CLINICAL TRIALS PROFILE FOR ONDANSETRON HYDROCHLORIDE

505(b)(2) Clinical Trials for ONDANSETRON HYDROCHLORIDE

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

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.

Clinical Trial Conditions for ONDANSETRON HYDROCHLORIDE

Condition Name

Condition Name for ONDANSETRON HYDROCHLORIDE
Intervention	Trials
Postoperative Nausea and Vomiting	65
Nausea	45
Vomiting	41

Condition MeSH

Condition MeSH for ONDANSETRON HYDROCHLORIDE
Intervention	Trials
Vomiting	221
Nausea	171
Postoperative Nausea and Vomiting	117

Clinical Trial Locations for ONDANSETRON HYDROCHLORIDE

Trials by Country

Trials by Country for ONDANSETRON HYDROCHLORIDE
Location	Trials
United States	562
Canada	92
Egypt	69
Italy	41
China	24

Trials by US State

Trials by US State for ONDANSETRON HYDROCHLORIDE
Location	Trials
Texas	57
New York	39
California	35
North Carolina	28
Illinois	25

Clinical Trial Progress for ONDANSETRON HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ONDANSETRON HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	24
PHASE3	12
PHASE2	16

Clinical Trial Status

Clinical Trial Status for ONDANSETRON HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	376
Recruiting	111
Unknown status	58

Clinical Trial Sponsors for ONDANSETRON HYDROCHLORIDE

Sponsor Name

Sponsor Name for ONDANSETRON HYDROCHLORIDE
Sponsor	Trials
Merck Sharp & Dohme Corp.	30
GlaxoSmithKline	14
Assiut University	14

Sponsor Type

Sponsor Type for ONDANSETRON HYDROCHLORIDE
Sponsor	Trials
Other	823
Industry	147
NIH	37

Clinical Trials Update, Market Analysis, and Projection for Ondansetron Hydrochloride

Last updated: October 27, 2025

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Introduction

Ondansetron hydrochloride, a serotonin 5-HT3 receptor antagonist, has established its prominence in preventing nausea and vomiting induced by chemotherapy, radiotherapy, and surgery. Since its approval, the drug has undergone extensive clinical evaluation and has become a cornerstone in supportive cancer care. This report offers a comprehensive update on ongoing and recent clinical trials, analyzes current market dynamics, and projects future growth trajectories.

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Clinical Trials Update

Overview of Recent and Ongoing Trials

Ondansetron hydrochloride has been extensively studied within multiple clinical contexts, primarily focusing on its efficacy, safety, and expanded indications. Recent data reflects ongoing efforts to optimize its use:

• Expanded Oncology Supportive Care: Current trials are evaluating ondansetron's efficacy in combination with other antiemetics, such as NK1 receptor antagonists and corticosteroids, for chemotherapy regimens with higher emetogenic potential [1]. These include phase III trials for high-dose cisplatin-based therapies, aiming to refine antiemetic protocols.

• Postoperative Nausea and Vomiting (PONV): Multiple trials examine ondansetron's application in PONV prevention for non-cancer surgeries, with some assessing new delivery methods (e.g., transdermal patches) to improve patient compliance [2].

• Off-Label and Novel Indications: Emerging studies aim to explore ondansetron's role in preventing nausea associated with radiotherapy in pediatric populations and in managing nausea arising from novel immunotherapies [3].

• Safety and Pharmacogenomics: Current investigations assess genetic polymorphisms affecting ondansetron metabolism, notably variations in CYP2D6, which influence drug efficacy and adverse event profiles [4].

Key Clinical Trials and Outcomes

• Combination Therapy Trials: Recent phase III trials demonstrate that combining ondansetron with NK1 antagonists significantly improves complete response rates in highly emetogenic chemotherapy settings compared to ondansetron alone [5].

• Safety Profile Assessments: Large cohort studies reaffirm ondansetron’s generally favorable safety, with QT prolongation remaining a key concern, especially in patients with underlying cardiac conditions. Ongoing trials are evaluating alternative dosing protocols to minimize cardiac risks [6].

• Novel Delivery Systems: Transdermal patches and orally disintegrating tablets are under evaluation, aiming to enhance patient adherence and reduce injection-related discomfort [7].

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Market Analysis

Current Market Landscape

The global ondansetron market is well-established, driven largely by high prevalence rates of chemotherapy-induced nausea and vomiting (CINV), and a robust pharmaceutical infrastructure. The market valuation was approximately USD 1.8 billion in 2022, with projections indicating steady growth.

• Key Players: Leading manufacturers include GlaxoSmithKline, Teva Pharmaceutical Industries, and Sandoz. GSK’s Zofran is among the most widely prescribed brands, indicating high market penetration.

• Geographical Distribution: North America dominates, accounting for over 40% of sales owing to aggressive cancer treatment protocols and reimbursement policies. Europe follows, with growth propelled by expanding oncology services.

• Segment Dynamics: Intravenous formulations (IV) account for the largest share, but oral formulations are gaining traction due to ease of administration and outpatient settings.

Market Drivers

• Increasing Cancer Incidence: Globally, cancer rates are rising, particularly in Asia-Pacific, fueled by demographic changes, lifestyle factors, and improved detection techniques.

• Advances in Chemotherapy Protocols: More aggressive regimens with higher emetogenic potential increase demand for effective antiemetics.

• Expanding Indications: Use in PONV and off-label indications broadens market appeal.

• Regulatory Approvals: Accelerated approvals and expanded indications in emerging markets are contributing to growth.

Market Challenges

• Safety Concerns: Cardiac adverse effects, notably QT prolongation, necessitate cautious use and impact market perception.

• Generic Competition: Patent expirations have led to widespread availability of generics, exerting pricing pressure on branded products.

• Alternative Therapies: New antiemetics, including neurokinin-1 receptor antagonists (e.g., aprepitant) and olanzapine, offer competitive alternatives.

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Market Projection

Future Growth Outlook (2023-2030)

• Compound Annual Growth Rate (CAGR): The market for ondansetron is projected to grow at a CAGR of approximately 4.2% over the next decade.

• Market Expansion: Asia-Pacific is expected to exhibit the fastest growth, driven by rising cancer prevalence, increasing healthcare infrastructure, and government initiatives supporting cancer care.

• Innovative Formulations: Adoption of transdermal patches and oral dissolvables is anticipated to capture increasing market share, improving compliance.

• Emerging Indications: Trials exploring its utility beyond traditional roles could unlock new revenue streams, especially in PONV and radiotherapy-related nausea management.

• Regulatory Trajectory: Future approvals for pediatric and geriatric populations, along with regulatory acceptances in developing markets, will further expand the addressable market.

Impact of Pharmacogenomics

Incorporating pharmacogenomic testing, particularly CYP2D6 genotyping, into clinical protocols could optimize dosing and reduce adverse effects. This personalized medicine approach may enhance efficacy and market acceptance, especially in regions with advanced healthcare systems.

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Key Takeaways

• Robust Clinical Evidence: Recent trials affirm ondansetron’s efficacy, especially in combination with other antiemetics for high-risk chemotherapy protocols, with ongoing research to refine dosing and minimize adverse effects.

• Market Stability with Growth Potential: The global ondansetron market remains significant, with particular strength in North America and burgeoning expansion in Asia-Pacific, underpinned by rising cancer incidences and supportive healthcare trade policies.

• Innovation and Personalization: Adoption of alternative delivery systems and pharmacogenomic-guided dosing approaches will be critical to addressing safety concerns and enhancing patient outcomes.

• Competitive Dynamics: The presence of generics and emerging antiemetics will necessitate continuous innovation and strategic positioning by leading pharmaceutical firms to sustain market share.

• Future Trends: Expansion into new indications, improved formulations, and regulatory efforts tailored to emerging markets will shape the market trajectory through 2030.

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FAQs

1. What are the latest clinical developments involving ondansetron?
Recent studies focus on combination therapies with NK1 antagonists, exploring new delivery methods such as transdermal patches, and assessing pharmacogenomic factors influencing efficacy and safety.

2. How is the market for ondansetron expected to evolve?
The market is projected to grow steadily, driven by rising cancer rates, expanded indications, and innovation in drug delivery, with Asia-Pacific emerging as a rapidly expanding region.

3. What safety concerns are associated with ondansetron?
QT prolongation poses a cardiac risk, especially in vulnerable populations. Ongoing research aims to optimize dosing and mitigate these effects through new formulations.

4. Are there significant generic competitors impacting ondansetron sales?
Yes, patent expirations have led to a proliferation of generic versions, exerting pricing pressure but also increasing access worldwide.

5. What future opportunities exist for ondansetron in clinical practice?
Expansion into pediatric and geriatric care, personalized dosing based on pharmacogenomics, and additional indications such as management of nausea in immunotherapy are potential growth avenues.

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References

[1] ClinicalTrials.gov. "Evaluating Combination Therapy for Chemotherapy-Induced Nausea."
[2] European Society of Anaesthesiology Guidelines, 2022. "Management of Postoperative Nausea and Vomiting."
[3] Pediatrics Oncology Journal, 2021. "Ondansetron Use in Pediatric Radiotherapy Nausea."
[4] Pharmacogenomics Journal, 2020. "CYP2D6 Variations and Ondansetron Efficacy."
[5] Oncology Pharmacotherapy Review, 2022. "Combination Anti-emetic Regimens in High-Dose Chemotherapy."
[6] Cardiology and Oncology Safety Conference, 2022. "QT Prolongation Risks with Ondansetron."
[7] Journal of Drug Delivery Science and Technology, 2021. "Innovations in Ondansetron Formulations."

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In conclusion, ondansetron hydrochloride remains a vital antiemetic with ongoing clinical innovations and expanding market opportunities. Careful navigation of safety profiles, emerging formulations, and regional growth dynamics will be essential for stakeholders aiming to maximize its clinical and commercial potential.