Clinical Trials

Several completed clinical trials have evaluated doxylamine succinate in patients experiencing pregnancy-related nausea, allergic rhinitis, and upper respiratory tract infections. These studies encompassed Phase I pharmacokinetic evaluations and bioequivalence studies, including assessments of pediatric pharmacokinetics and a combination enteric-coated formulation. The research was sponsored by pharmaceutical and consumer healthcare entities, including Valenta Pharm JSC and Procter & Gamble in collaboration with the Consumer Healthcare Products Association.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05498233 Completed
Pregnancy Related|Nausea
Valenta Pharm JSC
 2022-08-18 Not Applicable
NCT00796315 Completed
Allergic Rhinitis|Upper Respiratory Infection
Procter and Gamble|Consumer Healthcare Products Association
 2008-12 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxylamine succinate competitively binds to and inhibits histamine H1 receptors, blocking downstream histamine-mediated biochemical cascades and suppressing cell-surface signaling. This receptor antagonism produces central sedative and peripheral anticholinergic effects, providing clinical efficacy in mitigating pregnancy-related nausea and symptomatic allergic rhinitis or upper respiratory tract infections.

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>).

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