Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 are evaluating Terazosin across various therapeutic areas. Beyond its established indication for benign prostatic hyperplasia, research extends to neurodegenerative disorders—including Parkinson's disease, amyotrophic lateral sclerosis, and dementia with Lewy bodies—as well as hyperhidrosis and carotid artery stenosis. Sponsored by academic institutions, research foundations, and pharmaceutical companies, these protocols encompass completed, actively recruiting, active non-recruiting, and pending studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07796308 NOT_YET_RECRUITING
Alzheimer s Disease
Qiang Zhang
2027-08-01 PHASE2
NCT07207057 RECRUITING
Parkinsons Disease (PD)
University College, London
2025-09-12 PHASE3
NCT04760860 NOT_YET_RECRUITING
Dementia With Lewy Bodies
Qiang Zhang
2027-10 PHASE1; PHASE2
NCT07288450 NOT_YET_RECRUITING
Parkinson's Disease
Nandakumar Narayanan
2026-09-01 PHASE1; PHASE2
NCT07464028 NOT_YET_RECRUITING
Parkinson's Disease (PD)
Nandakumar Narayanan
2026-07-01 PHASE2
NCT07224269 RECRUITING
Amyotrophic Lateral Sclerosis; Adenosine Triphosphate Activities
University of Iowa
2026-08-12 EARLY_PHASE1
NCT06966804 RECRUITING
Stent Related Symptoms
Penang Hospital, Malaysia
2025-06-01 PHASE3
NCT05855577 UNKNOWN
Parkinson Disease; Gait Analysis; Therapy, Directly Observed; Metabolic Disease
I.R.C.C.S. Fondazione Santa Lucia
2023-12 PHASE4
NCT05109364 ACTIVE_NOT_RECRUITING
Symptomatic Parkinson Disease; REM Sleep Behavior Disorder; Pre-motor Parkinson's Disease
Cedars-Sinai Medical Center
2022-09-23 PHASE2
NCT04386317 ACTIVE_NOT_RECRUITING
REM Sleep Behavior Disorder; Pre-motor Parkinson's Disease; Symptomatic Parkinson Disease
Cedars-Sinai Medical Center
2020-11-01 PHASE2
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
2021-03-26 PHASE1
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
NCT03905811 COMPLETED
Parkinson Disease
Jordan Schultz
2019-09-24 PHASE1; PHASE2
NCT02046395 COMPLETED
Type 2 Diabetes; Hypertension
Tulane University School of Medicine
2012-01 PHASE4
NCT03195673 UNKNOWN
Carotid Artery Stenosis
Capital Medical University
2018-03-02 PHASE2
NCT01508637 UNKNOWN
Cardiovascular Effects
University of Washington
2012-01
NCT00449683 COMPLETED
Hyperhidrosis
Thomas Jefferson University
2007-03 PHASE4
NCT01530243 COMPLETED
Disorder of Urinary Stent
Urmia University of Medical Sciences
2012-01 PHASE2; PHASE3
NCT01366664 COMPLETED
Ejaculation
Janssen Research & Development, LLC
2011-04 PHASE1
NCT00700583 COMPLETED
Nocturia
Seoul National University Hospital
2008-05
NCT00449683 Completed
Hyperhidrosis
Thomas Jefferson University|National Alliance for Research on Schizophrenia and Depression
2007-03 Phase 4
NCT00693199 COMPLETED
Lower Urinary Tract Symptoms; Hypertension
Anhui Medical University
2006-07
NCT00237510 COMPLETED
Antidepressant Induced Excessive Sweating
Thomas Jefferson University
2005-05
NCT00237510 Completed
Antidepressant Induced Excessive Sweating
Thomas Jefferson University
2005-05 Not Applicable
NCT02244333 Completed
Prostatic Hyperplasia
Boehringer Ingelheim
2004-02 --
NCT00563485 TERMINATED
Prostatic Hyperplasia; Urinary Retention
Hospital Authority, Hong Kong
2005-10

(data from https://clinicaltrials.gov, updated on 2026-09-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Terazosin selectively binds to post-junctional alpha-1 adrenoceptors, competitively inhibiting catecholamine-induced activation and downstream intracellular calcium mobilization within target tissues. This signaling blockade promotes smooth muscle relaxation in vascular beds and the prostate stroma, thereby reducing peripheral vascular resistance and alleviating urinary outflow obstruction in clinical conditions such as benign prostatic hyperplasia and associated neurodegenerative disorders 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>).

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