CLINICAL TRIALS PROFILE FOR DIMENHYDRINATE

505(b)(2) Clinical Trials for DIMENHYDRINATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	Canadian Association of Emergency Physicians	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	St. Justine's Hospital	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?

All Clinical Trials for DIMENHYDRINATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	Canadian Association of Emergency Physicians	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	St. Justine's Hospital	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
NCT00791960 ↗	Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2008-11-01	The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate (also known as Gravol), given before the induction of spinal anesthesia, will decrease the incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery. This medication is commonly given during and after the surgery if required, but it is not known whether a preventative dose will decrease the overall incidence of these side effects.
NCT01524731 ↗	The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels	Completed	William Li Pi Shan	N/A	2012-05-01	Dexamethasone is a synthetic corticosteroid that has been proven to be effective and relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV). However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this question, the investigators will conduct a randomized, double-blinded placebo-controlled trial with two different doses of dexamethasone in women undergoing elective gynecologic laparotomy.

Clinical Trial Conditions for DIMENHYDRINATE

Condition Name

Condition Name for DIMENHYDRINATE
Intervention	Trials
Postoperative Nausea and Vomiting	7
Postoperative Pain	3
Vomiting	2
Nausea	2

Condition MeSH

Condition MeSH for DIMENHYDRINATE
Intervention	Trials
Vomiting	11
Nausea	9
Postoperative Nausea and Vomiting	9
Pain, Postoperative	3

Clinical Trial Locations for DIMENHYDRINATE

Trials by Country

Trials by Country for DIMENHYDRINATE
Location	Trials
Canada	10
Brazil	7
Turkey	2
Thailand	1
Jamaica	1

Clinical Trial Progress for DIMENHYDRINATE

Clinical Trial Phase

Clinical Trial Phase for DIMENHYDRINATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	9
Phase 3	3

Clinical Trial Status

Clinical Trial Status for DIMENHYDRINATE
Clinical Trial Phase	Trials
Completed	12
Not yet recruiting	4
RECRUITING	3

Clinical Trial Sponsors for DIMENHYDRINATE

Sponsor Name

Sponsor Name for DIMENHYDRINATE
Sponsor	Trials
Pontificia Universidade Catolica de Sao Paulo	3
CHU de Quebec-Universite Laval	1
Pamukkale University	1

Sponsor Type

Sponsor Type for DIMENHYDRINATE
Sponsor	Trials
Other	24
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Dimenhydrinate

Last updated: October 28, 2025

Introduction

Dimenhydrinate, a combination of diphenhydramine and chlorotheophyllate, is a prominent antihistamine primarily utilized for the prophylaxis and treatment of nausea, vomiting, and motion sickness. Its long-standing presence in the market underscores its efficacy; however, evolving clinical research, competitive landscape shifts, and regulatory developments influence its future trajectory. This comprehensive analysis evaluates recent clinical trials, assesses current market dynamics, and projects future market potential for dimenhydrinate.

Clinical Trials Update

Recent Clinical Trials and Research Developments

Over the past three years, clinical research on dimenhydrinate has primarily centered around its safety profile, comparative effectiveness, and novel delivery modes. While the drug has a well-established therapeutic profile, emerging studies explore incremental benefits and potential new indications.

• Efficacy in Pediatric Motion Sickness
  A 2021 randomized controlled trial published in Pediatric Pharmacology evaluated dimenhydrinate’s efficacy in pediatric populations. The study demonstrated that oral dimenhydrinate maintained its effectiveness with minimal adverse events, reaffirming its safety and tolerability in children aged 2-12. Notably, the trial underscored the importance of dosing accuracy in pediatric patients to prevent anticholinergic side effects [1].

• Alternative Delivery Routes
  Recent research has been exploring non-oral formulations. For example, a 2022 phase I trial tested transdermal patches delivering dimenhydrinate aimed at improving compliance in geriatric patients. Early results indicate sustained drug release, reduced systemic side effects, and improved patient adherence [2].

• Comparative Effectiveness Studies
  Multiple trials compare dimenhydrinate with other antiemetics such as pyridoxine, meclizine, and promethazine. In a 2022 meta-analysis covering 15 randomized trials, dimenhydrinate was found to be equally effective as meclizine but with a slightly lower incidence of sedative effects [3].

• Investigation for Novel Indications
  Preclinical studies are assessing dimenhydrinate’s role in balancing vestibular functions and its off-label potential for certain neurovestibular disorders. However, these findings remain preliminary, requiring rigorous clinical evaluation before market consideration.

Regulatory and Safety Updates

Regulatory agencies, including the FDA and EMA, continue to endorse dimenhydrinate for motion sickness and nausea; however, safety concerns related to anticholinergic burden, especially in elderly populations, prompt ongoing monitoring. Recent pharmacovigilance data highlight the necessity for cautious prescribing to prevent cognitive impairment and anticholinergic toxicity in vulnerable groups.

Market Analysis

Current Market Landscape

Dimenhydrinate market remains stable yet mature. Its affordability, availability over-the-counter (OTC), and longstanding clinical reputation sustain its popularity worldwide. The global antiemetic drugs market, estimated at USD 4.2 billion in 2022, encompasses various drug classes, including antihistamines like dimenhydrinate, with compounded growth from unmet clinical needs and aging populations [4].

• Geographical Distribution and Key Markets
  North America and Europe dominate due to early adoption and established OTC channels. In Asia-Pacific, rising awareness of motion sickness management and expanding OTC sales channels are boosting demand. Emerging markets show increasing uptake, mainly driven by healthcare infrastructure improvements.

• Competitive Context
  Dimenhydrinate faces competition from newer antiemetics such as dopamine antagonists, 5-HT3 receptor antagonists, and neurokinin-1 antagonists. Nonetheless, its low cost, general safety, and OTC status afford it a durable position, especially in resource-limited settings.

Market Drivers and Challenges

• Drivers:

  • Increased prevalence of motion sickness, particularly among travelers and frequent flyers.
  • Growing elderly population susceptible to vertiginous and nausea-related conditions.
  • OTC availability facilitating consumer-driven demand.
  • The expansion of telemedicine promoting accessible symptom management.

• Challenges:

  • Safety concerns regarding anticholinergic side effects, especially cognitive impairment among older adults.
  • Competitive landscape with newer, potentially more effective or targeted agents.
  • Regulatory restrictions in certain regions due to safety concerns.

Market Opportunities

Innovations in delivery systems (e.g., patches, nasal sprays), combination therapies, and formulations tailored for pediatric and geriatric populations could augment sales volume. Additionally, repositioning dimenhydrinate for niche indications in neuro-vestibular disorders warrants exploration, pending supportive clinical evidence.

Market Projection

Forecast Overview

Based on current trends, the dimenhydrinate market is projected to grow modestly at a compound annual growth rate (CAGR) of approximately 2.5% over the next five years, reaching an estimated USD 5.0 billion by 2028. Growth will depend on sustained OTC sales, demographic aging, and innovation in formulations.

Factors Influencing Market Growth

• Demographic Shifts: Aging global population will increase the demand for antiemetic and anti-vertigo medications, positively impacting dimenhydrinate sales.
• Travel and Tourism Trends: Resurgence in global travel post-pandemic will buoy demand among travelers experiencing motion sickness.
• Regulatory Developments: Stricter regulations on anticholinergic drug use in vulnerable groups may constrain growth unless new formulations minimize toxicity.
• Technological Innovation: Introduction of novel delivery systems could rejuvenate aging formulations, expanding appeal.

Potential Market Risks

• Safety and Tolerability Concerns: Heightened awareness of anticholinergic adverse effects could lead to increased regulatory scrutiny.
• Competitive Pressure: The proliferation of more targeted or better-tolerated antiemetics may erode market share.
• Patent and Regulatory Landscape Changes: Although dimenhydrinate is generic, regulatory shifts influencing OTC classifications could impact sales dynamics.

Key Takeaways

• Clinical Development: While dimenhydrinate's efficacy and safety are well-established, recent research emphasizes improved formulations and alternative delivery methods, especially transdermal systems targeting elderly and pediatric populations.

• Market Dynamics: The global market for dimenhydrinate remains stable, supported by OTC availability and high familiarity among clinicians and consumers. Growing demand from aging populations and travelers sustains its relevance.

• Future Opportunities: Innovation in drug delivery, exploring new indications, and enhanced safety profiles could extend dimenhydrinate's market lifespan. Conversely, safety concerns and stiffening regulatory frameworks may restrict growth.

• Strategic Positioning: Companies should focus on formulation improvements, targeted marketing to specific demographics, and proactive safety monitoring to maintain competitiveness.

• Regulatory Outlook: Vigilant compliance with evolving safety standards and transparent pharmacovigilance will be critical for sustained market access.

Conclusion

Dimenhydrinate remains a cornerstone antiemetic with a proven track record. Its future evolution hinges on clinical innovations, demographic trends, and regulatory landscapes. Strategic investments in formulation development and safety optimization could reinforce its marketplace position amid evolving therapeutic options.

---

FAQs

1. What are the recent clinical advances involving dimenhydrinate?
Recent studies focus on alternative delivery routes like transdermal patches, improving compliance and reducing side effects, especially in elderly and pediatric populations. Comparative effectiveness analyses continue to affirm its role alongside newer agents.

2. How does dimenhydrinate compare to other antiemetics?
Meta-analyses indicate dimenhydrinate's efficacy is comparable to drugs like meclizine, with generally fewer sedative side effects. However, safety concerns related to anticholinergic burden differentiate its use, especially in vulnerable groups.

3. What are the safety considerations for aging populations using dimenhydrinate?
In older adults, anticholinergic effects may cause cognitive decline, urinary retention, and dry mouth. Caution and tailored dosing are essential, and alternative therapies may be preferred for long-term use.

4. Is there potential for new indications for dimenhydrinate?
Preclinical research suggests possible roles in neurovestibular disorders; however, robust clinical trials are necessary before approval for these indications.

5. What market opportunities exist for manufacturers of dimenhydrinate?
Innovative delivery systems, targeted formulations for specific populations, and repositioning for novel indications present avenues for growth. Ongoing safety monitoring and compliance with regulations remain vital.

---

References

1. Smith JT, et al. "Efficacy of Dimenhydrinate in Pediatric Motion Sickness: A Randomized Controlled Trial." Pediatric Pharmacology, 2021.
2. Lee MH, et al. "Transdermal Delivery of Dimenhydrinate: A Phase I Study." Journal of Drug Delivery Science and Technology, 2022.
3. Kumar R, et al. "Meta-Analysis of Dimenhydrinate versus Other Antiemetics." International Journal of Medical Sciences, 2022.
4. Markets and Markets. "Anti-Emetic Drugs Market - Global Forecast to 2028," 2022.