CLINICAL TRIALS PROFILE FOR ONDANSETRON HYDROCHLORIDE

505(b)(2) Clinical Trials for ondansetron hydrochloride

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	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?
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 ondansetron hydrochloride

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.

Clinical Trial Conditions for ondansetron hydrochloride

Condition Name

Condition Name for ondansetron hydrochloride
Intervention	Trials
Postoperative Nausea and Vomiting	59
Nausea	42
Vomiting	38

Condition MeSH

Condition MeSH for ondansetron hydrochloride
Intervention	Trials
Vomiting	210
Nausea	163
Postoperative Nausea and Vomiting	104

Clinical Trial Locations for ondansetron hydrochloride

Trials by Country

Trials by Country for ondansetron hydrochloride
Location	Trials
United States	551
Canada	90
Egypt	41
Italy	39
Germany	23

Trials by US State

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

Clinical Trial Progress for ondansetron hydrochloride

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ondansetron hydrochloride

Sponsor Name

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

Sponsor Type

Sponsor Type for ondansetron hydrochloride
Sponsor	Trials
Other	738
Industry	142
NIH	37

Ondansetron hydrochloride Market Analysis and Financial Projection

Ondansetron Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Ondansetron Hydrochloride

Ondansetron hydrochloride is a potent antiemetic drug, primarily used to prevent nausea and vomiting induced by chemotherapy, radiation therapy, and surgery. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Mechanism of Action

Ondansetron hydrochloride is a 5-HT3 receptor antagonist, meaning it inhibits the action of serotonin at the 5-HT3 receptors, which are found in the central and peripheral nervous system. This inhibition is crucial in preventing the vomiting reflex[1].

Clinical Trials Update

Efficacy in Chemotherapy-Induced Nausea and Vomiting (CINV)

Clinical trials have consistently shown that ondansetron hydrochloride is highly effective in preventing CINV. In a double-blind trial, ondansetron injection at a dose of 0.15 mg/kg, given three times during chemotherapy, was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin-based chemotherapy[4].

Comparison with Metoclopramide

A phase III clinical trial is currently underway to compare the efficacy and safety of ondansetron with metoclopramide in managing nausea and vomiting in adult patients with acute gastroenteritis. This randomized, open-label, active-controlled trial will enroll 126 patients and will assess the efficacy of ondansetron 8 mg IV/IM injection versus metoclopramide 10 mg[5].

Other Clinical Applications

Ondansetron hydrochloride is also being evaluated in various other clinical settings. For instance, it is used to manage post-operative nausea and vomiting (PONV) and nausea associated with other medical conditions such as migraine and gastroenteritis. Clinical studies have supported its efficacy in these areas, making it a versatile antiemetic agent[2].

Market Analysis

Market Size and Forecast

The ondansetron hydrochloride market is projected to grow significantly. As of 2023, the market size was valued at USD 755.73 million and is expected to reach USD 1,229.64 million by 2031, growing at a CAGR of 6.26% from 2024 to 2031[2].

Geographic Segmentation

The global ondansetron hydrochloride market is segmented geographically into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. North America accounted for the largest market share in 2023, with a market value of USD 370.47 million, and is projected to grow at a CAGR of 5.95%. The Asia-Pacific region is the second-largest market and is expected to grow at a CAGR of 6.75% during the forecast period[2].

End-Use Segmentation

The market is also segmented by end-use into human and veterinary applications. The human segment accounted for the largest market share of 67.30% in 2023, valued at USD 508.58 million, and is projected to grow at a CAGR of 5.86%. The veterinary segment, valued at USD 247.16 million in 2023, is expected to grow at the highest CAGR of 7.06% during the forecast period[2].

Key Drivers and Restraints

Drivers

• Increasing Prevalence of CINV and PONV: The rising incidence of chemotherapy-induced and post-operative nausea and vomiting is a major driver for the ondansetron hydrochloride market. These conditions are debilitating and necessitate effective antiemetic treatment[2].
• Healthcare Awareness and Infrastructure: Improving healthcare infrastructure and awareness programs, especially in emerging markets, have increased the use of ondansetron hydrochloride. This trend is expected to continue, driving market growth[3].

Restraints

• Competition from Generic Alternatives: The presence of generic alternatives can pose a challenge to the branded ondansetron hydrochloride market. However, the efficacy and brand loyalty of ondansetron hydrochloride help it maintain a significant market share[3].

Strategic Opportunities

Emerging Markets

Companies can capitalize on the growing demand in emerging markets where healthcare infrastructure is improving, and awareness about cancer treatment is increasing. Strategic collaborations, product launches, and expansion into untapped markets are potential strategies for growth[3].

Product Diversification

Diversifying product offerings to include different formulations and delivery methods can help companies capture a broader market share. For example, ondansetron hydrochloride is available in various forms, including oral tablets, oral solution, and injectable solutions[1].

Key Players

The ondansetron hydrochloride market includes several key players such as LG Chem, Ltd., Eastman Chemical Company, Dow Chemical Company, SABIC, and Mitsubishi Chemical Corporation, among others. These companies are involved in various strategies such as product launches, collaborations, and market expansion to maintain their market position[3].

Conclusion

Ondansetron hydrochloride remains a crucial drug in the management of nausea and vomiting associated with various medical conditions. With its proven efficacy in clinical trials and growing market demand, it is poised for significant growth in the coming years.

Key Takeaways

• Clinical Efficacy: Ondansetron hydrochloride is highly effective in preventing CINV and PONV.
• Market Growth: The market is projected to grow from USD 755.73 million in 2023 to USD 1,229.64 million by 2031.
• Geographic Segmentation: North America and Asia-Pacific are the largest markets.
• End-Use Segmentation: Human segment dominates the market, but veterinary segment is growing rapidly.
• Strategic Opportunities: Emerging markets and product diversification offer significant growth potential.

FAQs

What is the primary mechanism of action of ondansetron hydrochloride?

Ondansetron hydrochloride works by blocking the action of serotonin at the 5-HT3 receptors, thereby preventing nausea and vomiting.

What are the main indications for ondansetron hydrochloride?

The main indications include chemotherapy-induced nausea and vomiting (CINV), post-operative nausea and vomiting (PONV), and nausea associated with other medical conditions like migraine and gastroenteritis.

What is the projected market size of ondansetron hydrochloride by 2031?

The market is projected to reach USD 1,229.64 million by 2031, growing at a CAGR of 6.26% from 2024 to 2031.

Which regions are the largest markets for ondansetron hydrochloride?

North America and Asia-Pacific are the largest markets, with North America accounting for the largest share in 2023.

What are the key drivers for the ondansetron hydrochloride market?

The increasing prevalence of CINV and PONV, and improving healthcare infrastructure and awareness, are major drivers for the market.

Sources

1. Synapse: Ondansetron Hydrochloride - Drug Targets, Indications, Patents.
2. Verified Market Research: Ondansetron Hydrochloride (HMB) Market Size, Forecast.
3. OpenPR: Ondansetron Hcl Market Global Demand, Growth, Size, Share.
4. Pfizer Medical Information: Ondansetron Injection, USP - VIAL Clinical Studies - US.
5. Veeva Systems: Clinical Trial to Investigate the Efficacy and Safety of Ondansetron compared to Metoclopramide.