Imipramine HCl Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 370

Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate imipramine across diverse therapeutic areas, ranging from major depressive disorder, dysthymia, and functional dyspepsia to stress urinary incontinence, rosacea, and photosensitivity. Sponsored by academic and medical institutions—such as Wright State University, the New York State Psychiatric Institute, and the Chinese University of Hong Kong—these investigations encompass active, completed, terminated, and withdrawn statuses. Evaluated protocols assess both systemic efficacy and topical applications, including investigations into ultraviolet B-induced inflammation and microvesicle particle release.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06778434	RECRUITING	Actinic Keratosis; Imipramine; Photodynamic Therapy	VA Office of Research and Development	2025-04-01	PHASE2
NCT06312813	RECRUITING	Rosacea	Wright State University	2024-02-27	PHASE2
NCT07074756	RECRUITING	Glioma; Recurrent Glioma; Recurrent Glioblastoma	Mayo Clinic	2025-09-12
NCT05688904	RECRUITING	Imipramine; Photodynamic Therapy; Actinic Keratosis	Wright State University	2023-01-19	PHASE1
NCT04520217	RECRUITING	Photosensitivity; Microvesicle Particle	Wright State University	2022-06-06	PHASE1
NCT04863950	RECRUITING	Glioblastoma	The University of Texas Health Science Center at San Antonio	2022-05-25	PHASE2
NCT06778824	RECRUITING	Gut-Brain Disorders; GERD Without Erosive Esophagitis	Hualien Tzu Chi General Hospital	2024-04-02
NCT05677295	UNKNOWN	Women With Stress Urinary Incontinence	Far Eastern Memorial Hospital	2023-04-18	PHASE3
NCT06497647	UNKNOWN	Nocturnal Enuresis in Children	Sohag University	2024-03-01
NCT06312813	Recruiting	Rosacea	Wright State University	2024-02-27	Phase 2
NCT03960125	WITHDRAWN	Photodynamic Therapy; Microvesicle Particle	Wright State University	2021-03-29	EARLY_PHASE1
NCT04520217	Recruiting	Photosensitivity\|Microvesicle Particle	Wright State University	2022-06-06	Phase 1
NCT03122444	COMPLETED	Breast Cancer	The University of Texas Health Science Center at San Antonio	2019-07-05	EARLY_PHASE1
NCT04412876	WITHDRAWN	Stress Urinary Incontinence	Far Eastern Memorial Hospital	2020-05-31	PHASE3
NCT02374567	TERMINATED	Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders	Hannover Medical School	2015-01	PHASE3
NCT03102645	COMPLETED	Urinary Incontinence, Stress; Fecal Incontinence	Jonatan Kornholt	2017-05-16	PHASE1
NCT01179828	COMPLETED	Low Back Pain	Insel Gruppe AG, University Hospital Bern	2010-07	PHASE3
NCT01518634	COMPLETED	Somatisation Disorder; Somatoform Disorders	University of Aarhus	2012-01	PHASE2
NCT01896349	UNKNOWN	Treatment Resistant Depression	Hospital de Clinicas de Porto Alegre	2013-04
NCT01753128	COMPLETED	Gastroesophageal Reflux Disease	Mahidol University	2012-12	PHASE3
NCT01047488	UNKNOWN	Polyneuropathy	Odense University Hospital	2010-02	PHASE4
NCT00404755	COMPLETED	Major Depressive Disorder; Dysthymia	New York State Psychiatric Institute	2006-07	PHASE4
NCT00296725	COMPLETED	Major Depression; Dysthymia; Depressive Disorder Not Otherwise Specified	New York State Psychiatric Institute	1994-04	PHASE1; PHASE2
NCT01028014	COMPLETED	Urethral Sphincter Activity	University of Alabama at Birmingham	2010-04
NCT00164775	COMPLETED	Functional Gastrointestinal Disorder	Chinese University of Hong Kong	2005-06	PHASE3
NCT01107353	COMPLETED	Depression	Roxane Laboratories	2008-08
NCT00296777	COMPLETED	Major Depression; Dysthymia	New York State Psychiatric Institute	2004-12	PHASE4
NCT00206999	COMPLETED	Healthy Volunteers	Birte Glenthoj	2004-09
NCT00946764	COMPLETED	Depression	Sandoz	2005-07	PHASE1
NCT00004834	COMPLETED	Panic Disorder	Northwell Health	1998-05
NCT00693680	Completed	Major Depression	Polish Academy of Sciences\|Jagiellonian University	2005-01	Not Applicable
NCT00000464	COMPLETED	Arrhythmia; Cardiovascular Diseases; Heart Arrest; Heart Diseases; Myocardial Infarction; Ventricular Fibrillation	University of Washington	1987-04	PHASE3
NCT00227955	COMPLETED	Depression	University of Pittsburgh	1987-12	PHASE4
NCT00000518	COMPLETED	Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation	University of Utah	1985-07	PHASE3
NCT00005575	COMPLETED	Chest Pain	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1999-01	PHASE3
NCT00000390	COMPLETED	Depression	GEIGY Pharmaceuticals		PHASE2
NCT00000504	COMPLETED	Arrhythmia; Cardiovascular Diseases; Heart Diseases; Ventricular Arrhythmia	National Heart, Lung, and Blood Institute (NHLBI)	1982-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Imipramine functions primarily by inhibiting the presynaptic reuptake of serotonin and norepinephrine through binding to their respective monoamine transporters, thereby elevating synaptic neurotransmitter concentrations in the central and peripheral nervous systems. This enhanced monoaminergic signaling downstream modulates central pain pathways, neuroendocrine regulation, and cutaneous inflammatory responses, providing therapeutic efficacy in major depressive disorder, functional gastrointestinal disorders, and photosensitive skin conditions studied in clinical trials.

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>).