Epinephrine bitartrate Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 297

Clinical Trials

Several clinical trials investigate adrenergic modulation across conditions including sepsis and septic shock, acute kidney injury post-liver transplantation, stress and sleep disorders, healthy energy metabolism, hemodynamic control during dental extractions, and symptomatic irreversible pulpitis. Spanning Phase 2, Phase 3, Phase 4, and non-interventional designs, these studies are sponsored by academic institutions, public healthcare networks, military dental research centers, and private commercial entities. Current trial statuses range from active preparation and recruitment to completed evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06302998	Not yet recruiting	Sepsis\|Septic Shock	Mansoura University	2024-06	Phase 2
NCT07013071	COMPLETED	Hemodynamics; Pain; ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth	King Abdulaziz University	2024-02-10	PHASE4
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
NCT06862570	COMPLETED	Symptomatic Irreversible Pulpitis	28 Military Dental Centre Lahore	2022-12-19	PHASE2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Epinephrine bitartrate acts as a dual agonist that directly binds to alpha- and beta-adrenergic receptors, triggering downstream G protein-coupled intracellular signaling cascades that alter vascular smooth muscle tone, induce bronchodilation, and regulate cardiac performance. Through these adrenergic-mediated contractile and metabolic responses, the compound provides key physiological modulation relevant to hemodynamic management in septic shock and localized vascular control during surgical dental procedures.

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>).