Clinical Trials

Promethazine HCl is evaluated across several clinical trials spanning Phase 1 through Phase 4 studies as well as unassigned phase protocols. These investigations encompass conditions such as post-operative nausea and vomiting, intrathecal morphine-induced pregnancy-related pruritus, labor pain management, and pharmacokinetic assessments in healthy subjects. Supported by both academic medical centers and corporate sponsors, trial recruitment statuses range from actively recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05759481 Recruiting
Post-operative Nausea and Vomiting
Milton S. Hershey Medical Center
 2024-02-01 Phase 2
NCT04805073 Recruiting
Pruritus|Pregnancy Related
University of Florida
 2021-08-09 Phase 4
NCT03539562 Completed
Labor Pain|Early Labor
University of California San Francisco
 2017-09-27 --
NCT02465866 Completed
Healthy
Charleston Laboratories Inc
 2014-11 Phase 1
NCT01644838 Completed
Labor Pain
Mashhad University of Medical Sciences
 2010-08 Phase 2|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Promethazine HCl selectively binds to histamine H1 receptors, competitively inhibiting histamine-induced activation of downstream G-protein signaling pathways to decrease capillary permeability and suppress vestibular pathway excitation. Consequently, this cellular dampening reduces central emetic signaling and peripheral hypersensitivity, providing clinical utility in mitigating post-operative nausea and vomiting, pruritus, and labor pain.

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.