Clinical Trials
Numerous clinical trials, ranging from Early Phase 1 to Phase 4 alongside unassigned studies, evaluate isoprenaline for cardiovascular and autonomic nervous system disorders, including out-of-hospital cardiac arrest, cardiac arrhythmias, long QT syndrome, postural tachycardia syndrome, and orthostatic hypotension. Sponsored largely by academic medical centers and universities such as Vanderbilt University Medical Center, the University of Southern Denmark, and the University of Calgary, these protocols encompass completed, actively recruiting, and upcoming studies.
| 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 |
| NCT06473116 | NOT_YET_RECRUITING | Out-Of-Hospital Cardiac Arrest |
University of Southern Denmark |
2025-03 | PHASE4 |
| NCT05997732 | RECRUITING | Vasoconstriction; Vasodilation |
University of Alberta |
2023-10-31 | PHASE4 |
| NCT05219799 | RECRUITING | Obesity; Vasodilation; Healthy |
University of Missouri-Columbia |
2023-03-14 | EARLY_PHASE1 |
| NCT06520982 | RECRUITING | Women; Sympathetic Nervous System; Aging; Blood Flow |
University of Missouri-Columbia |
2024-09-20 | EARLY_PHASE1 |
| NCT02725060 | ENROLLING_BY_INVITATION | Postural Orthostatic Tachycardia Syndrome; Postural Tachycardia Syndrome; Tachycardia; Arrhythmias, Cardiac; Autonomic Nervous System Diseases; Orthostatic Intolerance; Cardiovascular Diseases; Primary Dysautonomias |
Vanderbilt University Medical Center |
2016-02 | |
| NCT06082388 | UNKNOWN | Cardiac Arrhythmia; Supraventricular Arrhythmia |
Medical University of Lodz |
2023-11-09 | |
| NCT02615119 | COMPLETED | Anorexia Nervosa; Major Depressive Disorder; Generalized Anxiety Disorder; Panic Disorder; Brain Injury |
Laureate Institute for Brain Research, Inc. |
2015-10-01 | |
| NCT03019081 | UNKNOWN | Anorexia Nervosa |
Laureate Institute for Brain Research, Inc. |
2017-01 | |
| NCT00748059 | COMPLETED | Autonomic Nervous System Diseases; Orthostatic Hypotension; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Intolerance |
Vanderbilt University Medical Center |
1996-12 | PHASE1 |
| NCT04303689 | Completed | Essential Hypertension |
University of Copenhagen|University of Aarhus |
2020-08-01 | Not Applicable |
| NCT02726620 | COMPLETED | Hypotension |
Vanderbilt University Medical Center |
2017-01-05 | |
| NCT02524145 | COMPLETED | Heart Failure |
University of Texas Southwestern Medical Center |
2015-06 | |
| NCT03032965 | COMPLETED | Atrial Fibrillation |
University of Michigan |
2011-10 | PHASE2 |
| NCT02286934 | COMPLETED | Healthy |
Seoul National University Hospital |
2014-09 | PHASE1 |
| NCT01377636 | COMPLETED | Intraoperative Awareness |
NYU Langone Health |
2009-08 | |
| NCT00624416 | COMPLETED | Lipoma |
Pennington Biomedical Research Center |
2007-10 | PHASE1; PHASE2 |
| NCT00323843 | UNKNOWN | Kidney Stone; Ureteroscopy |
Fredericia Hosptial |
2006-06 | PHASE2 |
| NCT00226551 | COMPLETED | Coronary Disease |
Hadassah Medical Organization |
1999-08 | |
| NCT00428428 | COMPLETED | Kidney Stone; Unexplained Haematuria; Benignant Tumour Mass in the Upper Urinary Tract |
Fredericia Hosptial |
2007-02 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-05)
Compliance for Clinical Use
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>).
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