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.
Mechanism and Biochemical Profile
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.