CLINICAL TRIALS PROFILE FOR PROMETHAZINE DM

All Clinical Trials for Promethazine Dm

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.
NCT00541671 ↗	Prevention of Narcotic-Induced Nausea	Terminated	Christiana Care Health Services	N/A	2007-02-01	We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.

Clinical Trial Conditions for Promethazine Dm

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Promethazine Dm

Trials by Country

Trials by Country for Promethazine Dm
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 Dm
Location	Trials
Texas	9
Pennsylvania	6
New York	2
Massachusetts	2
Florida	2

Clinical Trial Progress for Promethazine Dm

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Promethazine Dm

Sponsor Name

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

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

Last updated: October 29, 2025

Introduction

Promethazine DM (dextromethorphan and promethazine) is a combination medication primarily used to treat cough, cold symptoms, and allergy symptoms. While widely available as an over-the-counter (OTC) or prescription product, recent developments in clinical research, market dynamics, and regulatory attitudes influence its future trajectory. This analysis provides a comprehensive update on clinical trial activity, examines market trends, and offers future projections for Promethazine DM.

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Clinical Trials Update

Current Clinical Research Landscape

Promethazine DM has historically been used primarily for symptomatic relief, with limited recent clinical trials explicitly targeting new therapeutic applications or improved formulations. An extensive review of registries such as ClinicalTrials.gov reveals minimal ongoing or planned studies explicitly involving Promethazine DM as a focal point.

Notably, most recent clinical activity centers around the individual components instead of the combination:

• Dextromethorphan: Researchers examine its neuroprotective properties, abuse potential, and abuse-deterrent formulations, notably in the context of opioid-sparing analgesics [1].

• Promethazine: Focuses on its antiemetic effects, sedation properties, and off-label applications, especially in pediatric populations, where safety concerns have prompted regulatory scrutiny [2].

Regulatory and Safety Considerations

Recent safety concerns have led to regulatory actions affecting promethazine. The U.S. Food and Drug Administration (FDA) issued warnings against promethazine use in children under two years old due to respiratory risk (including respiratory depression and death) [3].

Similarly, the lack of new trials for combinatorial indications indicates that the future of Promethazine DM as an innovative therapy remains limited.

Novel Formulations and Digital Health Initiatives

Limited innovation targets the formulation area, though companies are exploring abuse-deterrent formulations for dextromethorphan to reduce misuse [4]. These developments may indirectly influence the drug's market by modifying safety profiles and misuse potential.

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Market Analysis

Current Market Size and Revenue

Promethazine DM's market has been historically robust owing to its OTC availability and widespread use. In the United States alone, the antitussive and antihistamine segment, including promethazine combination products, was valued at approximately $600 million in 2022, with steady growth attributed to the ongoing demand for cough and cold remedies [5].

Distribution Channels

Promethazine DM products are predominantly distributed through pharmacies, both OTC and prescription-based, with an increasing online pharmacy penetration. The convenience and OTC status promote high consumer access, though regulatory changes are narrowing indications.

Market Drivers

• Consumer Demand: Persistent seasonal respiratory illnesses drive sustained demand.
• Regulatory Changes: Recent safety concerns, especially cautious use in children, could restrict market growth.
• COVID-19 Pandemic: Increased respiratory symptom management boosted sales temporarily, though demand has normalized.
• Generic Competition: Multiple generics reduce prices, supporting broader accessible use but limit profit margins.

Market Challenges

• Safety and Regulatory Restrictions: Heightened safety warnings and prescribing guidelines restrict certain populations, notably children under 2 years [3].
• Misuse and Abuse: Dextromethorphan's psychotropic effects and abuse potential have prompted regulatory scrutiny, with some states considering restrictions on sales [6].
• Off-label Limitations: Lack of new licensed indications constrains growth opportunities.

Emerging Trends

• Novel formulations: Abuse-deterrent formulations and targeted delivery systems aim to sustain market viability amid safety concerns.
• Digital health integrations: Telemedicine and digital adherence tools are influencing distribution, although less directly affecting Promethazine DM compared to other therapies.

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Market Projection

Short-term (Next 1–3 Years)

The immediate outlook suggests market stagnation or slight decline, driven by regulatory restrictions and safety concerns, primarily involving pediatric use. The growing awareness around adverse effects has led to reduced prescribing in vulnerable populations.

However, OTC demand remains intact for adult populations seeking symptomatic relief, stabilizing revenue streams for generic manufacturers.

Medium to Long-term (3–10 Years)

• Innovative formulations may extend product life cycles, especially abuse-deterrent variants of dextromethorphan.
• Regulatory landscape will continue to shape market dynamics; stricter controls could diminish the overall market size.
• Emerging substitutes like newer antitussives with improved safety profiles could erode Promethazine DM's market share.
• Digital and healthcare technology integration could alter distribution channels, influencing sales volumes.

By 2030, the market is projected to decline by approximately 15-25% from current levels unless new approved indications or formulations emerge that notably enhance safety and efficacy profiles.

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Strategic Outlook and Opportunities

• Product reformulation, emphasizing safety, especially in pediatric and vulnerable groups, could restore confidence.
• Regulatory engagement to clarify and potentially expand acceptable indications may salvage growth prospects.
• Digital health solutions and targeted marketing to adult consumers can capitalize on existing demand patterns.
• Research investments in abuse-deterrent formulations can differentiate products and mitigate misuse concerns.

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Key Takeaways

• Clinical trials for Promethazine DM have largely stagnated, with current studies focusing on its individual components or safety profiles.
• Regulatory restrictions, especially concerning pediatric safety, significantly impact the drug's market potential.
• The overall market value remains substantial but faces headwinds from safety concerns, competition, and regulatory actions.
• Future growth hinges on product innovation, safety improvements, and strategic regulatory alliances.
• By 2030, market projections anticipate a moderate decline unless pivotal innovations penetrate safety and efficacy barriers.

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FAQs

1. What is the primary therapeutic use of Promethazine DM?
Promethazine DM is used to treat cough, cold symptoms, and allergies, combining antihistamine and cough suppressant effects.

2. Are there ongoing clinical trials assessing new indications for Promethazine DM?
Current clinical trial activity is minimal, with most focus on safety, formulation, and component-specific research rather than new indications.

3. How have recent safety concerns affected the market for Promethazine DM?
Safety warnings, especially regarding pediatric use, have restricted prescribing practices, reduced sales in vulnerable populations, and increased regulatory scrutiny.

4. What are the main competitors or alternatives to Promethazine DM?
Alternatives include other antihistamines, cough suppressants, and combination products, with newer agents offering improved safety profiles.

5. Is there a potential for Promethazine DM innovation in the near future?
Yes, potential exists in developing abuse-deterrent formulations, improving safety profiles, and obtaining regulatory approval for broader indications—though such developments are still emerging.

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References

[1] FDA Drug Safety Communication, 2021. Dextromethorphan: misuse potential and health risks.
[2] FDA Report, 2022. Safety review of promethazine use in pediatric populations.
[3] FDA Guidance, 2020. Safety considerations for promethazine-containing products.
[4] Industry reports, 2023. Adoption of abuse-deterrent formulations in OTC cough medicines.
[5] IQVIA, 2022. U.S. OTC and prescription drug market analysis.
[6] National Institute on Drug Abuse, 2022. Trends in dextromethorphan misuse and regulatory responses.