Mometasone Furoate Hydrate Clinical Trials

Size	Price	Qty
5mg	USD 70

Clinical Trials

Multiple clinical trials have evaluated mometasone furoate hydrate for its therapeutic application in chronic sinusitis, including a Phase 1 safety study sponsored by Lyra Therapeutics and a Phase 2 trial sponsored by Intersect ENT. These studies evaluated specialized sustained-release localized delivery systems, including biomedical drug depots and steroid-releasing sinus implants, to manage mucosal tissue inflammation. The trials have reached completed recruitment status, demonstrating an established clinical research effort focused on local corticosteroid delivery for upper respiratory chronic inflammatory disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02967731	Completed	Chronic Sinusitis	Lyra Therapeutics	2017-06-06	Phase 1
NCT01894503	Completed	Chronic Sinusitis	Intersect ENT	2013-06	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mometasone furoate hydrate acts as a synthetic glucocorticoid receptor agonist that selectively binds cytosolic glucocorticoid receptors, thereby inhibiting the transcription of pro-inflammatory cytokines and blocking downstream signaling pathways. This transcriptional suppression decreases inflammatory cell activation and local tissue edema, mitigating mucosal tissue hyperresponsiveness in conditions such as chronic sinusitis.

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>).