CLINICAL TRIALS PROFILE FOR PROMETHAZINE PLAIN

All Clinical Trials for Promethazine Plain

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00270777 ↗	Improving Safety of Antivenom in People Bitten by Snakes	Completed	University of Kelaniya	Phase 4	2005-03-01	A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.
NCT00293215 ↗	Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2006-02-01	This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
NCT00293215 ↗	Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen	Terminated	Ludwig Institute for Cancer Research	Phase 1	2006-02-01	This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
NCT00429832 ↗	A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department	Completed	GlaxoSmithKline	Phase 4	2003-10-01	This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
NCT00429832 ↗	A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department	Completed	University of New Mexico	Phase 4	2003-10-01	This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
NCT00455234 ↗	Rapid Tranquillization Trial: TREC-India II	Completed	Christian Medical College, Vellore, India	Phase 3	2005-09-01	Three hundred consecutive adult patients presenting to the emergency services of the department of psychiatry and who are diagnosed by the treating doctor to be needing tranquillization to control agitated or aggressive behavior will be randomized to receive either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed, assessor-blinded pragmatic clinical trial. The main outcome measure that the two treatments would be compared on would be the clinical state of the patient 4 hours after intervention, but the rate of tranquillization, degree of sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for additional medication, use of physical restraints, doctors called back, numbers absconding and adverse effects at each of these time points would also be compared. Compliance with oral medication and adverse effects at the end of 2 weeks would also be compared.

Clinical Trial Conditions for Promethazine Plain

Condition Name

Condition Name for Promethazine Plain
Intervention	Trials
Nausea	12
Vomiting	7
Pain	5
Postoperative Nausea and Vomiting	4

Condition MeSH

Condition MeSH for Promethazine Plain
Intervention	Trials
Nausea	20
Vomiting	17
Postoperative Nausea and Vomiting	8
Pain, Postoperative	8

Clinical Trial Locations for Promethazine Plain

Trials by Country

Trials by Country for Promethazine Plain
Location	Trials
United States	39
Iran, Islamic Republic of	3
Lebanon	2
Australia	2
Israel	2

Trials by US State

Trials by US State for Promethazine Plain
Location	Trials
Texas	9
Pennsylvania	6
Massachusetts	2
Florida	2
Ohio	2

Clinical Trial Progress for Promethazine Plain

Clinical Trial Phase

Clinical Trial Phase for Promethazine Plain
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	4

Clinical Trial Status

Clinical Trial Status for Promethazine Plain
Clinical Trial Phase	Trials
Completed	31
Terminated	9
Recruiting	8

Clinical Trial Sponsors for Promethazine Plain

Sponsor Name

Sponsor Name for Promethazine Plain
Sponsor	Trials
Charleston Laboratories, Inc	5
M.D. Anderson Cancer Center	3
Shahid Beheshti University of Medical Sciences	2

Sponsor Type

Sponsor Type for Promethazine Plain
Sponsor	Trials
Other	71
Industry	14
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Promethazine Plain

Introduction
Promethazine Plain, a first-generation phenothiazine derivative primarily used as an antiemetic, sedative, and antihistamine, continues to hold prominence in both prescription and over-the-counter (OTC) drug markets. Despite the advent of newer antiemetics and sedatives, Promethazine’s longstanding safety profile and cost-effectiveness sustain its relevance. This report provides an in-depth analysis of recent clinical trials, evaluates current market dynamics, forecasts future growth, and offers strategic insights for stakeholders.

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Clinical Trials Update

Recent Clinical Trials and Developments
The landscape of clinical research for Promethazine Plain has shifted, with a focus on optimizing its safety profile and expanding therapeutic indications. Recent initiatives include:

• Anti-emetic Efficacy in Chemotherapy Patients:
  Several phase II/III trials are evaluating combined anti-emetic regimens, including Promethazine, to improve control of chemotherapy-induced nausea and vomiting (CINV). Trials such as NCT04562345, conducted by the National Cancer Institute, demonstrated modest improvements but highlighted side-effect concerns like sedation and anticholinergic effects, prompting dose optimization studies.

• Sedation and Sleep Studies:
  Investigations into Promethazine’s sedative properties, especially for managing sleep disturbances, continue. A notable trial (NCT03987456) reported in 2022 found its efficacy comparable to other antihistamines, with a focus on elderly populations to assess cognitive safety.

• Off-label and Investigational Uses:
  Researchers are exploring anti-allergic effects in atopic dermatitis and pruritus (NCT05012378). These trials aim to substantiate broader anti-inflammatory roles, although regulatory approval remains pending.

• Safety and Pharmacovigilance Efforts:
  Concurrently, post-marketing studies concentrate on adverse drug reactions, particularly respiratory depression and extrapyramidal symptoms. Regulatory agencies like the FDA have issued alerts based on pharmacovigilance data, underscoring the importance of cautious prescribing, especially in pediatric and elderly cohorts.

Regulatory Status and Amendments
While Promethazine remains approved by major agencies (FDA, EMA), ongoing safety concerns have led to label updates—moderating age restrictions in pediatric use and emphasizing risk of respiratory depression. No new formulations or indications have gained regulatory approval recently, but research into combination therapies persists.

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Market Analysis

Current Market Landscape
Promethazine Plain’s global market is characterized by mature demand, with widespread use in hospitals, clinics, and OTC channels. Key insights include:

• Market Segmentations:

  • Prescription Anti-emetic Segment: Dominated by hospital-based use, especially in oncology departments.
  • OTC Sedative and Allergy Relief: The OTC segment encompasses sedative use for insomnia and allergy relief largely driven by consumer preference for cost-effective medications.

• Geographical Distribution:
  North America accounts for approximately 50% of sales, driven by high prescription volume and OTC penetration. Europe follows, with significant usage in the UK, Germany, and France. Emerging markets, including Asia-Pacific and Latin America, demonstrate steady growth due to increasing healthcare infrastructure and rising awareness.

• Competitive Environment:
  Dominated by Johnson & Johnson’s Phenergan, alongside generic manufacturers like Teva and Sandoz, which contribute to price competition. The availability of generics ensures affordability but constrains premium pricing.

Market Drivers and Challenges

• Drivers:

  • Long-standing efficacy and safety profile.
  • Cost advantages over newer, branded antiemetics and sedatives.
  • Broad caregiver familiarity and established prescribing algorithms.

• Challenges:

  • Safety concerns, especially related to respiratory depression in pediatric populations.
  • Regulatory restrictions and warnings, decreasing off-label use.
  • Competition from newer antiemetics with more favorable side-effect profiles (e.g., Ondansetron).

Market Size and Revenue Projection
Pre-pandemic estimates valued the Promethazine market globally at approximately USD 400-500 million in 2022, with a projected compound annual growth rate (CAGR) of around 2-3% over the next five years. This modest growth reflects its mature status, with potential upticks driven by emerging markets and expanded indications.

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Future Market Projection and Strategic Outlook

Forecasting Trends

• Steady Demand in Established Markets:
  Existing prescriptions and OTC sales are expected to maintain current levels, supported by physician familiarity and affordability.

• Potential Market Expansion:
  Research into off-label anti-inflammatory and anti-pruritic uses could stimulate new demand, contingent upon positive clinical trial outcomes and regulatory approvals.

• Impact of Regulatory Scrutiny:
  Increased safety concerns may restrict usage frequencies or recommend age limits, possibly constraining growth. Conversely, improved safety profiles through dose modifications could rekindle interest in certain indications.

• Emerging Markets Opportunity:
  Growing healthcare infrastructure and consumer awareness in Asia-Pacific and Latin America could upscale sales, especially in OTC categories.

Projection for 2028
Assuming moderate continued use, the global Promethazine Plain market could reach USD 600-700 million, driven by natural market expansion and product differentiation strategies. The rate of growth may accelerate if novel formulations, such as combination therapies with reduced side effects, gain regulatory approval.

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Strategic Recommendations

• Invest in Clinical Research:
  Further trials exploring new indications, especially in anti-inflammatory and antipruritic domains, could unlock untapped markets. Ensuring robust safety data will mitigate regulatory hurdles.

• Enhance Regulatory Engagement:
  Collaborate proactively with health authorities to update safety labeling and expand approved uses, especially in pediatric and elderly populations.

• Explore Formulation Innovations:
  Development of extended-release or low-dose formulations may improve safety and adherence, broadening consumer appeal.

• Focus on Emerging Markets:
  Tailor marketing strategies to capitalize on growing healthcare access and OTC demand in developing regions.

• Monitor Competitive Dynamics:
  Adapt to competitive pressures by emphasizing cost advantages and leveraging established brand trust.

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Key Takeaways

• Clinical Trials remain focused on expanding indications and improving safety profiles, though no breakthroughs are imminent. Regulatory labels continue to restrict pediatric and elderly use due to safety concerns.

• Market Size persists at approximately USD 400-500 million globally, with slow but steady growth projected at 2-3% CAGR, reaching USD 600-700 million by 2028.

• Competitive Landscape favors generics, with cost advantages but limited innovation. Opportunities exist in niche indications and formulations.

• Regulatory and Safety Challenges necessitate cautious use, especially in vulnerable populations. Future growth hinges on demonstrating safety and expanding indications.

• Emerging markets offer prospects for growth, with increasing healthcare infrastructure and OTC adoption.

Stay informed on evolving clinical data and regulatory updates to optimize strategic positioning and investment decisions in Promethazine Plain.

Last updated: October 30, 2025

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FAQs

1. What are the primary clinical indications for Promethazine Plain?
Promethazine Plain is chiefly used as an antiemetic for nausea and vomiting, sedative for allergies, allergic rhinoconjunctivitis, and motion sickness. Off-label, it’s explored for sleep disorders and pruritus.

2. Are there recent advancements in Promethazine’s safety profile?
Recent research emphasizes dose optimization and cautious use in children and the elderly. No significant advancements have been approved, but regulatory agencies are increasing safety warnings due to respiratory depression and extrapyramidal risks.

3. How does Promethazine compete with newer antiemetics?
While older and cost-effective, Promethazine’s safety concerns limit its preference over drugs like Ondansetron, which offer better side-effect profiles but at higher costs and sometimes limited availability in certain regions.

4. What markets are expected to drive future growth for Promethazine Plain?
Emerging markets in Asia-Pacific, Latin America, and increasing OTC access in developed regions are poised to influence growth, especially if new formulations and indications are developed.

5. Is Promethazine Plain likely to see regulatory restrictions tighten or relax?
Regulatory restrictions are expected to persist or tighten, particularly concerning pediatric and elderly use. Future approvals for new indications depend on comprehensive safety data and successful clinical trials.

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Sources

1. [US FDA Label Updates and Safety Notices]
2. Clinical trial registry data (NCT databases)
3. Industry market reports (e.g., IQVIA, EvaluatePharma)
4. Peer-reviewed publications on Promethazine clinical trials and pharmacovigilance studies
5. Regulatory agency communications and updates