CLINICAL TRIALS PROFILE FOR ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00006205 ↗	Alcohol Dependency Study: Combining Medication Treatment for Alcoholism	Unknown status	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2005-03-01	The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
NCT00006205 ↗	Alcohol Dependency Study: Combining Medication Treatment for Alcoholism	Unknown status	Bankole Johnson	Phase 2	2005-03-01	The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
NCT00027079 ↗	Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2001-09-01	This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.
NCT00050167 ↗	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer	Completed	Roche Pharma AG	Phase 1	2002-11-01	Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).

Clinical Trial Conditions for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

Condition Name

Condition Name for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Nausea	18
Healthy	16
Vomiting	15
Postoperative Nausea and Vomiting	14

Condition MeSH

Condition MeSH for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Intervention	Trials
Vomiting	57
Nausea	49
Postoperative Nausea and Vomiting	29
Pain, Postoperative	10

Clinical Trial Locations for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Location	Trials
United States	148
Canada	32
Germany	11
India	9
Italy	7

Trials by US State

Trials by US State for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Location	Trials
Texas	27
New York	13
California	12
Virginia	8
Florida	8

Clinical Trial Progress for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	37

Clinical Trial Status

Clinical Trial Status for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	115
Recruiting	17
Terminated	15

Clinical Trial Sponsors for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
M.D. Anderson Cancer Center	11
Merck Sharp & Dohme Corp.	11
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	7

Sponsor Type

Sponsor Type for ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
Sponsor	Trials
Other	198
Industry	65
NIH	19

Last updated: May 4, 2026

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER: Clinical Trial Update, Market Analysis, and Projection

What is the product scope behind “Zofran and Dextrose in plastic container”?

“Zofran and Dextrose in plastic container” is a retail-facing naming convention that maps to ondansetron (Zofran) injection supplied in a dextrose-containing intravenous (IV) formulation and packaged in plastic containers (typically flexible plastic infusion bags or similar). Ondansetron is the active pharmaceutical ingredient, an antiemetic used for:

• Prevention of chemotherapy-induced nausea and vomiting (CINV)
• Prevention of postoperative nausea and vomiting (PONV)
• Prevention of nausea and vomiting in other approved settings depending on jurisdiction and product label

The clinical development and commercialization of “ondansetron in dextrose IV plastic container” tracks the broader ondansetron injection platform rather than a distinct new molecular entity. The market is driven by:

• Oncology infusion volumes (CINV)
• Perioperative workflows (PONV)
• Hospital formulary decisions for branded versus generic ondansetron injection
• Product readiness for shortages and supply reliability

What is the clinical trials update for ondansetron IV (dextrose, plastic container)?

No independent clinical trial program is required to market a packaged formulation when the drug substance and active strength are established. For “Zofran and Dextrose in plastic container,” most “updates” in the last several years for ondansetron injection tend to be:

• Bioequivalence / bridging studies tied to formulation or container changes
• Post-approval safety studies and observational analyses
• Label-maintenance submissions based on ongoing pharmacovigilance and published evidence

Across the ondansetron injection landscape, the measurable clinical-trial activity remains anchored in:

• Comparative oncology and perioperative efficacy studies for 5-HT3 antagonists
• Real-world outcome studies (antiemetic regimen optimization, rescue medication reduction, discharge outcomes)
• Regimen comparisons (ondansetron alone vs in combination pathways such as with dexamethasone or NK-1 antagonists)

Market implication: the clinical base for ondansetron injection is mature; current trial activity is most often incremental rather than creating brand-new use patterns.

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Where does ondansetron injection sit in the CINV and PONV treatment landscape?

Ondansetron remains one of the most widely used agents in both major indications where guidelines support 5-HT3 antagonists.

What are the dominant use channels?

Use channel	Clinical rationale	Typical procurement pattern
Chemotherapy centers	CINV prophylaxis is routine in infusion workflows	Multi-source hospital contracts; price competition after generic entry
Hospitals and ambulatory surgery	PONV prophylaxis is standard for at-risk populations	Standard order sets; formularies seek cost per administered dose
Emergency and inpatient wards	Rescue and symptom control for nausea/vomiting	Rapid access inventory and substitution rules

Market implication: ondansetron injection behaves like a high-volume hospital staple, where tendering and unit price dominate over incremental clinical differentiation.

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How large is the ondansetron injection market, and what segment drives “dextrose in plastic container”?

Public market sizing for “ondansetron injection” is generally reported under broader categories such as:

• Antiemetics
• Oncology supportive care
• PONV prevention
• IV antiemetic agents
• 5-HT3 antagonists

Most market data vendors treat ondansetron under a class-level lens (antiemetics) and/or within oncology supportive care.

Market drivers that pull demand

1. Rising cancer incidence and sustained chemotherapy throughput
2. Growth of day surgery and perioperative case volumes
3. Protocol standardization and order-set embedding of ondansetron
4. Continued use in resource-constrained settings due to broad clinical familiarity and accessible dosing

Market constraints that cap pricing

1. Generic competition (multiple manufacturers, tender-driven pricing)
2. Formulary substitution across 5-HT3 agents (e.g., granisetron where available)
3. Container and administration constraints (IV access protocols, infusion standards)

Segment implication for “plastic container”: the container format mainly affects supply chain and conversion costs (storage, infusion nursing workflows), not clinical differentiation. Demand typically tracks total administered IV ondansetron rather than a separate “plastic-only” market.

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What does the competitive landscape look like for Zofran-branded vs generic ondansetron injection?

Competitive structure

• Branded originator: ondansetron injection branded as Zofran and related products
• Generic entrants: ondansetron injection across standard IV presentations
• Therapeutic class rivals: other 5-HT3 antagonists and combination regimens used in oncology and perioperative care

Key commercialization dynamic

Ondansetron is a commodity-like acute-care drug once generics scale. Brand differentiation usually holds only through:

• Tender premiums tied to supply reliability or procurement preference
• Institutional preference for established SKU and dosing convenience
• Niche packaging compatibility requirements

Market implication: “Zofran and Dextrose in plastic container” sales tend to track hospital demand for IV ondansetron, with share dependent on contract pricing and SKU substitution.

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Clinical and regulatory implications for formulation and container changes

“Plastic container” matters operationally:

• Inventory handling and storage conditions
• Compatibility with infusion sets and administration standards
• Nursing workflow consistency and infusion stability expectations

Regulatory pathways for container changes typically rely on:

• Chemistry, manufacturing, and controls updates
• Stability programs
• If needed, comparability bridging studies or label updates

Market implication: formulation and container variants rarely create independent uptake curves; they mainly reduce switching friction and improve supply resilience.

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Market projection: base case, upside, downside

Because ondansetron injection behaves as a high-volume, generic-competed hospital product, projections are best structured around case volumes and tender economics, not scientific breakthrough risk.

Projection model structure

• Demand anchor: hospital procedure volumes (oncology infusion and perioperative)
• Price and margin anchor: contract tender pricing pressure and generic penetration
• Share anchor: ability to maintain preferred-SKU status within institution formularies

Base case (most likely)

• Unit demand grows with healthcare utilization and cancer and surgery volumes.
• Revenue growth stays modest because price compression offsets dosing growth.
• “Plastic container” SKUs hold share if they match institutional supply and nursing workflow constraints.

Upside case

• Accelerated adoption in additional perioperative protocols or broader prophylaxis coverage where 5-HT3 use expands.
• Supply constraints for certain competitors temporarily shift share toward available SKUs.
• Higher-than-expected retention of branded or preferred-SKU status due to procurement preference.

Downside case

• Faster substitution to other 5-HT3 agents or to combination antiemetic protocols that reduce ondansetron dosing frequency.
• Stronger tender price compression and loss of preferred-SKU status in large contracts.
• Supply normalization across all vendors reduces any availability premium.

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What is the forecast trajectory for “Zofran and Dextrose in plastic container”?

A specific forecast for that exact containerized dextrose presentation is not cleanly separable from overall ondansetron injection unless the market dataset reports container-level granularity. In practical commercial planning, buyers and investors model ondansetron injection by:

• Dosage form (IV)
• Strength and dosing schedules
• Brand vs generic contract share
• Hospital tender cycles

Projection directionality (typical for mature antiemetics):

• Volume: modest upward trend driven by procedure growth
• Value: flatter to modest growth due to generics and contracting economics

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Key Takeaways

• “Zofran and Dextrose in plastic container” is best treated as ondansetron injection in a dextrose IV presentation packaged in plastic, which tracks the mature ondansetron injection market rather than a standalone clinical franchise.
• Clinical activity for ondansetron IV is typically incremental (formulation, container, bridging, safety) because the drug’s core efficacy is already established across CINV and PONV workflows.
• The market behaves like a high-volume hospital commodity: demand follows oncology and perioperative throughput; revenue growth is constrained by generic competition and tender pricing.
• Projections should be built around procedure volumes, contract pricing cycles, and SKU retention rather than expecting clinical differentiation to drive step-change growth.

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FAQs

1) Is “Zofran and Dextrose in plastic container” a new drug?
No. It is a naming convention tied to an existing ondansetron injection drug substance and an IV dextrose presentation in plastic packaging.

2) Do new clinical trials materially change ondansetron’s adoption?
Not typically. For mature ondansetron injection, clinical updates often reinforce existing use patterns rather than creating a new standard of care.

3) What most impacts revenue for this product presentation?
Hospital tender pricing, generic competition, and whether the SKU remains preferred in large purchasing contracts.

4) Does plastic container format create a unique market?
It can reduce switching friction within institutions but usually does not create a fully separable clinical market. Demand largely follows total IV ondansetron usage.

5) What is the most likely long-term growth pattern?
Stable to modest value growth and modest volume growth, with value pressured by contracting and generics.

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References

[1] U.S. Food and Drug Administration. Zofran (ondansetron) product and labeling information. FDA.
[2] U.S. National Library of Medicine. ClinicalTrials.gov. Search results for ondansetron and IV formulation studies.
[3] National Comprehensive Cancer Network (NCCN). Supportive Care Guidelines for antiemetic prophylaxis (CINV).
[4] American Society of Anesthesiologists (ASA). Guidelines and evidence on PONV prevention and prophylaxis using 5-HT3 antagonists.