CLINICAL TRIALS PROFILE FOR PROMETHAZINE HYDROCHLORIDE PLAIN

All Clinical Trials for Promethazine Hydrochloride 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 Hydrochloride Plain

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Promethazine Hydrochloride Plain

Trials by Country

Trials by Country for Promethazine Hydrochloride Plain
Location	Trials
United States	39
Iran, Islamic Republic of	3
Israel	2
Brazil	2
Germany	2

Trials by US State

Trials by US State for Promethazine Hydrochloride Plain
Location	Trials
Texas	9
Pennsylvania	6
Ohio	2
Tennessee	2
New York	2

Clinical Trial Progress for Promethazine Hydrochloride Plain

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Promethazine Hydrochloride Plain

Sponsor Name

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

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

Last updated: October 30, 2025

Introduction

Promethazine Hydrochloride Plain, a first-generation antihistamine with antiemetic and sedative properties, remains a vital component in therapeutic regimens for allergy, nausea, and motion sickness. Despite its longstanding market presence, recent regulatory shifts, clinical developments, and market dynamics influence its current and future landscape. This report provides an in-depth update on clinical trials, market analysis, and future projections for Promethazine Hydrochloride Plain, equipping stakeholders with strategic insights.

Clinical Trials Update

Overview of Recent and Ongoing Clinical Trials

While Promethazine Hydrochloride has a well-established safety and efficacy profile, innovative clinical studies continue to explore its novel applications and formulations. As of 2023, clinical trial repositories indicate several active investigations:

• Psychiatric Applications: Trials assessing adjunctive use in depression and anxiety management, focusing on sedative effects and potential modulation of neurotransmitter pathways.
• Nausea and Vomiting in Oncology: Evaluations of combination therapies with newer antiemetics to enhance control over chemotherapy-induced nausea.
• Pediatric and Geriatric Use: Studies examining safety profiles and dosing modifications specific to vulnerable populations.
• Novel Formulations: Development of transdermal patches and sustained-release variants aimed at improving compliance and reducing adverse effects.

Regulatory and Safety Considerations

Recent updates from agencies such as the FDA and EMA emphasize caution due to risks of severe tissue injury upon extravasation and respiratory depression, especially with off-label uses. Ongoing trials incorporate rigorous safety monitoring, with some studies exploring reduced dosing or alternative delivery routes to mitigate adverse events.

Clinical Trial Outcomes and Relevance

While many of these investigations are preliminary, the general consensus supports the continued utility of Promethazine Hydrochloride Plain in selected indications. However, the safety concerns necessitate strict adherence to dosing guidelines and careful patient monitoring.

Market Analysis

Current Market Landscape

Despite the advent of newer antiemetics, Promethazine Hydrochloride Plain sustains demand in specific segments:

• Pharmacovigilance in Emerging Markets: Increased availability due to cost advantages and established manufacturing in regions like India and China.
• Hospitals and Clinics: Utilization for postoperative nausea, allergy relief, and sedation, especially in settings with limited access to newer agents.
• Off-Label Use: Widely employed in pediatric and psychiatric contexts, although with caution due to safety concerns.

Competitive Environment

The drug faces competition from second- and third-generation antihistamines (e.g., loratadine, cetirizine) and advanced antiemetics such as ondansetron and aprepitant. However, Promethazine's versatility and low cost sustain its relevance, notably in resource-constrained healthcare settings.

Regulatory and Quality Challenges

In recent years, regulatory agencies have tightened restrictions on Promethazine’s labeling and usage guidelines, citing safety risks. This has led to increased scrutiny and, in some cases, temporary market withdrawals or usage bans in certain jurisdictions (e.g., the UK recommended against use in children under 2 years).

Market Size and Revenue

Estimates suggest that the global market for Promethazine Hydrochloride, including combinations, exceeds $300 million annually, with a compound annual growth rate (CAGR) of approximately 2-3% over the past five years. The growth is primarily driven by emerging markets and expanding pediatric and palliative care applications.

Market Projection

Short-Term Outlook (2023–2027)

• Steady Demand in Traditional Sectors: Continued use in allergy and nausea management, particularly in developing countries.
• Regulatory Impact: Potential reductions in prescriber use due to safety warnings, leading to a phased decline or stabilization.
• Formulation Innovations: Introduction of safer, alternative delivery systems may sustain market share and open new avenues.

Medium- to Long-Term Outlook (2028–2033)

• Shift Toward Safer Alternatives: Expected gradual decline as newer, safer antiemetics and antihistamines dominate the market.
• Niche Applications: Persistent use in specific populations (e.g., pediatric, psychiatric) where safety profiles and cost advantages favor its continued employment.
• Regional Variations: Higher resilience in low- and middle-income regions with limited access to newer drugs and lesser regulatory restrictions.

Key Market Drivers and Restraints

• Drivers: Cost-effectiveness, longstanding clinical familiarity, broad-spectrum indications.
• Restraints: Safety concerns, regulatory restrictions, competition from newer drugs with better safety profiles, and increasing awareness of adverse events.

Future Opportunities

• Reformulation: Development of transdermal patches or sustained-release formulations to address safety concerns and improve patient adherence.
• Expanded Indications: Investigations into additional therapeutic uses, like sedation in pediatric diagnoses and adjunctive perioperative care.
• Market Penetration: Strategies targeting emerging markets where access to newer therapies remains limited.

Key Takeaways

• Promethazine Hydrochloride Plain continues to be relevant primarily in resource-limited settings and specific clinical contexts, with its demand expected to decline gradually due to safety and regulatory issues.
• Ongoing clinical trials focus on expanding therapeutic applications and improving safety profiles, which may influence future market dynamics.
• Industry players should monitor regulatory developments and invest in reformulation efforts to mitigate safety concerns and extend product lifecycle.
• Market opportunities lie in niche applications, cost-effective formulations, and emerging markets, where the drug’s longstanding clinical utility sustains interest.
• Strategic alliances and investments in innovation can help maintain competitiveness amid evolving regulatory landscapes and competitive pressures.

FAQs

1. What are the main clinical indications for Promethazine Hydrochloride Plain?
Promethazine primarily treats allergy symptoms, nausea, vomiting, motion sickness, and sedation. Its off-label uses include management of insomnia and psychiatric conditions under cautious protocols.

2. How do recent safety concerns affect the use of Promethazine Hydrochloride Plain?
Safety warnings, including risks of respiratory depression and tissue injury, have led to regulatory restrictions, particularly in pediatric populations and for parenteral administration, impacting prescription practices.

3. Are there ongoing clinical trials exploring new therapeutic uses of Promethazine?
Yes. Current studies investigate its adjunct role in psychiatric disorders, potential anti-inflammatory activities, and improved delivery systems aimed at reducing adverse effects.

4. What is the market outlook for Promethazine Hydrochloride Plain over the next decade?
Demand will likely decline gradually due to safety concerns but will persist in low-resource settings and niche applications. Market share may shift with reformulations and regulatory adaptations.

5. How can pharmaceutical companies ensure the continued relevance of Promethazine Hydrochloride Plain?
By investing in safer formulations, expanding approved indications, and targeting emerging markets, companies can maintain competitiveness amid evolving regulatory and clinical landscapes.

References

[1] U.S. Food and Drug Administration. (2022). Promethazine: Drug safety communication.
[2] European Medicines Agency. (2021). Assessment report on Promethazine use and safety.
[3] MarketWatch. (2023). Global antihistamines market size and forecast.
[4] ClinicalTrials.gov. (2023). Active studies involving Promethazine.
[5] IQVIA. (2022). Pharmaceutical market trends in emerging economies.