Clomipramine HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple Phase 3 clinical trials sponsored by organizations including Biohaven Pharmaceuticals Inc. and AstraZeneca evaluate clomipramine hydrochloride regimens for Obsessive-Compulsive Disorder. These studies encompass both completed investigations and trials currently enrolling by invitation for long-term open-label safety evaluation. Overall, these late-phase clinical efforts reflect ongoing research into optimizing treatment protocols for obsessive-compulsive manifestations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04708834	Enrolling by invitation	Obsessive Compulsive Disorder	Biohaven Pharmaceuticals Inc.	2021-03-30	Phase 3
NCT00254735	Completed	Obsessive Compulsive Disorder	AstraZeneca	2002-04	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clomipramine hydrochloride functions as a potent inhibitor that binds the serotonin transporter alongside norepinephrine and dopamine transporters, thereby blocking presynaptic serotonin reuptake and increasing synaptic monoamine availability. This accumulation alters downstream monoaminergic neurotransmission and synaptic plasticity, which ultimately contributes to symptom reduction and behavioral regulation in obsessive-compulsive 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>).