Butyl isobutyl phthalate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials involve observational and interventional protocols evaluating conditions such as pregnancy-related pelvic girdle pain, metastatic prostate cancer, chronic shoulder pain, and post-cardiac surgery intensive care. Characterized by unassigned phase classifications, these studies report recruitment statuses ranging from completed and recruiting to unknown. Project sponsorship encompasses academic institutions, clinical research centers, and commercial entities.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05990361	Completed	Pregnancy-Related Pelvic Girdle Pain	Muş Alparlan University	2023-04-24	--
NCT04746300	Recruiting	Metastatic Prostate Cancer	Radboud University Medical Center\|VGZ health insurance (NL)\|Paul Speth Foundation (NL)\|Radboud Oncology Fund (NL)	2020-02-04	--
NCT04081987	Unknown status	Post-cardiac Surgery\|Intensive Care Unit Patients	BiPS Medical\|Tel-Aviv Sourasky Medical Center\|Carmel Medical Center	2019-11-20	--
NCT02738372	Completed	Chronic Shoulder Pain	University of Malaga	2016-11	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Butyl isobutyl phthalate acts as a non-competitive inhibitor of α-glucosidase with an IC50 of 38 μM, thereby preventing the enzymatic breakdown of complex carbohydrates into absorbable monosaccharides in the intestinal tract. This inhibition reduces postprandial glucose absorption and lowers blood glucose levels, establishing a biochemical rationale for glycemic control in clinical study contexts such as metastatic prostate cancer, pregnancy-related pelvic girdle pain, chronic shoulder pain, and post-cardiac surgery care.

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>).