CLINICAL TRIALS PROFILE FOR ONDANSETRON

505(b)(2) Clinical Trials for ONDANSETRON

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).
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?

All Clinical Trials for ONDANSETRON

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.

Clinical Trial Conditions for ONDANSETRON

Condition Name

Condition Name for ONDANSETRON
Intervention	Trials
Postoperative Nausea and Vomiting	59
Nausea	42
Vomiting	38
Postoperative Pain	32

Condition MeSH

Condition MeSH for ONDANSETRON
Intervention	Trials
Vomiting	210
Nausea	163
Postoperative Nausea and Vomiting	104
Pain, Postoperative	66

Clinical Trial Locations for ONDANSETRON

Trials by Country

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Trials by Country for ONDANSETRON
Location	Trials
United States	551
Canada	90
Egypt	41
Italy	39
United Kingdom	23

Trials by US State

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−

Trials by US State for ONDANSETRON
Location	Trials
Texas	55
New York	37
California	35
North Carolina	27
Illinois	25

Clinical Trial Progress for ONDANSETRON

Clinical Trial Phase

Clinical Trial Phase for ONDANSETRON
Clinical Trial Phase	Trials
Phase 4	164
Phase 3	87
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for ONDANSETRON
Clinical Trial Phase	Trials
Completed	349
Recruiting	78
Unknown status	58

Clinical Trial Sponsors for ONDANSETRON

Sponsor Name

Sponsor Name for ONDANSETRON
Sponsor	Trials
Merck Sharp & Dohme Corp.	30
GlaxoSmithKline	14
M.D. Anderson Cancer Center	13

Sponsor Type

Sponsor Type for ONDANSETRON
Sponsor	Trials
Other	738
Industry	142
NIH	37

Ondansetron: Clinical Trials, Market Analysis, and Projections

Introduction to Ondansetron

Ondansetron, commonly known by its brand name Zofran, is a selective serotonin 5-HT3 receptor antagonist widely used to prevent and treat nausea and vomiting associated with chemotherapy, radiotherapy, and surgery. Here, we will delve into the recent clinical trials, market analysis, and future projections for this crucial medication.

Clinical Trials Update

Efficacy in CINV Management

Recent clinical trials have reaffirmed the efficacy of ondansetron in managing chemotherapy-induced nausea and vomiting (CINV). A comprehensive review of 23 clinical trials, with 13 focusing specifically on the preventive effects of ondansetron on CINV in adult cancer patients, showed significant benefits. These trials, conducted and analyzed as of September 2023, highlighted ondansetron's ability to effectively manage both acute and delayed phases of CINV[1].

Safety Profile

The safety profile of ondansetron has been a critical aspect of its pharmacotherapy. Clinical trials and real-world experience have generally shown that ondansetron is well tolerated, with a low incidence of severe adverse effects. Common side effects include constipation, headache, and transient alterations in liver enzyme levels, which are typically mild[1].

Ongoing Research and Future Directions

Despite the limited number of trials, the collective evidence underscores the critical role of ondansetron in enhancing the quality of life for cancer patients undergoing chemotherapy. There is a pressing need for further research to expand our understanding of its potential applications and to improve treatment protocols and patient outcomes[1].

Market Analysis

Global Market Size and Growth

The global ondansetron market is projected to experience significant growth. As of 2023, the market was valued at USD 1.45 billion and is expected to reach USD 2.35 billion by 2031, growing at a CAGR of 4.8% from 2024 to 2031[5].

Key Drivers of Growth

The growth of the ondansetron market is driven by several factors:

• Increasing Incidence of Cancer: The rising prevalence of cancer globally is a major driver, as ondansetron is widely used to manage CINV associated with chemotherapy and radiotherapy[2][3].
• Expanding Use in Other Settings: The growing use of ondansetron in surgery and post-operative care is another significant factor contributing to market growth[2][3].
• Development of New Formulations: The introduction of new formulations such as long-acting and sublingual tablets is expected to further boost the market[2].

Market Segmentation and Key Players

The global ondansetron market is highly competitive, with key players including Qilu Pharma, CSPC, Fuan Pharma, GSK, and others. The market is segmented into hospital pharmacy and retail pharmacy segments, with the hospital pharmacy segment currently dominating the market[2].

Regional Market Dynamics

North America is the largest market for ondansetron, accounting for over 40% of the global market share. However, the Asia-Pacific region is expected to be the fastest-growing market due to the rising incidence of cancer in this region[2].

Market Projections

Future Growth and Trends

The ondansetron market is expected to grow at a CAGR of 4.0% to 4.8% over the forecast period from 2024 to 2031. Here are some key trends and projections:

• Increasing Use in Combination Therapies: The use of ondansetron in combination with other antiemetic drugs is expected to increase, enhancing its market position[2].
• Emergence of Biosimilars: While the emergence of biosimilars may restrain market growth to some extent, it also presents opportunities for cost-effective alternatives[2].
• Geographical Expansion: Manufacturers are focusing on geographical expansion to maintain and increase their market share, particularly in regions with high cancer incidence rates[2].

Challenges and Restraints

Competition from Generic Manufacturers

The ondansetron market faces significant competition from generic manufacturers, which has led to a decline in prices. This competition is a major restraint on the market growth of branded ondansetron products[2].

Development of New Antiemetic Drugs

The development of new antiemetic drugs could also pose a challenge to the market dominance of ondansetron. However, its established efficacy and safety profile make it a hard competitor to replace[2].

Emerging Trends

New Formulations and Delivery Methods

The development of new formulations such as long-acting and sublingual tablets is an emerging trend. These formulations are designed to enhance patient compliance and efficacy[2].

Increasing Use in Surgical Settings

The growing use of ondansetron in the prevention of nausea and vomiting in patients undergoing surgery is another trend that is expected to drive market growth[2].

Key Takeaways

• Clinical Efficacy: Ondansetron has been consistently shown to be effective in managing CINV in clinical trials.
• Market Growth: The global ondansetron market is projected to grow significantly, driven by the increasing incidence of cancer and expanding use in other medical settings.
• Competitive Landscape: The market is highly competitive with key players focusing on product innovation and geographical expansion.
• Emerging Trends: New formulations and increasing use in surgical settings are key trends expected to drive future growth.

FAQs

What is the primary use of ondansetron?

Ondansetron is primarily used to prevent and treat nausea and vomiting associated with chemotherapy, radiotherapy, and surgery.

How effective is ondansetron in managing CINV?

Clinical trials have shown that ondansetron is highly effective in managing both acute and delayed phases of CINV in adult cancer patients[1].

What are the common side effects of ondansetron?

Common side effects include constipation, headache, and transient alterations in liver enzyme levels, which are typically mild[1].

Which regions are expected to drive the growth of the ondansetron market?

North America is currently the largest market, but the Asia-Pacific region is expected to be the fastest-growing market due to the rising incidence of cancer[2].

What are the emerging trends in the ondansetron market?

Emerging trends include the development of new formulations such as long-acting and sublingual tablets, and the increasing use of ondansetron in surgical settings[2].

Sources

1. Frontiers in Pharmacology: "The preventive effects of ondansetron on chemotherapy-induced nausea and vomiting (CINV): A systematic review of clinical trials."
2. Data Insights Market: "Ondansetron Market Analysis and Forecasts."
3. Grand View Research: "Antiemetics Drugs Market Size & Share Analysis Report 2030."
4. Adial Pharmaceuticals: "Press Release - Adial Pharmaceuticals Announces Positive Topline Results From the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder."
5. Market Research Intellect: "Ondansetron Hydrochloride Market Size and Forecast."