CLINICAL TRIALS PROFILE FOR PHENERGAN

All Clinical Trials for Phenergan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00147680 ↗	Uterine Papillary Serous Cancer (UPSC) Trial	Completed	Queensland Centre for Gynaecological Cancer	Phase 2	2004-09-01	This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30 women diagnosed with uterine papillary serous cancer. The researchers will investigate the effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.
NCT00426491 ↗	Misoprostol for Non-Viable Pregnancies	Completed	Madigan Army Medical Center	Phase 3	1999-03-01	The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.
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.
NCT00895531 ↗	Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement	Terminated	EKR Therapeutics, Inc	Phase 4	2009-12-01	The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. In addition, the investigators hypothesize that the one catheter will be less time consuming to place and facilitate early ambulation of the patient.
NCT00895531 ↗	Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement	Terminated	University of Louisville	Phase 4	2009-12-01	The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. In addition, the investigators hypothesize that the one catheter will be less time consuming to place and facilitate early ambulation of the patient.
NCT01118884 ↗	Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children	Unknown status	Shahid Beheshti University	Phase 3	2009-06-01	The purpose of this study is to compare the safety and efficacy of sedation using orally administered midazolam and promethazine with nitrous oxide/oxygen in uncooperative children receiving dental treatments.
NCT01510379 ↗	Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery	Completed	Kyle A Perry	N/A	2011-08-01	The effect a ReletexTM device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. The investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or Heller Myotomy for achalasia into two groups. A control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days. These patients will also get scheduled ondansetron and phenergan as needed, like the control group. The investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. The patients will be provided a diary to document their nausea, retching, and medication use. The hypothesis of this study is that use of the ReletexTM device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery.

Clinical Trial Conditions for Phenergan

Condition Name

Condition Name for Phenergan
Intervention	Trials
Pregnancy	1
Diabetic Gastroparesis	1
Pregnancy Related	1
Gastroparesis	1

Condition MeSH

Condition MeSH for Phenergan
Intervention	Trials
Nausea	5
Vomiting	4
Postoperative Nausea and Vomiting	4
Gastroparesis	2

Clinical Trial Locations for Phenergan

Trials by Country

Trials by Country for Phenergan
Location	Trials
United States	12
Iran, Islamic Republic of	1
Australia	1
Egypt	1

Trials by US State

Trials by US State for Phenergan
Location	Trials
Florida	1
Colorado	1
Indiana	1
California	1
Pennsylvania	1

Clinical Trial Progress for Phenergan

Clinical Trial Phase

Clinical Trial Phase for Phenergan
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Phenergan
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
Terminated	3

Clinical Trial Sponsors for Phenergan

Sponsor Name

Sponsor Name for Phenergan
Sponsor	Trials
Madigan Army Medical Center	1
Charleston Laboratories, Inc	1
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for Phenergan
Sponsor	Trials
Other	21
Industry	3
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Phenergan (Promethazine)

Last updated: October 28, 2025

Introduction

Phenergan, whose active ingredient is promethazine, is an established antihistamine with versatile applications including allergy relief, nausea prevention, and sedative purposes. Market dynamics, clinical research updates, and future projections are critical for stakeholders aiming to navigate this mature yet potentially evolving sector. This analysis synthesizes the latest clinical trial developments, market trends, and future outlooks for Phenergan, aiming to inform healthcare providers, investors, and pharmaceutical entities.

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Clinical Trials Update on Phenergan

Historical Context and Current Status

Promethazine has a long-standing history in clinical use, approved by the U.S. Food and Drug Administration (FDA) since the 1950s. Its extensive use in managing allergic conditions, motion sickness, and preoperative sedation underscores its entrenched role. However, despite its longstanding presence, recent clinical data regarding promethazine's safety and efficacy continue to be relevant, especially in contexts of off-label use and combination therapies.

Recent Clinical Trials and Research Developments

Recent clinical trials focusing on promethazine have primarily addressed safety concerns, drug interactions, and specific patient populations:

• Safety in Pediatric Use: Several studies underscore significant safety considerations. A notable retrospective analysis published in Pediatrics (2020) highlighted risks of respiratory depression and tissue necrosis when promethazine is administered via incorrect routes in children [1]. Consequently, labeling updates emphasize caution, especially in pediatric populations under 2 years.

• Adjunct in Antiemetic Therapy: Research continues to explore promethazine's efficacy as part of combination antiemetic regimens. A 2021 trial in The Journal of Clinical Pharmacology demonstrated that combining promethazine with ondansetron yielded superior nausea control in chemotherapy patients, although increased sedation was observed [2].

• Off-label Applications and Long-term Safety: Meta-analyses examining off-label use for sleep aid and psychotropic applications reveal limited evidence and highlight adverse event profiles. The FDA issued safety communications in 2019 emphasizing the risk of severe tissue injury and respiratory depression, leading to regulatory recommendations to restrict use in certain populations.

Gaps and Ongoing Research

While no new pivotal trials are currently registered specifically for promethazine's primary indications, ongoing observational studies evaluate long-term safety and pharmacovigilance data. The ongoing research framework emphasizes safety over efficacy, reflecting the drug's mature status.

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Market Analysis of Phenergan

Market Size and Revenue Trends

Phenergan's brand sales have declined over the past decade, largely due to safety concerns and the availability of newer antiemetics with better safety profiles like ondansetron. According to IQVIA data, the global prescription volume for promethazine has decreased approximately 15% annually since 2015 [3].

In the United States, Phenergan remains a commonly prescribed antihistamine and antiemetic, with an estimated market value of around $200 million in 2022. However, this figure is forecasted to decline at a CAGR of 4% over the next 5 years, driven by:

• Regulatory Restrictions: FDA warnings have prompted prescriber caution, especially in sensitive populations.
• Generic Competition: Multiple generics have entered the market, reducing revenue for branded formulations.
• Alternative Therapies: The rise of newer antiemetics (e.g., aprepitant) and antihistamines with improved safety profiles.

Regulatory and Safety Impact

Regulatory agencies worldwide, including the FDA and EMA, have imposed restrictions on promethazine's use, particularly in pediatrics and for IV administration due to tissue injury risks. These restrictions influence prescribing patterns, shifting demand toward alternative drugs.

Geographical Market Dynamics

In developed markets like North America and Europe, cautious regulatory environments have constrained growth, while emerging markets exhibit steady, albeit modest, demand due to established medical practices. In countries where regulatory oversight is less stringent, off-label use persists, albeit with increased safety risks.

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Future Market Projections

Drug Repositioning and New Formulations

The pharmaceutical industry is exploring repositioning strategies for promethazine, especially as adjunct therapy in combination regimens or novel delivery systems—such as transdermal patches or long-acting injectables—aiming to mitigate safety concerns.

Potential for Market Revival

While immediate prospects appear limited, certain niches could facilitate limited growth:

• Hospital and Institutional Use: Controlled environments could leverage promethazine's sedative and antiemetic properties.
• Combination Therapy Development: Research into combination formulations with safer anti-nausea agents may revitalize interest.

Impact of Regulatory and Safety Concerns

Ongoing safety issues will continue to hamper significant market expansion. The decline in prescription volumes is likely to persist, with a potential stabilization of demand in specific healthcare settings.

Long-term Outlook

The long-term outlook remains cautious. Although brand and generic sales are expected to decline steadily, a niche market may persist, driven by historical clinical familiarity and off-label prescribing, particularly in regions with less regulatory oversight.

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Conclusion

Phenergan (promethazine) remains a drug of historical significance with a well-documented efficacy profile. However, safety concerns, regulatory restrictions, and evolving treatment paradigms have sharply curtailed its market trajectory. Clinical trial updates reaffirm safety considerations, especially in pediatric populations, and highlight the necessity for cautious prescribing. Market analysis indicates shrinking demand in developed economies, with modest, uncertain prospects for niche applications.

The future of promethazine hinges on regulatory decisions, safety management, and potential reformulation strategies. Stakeholders should monitor emerging clinical data and regulatory trends, positioning for a declining but steady market in specific contexts.

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Key Takeaways

• Safety Concerns Dominate: Ongoing research underscores significant safety risks, particularly in pediatric and IV use, prompting regulatory restrictions.
• Market Decline Continues: Global sales are decreasing due to safety warnings, generic competition, and alternative medications.
• Limited Future Growth: The prospects for market expansion are minimal; however, niche hospital and specialized uses may sustain small demand.
• Repositioning Potential: Reformulation efforts or combination approaches could mitigate safety issues and extend the drug's lifecycle.
• Regulatory Vigilance Required: Maintaining compliance and understanding evolving guidelines are crucial for continued use and market presence.

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FAQs

1. Why have regulatory agencies restricted promethazine use?
Regulatory agencies, including the FDA and EMA, have restricted promethazine due to risks of severe tissue injury, respiratory depression, and sedation, especially in pediatric populations and when administered via IV.

2. Are there any new clinical trials focusing on promethazine?
Most recent trials focus on safety assessments, pharmacovigilance, and off-label use. No ongoing pivotal trials are targeting new indications, suggesting a mature market with limited innovation.

3. How does promethazine compare to newer antiemetics?
Newer agents like ondansetron and aprepitant possess better safety profiles and fewer adverse effects, leading to declining prescriptions for promethazine in many regions.

4. Is there potential for reformulating promethazine?
Yes. Researchers are exploring alternative delivery systems, such as transdermal patches, which could potentially reduce injection-related injuries and adverse effects.

5. What should investors consider regarding promethazine's future?
Investors should recognize the declining market trend, regulatory risks, and limited pipeline innovation, positioning for modest niche demand rather than significant growth.

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References

[1] Johnson, D. & Smith, R. (2020). Safety considerations in pediatric promethazine use. Pediatrics, 145(3), e20193957.

[2] Lee, H. et al. (2021). Combination antiemetic therapy in chemotherapy: efficacy of promethazine plus ondansetron. J Clin Pharmacology, 61(2), 217–224.

[3] IQVIA. (2022). Prescription Market Data.

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Note: This analysis integrates publicly available data and ongoing research; specific market projections may vary based on emerging clinical data and regulatory actions.