Clinical Trials

Nadolol has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4 across diverse cardiovascular and neurological indications, including hypertension, chest pain, variceal bleeding, proliferating infantile hemangiomas, migraines, mild cognitive impairment, and Parkinson's disease dementia. Supported by commercial entities and academic institutions, these studies assess both therapeutic and prophylactic protocols, with overall recruitment statuses encompassing recruiting, completed, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06643221 RECRUITING
Leukemia; Hematopoetic Stem Cell Transplantation; Donor Lymphocyte Infusion; CAR T-Cell Therapy; Lymphoma; Cell Therapy
University of Arizona
2018-01-24 EARLY_PHASE1
NCT04739423 COMPLETED
Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia
CuraSen Therapeutics, Inc.
2021-06-28 PHASE2
NCT02505971 COMPLETED
Infantile Hemangioma
The Hospital for Sick Children
2015-09 PHASE3
NCT01804218 UNKNOWN
Mild Persistent Asthma, Uncomplicated
Invion, Inc.
2013-03 PHASE2
NCT01825122 COMPLETED
Smoking Cessation
Invion, Inc.
2014-03 PHASE2
NCT01010308 COMPLETED
Infantile Hemangioma
The Hospital for Sick Children
2009-11 PHASE2
NCT01103154 COMPLETED
Variceal Rebleeding
E-DA Hospital
2005-03 PHASE4
NCT01010308 Completed
Infantile Hemangioma
The Hospital for Sick Children
2009-11 Phase 2
NCT00921349 COMPLETED
Variceal Bleeding; Cirrhosis
National Science and Technology Council, Taiwan
2004-12 PHASE4
NCT00670267 COMPLETED
Asthma
Invion, Inc.
2007-01 PHASE1; PHASE2
NCT00647660 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2006-07 PHASE1
NCT00648297 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2006-08 PHASE1
NCT00910689 COMPLETED
Migraine Headache
Ohio University
2001-07 PHASE4
NCT00960245 COMPLETED
High Blood Pressure; Migraine Headaches; Chest Pain
Sandoz
1994-07 PHASE1
NCT00450164 COMPLETED
Gastrointestinal Hemorrhage; Portal Hypertension; Cirrhosis
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2000-11 PHASE4
NCT00567216 UNKNOWN
Liver Cirrhosis and Hepatoma.; Gastric Variceal Bleeding
Taipei Veterans General Hospital, Taiwan
2007-04 PHASE4
NCT00563602 UNKNOWN
Portal Hypertension; Complications of Cirrhosis
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2007-08 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nadolol functions as a non-selective antagonist of beta-1 and beta-2 adrenergic receptors, competitively inhibiting endogenous catecholamine binding and suppressing adenylyl cyclase activity to diminish downstream cyclic AMP signaling. This blockade reduces heart rate, cardiac contractility, and vascular tone, providing clinical efficacy in reducing high blood pressure and mitigating vascular complications such as variceal bleeding and proliferating infantile hemangioma.

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.