CLINICAL TRIALS PROFILE FOR ZOFRAN ODT

505(b)(2) Clinical Trials for Zofran Odt

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 Odt

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).
NCT00050167 ↗	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer	Completed	M.D. Anderson Cancer Center	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).
NCT00134706 ↗	A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer	Completed	Beth Israel Deaconess Medical Center	Phase 2	2004-01-01	The purpose of this study is to look at the effects (good and bad) of the combination of docetaxel and carboplatin for patients who have progressive prostate cancer after chemotherapy with drugs such as docetaxel. The investigators are also studying whether the measurement of two proteins in the blood may predict who will respond to the combination of docetaxel and carboplatin.

Clinical Trial Conditions for Zofran Odt

Condition Name

Condition Name for Zofran Odt
Intervention	Trials
Nausea	18
Healthy	16
Vomiting	15
Postoperative Nausea and Vomiting	14

Condition MeSH

Condition MeSH for Zofran Odt
Intervention	Trials
Vomiting	57
Nausea	49
Postoperative Nausea and Vomiting	29
Pain, Postoperative	10

Clinical Trial Locations for Zofran Odt

Trials by Country

Trials by Country for Zofran Odt
Location	Trials
United States	148
Canada	32
Germany	11
India	9
Italy	7

Trials by US State

Trials by US State for Zofran Odt
Location	Trials
Texas	27
New York	13
California	12
Virginia	8
Florida	8

Clinical Trial Progress for Zofran Odt

Clinical Trial Phase

Clinical Trial Phase for Zofran Odt
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	37

Clinical Trial Status

Clinical Trial Status for Zofran Odt
Clinical Trial Phase	Trials
Completed	115
Recruiting	17
Terminated	15

Clinical Trial Sponsors for Zofran Odt

Sponsor Name

Sponsor Name for Zofran Odt
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 Odt
Sponsor	Trials
Other	198
Industry	65
NIH	19

Zofran Odt Market Analysis and Financial Projection

Last updated: April 28, 2026

Zofran ODT (ondansetron) clinical trials update, market analysis, and projections

Zofran ODT is the branded, orally disintegrating tablet formulation of ondansetron. The drug’s core clinical package is mature and largely anchored by long-established oncology and emesis indications. Current commercialization is driven by (1) continued demand in established settings (post-operative nausea and vomiting; chemotherapy-induced nausea and vomiting), and (2) formulary persistence versus generics for branded access. Growth is therefore supply-and-access dependent (coverage, interchange policies, contracting), not trial-driven, because no new, breakthrough regulatory expansion is evident from recent public trial releases.

What is Zofran ODT and where does it sit in the clinical and regulatory landscape?

Zofran ODT is an ondansetron ODT dosage form. Ondansetron is a selective 5-HT3 (serotonin) receptor antagonist used to prevent or treat nausea and vomiting associated with:

• Chemotherapy-induced nausea and vomiting (CINV)
• Radiation-induced nausea and vomiting (RINV)
• Post-operative nausea and vomiting (PONV)

The regulatory and clinical foundation for ondansetron is longstanding, and the ODT formulation’s clinical value has historically been convenience and adherence rather than a novel mechanism.

Which clinical trials are active and what is the status directionally?

A comprehensive “current active trials” view requires a live registry pull. With static information, the most accurate statement is scope-limited: Zofran ODT is not currently positioned as a late-stage, mechanism-changing asset based on widely published, trial-defining readouts. The clinical evidence for ondansetron already supports broad emesis control, and ODT versions typically generate incremental evidence focused on usability, pharmacokinetics (bioavailability equivalence), or comparative tolerability in routine practice rather than new indication separations.

Implication for investors and R&D teams: Zofran ODT’s near-term pipeline risk is more about regulatory maintenance, patent/composition longevity, and payer access than about trial outcomes shifting label scope.

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What does the market look like for ondansetron ODT and branded emesis therapy?

Market structure: brand vs generic dominance

Ondansetron is widely generic. That structure shapes the business equation for Zofran ODT:

• Generic entry pressures net price and limits brand prescription share growth.
• Branded ODT advantage concentrates in formulary carve-outs where ODT convenience reduces administration friction (patient preference, swallowing difficulty, outpatient settings).
• Therapeutic interchange policies influence the realized market more than clinical differentiation.

Commercial demand drivers

1) High baseline emesis incidence in chemotherapy pathways and post-operative care keeps demand structurally stable. 2) Outpatient shift (chemo in outpatient infusion centers; ambulatory surgery) supports ODT utility due to ease of dosing without water. 3) Guideline reinforcement for 5-HT3 antagonists in antiemetic regimens maintains baseline prescribing even as combination regimens evolve.

Market sizing approach (projection logic rather than single-point certainty)

With ondansetron generics saturating volume, branded Zofran ODT tends to track:

• total ondansetron-category volume in relevant settings
• brand share under managed care (contracting and step therapy)
• gross-to-net dynamics driven by rebate and acquisition channel

Projection logic used by category forecasters:

• If chemotherapy volumes and ambulatory procedure volume rise, total antiemetic demand rises.
• Brand share typically decays after generic penetration unless payer policies preserve brand ODT.
• Net sales for branded ODT can still grow modestly if (a) ODT-specific coverage improves, or (b) contract terms offset price erosion.

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What are the near-, mid-, and long-term market projections for Zofran ODT?

Base case projection (directional): modest brand share pressure, stable category volume

• Near term (0–2 years): net sales likely flat to low single-digit decline, driven by ongoing generic substitution and rebate pressure, partially offset by ODT convenience in payer-favored use cases.
• Mid term (3–5 years): likely low-to-mid single-digit decline in branded value unless contracts or pharmacy benefit carve-outs materially preserve share.
• Long term (5–10 years): branded ODT value typically trends toward more pronounced share compression in a mature generic market, with any upside tied to formulary persistence, specific patient populations, and contracting strategy.

Bull and bear scenarios (projection range)

• Bull case: payer and provider inertia for ODT in swallowing-compromised and outpatient workflows improves net retention; brand share stabilizes; category volume grows faster than replacement substitution.
• Bear case: increased therapeutic interchange and expanded generic utilization erode ODT brand share; net price declines accelerate.

Because ondansetron already holds broad standard-of-care placement, these scenarios hinge on access mechanics, not label expansion.

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What are the key patent and exclusivity dynamics impacting Zofran ODT?

Zofran ODT’s competitive landscape is dominated by:

• Generic competition for ondansetron tablets and ODT.
• Potential residual exclusivity that can remain only if specific formulation or method-of-use protections exist and remain enforceable in the relevant jurisdictions.

For investment screening, the key is to treat Zofran ODT as a brand-under-general-competition asset: the main question is not whether it has clinical differentiation, but whether legal and formulary leverage sustain net sales.

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What does competitive intensity look like in ondansetron ODT?

Competitive pressure comes from:

• Generic ondansetron ODT equivalents with interchangeable prescribing.
• Formulary substitution between oral tablet and ODT forms depending on patient and setting workflows.
• Alternative antiemetic classes in combination regimens (NK1 antagonists, dopamine antagonists, corticosteroids, and others), which reduce reliance on any single agent even when 5-HT3 antagonists remain common.

The result is a market where branded ODT must defend its niche through contracting and pharmacy-level behavior, not through a distinct mechanism.

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Business impact summary: what should R&D and investment teams do with this profile?

1) Treat Zofran ODT as a cash-flow and contract-defense target, not a trial-led growth engine. 2) In commercial planning, prioritize:

• ODT-specific access retention
• outpatient and dysphagia patient routing
• contracting that reduces interchange 3) In R&D, new clinical studies likely need to be framed around:
• administration convenience metrics
• adherence and patient-reported outcomes
• economic endpoints in real-world workflows rather than novel emesis efficacy.

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Key Takeaways

• Zofran ODT is an established ondansetron formulation where clinical evidence is mature and incremental updates do not typically drive label expansion.
• Market outcomes are primarily governed by generic substitution, payer contracting, and ODT-specific coverage rather than by new trial-defining data.
• Projections for branded performance are modest: flat to low single-digit change near term under typical access erosion; larger value decline mid-to-long term unless ODT formulary retention improves.
• Competitive intensity remains high because ondansetron is broadly generic and used within combination antiemetic regimens.

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FAQs

1) Is Zofran ODT’s growth likely to be driven by new clinical trial results?

No. The drug class has long-established efficacy in standard emesis indications, so branded performance is more sensitive to access and contracting than to trial readouts.

2) What matters most for Zofran ODT revenue?

Net price and brand share under managed care, driven by interchange rules, step edits, rebate structures, and whether payers protect the ODT form.

3) Does ODT convenience still create a defensible niche?

Yes, in practical workflows where dosing without water improves adherence or reduces administration friction, especially outpatient and swallowing-compromised populations.

4) How does combination antiemetic practice affect ondansetron ODT demand?

Combination regimens can reduce reliance on any single agent, but ondansetron remains common in guideline-based therapy, keeping baseline demand structurally supported.

5) What is the biggest competitive risk to Zofran ODT?

Generic ondansetron ODT and broader therapeutic interchange that shifts volume away from branded ODT unless contracts preserve formulary position.

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References (APA)

[1] FDA. (n.d.). Zofran ODT (ondansetron) prescribing information. U.S. Food and Drug Administration.
[2] EMA. (n.d.). Ondansetron: EPAR product information. European Medicines Agency.
[3] ClinicalTrials.gov. (n.d.). Ondansetron ODT studies and related trials. National Library of Medicine.