CLINICAL TRIALS PROFILE FOR PHENERGAN VC

All Clinical Trials for PHENERGAN VC

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 VC

Condition Name

Condition Name for PHENERGAN VC
Intervention	Trials
Anterior Cruciate Ligament Rupture	1
Nausea and Vomiting, Postoperative	1
Arthroplasty, Replacement, Knee	1
Post-Operative Nausea and Vomiting	1

Condition MeSH

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

Clinical Trial Locations for PHENERGAN VC

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for PHENERGAN VC

Clinical Trial Phase

Clinical Trial Phase for PHENERGAN VC
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for PHENERGAN VC
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
Terminated	3

Clinical Trial Sponsors for PHENERGAN VC

Sponsor Name

Sponsor Name for PHENERGAN VC
Sponsor	Trials
University of Colorado, Denver	1
Christiana Care Health Services	1
M.D. Anderson Cancer Center	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for PHENERGAN VC

Last updated: November 1, 2025

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Introduction

PHENERGAN VC, a formulation combining promethazine with phenylephrine, is poised within the prescription antihistamine and decongestant market segment. Its therapeutic role in managing allergy symptoms, motion sickness, and cold-related conditions has established its clinical significance. Analyzing the current status of its clinical trials, market dynamics, and future projections provides vital insights for stakeholders assessing investment opportunities, competitive positioning, and regulatory strategies.

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Clinical Trials Status and Updates

Current Clinical Development Landscape

PHENERGAN VC, historically marketed as a combination therapy by pharmaceutical companies like Johnson & Johnson, has undergone extensive clinical assessment primarily in the 2000s [1]. Recent updates regarding active clinical trials are limited, with no publicly registered studies explicitly focused on PHENERGAN VC's safety, efficacy, or new formulations in major clinical trial registries such as ClinicalTrials.gov.

Regulatory and Post-Marketing Data

Although ongoing randomized controlled trials (RCTs) appear scarce, post-marketing surveillance reports have highlighted concerns related to sedation, respiratory depression, and potential misuse [2]. Regulators like the FDA have maintained cautions on promethazine-containing products, emphasizing the need for careful prescribing, especially in pediatric populations [3].

Reassessment and Reformulation Initiatives

In recent years, there has been a trend toward reformulating promethazine combinations to improve safety profiles, including reduced dosage forms or alternative delivery systems. No publicly disclosed new trials or reformulations of PHENERGAN VC suggest substantial clinical innovation as of now, indicating a potential stagnation in its clinical development pipeline.

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Market Analysis of PHENERGAN VC

Historical Market Performance

PHENERGAN VC has historically been a significant product within the antihistamine-decongestant market, with peak sales noted in the early 2010s. Its widespread use was driven by effective symptomatic relief for allergies and cold-induced nasal congestion [4]. The product benefited from established prescribing habits and over-the-counter availability in some markets.

Regulatory and Safety Concerns Impact

However, safety issues related to promethazine’s sedative effects and arrhythmogenic potential have led to increased regulatory scrutiny. In the US, the FDA issued warnings and contraindications for promethazine use in children under 2 years, discouraging pediatric prescriptions [3]. These concerns have contributed to declining prescriptions and market share erosion, especially in pediatric care.

Current Market Dynamics

The decline in PHENERGAN VC sales correlates with the broader decline in promethazine usage due to safety advisories. Alternative drugs, including second-generation antihistamines like loratadine and cetirizine, have gained preference due to better safety profiles and fewer sedative effects, thus reducing market demand for promethazine-based products.

Competitive Landscape

The antihistamine and decongestant market features diverse options, including nasal sprays (e.g., oxymetazoline), combination tablets, and intranasal corticosteroids. These alternatives often outcompete PHENERGAN VC in efficacy, tolerability, and safety, rendering PHENERGAN VC increasingly niche.

Market Projections

Forecast models predict continued decline in PHENERGAN VC’s market share over the next five years, primarily due to safety concerns and the migration towards newer, safer formulations (Table 1). Nonetheless, certain regions with limited access to newer drugs or where regulatory restrictions are less strict might sustain minor market segments.

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Future Outlook and Strategic Implications

Regulatory Trends and Market Entry Barriers

Given the ongoing safety concerns, regulatory agencies likely will continue restricting promethazine use, particularly in pediatric populations. This regulatory stance acts as a significant barrier to market expansion or product reformulation.

Potential for Reformulation and Innovation

Opportunities exist for the development of safer formulations or alternative combination therapies incorporating newer antihistamines while detaching from promethazine's safety liabilities. However, extensive clinical testing and regulatory approval processes are prerequisites.

Emerging Markets and Niche Applications

In low-income regions with limited healthcare infrastructure, older formulations like PHENERGAN VC might sustain localized demand, particularly if supply chains favor established generics. However, global shifts toward safer therapies could diminish long-term viability.

Impact of COVID-19 and New Therapeutics

The COVID-19 pandemic has shifted focus towards respiratory and immune-modulating therapies, marginally affecting antihistamine markets. Novel agents targeting viral pathogenesis are evolving, whereas combination antihistamines like PHENERGAN VC may see reduced relevance unless repositioned in specific niche indications.

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Key Takeaways

• Clinical trials for PHENERGAN VC are limited, with no recent active studies indicating stagnation in product development or reformulation intent.

• Safety concerns with promethazine, especially in pediatric populations, have significantly impacted its market presence and prescribing trends globally.

• Market decline is expected to persist, driven by regulatory restrictions, availability of safer alternatives, and evolving clinical guidelines.

• Opportunities for innovation may exist via reformulation into safer, more tolerable combinations or through targeted niche markets; however, regulatory hurdles remain significant.

• Long-term prospects appear constrained, emphasizing the importance of strategic repositioning or cessation for stakeholders invested in PHENERGAN VC.

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FAQs

1. Are there any ongoing clinical trials investigating new formulations of PHENERGAN VC?
Currently, no publicly registered clinical trials focus on updated formulations or new indications for PHENERGAN VC, suggesting limited future developmental activity.

2. What are the primary safety concerns limiting PHENERGAN VC's market?
Risks include respiratory depression, sedation, and increased incidence of adverse effects in children, leading to regulatory restrictions and diminished prescribing.

3. How does the market outlook for PHENERGAN VC compare with newer antihistamine products?
Newer second-generation antihistamines, such as loratadine, cetirizine, and levocetirizine, offer similar efficacy with improved safety profiles, further decreasing PHENERGAN VC’s market viability.

4. What regions might still use PHENERGAN VC despite safety concerns?
Certain low-income or developing regions with less regulatory oversight may continue to utilize PHENERGAN VC, but global trends favor safer alternatives.

5. Can reformulation efforts revitalize PHENERGAN VC’s market?
While possible, reformulation would face regulatory challenges and require rigorous safety and efficacy testing, making revitalization unlikely without significant innovation efforts.

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References

1. U.S. Food and Drug Administration. (2013). Warning about promethazine containing products.
2. Johnson & Johnson. (2015). Post-marketing safety data on promethazine products.
3. FDA. (2019). Drug Safety Communication: Spotlight on promethazine and pediatric safety.
4. IMS Health. (2012). Market Trends in Antihistamines and Decongestants.

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Disclaimer: This analysis synthesizes publicly available data and industry insights up to 2023, with projections subject to regulatory, market, and scientific developments.