Clinical Trials

Desipramine hydrochloride has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4, investigating major depressive disorder, anxiety, chronic pain, substance-related disorders, and pharmacokinetic drug interactions. Sponsored by academic medical centers, government entities, and pharmaceutical companies—including the University of Pennsylvania, the US Department of Veterans Affairs, and Vertex Pharmaceuticals—these studies demonstrate predominantly completed and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03548454 COMPLETED
Chronic Pain
Stanford University
 2018-09-20 PHASE4
NCT03726996 TERMINATED
Infantile Neuroaxonal Dystrophy
Duke University
 2019-01-14 PHASE4
NCT01265550 COMPLETED
GERD
VA Office of Research and Development
 2012-08-13 PHASE3
NCT02436031 COMPLETED
Sleep Apnea, Obstructive
Brigham and Women's Hospital
 2015-04 PHASE2
NCT02428478 COMPLETED
Sleep Apnea, Obstructive
Brigham and Women's Hospital
 2015-03 PHASE2
NCT00338962 COMPLETED
Alcoholism; Depression; PTSD
Yale University
 2001-10 PHASE3
NCT01899326 TERMINATED
DS (Durie/Salmon) Stage I Plasma Cell Myeloma; DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
Albert Einstein College of Medicine
 2013-09
NCT00964886 COMPLETED
Back Pain
VA Office of Research and Development
 2010-01 PHASE2
NCT00880594 TERMINATED
Irritable Bowel Syndrome
Washington University School of Medicine
 2009-02
NCT00990691 COMPLETED
Rett Syndrome
Assistance Publique Hopitaux De Marseille
 2009-02-17 PHASE2
NCT01411085 COMPLETED
Schizophrenia; Alcoholism; Dual Diagnosis
Dartmouth-Hitchcock Medical Center
 2011-12 PHASE2
NCT00220844 TERMINATED
Dyspepsia
Temple University
 2005-09
NCT01719861 TERMINATED
Small Cell Lung Cancer (SCLC); Neuroendocrine Tumors
Joel Neal
 2012-10 PHASE2
NCT00456014 COMPLETED
Depression
New York State Psychiatric Institute
 2006-09
NCT01358968 COMPLETED
Cancer
Eli Lilly and Company
 2011-06 PHASE1
NCT01153542 COMPLETED
In Development for Cystic Fibrosis
Vertex Pharmaceuticals Incorporated
 2010-06 PHASE1
NCT01415128 COMPLETED
Erectile Dysfunction
VIVUS LLC
 2010-04 PHASE1
NCT00166114 COMPLETED
Major Depressive Disorder
Emory University
 2002-02 PHASE4
NCT01478568 COMPLETED
Pharmacokinetics of Mirabegron; Healthy Subjects
Astellas Pharma Inc
 2008-10 PHASE1
NCT00500721 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-06 PHASE1
NCT00265291 COMPLETED
Major Depressive Disorder; Major Depression; Unipolar Depression
National Institute of General Medical Sciences (NIGMS)
 1999-11 PHASE2
NCT00018200 COMPLETED
Back Pain; Sciatica
US Department of Veterans Affairs
 1999-04 PHASE2
NCT00000271 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
New York State Psychiatric Institute
 1995-01 PHASE2
NCT02273466 COMPLETED
Healthy
Boehringer Ingelheim
 2002-02 PHASE1
NCT00000212 COMPLETED
Cocaine-Related Disorders
New York State Psychiatric Institute
 1987-07 PHASE2
NCT00913809 COMPLETED
Depression
Sandoz
 1987-12 PHASE1
NCT00913822 COMPLETED
Depression
Sandoz
 1987-12 PHASE1
NCT00913237 COMPLETED
Depression
Sandoz
 1987-07 PHASE1
NCT00000376 COMPLETED
Depression; Anxiety Disorders; Personality Disorders; Drug-resistant Depression
University of Pennsylvania
 1996-03
NCT00366652 COMPLETED
Depression; Depressive Disorder; Depressive Disorder, Major
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-09 PHASE3
NCT00004390 COMPLETED
Pain; Herpes Zoster
National Center for Research Resources (NCRR)
 1995-02 PHASE3
NCT00329147 COMPLETED
Depression
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-05 PHASE3
NCT00276068 COMPLETED
Vulvar Disease
University of Rochester
 2002-08
NCT00000321 COMPLETED
Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 1996-10 PHASE4
NCT00018733 COMPLETED
Depression
US Department of Veterans Affairs
 1996-09
NCT00320632 COMPLETED
Depression
Harvard Medical School (HMS and HSDM)
 1990-08 PHASE4
NCT00006157 COMPLETED
Irritable Bowel Syndrome; Constipation; Abdominal Pain; Functional Colonic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1996-07 PHASE3
NCT00000245 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 1994-05 PHASE2
NCT00914004 COMPLETED
Depression
Sandoz
 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Desipramine hydrochloride functions as a selective norepinephrine reuptake inhibitor by binding to the presynaptic norepinephrine transporter and blocking the reuptake of norepinephrine into presynaptic terminals. This blockade elevates synaptic norepinephrine levels and enhances noradrenergic neurotransmission in the central nervous system, relieving depressive symptoms and modulating central pain pathways relevant to major depressive disorder and chronic pain.

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>).

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Note: Technical data last updated: Sep 1, 2026.