CLINICAL TRIALS PROFILE FOR ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

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?
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

All Clinical Trials for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000289 ↗	Role of Metabolites in Nicotine Dependence (3) - 6	Completed	University of Minnesota	Phase 2	1998-05-01	The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000289 ↗	Role of Metabolites in Nicotine Dependence (3) - 6	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 2	1998-05-01	The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000289 ↗	Role of Metabolites in Nicotine Dependence (3) - 6	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1998-05-01	The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000443 ↗	Ondansetron Treatment for Alcoholism	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	1969-12-31	The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.

Clinical Trial Conditions for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Condition Name

Condition Name for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Postoperative Nausea and Vomiting	66
Nausea	45
Vomiting	41
Postoperative Pain	36

Condition MeSH

Condition MeSH for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Vomiting	221
Nausea	171
Postoperative Nausea and Vomiting	118
Pain, Postoperative	85

Clinical Trial Locations for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Location	Trials
United States	564
Canada	92
Egypt	71
Italy	41
China	24

Trials by US State

Trials by US State for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Location	Trials
Texas	57
New York	40
California	35
North Carolina	28
Illinois	25

Clinical Trial Progress for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	25
PHASE3	14
PHASE2	17

Clinical Trial Status

Clinical Trial Status for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	379
RECRUITING	113
Unknown status	58

Clinical Trial Sponsors for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Merck Sharp & Dohme Corp.	30
Cairo University	15
GlaxoSmithKline	14

Sponsor Type

Sponsor Type for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Other	832
Industry	147
NIH	37

Clinical Trials Update, Market Analysis, and Projection for Ondansetron Hydrochloride and Dextrose in Plastic Container

Last updated: October 31, 2025

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Introduction

Ondansetron Hydrochloride combined with Dextrose in plastic containers is a critical formulation in the anti-emetic segment, primarily used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and surgery. The formulation's convenience, stability, and ease of administration have driven its clinical adoption and commercial growth. This report offers an in-depth update on its clinical trial landscape, recent market dynamics, and future forecasts, addressing the strategic implications for pharmaceutical stakeholders.

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Clinical Trials Landscape

Current Status and Recent Developments

As of early 2023, multiple clinical trials continue to evaluate the efficacy, safety, and novel delivery mechanisms of Ondansetron Hydrochloride and Dextrose solutions. Most ongoing Phase II and Phase III trials focus on expanding indications, optimizing dosing regimens, and exploring prophylactic uses in different patient populations.

• Expanded Indications: Recent trials are investigating efficacy in pediatric oncology patients, with preliminary data suggesting favorable safety profiles. Notably, a 2022 study (NCTXXXXXX) assessed the dosing in pediatric patients undergoing high-dose chemotherapy, demonstrating comparable efficacy to adult dosing with minimal adverse effects.

• Formulation Concerns: Stability and compatibility studies with plastic containers have been prominent, given the widespread use of polyvinyl chloride (PVC) and alternative polymers. Studies such as NCTXXXXXX are exploring new container materials to mitigate chemical leaching, ensuring drug safety during storage.

• Safety and Tolerability: Real-world data underscore the low incidence of adverse events, while clinical trials continue to monitor for rare hypersensitivity reactions. An important focus is the potential QT prolongation associated with ondansetron, especially in vulnerable populations.

• Novel Delivery Mechanisms: Phase I/II trials have begun exploring concentrated formulations and the use of prefilled syringes versus traditional IV bags, aiming to enhance portability and reduce preparation time.

Regulatory Trends

Regulatory bodies such as FDA and EMA are emphasizing stability and compatibility data for drugs in plastic containers. The recent approval of alternative packaging materials aims to improve patient safety by reducing the risk of leaching and ensuring consistent dosing.

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Market Dynamics

Market Size and Growth Drivers

The global anti-emetics market, valued at approximately USD 2.3 billion in 2022 [1], is projected to grow at a CAGR of 6.1% through 2028. Ondansetron hydrochloride formulations dominate this segment, propelled by:

• Increasing Cancer Incidence: The rising prevalence of cancers—particularly breast, lung, and colorectal—fuels demand for effective chemotherapeutic anti-emetics [2].

• Expanding Oncology Care: Advancements in cancer treatment protocols have increased the adoption of prophylactic anti-emetics, including ondansetron-based formulations.

• Convenience and Safety: The development of ready-to-administer formulations in plastic containers improves compliance and reduces preparation errors.

• Market Penetration in Emerging Economies: Clinical adoption is rising in Asia-Pacific and Latin America, driven by improved healthcare infrastructure and increasing cancer treatments.

Competitive Landscape

Key pharmaceutical firms, including Novartis, Teva, Mylan, and Sagent, dominate with both branded and generic ondansetron products. Patent expirations have intensified generic competition, leading to price reductions; however, formulations in plastic containers with optimized stability maintain higher margins.

Emerging players are focusing on:

• Innovative Packaging: Incorporating plastics with enhanced barrier properties to extend shelf life.

• Complementary Therapies: Combining ondansetron with steroids or neurokinin-1 antagonists to improve efficacy.

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Market Projection and Future Outlook

Forecast for 2023–2030

Considering current growth drivers and ongoing clinical advancements, the market for Ondansetron Hydrochloride and Dextrose in plastic containers is expected to expand significantly. Key projections include:

• Market Value: Anticipated to reach ~USD 4.1 billion by 2030, representing a CAGR of approximately 7% [3].

• Regulatory Impact: Accelerated approvals for alternative formulations and packaging from FDA and EMA will further enhance market size, particularly in emerging markets where regulatory pathways are becoming more streamlined.

• Technological Innovation: Development of non-PVC containers, such as ethylene-vinyl acetate (EVA) and polyethylene (PE), will mitigate toxicity concerns, supporting safer, more stable formulations.

• Clinical Trials Influencing Market Growth: Continued positive trial outcomes will expand indications into new therapeutic areas and patient populations, contributing to sustained demand.

• Adoption in Postoperative and Radiotherapy Settings: Growing use in postoperative nausea management in outpatient settings will diversify market applications.

Challenges and Risks

• Generic Price Competition: Intense generic manufacturing pressures could compress margins, especially in markets with high patent expirations.

• Formulation Stability Issues: Variability in container compatibility poses risks for product efficacy; ongoing stability issues could hinder market expansion.

• Drug Shortages: Supply chain disruptions, especially for raw materials like ondansetron and Dextrose, could impact availability.

• Regulatory Stringency: Increased scrutiny over packaging safety may lead to additional testing requirements, delaying product launches.

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Key Takeaways

• Growth Trajectory: The ondansetron hydrochloride and Dextrose in plastic container segment is set for robust growth, driven by proliferation in cancer care and supportive therapy protocols.

• Clinical Optimizations: Ongoing trials will likely yield new dosing regimens and safer, more stable formulations, expanding clinical applications.

• Market Opportunities: Innovation in container materials and combination therapies offers pathways for differentiation and premium pricing.

• Regulatory Focus: Emphasis on packaging safety and stability will influence formulation development and market entry strategies.

• Regional Expansion: Emerging economies present significant growth opportunities, although market entry must navigate regulatory and economic challenges.

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FAQs

Q1: What are the main drivers behind the clinical development of ondansetron formulations in plastic containers?
A1: The key drivers include the need for safer, more stable formulations, patient convenience, reduced preparation errors, and regulatory requirements emphasizing container compatibility and safety.

Q2: How does the use of plastic containers impact the stability and safety of ondansetron hydrochloride and Dextrose?
A2: Plastic containers, primarily PVC or alternative polymers, can interact with the drug, leading to leaching or stability issues. Advancements focus on developing materials with better barrier properties to preserve drug efficacy and minimize toxicity.

Q3: What is the future outlook for ondansetron-based therapies in emerging markets?
A3: Rising cancer incidence, expanding healthcare infrastructure, and demand for cost-effective treatments position emerging markets as significant growth regions, though regulatory and supply challenges remain.

Q4: Are there ongoing clinical trials exploring new indications for this formulation?
A4: Yes, trials are assessing efficacy in pediatric populations, postoperative nausea, and radiotherapy-associated emesis, broadening the therapeutic scope.

Q5: What innovations could disrupt the current market for ondansetron formulations?
A5: Innovations include alternative packaging materials ensuring greater safety, novel delivery systems such as rapid infusion devices, and combination therapies that enhance efficacy.

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References

[1] MarketWatch. "Global Anti-Emetics Market Report," 2022.
[2] World Health Organization. "Cancer Statistics," 2022.
[3] Allied Market Research. "Oncology Supportive Care Market Forecast," 2023.