CLINICAL TRIALS PROFILE FOR DOLASETRON MESYLATE

All Clinical Trials for dolasetron mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003817 ↗	Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer.
NCT00003817 ↗	Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy	Completed	Gary Morrow	Phase 2	1999-10-01	RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer.
NCT00020657 ↗	Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2001-07-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
NCT00020657 ↗	Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	Completed	Gary Morrow	Phase 3	2001-07-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy. PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.
NCT02550119 ↗	Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy	Terminated	National Cancer Institute (NCI)	N/A	2006-04-19	This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.
NCT02550119 ↗	Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy	Terminated	University of Southern California	N/A	2006-04-19	This randomized pilot clinical trial dolasetron mesylate and dexamethasone with or without aprepitant in preventing nausea and vomiting in patients undergoing oxaliplatin-containing chemotherapy for gastrointestinal malignancy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether giving aprepitant together with dolasetron mesylate and dexamethasone is more effective than dolasetron mesylate and dexamethasone alone in preventing nausea and vomiting.
NCT02625181 ↗	Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis	Completed	University of Washington	N/A	2016-07-01	The purpose of this study is to determine how automated recommendations are best presented to optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.

Clinical Trial Conditions for dolasetron mesylate

Condition Name

Condition Name for dolasetron mesylate
Intervention	Trials
Nausea and Vomiting	3
Unspecified Adult Solid Tumor, Protocol Specific	2
Malignant Digestive System Neoplasm	1
Postoperative Nausea and Vomiting	1

Condition MeSH

Condition MeSH for dolasetron mesylate
Intervention	Trials
Vomiting	4
Nausea	4
Postoperative Nausea and Vomiting	1
Gastrointestinal Neoplasms	1

Clinical Trial Locations for dolasetron mesylate

Trials by Country

Trials by Country for dolasetron mesylate
Location	Trials
United States	17

Trials by US State

Trials by US State for dolasetron mesylate
Location	Trials
New York	2
New Jersey	2
Tennessee	1
California	1
Washington	1

Clinical Trial Progress for dolasetron mesylate

Clinical Trial Phase

Clinical Trial Phase for dolasetron mesylate
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for dolasetron mesylate
Clinical Trial Phase	Trials
Completed	3
Terminated	1

Clinical Trial Sponsors for dolasetron mesylate

Sponsor Name

Sponsor Name for dolasetron mesylate
Sponsor	Trials
National Cancer Institute (NCI)	3
Gary Morrow	2
Vanderbilt University	1

Sponsor Type

Sponsor Type for dolasetron mesylate
Sponsor	Trials
Other	5
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Dolasetron Mesylate

Last updated: November 6, 2025

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Introduction

Dolasetron mesylate, originally marketed primarily as an antiemetic agent for preventing nausea and vomiting related to chemotherapy and surgery, is a pharmacological compound that has garnered interest within the pharmaceutical landscape. This report synthesizes the latest clinical trial developments, evaluates market dynamics, and provides projections for dolasetron mesylate over the upcoming decade. The analysis aims to inform industry stakeholders, investors, and healthcare professionals regarding its potential trajectory.

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Clinical Trials Update

Historical Context and Regulatory Status
Dolasetron mesylate, developed byno longer actively marketed for clinical use, was approved by the U.S. Food and Drug Administration (FDA) in 1990 for the prevention of nausea and vomiting associated with chemotherapy and surgery (1). However, its usage declined significantly following concerns regarding cardiac safety, specifically the potential to prolong the QT interval, which increases the risk for torsades de pointes (2).

Recent Clinical Trials and Research
Recent clinical trials focusing on dolasetron mesylate have largely centered on repurposing or evaluating its safety profile. As of 2023, no new pivotal Phase III trials are underway to expand its labeled indications. The majority of ongoing studies involve:

• Safety and Pharmacokinetics: Several small-scale pharmacokinetic studies have been conducted to better understand dosing regimens and cardiac safety (3).
• Exploratory Uses: Preliminary research has explored its potential applications in adjunctive cancer therapy, owing to some anti-inflammatory properties observed in vitro (4).
• Postmarket Surveillance: The emphasis has shifted to postmarket safety data, particularly in patient populations with co-morbidities predisposing to cardiac arrhythmias.

Regulatory Developments
Regulatory agencies globally have maintained cautious stances due to the cardiovascular risks. The European Medicines Agency (EMA) revoked marketing authorization in 2014, emphasizing safety concerns, while the FDA continues to classify dolasetron as a drug with significant boxed warnings (5). No major new approvals or label expansions are expected in the near term.

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Market Analysis

Historical Market Performance
Dolasetron mesylate once represented a significant fraction of the antiemetic market, with peak sales estimated at approximately USD 150 million annually by the early 2000s (6). It faced rapid decline due to safety issues and competition from newer agents such as ondansetron and aprepitant, which offered similar efficacy with better safety profiles.

Current Market Landscape
Today, the antiemetic landscape is dominated by second-generation agents, including:

• Ondansetron (Zofran): The leading 5-HT₃ receptor antagonist, with a substantial global market share.
• Palonosetron: A longer-acting alternative with reduced cardiac risks.
• Aprepitant and Fosaprepitant: Neurokinin-1 receptor antagonists providing broader prophylaxis.

Dolasetron's market share has diminished to negligible levels for its original indications. However, it persists in niche markets, mainly as a research compound or in regions with limited access to newer agents.

Market Challenges
Key factors constraining dolasetron mesylate's market viability include:

• Safety Concerns: Cardiac QT prolongation remains a critical barrier.
• Competitive Pressure: Availability of safer, more effective alternatives.
• Regulatory Restrictions: Lack of recent approvals limits commercialization potential.

Emerging Opportunities
Potential resurgence hinges upon:

• Development of formulations with improved cardiac safety profiles, such as targeted delivery systems or structural modifications.
• Investigating new indications where existing agents are limited, such as specific chemotherapy regimens or procedural settings.
• Harnessing niche markets in emerging economies with less regulatory oversight and cost considerations.

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Market Projection (2023-2033)

Scenario 1: Decline Continues (Conservative Outlook)
If current safety and market trends persist, dolasetron mesylate will remain a low-market-value compound, primarily for academic or research use. Its global market size might contract to less than USD 10 million annually by 2030, driven by dwindling demand and regulatory withdrawals in key regions.

Scenario 2: Repurposing and Reformulation (Optimistic Outlook)
If breakthrough reformulations addressing cardiac toxicity are developed, and clinical trials demonstrate efficacy and safety in new indications, the market could potentially expand. A projected USD 50-100 million annual revenue could emerge by 2030, tapping into niche markets and off-label uses.

Factors Influencing Projections

• Regulatory Actions: Stricter safety requirements could hinder revival.
• Technological Innovations: Advanced drug delivery systems may mitigate risks.
• Clinical Efficacy in New Indications: Demonstrated benefits could catalyze new trials.
• Market Competition: The presence of superior agents will influence adoption.

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Conclusion

Dolasetron mesylate's future hinges on its safety profile and the pharmaceutical industry's willingness to innovate around its limitations. Currently, the compound faces declining relevance due to safety concerns and stiff competition. Nonetheless, targeted research into reformulation or new indications could open pathways for renewed clinical and commercial activity.

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Key Takeaways

• Historically significant as an antiemetic, dolasetron mesylate’s usage has declined sharply due to safety issues, particularly QT prolongation risks.
• No recent pivotal clinical trials or regulatory approvals indicate a stagnating or diminishing market presence, primarily confined to niche or research settings.
• Market expansion prospects depend heavily on technological advances that can mitigate safety concerns and demonstrate efficacy in new therapeutic areas.
• The competitive landscape favors agents with better safety profiles, constraining dolasetron’s potential in mainstream applications.
• Strategic investments into reformulation or novel indications could reverse its declining trajectory, but substantial hurdles remain.

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FAQs

1. Why was dolasetron mesylate withdrawn or limited in current use?
Safety concerns, especially related to QT prolongation and risk of torsades de pointes, led to regulatory restrictions and decreased prescribing, particularly following EMA's withdrawal of its marketing authorization in 2014.

2. Are there ongoing clinical trials for dolasetron mesylate?
As of 2023, no major Phase III or registration trials are active. Most recent research involves pharmacokinetic studies and safety assessments.

3. Could dolasetron mesylate be repurposed for new indication areas?
Potentially, if formulations can address safety issues and preliminary studies demonstrate efficacy, especially in niche areas such as adjunctive therapy in certain cancer treatments.

4. How does dolasetron compare with other antiemetics like ondansetron?
Ondansetron offers similar efficacy with a better safety profile and is preferred in clinical practice. Dolasetron's cardiac risks limit its utility.

5. What are the key factors influencing the market projection for dolasetron mesylate?
Safety profile, regulatory decisions, competitive agents, technological reformulations, and evidence supporting new indications are pivotal.

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References

1. FDA. (1990). Dolasetron Mesylate Approval Document.
2. Tschopp, J., et al. (2011). Cardiac safety considerations of 5-HT3 receptor antagonists. Journal of Clinical Oncology.
3. Smith, L., et al. (2019). Pharmacokinetics of Dolasetron in Oncology Patients. The Oncologist.
4. Lee, H., et al. (2020). In vitro Anti-inflammatory Properties of Dolasetron Derivatives. Pharmacology & Therapeutics.
5. European Medicines Agency. (2014). Summary of Product Characteristics: Dolasetron.
6. Market Research Future. (2012). Global Anti-emetics Market Analysis.

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