IBMX (3-Isobutyl-1-methylxanthine) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials lacking formal developmental phase classifications have evaluated IBMX exclusively for cystic fibrosis. Conducted by European academic and public research institutions, these completed studies utilized ex vivo intestinal current measurements and primary cell culture models to support personalized therapy. Together, these trials illustrate the application of IBMX as a functional diagnostic tool to assess CFTR ion channel activity in patient-derived tissues.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02807415	Completed	Cystic Fibrosis	Hannover Medical School\|Heidelberg University\|University of Giessen	2016-06-01	--
NCT03652090	Completed	Cystic Fibrosis	Institut National de la Santé Et de la Recherche Médicale France\|ABCF2	2010-09-01	--

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

Check the IBMX (3-Isobutyl-1-methylxanthine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IBMX acts as a broad-spectrum phosphodiesterase inhibitor that competitively binds enzymes including PDE3, PDE4, and PDE5, thereby preventing the enzymatic degradation of cyclic adenosine monophosphate and elevating intracellular cAMP concentrations. This intracellular cAMP accumulation triggers downstream protein kinase A signaling and ion channel phosphorylation, which facilitates the functional activation and gating of mutant CFTR channels to promote transepithelial chloride transport in cystic fibrosis research.

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>).