Clinical Trials

Multiple clinical trials—encompassing Phase 2, Phase 3, and non-phase interventional studies—evaluate the clinical applications and physiological parameters of this intervention. These investigations target conditions including sepsis and septic shock, post-liver transplantation acute kidney injury, workplace-related stress and sleep disorders, and metabolic responses in healthy volunteers. Sponsored by academic institutions and healthcare organizations such as Mansoura University, Assistance Publique - Hôpitaux de Paris, National Taiwan Sport University, and Rigshospitalet Denmark, participant recruitment across these studies ranges from not yet recruiting to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06302998 Not yet recruiting
Sepsis|Septic Shock
Mansoura University
2024-06 Phase 2
NCT06344442 Not yet recruiting
Acute Kidney Injury Post Liver Transplantation
Assistance Publique - Hôpitaux de Paris
2024-05-05 Phase 3
NCT06381479 Recruiting
Stress|Sleep Disorder
National Taiwan Sport University|Bened Biomedical Co. Ltd.
2024-04-19 Not Applicable
NCT06334653 Not yet recruiting
Healthy Volunteers Only|Energy Metabolism
Helga Ellingsgaard|Rigshospitalet Denmark
2024-04-09 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Adrenaline binds directly to alpha- and beta-adrenergic receptors, triggering downstream G-protein-coupled signaling pathways that regulate intracellular cyclic AMP accumulation and vascular smooth muscle tone. This signaling cascade mediates vascular constriction, enhanced myocardial contractility, and metabolic substrate mobilization, providing critical therapeutic relevance in restoring systemic perfusion during septic shock and modulating metabolic energy expenditure.

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.