4 and interleukin-5, thereby blocking downstream IgE production and preventing the infiltration of eosinophils and CD4+ T cells into respiratory tissues. By suppressing Th2-mediated inflammatory cascades and airway hyperresponsiveness, this mechanism provides a rational therapeutic basis for mitigating chronic cough and airway inflammation in conditions such as idiopathic pulmonary fibrosis.

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>).