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.

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
Nausea	4
Vomiting	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
Arizona	1
Alabama	1
Tennessee	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
University of Southern California	1

Sponsor Type

Sponsor Type for dolasetron mesylate
Sponsor	Trials
Other	5
NIH	3

Dolasetron Mesylate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 11, 2026

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What is Dolasetron Mesylate and How is it Used?

Dolasetron mesylate is a serotonin 3 (5-HT3) receptor antagonist originally developed for preventing nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. The drug is marketed under brand names like Anzemet. Its mechanism involves blocking serotonin receptors in the central nervous system and gastrointestinal tract, reducing nausea symptoms.

What Is the Current Status of Clinical Trials?

Dolasetron mesylate's clinical development has faced significant setbacks, primarily related to safety concerns and regulatory decisions. Anzemet was approved by the FDA in 1991 for chemotherapy-induced nausea and vomiting (CINV) but was withdrawn from the U.S. market in 2013.

Key developments:

• FDA Withdrawal (2013): The manufacturer, Duramed Pharmaceuticals, withdrew Anzemet after post-marketing studies linked it to increased cardiac risks, especially QT prolongation and arrhythmias.

• Ongoing Research: Limited active clinical trials exist focused on dolasetron or its derivatives. Investigations into newer formulations or alternative indications are scarce, with most research halted or redirected toward other 5-HT3 antagonists like ondansetron.

• Recent Trials: A search in clinical trial registries reveals minimal recent activity. One trial from 2014 explored dolasetron for postoperative nausea but was terminated early, citing safety concerns.

How Does Dolasetron Mesylate’s Clinical Profile Compare with Similar Drugs?

The main competitors include ondansetron, granisetron, palonosetron, and tropisetron. These drugs share identical therapeutic targets but differ in pharmacokinetics and safety profiles.

Attribute	Dolasetron Mesylate	Ondansetron	Granisetron	Palonosetron
Marketed	Yes (until 2013 in US)	Yes	Yes	Yes
Approved for	CINV	CINV, nausea	CINV	CINV
Half-life	2-4 hours	3-6 hours	4-9 hours	40 hours
Cardiac risk	Elevated	Low	Low	Very low

Dolasetron's cardiac safety issues largely restrict its clinical utility relative to these alternatives.

What Is the Market Size and Growth for 5-HT3 Receptor Antagonists?

The global antiemetics market, driven mainly by oncology, surgical, and radiotherapy indications, is projected to reach approximately $2.2 billion by 2027, expanding at a compound annual growth rate (CAGR) of 4.5% (Research and Markets, 2022).

Key factors influencing growth:

• Increase in cancer incidence globally.
• Rising awareness and diagnosis of chemotherapy-induced nausea.
• Development of long-acting formulations and combination therapies.

Market share distribution:

Ondansetron dominates with over 60% of the market volume, attributable to its established safety profile and extensive generic options. Other drugs occupy residual market shares.

Will Dolasetron Mesylate Return to the Market?

Regulatory agencies have not indicated plans to reintroduce dolasetron, citing safety concerns. Its early withdrawal limits facing future approval unless safety issues are comprehensively addressed.

Potential for reformulation or derivatives exists but is unconfirmed. Companies might evaluate, but the clinical evidence and regulatory barriers remain significant hurdles.

What Are the Market Opportunities and Risks?

Opportunities:

• Development of safer, longer-acting 5-HT3 antagonists.
• Specific niches in combination therapies with targeted anti-nausea drugs.
• Application in non-oncology indications such as postoperative nausea in high-risk populations.

Risks:

• Entrenched competition from established drugs with superior safety profiles.
• Regulatory risks given historical safety concerns.
• Market reluctance due to previous withdrawal and perception issues.

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Key Takeaways

• Clinical viability: No active, recent clinical trials suggest ongoing development or interest.
• Regulatory status: Withdrawn from the US market in 2013 due to safety concerns; unlikely to return without significant reformulation.
• Market position: Dominated by ondansetron and other newer 5-HT3 antagonists with favorable safety profiles.
• Market growth: The antiemetics market continues to grow, but new entrants must navigate high safety and efficacy standards.
• Future prospects: Limited unless a novel formulation addresses safety issues or new indications emerge.

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FAQs

1. Why was dolasetron mesylate withdrawn from the U.S. market?
It was withdrawn due to safety concerns, specifically cardiac risks like QT prolongation and arrhythmias.

2. Are there any ongoing clinical trials for dolasetron?
Few, if any, active trials exist. Most research was discontinued following safety issues.

3. Can dolasetron be used for indications outside CINV?
Current data do not support use outside established indications, and safety issues restrict exploration.

4. How does dolasetron compare to newer antiemetics?
It has a shorter half-life and higher cardiac risk profile compared to drugs like ondansetron and palonosetron, limiting its clinical utility.

5. What is the outlook for developing new drugs based on dolasetron’s mechanism?
Potential exists if safety concerns are addressed, but regulatory hurdles and market competition favor newer drugs.

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References

[1] Research and Markets. "Global Anti-Emetics Market Forecast 2022-2027."
[2] FDA. "Anzemet (dolasetron) Oral and Intravenous Drug Label." 2013.
[3] ClinicalTrials.gov. "Search results for dolasetron." Accessed 2023.
[4] IQVIA. "Pharmaceutical Market Data." 2022.