CLINICAL TRIALS PROFILE FOR ZOFRAN

505(b)(2) Clinical Trials for ZOFRAN

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for ZOFRAN

Condition Name

Condition Name for ZOFRAN
Intervention	Trials
Nausea	18
Healthy	16
Vomiting	15
Postoperative Nausea and Vomiting	13

Condition MeSH

Condition MeSH for ZOFRAN
Intervention	Trials
Vomiting	57
Nausea	49
Postoperative Nausea and Vomiting	28
Pain, Postoperative	10

Clinical Trial Locations for ZOFRAN

Trials by Country

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Trials by Country for ZOFRAN
Location	Trials
United States	146
Canada	32
Germany	11
India	9
Italy	7

Trials by US State

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Trials by US State for ZOFRAN
Location	Trials
Texas	27
New York	13
California	12
Florida	8
Virginia	7

Clinical Trial Progress for ZOFRAN

Clinical Trial Phase

Clinical Trial Phase for ZOFRAN
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	14
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for ZOFRAN
Clinical Trial Phase	Trials
Completed	115
Recruiting	15
Terminated	15

Clinical Trial Sponsors for ZOFRAN

Sponsor Name

Sponsor Name for ZOFRAN
Sponsor	Trials
M.D. Anderson Cancer Center	11
Merck Sharp & Dohme Corp.	11
Par Pharmaceutical, Inc.	7

Sponsor Type

Sponsor Type for ZOFRAN
Sponsor	Trials
Other	198
Industry	64
NIH	18

Zofran (Ondansetron): Clinical Trials, Market Analysis, and Projections

Introduction

Zofran, commonly known by its generic name ondansetron, is a widely used antiemetic drug, particularly for managing nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy in Chemotherapy-Induced Nausea and Vomiting (CINV)

Numerous clinical trials have consistently demonstrated the efficacy of ondansetron in managing CINV. A comprehensive review of 23 clinical trials, with 13 focusing exclusively on CINV, highlighted the significant benefits of ondansetron in alleviating both acute and delayed phases of vomiting and nausea triggered by chemotherapy regimens[4].

Safety and Dosage Adjustments

The FDA has been closely monitoring the safety profile of ondansetron, particularly regarding its potential to prolong the QT interval. Following thorough QT studies, the FDA mandated changes to the drug label, recommending lower intravenous doses to mitigate this risk. Specifically, the label now advises against single intravenous doses exceeding 16 mg, with a recommended dose of 0.15 mg/kg administered every 4 hours for three doses[3].

Market Analysis

Global Market Size and Growth

The global antiemetics drugs market, which includes ondansetron, was valued at USD 7.49 billion in 2023 and is expected to grow at a CAGR of 5.98% from 2024 to 2030. The serotonin-receptor antagonists segment, where ondansetron is categorized, accounted for the largest market share of 29.71% in 2023 and is anticipated to witness the fastest growth during the forecast period[2].

Regional Market Dynamics

North America currently dominates the market with a share of 36.52% in 2023, driven by the presence of key players like Pfizer and GSK. However, the Asia Pacific region is expected to grow at a significant CAGR due to rising incidences of cancer and the growing availability of antiemetics medications[2].

Key Drivers and Restraints

The global ondansetron market is driven by the increasing incidence of cancer, the growing use of ondansetron in surgery and post-operative care, and the development of new formulations such as long-acting and sublingual tablets. However, the emergence of biosimilars is anticipated to restrain market growth to some extent[5].

Market Projections

Growth Forecast

The global ondansetron market is projected to reach a value of $2.4 billion by 2030, growing at a CAGR of 4.0% from 2022 to 2030. This growth is largely attributed to the increasing demand for ondansetron in treating nausea and vomiting associated with chemotherapy, radiotherapy, and surgery[5].

Segment Dominance

The hospital pharmacy segment currently holds the largest share of the ondansetron market, accounting for over 50% of the global market share. However, the retail pharmacy segment is expected to grow at a faster rate due to the increasing availability of generic formulations of ondansetron[5].

Competitive Landscape

Key Market Players

The ondansetron market is highly competitive, with several key players including Qilu Pharma, CSPC, Fuan Pharma, GSK, PKU HealthCare, Sino-Pharma, Aosaikang Pharma, Zhongbao Pharma, Wockhardt, Sun Pharma, Aelida Healthcare, Hospira, Drums Healthcare, and SANDOZ. These manufacturers are focusing on product innovation and geographical expansion to maintain their market share[5].

New Developments and Partnerships

Adial Pharmaceuticals and AD04

While ondansetron is well-established, other related drugs like AD04, developed by Adial Pharmaceuticals, are also making significant strides. AD04, which is based on ondansetron, has shown positive topline results in its pharmacokinetics study, paving the way for its Phase 3 trial and potential approval under the 505(b)(2) regulatory pathway. This development could expand the therapeutic applications of ondansetron-like compounds, such as treating alcohol use disorder and other addictive disorders[1].

Key Takeaways

• Clinical Efficacy: Ondansetron has consistently demonstrated efficacy in managing CINV and other forms of nausea and vomiting.
• Safety Adjustments: The FDA has mandated dosage adjustments to mitigate the risk of QT interval prolongation.
• Market Growth: The global ondansetron market is expected to grow significantly, driven by increasing cancer incidence and new formulations.
• Regional Dynamics: North America currently dominates, but the Asia Pacific region is expected to grow rapidly.
• Competitive Landscape: The market is highly competitive with multiple key players focusing on innovation and expansion.

FAQs

What is the primary use of ondansetron?

Ondansetron is primarily used to manage nausea and vomiting associated with chemotherapy, radiation therapy, and surgery.

What are the recent safety concerns related to ondansetron?

Recent safety concerns include the potential for ondansetron to prolong the QT interval, leading to dosage adjustments recommended by the FDA.

How is the global ondansetron market expected to grow?

The global ondansetron market is projected to grow at a CAGR of 4.0% from 2022 to 2030, reaching a value of $2.4 billion by 2030.

Which region is expected to see the fastest growth in the ondansetron market?

The Asia Pacific region is expected to see the fastest growth due to rising cancer incidence and increasing availability of antiemetics medications.

What are the key drivers of the ondansetron market growth?

Key drivers include the increasing incidence of cancer, growing use in surgery and post-operative care, and the development of new formulations.

Sources

1. Adial Pharmaceuticals Announces Positive Topline Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder. Biospace.
2. Antiemetics Drugs Market Size & Share Analysis Report 2030. Grand View Research.
3. New information regarding QT prolongation with ondansetron (Zofran). FDA.
4. The preventive effects of ondansetron on chemotherapy-induced nausea and vomiting. Frontiers in Pharmacology.
5. Ondansetron Market Analysis and Forecasts. Data Insights Market.