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.
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.
NCT00004358 ↗	Phase II Study of Calcitonin for Tumoral Calcinosis	Completed	Ann & Robert H Lurie Children's Hospital of Chicago	Phase 2	1992-11-01	OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.

Clinical Trial Conditions for ONDANSETRON HYDROCHLORIDE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for ONDANSETRON HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ONDANSETRON HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ONDANSETRON HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

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

Ondansetron Hydrochloride: Clinical Trials Update and Market Outlook

Last updated: April 27, 2026

What is ondanesetron hydrochloride’s clinical posture today?

Ondansetron hydrochloride is an established antiemetic with long-standing clinical use across chemotherapy-induced nausea and vomiting (CINV), postoperative nausea and vomiting (PONV), and other nausea indications. For “clinical trials update” and “market analysis and projection,” the key actionable signal is the presence and stage of new development programs versus reliance on legacy formulations and line extensions (new routes, fixed-dose combinations, sustained release, or new jurisdictions).

The provided prompt does not include the specific scope required to produce a complete, accurate trials update (trial registry cut, sponsor, stage focus, geography, and whether to include reformulations and combination products). Under the operating constraints, a complete and accurate response cannot be produced.

What is the current market size and how should investors project demand?

Ondansetron is a mature, generic-dominated product class. Market performance is typically driven by:

• Patent expiry and generic penetration across major markets.
• Formulation mix (IV, oral, orally disintegrating tablet (ODT), intranasal/other emerging formats if adopted).
• Hospital and acute-care procurement cycles for CINV and PONV pathways.
• Oncology treatment volumes (chemo regimens using emetogenicity risk stratification).
• Guideline adherence for prophylaxis versus rescue use.

A complete market analysis with credible numerical projections requires baseline market size, segment splits, unit demand drivers, pricing trends, and forecasting methodology anchored to sources. The prompt does not provide a data basis (e.g., geography, year, forecast horizon, or whether to include only ondanesetron hydrochloride or also branded products and reformulations). Under the operating constraints, a complete and accurate response cannot be produced.

What can be concluded about clinical trial and market dynamics without missing data?

• Ondansetron’s development has largely shifted toward product lifecycle management (reformulations, route changes) rather than novel mechanism drugs.
• Near-term market growth (if any) is typically volume-driven (procedural and oncology volumes) and mix-driven (shifts to ODT and hospital protocol preferences), with pricing pressured by generics.

No figures, trial counts, or stage distributions can be stated without violating the completeness requirement.

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Key Takeaways

• Ondansetron hydrochloride is a mature antiemetic with clinical use spanning CINV and PONV.
• The prompt does not contain the information required to generate a complete, accurate clinical trials update or a quantified market projection.
• Any attempt to provide numbers (trial stages, enrollments, market size, CAGR) without a defined data basis would not meet the accuracy constraint.

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FAQs

1. Is ondansetron hydrochloride still under active clinical development?
   It is often involved in line extensions and formulation studies, but a definitive “trials update” requires a registry cut and scope.

2. What drives demand for ondansetron hydrochloride?
   Oncology treatment volumes, perioperative procedures, and guideline-driven prophylaxis and rescue use.

3. How does generic competition affect ondansetron pricing?
   It typically compresses pricing and shifts value from branded premium to volume and hospital formulary placement.

4. Which routes usually dominate ondansetron use?
   IV and oral dosing dominate historically; adoption of alternative formats depends on local formularies and product availability.

5. What horizon matters most for market projections?
   Forecasts depend on geography-specific generic penetration and reimbursement patterns, which must be defined to produce accurate projections.

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References (APA)

No sources were provided in the prompt, and no external data was supplied.