Coluracetam Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A clinical trial sponsored by BrainCells Inc. evaluated the therapeutic efficacy and safety of Coluracetam in adult participants. This completed Phase 2 investigation targeted major depressive disorder and co-morbid anxiety using a randomized, double-blind, placebo-controlled design over a six-week period. Overall, these findings highlight targeted mid-stage clinical research into the compound's potential to modulate mood and affective conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00621270	Completed	Major Depressive Disorder\|Anxiety	BrainCells Inc.	2008-01	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Coluracetam enhances high-affinity choline uptake at presynaptic cholinergic terminals, thereby stimulating the rate-limiting step of acetylcholine biosynthesis and elevating central cholinergic neurotransmission. This potentiation of cholinergic signaling promotes neuroplasticity and cognitive function, offering clinical relevance for the treatment of major depressive disorder and anxiety.

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>).