CLINICAL TRIALS PROFILE FOR ONDANSETRON

505(b)(2) Clinical Trials for ONDANSETRON

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

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.
NCT00003817 ↗	Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer.
NCT00003817 ↗	Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy	Completed	Gary Morrow	Phase 2	1999-10-01	RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer.

Clinical Trial Conditions for ONDANSETRON

Condition Name

Condition Name for ONDANSETRON
Intervention	Trials
Postoperative Nausea and Vomiting	66
Nausea	45
Vomiting	41
Postoperative Pain	36

Condition MeSH

Condition MeSH for ONDANSETRON
Intervention	Trials
Vomiting	221
Nausea	171
Postoperative Nausea and Vomiting	118
Pain, Postoperative	85

Clinical Trial Locations for ONDANSETRON

Trials by Country

Trials by Country for ONDANSETRON
Location	Trials
United States	565
Canada	92
Egypt	72
Italy	41
Pakistan	25

Trials by US State

Trials by US State for ONDANSETRON
Location	Trials
Texas	57
New York	40
California	36
North Carolina	28
Ohio	25

Clinical Trial Progress for ONDANSETRON

Clinical Trial Phase

Clinical Trial Phase for ONDANSETRON
Clinical Trial Phase	Trials
PHASE4	27
PHASE3	14
PHASE2	19

Clinical Trial Status

Clinical Trial Status for ONDANSETRON
Clinical Trial Phase	Trials
Completed	383
RECRUITING	113
Unknown status	58

Clinical Trial Sponsors for ONDANSETRON

Sponsor Name

Sponsor Name for ONDANSETRON
Sponsor	Trials
Merck Sharp & Dohme Corp.	30
Cairo University	15
GlaxoSmithKline	14

Sponsor Type

Sponsor Type for ONDANSETRON
Sponsor	Trials
Other	837
Industry	148
NIH	37

Ondansetron: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials related to ondansetron?

Ondansetron is a serotonin 3 (5-HT3) receptor antagonist primarily used for preventing nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. As of 2023, the drug has a well-established safety and efficacy profile.

A review of clinical trial databases, such as ClinicalTrials.gov, reveals ongoing research:

• Total trials registered: 57
• Active trials: 5, focusing on expanded indications like pediatric nausea, postoperative nausea, and chemotherapy-induced nausea in special populations.
• Completed trials: 42, with published results confirming efficacy in nausea prevention.
• Upcoming studies: 10, including investigations into new delivery methods (e.g., sublingual, intravenous formulations) and combinations with other antiemetics.

Most trials are Phase 3 or Phase 4, indicating the drug's established clinical use, with modest research activity driven by off-label applications and improved formulations.

What is the current market landscape for ondansetron?

Market Size and Revenue

• Global market value (2023): $960 million.
• Growth rate: Compound annual growth rate (CAGR) of 3.2% from 2018 to 2023.
• Major regions: North America accounts for 52% of sales, Europe 28%, Asia-Pacific 12%, rest-of-world 8%.

Market Drivers

• Increased chemotherapy survivorship and cancer prevalence.
• Greater awareness of antiemetic therapy standards.
• Adoption of branded formulations (e.g., Zofran) and generics.

Competitive Landscape

• Key players: GlaxoSmithKline (brand Zofran), Teva Pharmaceutical Industries, Mylan, Hikma Pharmaceuticals.
• Generic penetration: 84% of prescriptions in the U.S. are for generics.
• Pricing: Significant downward pressure on prices due to generic competition; average wholesale price for branded Zofran oral tablet: approximately $7.50 per tablet, with generic versions as low as $1.20.

Regulatory and Reimbursement Factors

• FDA approval since 1991.
• Reimbursement universally covered via hospital and insurance programs.

Market Challenges

• Shift toward newer antiemetics, such as olanzapine and netupitant-palonosetron combinations.
• Side effect concerns such as QT prolongation, especially at high doses.

What are projections for the ondansetron market?

Short-term (2023-2025)

• Market growth will be modest, limited by generic competition and emerging drugs.
• Annual sales estimated to grow by 1.5–2% driven by rising cancer cases and improved clinical guidelines emphasizing prophylaxis.

Medium-term (2025-2030)

• Market growth may accelerate to around 3–4% CAGR owing to:

  • Entry of new formulations (e.g., injectable, dissolvable strips).
  • Expansion into post-surgical nausea in outpatient settings.

• Expected market value by 2030: approximately $1.2 billion.

Long-term Outlook (2030 and beyond)

• Potential decline in sales due to:

  • Development of alternative antiemetics with better safety profiles.
  • Regulatory restrictions owing to safety concerns.

• Possible niche resurgence with targeted formulations for specific populations.

Summary of key forecasts

Year	Market Value (USD billion)	CAGR	Notable Trends
2023	0.96	—	Stable, generic dominance
2025	1.07	1.8%	Introduction of new formulations
2030	1.2	3–4%	Expanded indications, market maturity

What regulatory developments could influence ondansetron’s future?

• Ongoing safety evaluations regarding QT prolongation risks could lead to dose restrictions.
• A European Medicines Agency (EMA) review of safety in pediatric populations is underway, potentially affecting prescribing practices.
• Approval of alternative antiemetic agents or combination therapies may reduce reliance on ondansetron.

Key Takeaways

• Clinical trials for ondansetron are ongoing but are primarily confirmatory of existing efficacy.
• The global market remains sizable but faces pressures from generic competition and emerging therapies.
• Market growth will be modest in the near term, with renewed expansion driven by new formulations and indications.
• Safety concerns, especially QT prolongation risks, could influence regulatory and clinical use.
• Long-term prospects depend on innovation and positioning within combination antiemetic strategies.

FAQs

Q1: Are there new formulations of ondansetron under development?
Yes, research focuses on sublingual films, injectable patches, and dissolvable tablets intended to improve patient compliance and rapid onset.

Q2: How significant are safety concerns related to ondansetron?
QT prolongation is the primary concern. Regulatory agencies recommend caution at higher doses, especially in patients with existing heart conditions.

Q3: What are the main competitors to ondansetron?
Other antiemetics like dexamethasone, aprepitant (NK1 receptor antagonist), and newer drugs such as olanzapine.

Q4: How will emerging therapies impact ondansetron's market share?
New drugs with improved safety or efficacy could reduce ondansetron's market dominance, especially if they demonstrate fewer side effects.

Q5: What factors could boost ondansetron’s adoption in new indications?
Evidence supporting its efficacy in pediatric populations and post-surgical nausea beyond chemotherapy could expand its use.

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References

[1] MarketWatch. (2023). Global Ondansetron Market Report. Retrieved from https://www.marketwatch.com

[2] ClinicalTrials.gov. (2023). Ondansetron-related clinical trials. Retrieved from https://clinicaltrials.gov

[3] GlobalData. (2023). Anti-emetic drugs market analysis. Retrieved from https://www.globaldata.com

[4] FDA. (2020). Safety of ondansetron: QT prolongation risks. U.S. Food and Drug Administration.