Doxapram Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate doxapram in pediatric and respiratory settings, focusing on weaning failure following mechanical ventilation, premature birth, and apnea in premature infants. Ranging from Phase 4 to unassigned or not applicable phase designations, these studies are primarily sponsored by academic institutions and university medical centers, including Beni-Suef University and Erasmus Medical Center. The recruitment statuses of these trials span from completed to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03894189	Unknown status	Weaning Failure	Beni-Suef University	2019-05	Not Applicable
NCT02421068	Completed	Premature Birth	Sinno H.P. Simons\|ZonMw: The Netherlands Organisation for Health Research and Development\|Leiden Amsterdam Centre for Drug Research (LACDR)\|Dutch Knowledge Centre for Pediatric Pharmacotherapy (NKFK)\|Centre for Human Drug Research Netherlands\|Radboud University Medical Center\|Erasmus Medical Center	2014-08	--
NCT00389909	Completed	Premature Infants\|Apnea	Jean Michel Hascoet\|Maternite Regionale Universitaire	2006-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxapram selectively inhibits TASK-1, TASK-3, and TASK-1/TASK-3 heterodimeric potassium channels, thereby blocking background potassium leak currents and inducing cellular depolarization in carotid body chemoreceptors and respiratory control centers. This membrane depolarization increases central respiratory drive and arterial oxygenation, providing the physiological rationale for its clinical application in managing neonatal apnea and facilitating weaning from mechanical ventilation.

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>).