Clinical Trials

Promethazine has been evaluated in numerous clinical trials spanning Phases 1 through 4, sponsored by academic medical centers, government institutes such as the National Cancer Institute, and industry partners including Charleston Laboratories. Key investigated indications include post-operative nausea and vomiting, intrathecal morphine-induced pruritus in pregnancy, labor pain, acute agitation in psychiatric emergencies, migraine, and peripheral vertigo. These studies reflect varied recruitment statuses, ranging from completed trials for acute agitation to active recruiting protocols evaluating post-operative nausea.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07364344 NOT_YET_RECRUITING
Acute Ischemic Stroke
Ji Xunming,MD,PhD
 2026-01
NCT06663631 RECRUITING
Acute Ischemic Stroke
Capital Medical University
 2024-11-09 PHASE1
NCT05586763 UNKNOWN
Peripheral Vertigo
Oman Medical Speciality Board
 2022-02-01 PHASE3
NCT05759481 Recruiting
Post-operative Nausea and Vomiting
Milton S. Hershey Medical Center
 2024-02-01 Phase 2
NCT01391962 COMPLETED
Sarcoma, Alveolar Soft Part
National Cancer Institute (NCI)
 2011-07-18 PHASE2
NCT04805073 Recruiting
Pruritus|Pregnancy Related
University of Florida
 2021-08-09 Phase 4
NCT03877718 COMPLETED
Migraine; Pain; Nausea; Vomiting; Aura
Charleston Laboratories, Inc
 2019-02-01 PHASE2
NCT03639558 COMPLETED
Psychiatric Emergency; Aggression; Agitation
Joseph Dib
 2018-08-28 PHASE4
NCT02765256 COMPLETED
Crohn's Disease
University of Pennsylvania
 2016-08 PHASE2
NCT03657810 COMPLETED
Pain; Nausea; Vomiting
Charleston Laboratories, Inc
 2017-08-02 PHASE3
NCT03237533 UNKNOWN
Oral Lichen Planus
University of Faisalabad
 2017-06-01 EARLY_PHASE1
NCT02625181 COMPLETED
Postoperative Nausea and Vomiting
Vanderbilt University
 2016-07
NCT03539562 Completed
Labor Pain|Early Labor
University of California San Francisco
 2017-09-27 --
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02136420 COMPLETED
Vestibular
Faisal_Karmali@MEEI.HARVARD.EDU
 2014-06 PHASE4
NCT02462811 COMPLETED
Pain; Nausea; Vomiting
Joseph Hazelton
 2014-09 PHASE3
NCT02130622 TERMINATED
Diabetic Gastroparesis
Dartmouth-Hitchcock Medical Center
 2014-07 PHASE2
NCT02465866 Completed
Healthy
Charleston Laboratories Inc
 2014-11 Phase 1
NCT01780428 COMPLETED
Pain; Nausea; Vomiting
Charleston Laboratories, Inc
 2013-01 PHASE3
NCT01827293 COMPLETED
Peripheral Vertigo.
Shahid Beheshti University of Medical Sciences
 2013-04 PHASE3
NCT01846455 COMPLETED
Hepatic Failure; Hepatic Impairment; Chronic Hepatitis C Infection With Hepatic Coma
Indivior Inc.
 2012-09 PHASE4
NCT01814189 COMPLETED
Migraine With Aura; Migraine Without Aura
Shahid Beheshti University of Medical Sciences
 2013-01 PHASE3
NCT01474915 COMPLETED
Postoperative Nausea and Vomiting (PONV); Nausea
Sergio Bergese
 2007-06 PHASE4
NCT01644838 COMPLETED
Labor Pain
Mashhad University of Medical Sciences
 2010-08 PHASE2; PHASE3
NCT01485692 COMPLETED
Psychomotor Agitation
University of Sao Paulo
 2009-02
NCT01644838 Completed
Labor Pain
Mashhad University of Medical Sciences
 2010-08 Phase 2|Phase 3
NCT01118884 UNKNOWN
Conscious Sedation
Shahid Beheshti University
 2009-06 PHASE3
NCT00541671 TERMINATED
Nausea
Christiana Care Health Services
 2007-02
NCT00655642 TERMINATED
Nausea
Vanderbilt University
 2007-03
NCT00270777 COMPLETED
Snake Bites
University of Kelaniya
 2005-03 PHASE4
NCT00947063 COMPLETED
Allergy
Sandoz
 2004-07 PHASE1
NCT00455234 COMPLETED
Psychotic Disorders; Aggression
Christian Medical College, Vellore, India
 2005-09 PHASE3
NCT00429832 COMPLETED
Nausea; Vomiting
University of New Mexico
 2003-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-01-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Promethazine acts as a potent histamine H1 receptor antagonist, binding selectively to H1 receptors to competitively block histamine-mediated downstream signaling pathways in peripheral tissues and the central nervous system. This receptor blockade suppresses histaminergic sensory transmission and central vestibular stimulation, thereby providing clinical utility in alleviating allergic symptoms, motion sickness, and post-operative or opioid-induced nausea and vomiting.

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.