Clinical Trials

Multiple clinical trials are currently evaluating the therapeutic utility of droperidol in managing acute emetic disorders, specifically focusing on post-operative nausea and vomiting alongside cannabis hyperemesis syndrome. Spanning Phase 2 and Phase 3 evaluations, these active, recruiting studies are led by academic and healthcare institutions, including the Milton S. Hershey Medical Center, Mercy Health Ohio, and the Lake Erie College of Osteopathic Medicine.

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
NCT05244460 Recruiting
Cannabis Hyperemesis Syndrome
Mercy Health Ohio|Lake Erie College of Osteopathic Medicine
2021-12-02 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Droperidol selectively binds to and potently antagonizes dopamine subtype 2 receptors in the limbic system and chemoreceptor trigger zone, thereby blocking dopamine-mediated signal transduction. This targeted receptor inhibition dampens central emetic signaling pathways, providing therapeutic antiemetic effects for post-operative nausea and vomiting and cannabis hyperemesis syndrome.

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>).

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