3-Indolebutyric acid (IBA) Clinical Trials

Size	Price	Qty
10mg	USD 197

Clinical Trials

A clinical trial is currently evaluating 3-indolebutyric acid and radiodynamic therapy using 5-aminolevulinic acid in patients with recurrent glioblastoma. Actively recruiting participants, this combined Phase I/II dose-escalation study is conducted through a collaboration between academic sponsor Universität Münster and industry partner photonamic GmbH & Co. KG. The initiative aims to establish the safety profile and therapeutic potential of the regimen in high-grade glioma clinical settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05590689	Recruiting	Glioblastoma	Universität Münster\|photonamic GmbH & Co. KG	2022-11-09	Phase 1\|Phase 2

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

Check the 3-Indolebutyric acid (IBA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

3-Indolebutyric acid acts as a functional plant auxin that binds to auxin receptor complexes, thereby modulating repressor degradation and downstream gene transcription to influence cellular division and growth pathways. In clinical research targeting glioblastoma, altering these core growth and signaling cascades provides a mechanistic approach to inhibit aberrant cellular proliferation and suppress recurrent tumor progression.

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>).