Palonosetron

Generic Name: Palonosetron

Brand Names: Akynzeo, Aloxi, Palonosetron Accord

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₄N_₂O

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

Clinical Trials

PALONOSETRON X FOSAPREPITANT IN PONV

Phase 4

Conditions: Nausea and Vomiting, Postoperative

Interventions: Drug: Palonosetron
Drug: Fosaprepitant

First Posted Date: 2018-07-16

Last Posted Date: 2019-03-12

Lead Sponsor: Hospital Federal de Bonsucesso

Target Recruit Count: 100

Registration Number: NCT03586817

Locations: 🇧🇷
Hospital Federal de Bonsucesso, Rio de Janeiro, Brazil

Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy

Phase 3

Completed

Conditions: Malignant Neoplasm

Interventions: Drug: Palonosetron Hydrochloride
Drug: Ondansetron Hydrochloride
Drug: Dexamethasone
Drug: Fosaprepitant Dimeglumine
Other: Placebo
Drug: Olanzapine

First Posted Date: 2018-07-05

Last Posted Date: 2025-04-06

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 690

Registration Number: NCT03578081

Locations: 🇺🇸
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
🇺🇸
Hurley Medical Center, Flint, Michigan, United States
🇺🇸
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

and more 562 locations

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

Phase 3

Completed

Conditions: Chemotherapy-induced Nausea and Vomiting

Interventions: Drug: netupitant/palonosetron
Drug: fosnetupitant/ palonosetron
Drug: dexamethasone

First Posted Date: 2018-01-19

Last Posted Date: 2020-06-01

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 404

Registration Number: NCT03403712

Locations: 🇺🇸
CBCC Global Research, INC at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
🇺🇸
Mercy Medical Center, Medical Oncology and Hematology, Baltimore, Maryland, United States

and more 37 locations

PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting

Phase 2

Completed

Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)

Interventions: Drug: Netupitant
Drug: Palonosetron

First Posted Date: 2017-07-02

Last Posted Date: 2024-06-25

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 67

Registration Number: NCT03204279

Locations: 🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇷🇺
Chelyabinsk Regional Children's Clinical Hospital, Chelyabinsk, Russian Federation
🇺🇦
National Institute of Cancer, Research Department of Pediatric Oncology, Kyiv, Ukraine

and more 14 locations