Clinical Trials

Several clinical trials evaluate Terazosin Hydrochloride across Phase 1 through Phase 4 and non-phased designs for indications such as prostatic hyperplasia, hyperhidrosis, dementia with Lewy bodies, REM sleep behavior disorder, Parkinson's disease, and target engagement in healthy adults. Sponsored by academic medical centers, research foundations, and industry partners, these studies encompass completed, active, and upcoming protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04760860 Not yet recruiting
Dementia With Lewy Bodies
Qiang Zhang|University of Iowa
 2024-10 Phase 1|Phase 2
NCT04551040 Active not recruiting
Healthy
University of Iowa|Michael J. Fox Foundation for Parkinson''s Research
 2021-03-26 Phase 1
NCT04386317 Recruiting
REM Sleep Behavior Disorder|Pre-motor Parkinson''s Disease|Symptomatic Parkinson Disease
Cedars-Sinai Medical Center
 2020-11-01 Phase 2
NCT00449683 Completed
Hyperhidrosis
Thomas Jefferson University|National Alliance for Research on Schizophrenia and Depression
 2007-03 Phase 4
NCT00237510 Completed
Antidepressant Induced Excessive Sweating
Thomas Jefferson University
 2005-05 Not Applicable
NCT02244333 Completed
Prostatic Hyperplasia
Boehringer Ingelheim
 2004-02 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Terazosin Hydrochloride selectively binds to alpha-1 adrenergic receptors, blocking adrenaline-mediated receptor activation and downstream intracellular signaling cascades in smooth muscle cells. This target inhibition induces smooth muscle relaxation in vascular and prostatic tissues, providing a mechanism relevant to reducing urinary resistance in prostatic hyperplasia and modulating adrenergic responses studied in neurodegenerative and hyperhidrosis 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>).

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