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Palonosetron

Generic Name
Palonosetron
Brand Names
Akynzeo, Aloxi, Palonosetron Accord
Drug Type
Small Molecule
Chemical Formula
C19H24N2O
CAS Number
135729-56-5
Unique Ingredient Identifier
5D06587D6R
Background

Palonosetron (INN, trade name Aloxi) is an antagonist of 5-HT3 receptors that is indicated for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is the most effective of the 5-HT3 antagonists in controlling delayed CINV nausea and vomiting that appear more than 24 hours after the first dose of a course of chemotherapy and is the only drug of its class approved for this use by the U.S. Food and Drug Administration. As of 2008, it is the most recent 5-HT3 antagonist to enter clinical use.

Indication

For the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, as well as prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy. Also used for the prevention of postoperative nausea and vomiting for up to 24 hours post operation.

Associated Conditions
Nausea caused by Chemotherapy, Post Operative Nausea and Vomiting (PONV), Acute chemotherapy-induced nausea and vomiting, Delayed chemotherapy-induced nausea and vomiting

HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

Phase 3
Not yet recruiting
Conditions
Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
Interventions
First Posted Date
2024-08-15
Last Posted Date
2024-08-15
Lead Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Target Recruit Count
700
Registration Number
NCT06554184
Locations
🇨🇳

Sun Yat-sen University Cancer Center Yuexiu Campus, Guangzhou, Guangdong, China

A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery

Phase 4
Recruiting
Conditions
Postoperative Nausea and Vomiting
Scoliosis
Interventions
First Posted Date
2024-08-06
Last Posted Date
2025-04-25
Lead Sponsor
University of Malaya
Target Recruit Count
74
Registration Number
NCT06540885
Locations
🇲🇾

University Malaya Medical Centre, Kuala Lumpur, Malaysia

🇲🇾

University Malaya, Pantai Valley, Kuala Lumpur, Malaysia

Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

Phase 4
Completed
Conditions
Idiopathic Scoliosis
Postoperative Nausea and Vomiting
Interventions
First Posted Date
2023-07-24
Last Posted Date
2024-12-10
Lead Sponsor
University of Malaya
Target Recruit Count
92
Registration Number
NCT05956899
Locations
🇲🇾

University Malaya, Pantai Valley, Kuala Lumpur, Malaysia

Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of CINV in Breast Cancer

Phase 4
Not yet recruiting
Conditions
Chemotherapy-induced Nausea and Vomiting
Breast Cancer
Interventions
First Posted Date
2023-05-03
Last Posted Date
2023-05-03
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
1028
Registration Number
NCT05841849
Locations
🇨🇳

the Second Affiliated Hospital of Zhejiang Univercity School of Medicine, Hanzhou, Zhejiang, China

The Safety and Effectiveness of Palonosetron Hydrochloride Capsule Was Used to CINV

Not Applicable
Recruiting
Conditions
Nausea and Vomiting
Interventions
First Posted Date
2023-01-19
Last Posted Date
2023-01-19
Lead Sponsor
Xijing Hospital
Target Recruit Count
1060
Registration Number
NCT05690802
Locations
🇨🇳

The First Affiliated Hospital, the Air Force Medical University, Xi'an, Shaanxi, China

Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care

Phase 2
Completed
Conditions
Nausea
Vomiting
Pain
Advanced Cancer
Interventions
First Posted Date
2022-04-07
Last Posted Date
2025-03-19
Lead Sponsor
Gerhild Becker
Target Recruit Count
30
Registration Number
NCT05315999
Locations
🇩🇪

Clinic for Palliative Care, Medical Center, University of Freiburg, Freiburg, Germany

Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC

Phase 3
Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
Drug: IV Palonosetron 0.25 mg
First Posted Date
2022-01-20
Last Posted Date
2023-01-20
Lead Sponsor
Xiamen LP Pharmaceutical Co., Ltd
Target Recruit Count
328
Registration Number
NCT05199818
Locations
🇺🇸

Orchard Healthcare research, Inc., Skokie, Illinois, United States

🇺🇸

Pacific Cancer Medical Center, Anaheim, California, United States

🇺🇸

Tri-County Hematology & Oncology Associates, Massillon, Ohio, United States

and more 10 locations

Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

Phase 3
Conditions
Chemotherapy-induced Nausea and Vomiting (CINV)
Interventions
First Posted Date
2021-06-03
Last Posted Date
2021-06-03
Lead Sponsor
Fudan University
Target Recruit Count
140
Registration Number
NCT04912271

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting

First Posted Date
2020-10-19
Last Posted Date
2025-03-24
Lead Sponsor
Xiamen LP Pharmaceutical Co., Ltd
Target Recruit Count
22
Registration Number
NCT04592198
Locations
🇺🇸

Pacific Cancer Medical Center, Inc., Anaheim, California, United States

🇺🇸

Ocala Oncology Center PL DBA Florida Cancer Affiliates, Ocala, Florida, United States

🇺🇸

Edward H. Kaplan MD & Associates, Skokie, Illinois, United States

and more 4 locations

Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)

Phase 4
Completed
Conditions
Chemotherapy-induced Nausea and Vomiting, Prophylaxis
Interventions
First Posted Date
2020-10-14
Last Posted Date
2021-08-04
Lead Sponsor
Yung Shin Pharm. Ind. Co., Ltd.
Target Recruit Count
16
Registration Number
NCT04585412
Locations
🇨🇳

Taichung Veterans General Hospital, Taichung, Taiwan

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