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.
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 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	565
Canada	92
Egypt	72
Italy	41
China	25

Trials by US State

Trials by US State for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Location	Trials
Texas	57
New York	40
California	36
North Carolina	28
Ohio	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	27
PHASE3	14
PHASE2	19

Clinical Trial Status

Clinical Trial Status for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	383
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
Assiut University	14

Sponsor Type

Sponsor Type for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Other	837
Industry	148
NIH	37

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: May 1, 2026

Ondansetron Hydrochloride and Dextrose in Plastic Container: Clinical Trial Update, Market Analysis, and Projection

What is the product and how is it positioned commercially?

Ondansetron hydrochloride and dextrose in plastic container is an injectable formulation of the 5-HT3 receptor antagonist ondansetron, supplied in a plastic container and dosed for antiemetic use. Clinically, it targets nausea and vomiting from chemotherapy, radiotherapy, and postoperative settings. Market positioning is dominated by generic and authorized generic availability in hospital channels, with pricing and supply stability dependent on container form factors (plastic bag vs vial), distribution contracts, and pharmacy purchasing tenders.

Key commercial reality: the active ingredient is off-patent in most major markets, which drives the product toward low-margin, volume-based procurement rather than premium differentiation. Container format still matters for operational preference, cold-chain logistics, and compatibility with infusion workflows in acute-care settings.

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What does the clinical-trial landscape look like right now?

No consolidated, product-specific clinical trial register dataset is available in the information provided to support a definitive “as-of” update for this exact combination (ondansetron hydrochloride + dextrose + plastic container) across registries, including trial identifiers, dosing regimens, comparators, endpoints, and enrollment status.

What can be stated from the established clinical role of ondansetron injectable products is limited to class-level indications, which typically include:

• Prevention of nausea and vomiting associated with emetogenic chemotherapy and radiotherapy
• Prevention of postoperative nausea and vomiting (PONV)

However, without product-level registry evidence in the supplied material, a concrete trial update (phase, status, locations, timelines) cannot be produced for the exact formulation.

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What is the market size and demand driver profile?

The market demand for injectable ondansetron is driven by three recurring hospital purchase categories:

1. Oncology infusion and day-care chemotherapy units
2. Radiotherapy supportive care pathways
3. Perioperative anesthesia workflows (PONV prophylaxis and rescue)

Procurement behavior:

• Hospitals buy based on contract pricing, formulary status, and supply reliability.
• Product conversion decisions often follow tender cycles (quarterly to annual) and therapeutic interchange rules.
• In practice, buyers prefer presentations that reduce pharmacy handling complexity (for example, ready-to-use or container types compatible with standard infusion practice).

Competitive structure:

• The competitive set is largely multi-source generics of IV ondansetron, with differentiation tied to:
  • container type (plastic bag formats),
  • concentration and pack size (unit economics),
  • stability and handling documentation,
  • rebate and distribution terms.

Pricing tends to follow generic market dynamics: pressure to the floor, with episodic increases tied to raw material and manufacturing capacity constraints. The presence of dextrose and the plastic container format can influence tender preference but usually does not create lasting pricing power.

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What is the near-term commercial projection (12 to 24 months)?

Projection logic for this product class:

• Ondansetron injectable volume is relatively resilient because it is used as a standard supportive care option.
• Growth typically comes from:
  • increasing chemotherapy and surgical volumes,
  • expanded adoption in institutional protocols,
  • inventory restocking cycles after supply variability.

Expected direction for generic IV ondansetron with plastic container format:

• Units: stable to modest growth in line with procedure volumes.
• Average selling price (ASP): flat to down, constrained by generic competition and tender price resets.
• Share movement: likely rotates between suppliers depending on contract renewals and supply continuity.

A precise numeric forecast cannot be produced from the supplied material because no baseline market size, current ASP, distribution coverage, or brand/generic share data is included.

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What is the medium-term projection (3 to 5 years)?

Medium-term outcomes for injectable ondansetron are typically shaped by:

• ongoing generic competition and margin compression,
• supply chain consolidation and plant capacity decisions,
• institutional protocol updates (e.g., multimodal PONV prophylaxis strategies),
• potential substitution with alternative antiemetics in certain clinical pathways.

Given that ondansetron is entrenched across oncology and perioperative settings, long-term demand is more likely to be:

• volume-positive but price-neutral to negative.

For this specific formulation, the differentiator remains container and ready-to-use workflow fit rather than a novel mechanism. That tends to support continued market inclusion in hospital formularies but does not prevent generic price pressure.

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How to benchmark the product against competitors (actionable purchase and R&D lenses)

Without a registry-anchored trial set, the most actionable competitive benchmarking remains operational and regulatory.

Commercial benchmarking

• Tender readiness: ability to meet contracted fill schedules and emergency supply commitments.
• Pharmacy workflow compatibility: plastic container handling, infusion compatibility, and documentation.
• Cost per dose: pack size and vial/bag equivalency.
• Distribution coverage: cold-chain needs and regional logistics.

R&D/portfolio benchmarking

• For formulary expansion, companies usually compete on:
  • container presentations,
  • concentration options,
  • stability and shelf-life claims,
  • labeling alignment with institutional protocols.

Because the mechanism is class-established and the active is widely generic, the product-level opportunity is primarily presentation-led, not mechanism-led.

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What are the key risks and upside levers for forecasting?

Risks

• ASP erosion from competitive tender cycles.
• Substitution by other antiemetics in specific protocols (depends on local clinical guideline adherence).
• Supply disruptions tied to manufacturing capacity or container material constraints.

Upside levers

• Contract wins in large integrated health systems.
• Improved clinician preference for the plastic container workflow.
• Inventory normalization after prior shortages.

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Key Takeaways

1. Ondansetron hydrochloride with dextrose in plastic container sits in a mature, procurement-driven IV antiemetic market where demand tracks oncology and perioperative procedure volumes.
2. A product-specific clinical trials update cannot be produced from the supplied material because no registry-level evidence (trial IDs, phase/status, endpoints, timelines) is provided.
3. Near-term (12 to 24 months) expectations for this generic class are stable-to-modest unit growth with flat-to-down pricing shaped by tender cycles and supplier switching.
4. Medium-term (3 to 5 years) demand is likely volume-supported but margin-constrained, with differentiation concentrated in container presentation and operational fit.

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FAQs

1. Is ondansetron injectable growth tied to oncology or perioperative care more?
   Demand is driven by both oncology supportive care and PONV pathways; institutional usage patterns vary by health system and anesthesia protocols.

2. Does the plastic container format change clinical efficacy?
   The clinical effect is mechanism-led (ondansetron), while container choice typically affects handling, pharmacy workflow, and procurement preferences.

3. What typically happens to prices for injectable ondansetron generics?
   Prices generally face pressure from multi-source competition and periodic contract resets, leading to flat-to-down ASP trends over time.

4. What would justify a meaningful market share shift among suppliers?
   Contract wins, consistent supply performance, and pharmacy workflow compatibility that reduce total handling and infusion friction.

5. Can this formulation’s market be projected without registries and pricing baselines?
   Broad direction can be inferred from class maturity, but numeric forecasts require baseline market and commercial data that is not included in the provided material.

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References

[1] FDA. Ondansetron injection prescribing information (product and label pages for ondansetron-containing injections). U.S. Food and Drug Administration.
[2] EMA. Ondansetron assessment and product information (EU product information pages for ondansetron IV formulations). European Medicines Agency.
[3] ClinicalTrials.gov. Search results for ondansetron intravenous trials (registry entries vary by formulation and container). National Library of Medicine.
[4] World Health Organization. Antiemetic supportive care guidance and oncology supportive care context (class-level use). World Health Organization.