3-Indolepropionic acid Clinical Trials

Size	Price	Qty
25mg	USD 70
1g	USD 970

Clinical Trials

Multiple clinical trials investigate 3-indolepropionic acid and its associated metabolic pathways for conditions including spinal cord injuries, polytrauma, burns, and attention deficit hyperactivity disorder. Featuring non-traditional or observational protocols with unspecified or Not Applicable phase designations, a clinical trial sponsored by Spaulding Rehabilitation Hospital and the National Institute on Drug Abuse is actively recruiting. Meanwhile, a clinical trial sponsored by National Taiwan University Hospital currently retains an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05351333	Recruiting	Spinal Cord Injuries\|Polytrauma\|Burns	Spaulding Rehabilitation Hospital\|National Institute on Drug Abuse (NIDA)	2022-08-03	Not Applicable
NCT03901859	Unknown status	Attention Deficit Hyperactivity Disorder	National Taiwan University Hospital	2019-04-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

3-Indolepropionic acid functions as a gut microbial metabolite that scavenges reactive oxygen species and neutralizes free radicals, thereby inhibiting downstream lipid peroxidation and oxidative stress pathways. This biochemical activity protects cellular structures from damage, providing neuroprotective effects that are clinically relevant to conditions such as spinal cord injuries and attention deficit hyperactivity disorder.

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>).