Doxapram HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials evaluate Doxapram HCl across pediatric and respiratory indications, including weaning failure following mechanical ventilation, premature birth, and neonatal apnea. Sponsored by academic and clinical entities such as Beni-Suef University, Maternité Régionale Universitaire, and a Dutch research consortium involving Erasmus Medical Center and Radboud University Medical Center, these studies span Phase 4 as well as unassigned or non-applicable phases, with recruitment statuses reported as completed or unknown. Overall, these trials focus on evaluating dosing strategies, pharmacokinetic-pharmacodynamic modeling, and respiratory outcomes in these patient cohorts.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxapram HCl functions by inhibiting TASK-1, TASK-3, and TASK-1/TASK-3 heterodimeric potassium channels with EC50 values of 410 nM, 37 μM, and 9 μM, respectively, which blocks background leak potassium currents and triggers cell membrane depolarization in chemosensitive cells. This cellular excitation stimulates carotid body chemoreceptors and central respiratory centers to promote ventilatory drive, directly addressing clinical conditions such as apnea in premature infants and weaning failure 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>).