Cilomilast Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 670

Clinical Trials

A completed Phase 3 clinical trial sponsored by the pharmaceutical company GlaxoSmithKline evaluated the safety, tolerability, and long-term therapeutic efficacy of Cilomilast for respiratory disorders, primarily chronic obstructive pulmonary disease. This late-stage evaluation provides valuable clinical data regarding the compound's performance in respiratory disease management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00103922	COMPLETED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2004-11	PHASE3

(data from https://clinicaltrials.gov, updated on 2016-10-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilomilast selectively binds to phosphodiesterase-4 (PDE4) and inhibits its catalytic activity, thereby preventing the degradation of cyclic adenosine monophosphate (cAMP) and elevating intracellular cAMP levels in inflammatory cells. This elevation of cAMP suppresses pro-inflammatory signaling and mediator release, ultimately reducing pulmonary inflammatory responses associated with chronic obstructive pulmonary disease.

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>).