Clinical Trials

Noradrenaline bitartrate monohydrate has been evaluated across multiple clinical trials, underscoring its pivotal role in cardiovascular management and hemodynamic support. Predominantly sponsored by academic research centers and university hospitals, these Phase 3, Phase 4, and observational protocols investigate conditions including drug-induced hypotension, heart failure, coronary artery disease, atrial fibrillation, acute-on-chronic liver failure, and metabolic inflammatory responses. Recruitment across these studies ranges from completed trials to active and upcoming evaluations in perioperative and critical care settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06323512 Not yet recruiting
Heart Failure
Nanjing First Hospital Nanjing Medical University
 2024-06-01 --
NCT06068764 Recruiting
Coronary Artery Disease
Hartford Hospital
 2023-12-05 Phase 4
NCT06116305 Not yet recruiting
Acute on Chronic Liver Failure
Institute of Liver and Biliary Sciences India
 2023-11-05 --
NCT06013345 Recruiting
Atrial Fibrillation
Charles University Czech Republic
 2023-10-25 Phase 3
NCT05990933 Not yet recruiting
Inflammatory Response|Diabetes type1|Hypoglycemia
Cees Tack|Radboud University Medical Center
 2023-09 Not Applicable
NCT05502146 COMPLETED
Spinal Anesthetic Toxicity; Hypotension Drug-Induced; Cesarean Section Complications
Mersin University
 2022-08-17 PHASE4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Noradrenaline bitartrate monohydrate acts as a direct adrenergic receptor agonist that targets α1, α2, and β1 receptors to trigger downstream G-protein mediated signaling, inducing vascular smooth muscle contraction and increasing myocardial force. This peripheral vasoconstriction and positive inotropic action restore systemic blood pressure, providing essential hemodynamic stabilization in clinical conditions such as drug-induced hypotension and heart failure.

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>).

Jump to

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