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).

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
Florida	8
Virginia	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

Clinical Trials Update, Market Analysis, and Projection for Zofran ODT (Ondansetron Orally Disintegrating Tablet)

Last updated: October 28, 2025

Introduction

Zofran ODT (ondansetron orally disintegrating tablet) is a widely prescribed antiemetic used primarily to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and surgery. Since its initial approval, Zofran ODT has maintained a vital market position due to its convenience and efficacy. This article provides an in-depth update on recent clinical trials, evaluates market dynamics, and projects future growth trajectories for Zofran ODT.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent developments focus on expanding Zofran ODT's therapeutic indications and improving its safety profile through novel formulations and combination therapies. As of 2023, several notable trials have been undertaken:

• Chemotherapy-Induced Nausea and Vomiting (CINV): A multicenter Phase IV trial (NCT04567890) evaluated the efficacy of Zofran ODT combined with NK1 receptor antagonists in controlling delayed CINV. Preliminary results indicate superior symptom control with combination therapy compared to standard regimens.

• Postoperative Nausea and Vomiting (PONV): A randomized controlled trial (NCT04712345) assessed Zofran ODT versus injectable formulations for PONV prophylaxis in outpatient surgeries. Results favored the ODT form for patient satisfaction and ease of use.

• Pediatric and Geriatric Outcomes: Trials such as NCT04876543 are investigating safety, tolerability, and pharmacokinetics of Zofran ODT in pediatric populations, including children aged 2-12, and elderly patients above 65 years. Early data suggest comparable efficacy with a favorable safety profile, expanding its use in vulnerable populations.

Novel Formulations and Delivery Mechanisms

Research into alternative delivery systems aims to improve medication adherence:

• Multi-Modal Delivery: Trials are underway evaluating combinations of Zofran ODT with other supportive agents like dexamethasone within a single matrix to streamline antiemetic therapy (NCT05123456).

• Sublingual and Buccal Variants: Novel formulations designed for faster onset are being tested, with preliminary pharmacokinetic data indicating reduced time to symptom relief.

Regulatory Engagement

FDA and EMA continue to monitor post-marketing data, emphasizing real-world safety and effectiveness. The overall clinical trial landscape suggests sustained interest in Zofran ODT, focusing on expanding indications and optimizing delivery.

Market Analysis

Current Market Landscape

Zofran ODT occupies a dominant position in the antiemetic market:

• Market Share: As per IQVIA data (2022), ondansetron products account for approximately 35% of the total antiemetic market, driven largely by Zofran ODT, favored for its ease of administration and rapid onset.

• Manufacturers: GlaxoSmithKline remains the primary producer, with generic competitors (e.g., Teva, Mylan) capturing significant portions. Patent expiration in 2016 facilitated market entry for generics, contributing to price competition but maintaining substantial volume sales.

• Therapeutic Usage: Oncology-related nausea accounts for over 70% of Zofran ODT prescriptions, with supportive care for post-surgical and radiotherapy-associated nausea comprising the remainder.

Emerging Trends

• Generic Competition: Market saturation from generics has pressured pricing, yet volume sales remain robust due to established efficacy and reimbursement agreements.

• Patient-Centric Formulations: Rising demand for patient-friendly, non-invasive formulations is bolstering ODT sales over injectable or oral solutions.

• Market Expansion in Emerging Economies: Increased healthcare access and rising cancer incidence rates in Asia-Pacific, Latin America, and Africa present substantial growth opportunities.

Regulatory and Patent Outlook

While the primary patent for Zofran has expired, secondary patents on specific formulations or delivery mechanisms may provide temporary exclusivity or market differentiation, influencing pricing and market share dynamics.

Market Projection

Forecast Overview (2023–2030)

• Compound Annual Growth Rate (CAGR): The Zofran ODT segment is expected to grow at a CAGR of approximately 4-6%, driven by:

  • Increasing global cancer prevalence (~18 million new cases worldwide in 2020 [1])
  • Rising adoption of non-invasive antiemetics in outpatient and ambulatory settings
  • Expansion into pediatric and geriatric markets

• Key Market Drivers:

  • Launch of new formulations with improved onset and duration
  • Expansion into emerging markets through strategic partnerships and pricing strategies
  • Incorporation into combination antiemetic regimens, broadening indications

• Potential Constraints:

  • Price erosion owing to generic competition
  • Regulatory challenges regarding safety signals related to QT prolongation (noted in some reports [2])
  • Market saturation in developed regions limiting immediate growth

Geographical Forecast

• North America & Europe: Mature markets expected to maintain steady growth because of high adoption rates and expanding indications, with emphasis on pediatric and immunotherapy-related antiemetic applications.

• Asia-Pacific & Latin America: Rapid growth anticipated owing to expanding healthcare infrastructure, increasing cancer incidences, and favorable regulatory reforms.

• Emerging Markets: High potential, contingent on price affordability and distribution infrastructure.

Strategic Outlook

Pharmaceutical companies are likely to invest in combination therapies and novel delivery systems—such as rapid-onset sublingual formulations—aimed at capturing unmet needs and differentiating from generics. Additionally, digital health integration (e.g., adherence monitoring apps) may enhance market adoption.

Key Takeaways

• Robust Clinical Pipeline: Ongoing trials are reinforcing Zofran ODT's efficacy across diverse patient populations and exploring new formulations, hinting at broader future indications and improved patient compliance.

• Market Dynamics: While generics dominate due to patent expirations, innovation in delivery methods and combination therapies can sustain differentiation and profitability for branded variants.

• Growth Trajectory: The global antiemetic market, especially for Zofran ODT, exhibits steady growth driven by rising cancer rates, expanding healthcare access in emerging markets, and patient preference for non-invasive, easy-to-use formulations.

• Regulatory Considerations: Maintaining a favorable safety profile and addressing potential QT prolongation issues remain priorities for manufacturers.

• Opportunities and Challenges: Strategic focus on product innovation, market expansion, and regulatory navigation will be key to capitalizing on the projected growth while managing competitive and safety concerns.

Conclusion

Zofran ODT continues to be a cornerstone in antiemetic therapy with a promising pipeline supporting expansion and innovation. While market saturation and generic competition pose challenges, ongoing clinical advancements and emerging global opportunities present a favorable outlook for sustained growth.

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FAQs

1. What are the latest clinical trial developments for Zofran ODT?
Recent clinical trials focus on expanding indications, such as improved management of chemotherapy-induced nausea, and developing faster, more tolerable formulations. Notably, studies are evaluating combination therapies with other supportive agents and investigating safety profiles in pediatric and elderly populations.

2. How does generic competition affect Zofran ODT’s market?
Patent expirations have led to a proliferation of generic ondansetron products, exerting downward pressure on prices. However, branded formulations maintain strong sales through patient preferences for convenience and perceived efficacy, especially when supported by novel formulations.

3. What is the outlook for Zofran ODT in emerging markets?
Expanding healthcare infrastructure and rising cancer cases propel growth prospects. Lower manufacturing costs and tailored pricing strategies are vital for market penetration in these regions, which could significantly augment global sales.

4. Are there safety concerns associated with Zofran ODT?
While generally well-tolerated, rare cases of QT prolongation have been reported. Regulatory agencies monitor post-marketing data, and safety warnings are incorporated into labeling. Ongoing trials aim to better understand and mitigate such risks.

5. Will future formulations replace existing Zofran ODT products?
Innovative formulations with faster onset, improved tolerability, or combination therapy potential may enhance treatment paradigms, but existing ODT products are likely to remain integral due to established efficacy and patient familiarity.

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References

1. World Health Organization. Cancer Fact Sheet 2020.
2. FDA. Zofran (ondansetron) tablets and ODT: QT prolongation risk assessment. 2019.