Pranlukast Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials have evaluated the therapeutic potential and pharmacokinetic profile of pranlukast across Phase 1 and Phase 3 studies. Sponsored by entities including Ono Pharmaceutical Co., Ltd., SamA Pharmaceutical Co., Ltd., and Organon and Co., these completed studies evaluated clinical efficacy in upper respiratory conditions—such as chronic sinusitis and seasonal allergic rhinitis—alongside single-dose pharmacokinetics in healthy volunteers. Collectively, these investigations reflect a focused clinical evaluation of pranlukast for managing inflammatory airway disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03826485	UNKNOWN	Healthy	SamA Pharmaceutical Co., Ltd	2019-04-01	PHASE1
NCT00410735	COMPLETED	Chronic Sinusitis	Ono Pharmaceutical Co., Ltd.	2006-12	PHASE3
NCT00127647	COMPLETED	Rhinitis, Allergic, Seasonal	Organon and Co	2004-11	PHASE3

(data from https://clinicaltrials.gov, updated on 2019-02-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pranlukast acts as a selective antagonist of cysteinyl leukotriene receptors, specifically binding to prevent downstream signaling triggered by leukotrienes C4, D4, and E4. By inhibiting leukotriene-mediated eosinophilic infiltration and vascular permeability, this receptor blockade attenuates mucosal airway inflammation, rendering it clinically relevant for treating conditions such as chronic sinusitis and seasonal allergic rhinitis.

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>).