Disodium Cromoglycate Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple completed Phase 2 clinical trials have evaluated the therapeutic potential of Disodium Cromoglycate in respiratory management, specifically targeting exercise-induced asthma. Sponsored by industry partners including MEDA Pharma, ClinResearch, Sanofi, and Viatris, these investigations assessed the drug's protective efficacy both as a monotherapy and within fixed-dose combinations. Overall, these evaluations provide established clinical evidence regarding the ability of Disodium Cromoglycate to prevent exercise-triggered airway hyperresponsiveness.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00777348	COMPLETED	Asthma, Exercise-Induced	MEDA Pharma GmbH & Co. KG	2007-11	PHASE2
NCT00777348	Completed	Asthma Exercise-Induced	MEDA Pharma GmbH & Co. KG\|ClinResearch GmbH\|Sanofi\|Viatris Inc.	2007-11	Phase 2

(data from https://clinicaltrials.gov, updated on 2022-02-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Disodium Cromoglycate functions as a mast cell stabilizer by blocking chloride channels and preventing extracellular calcium influx, which suppresses mast cell degranulation and the subsequent release of inflammatory mediators such as histamine and leukotrienes. This inhibition prevents early and late-phase allergic airway cascades, offering therapeutic relevance by mitigating bronchoconstriction and bronchial hyperreactivity in patients with exercise-induced asthma.

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>).